Lawsuit: Denture Cream Caused Illness

From the Denver Post:

Doctors and specialists spent two years testing Rae Ann Schmaltz, initially believing she had multiple sclerosis but later looking for anything, including tropical diseases and Lou Gehrig's disease. She endured endless poking and prodding, including 160 blood tests, urine tests, MRIs, even spinal taps. All were negative.

And then, prodded by Schmaltz's 19-year-old daughter, they looked in her mouth.

Doctors now believe Schmaltz suffers from a copper deficiency caused by an abundance of zinc found in the Poligrip she used to secure her dentures.

For more, go here.

Federal Rules of Civ. Pro.: Computation of Time/Date Changes on 12/9/09

From the Judicial Conference Report:

“The principal simplifying change in the amended time-computation rules is the adoption of a “days-are-days” approach to computing all time periods. Under some of the current rules, intermediate weekends and holidays are omitted when computing short periods but included when computing longer periods. By contrast, under the proposed rules amendments, intermediate weekends and holidays are counted regardless of the length of the specified period. Other changes in the amended time-computation rules clarify how to count forward when the period measured is after an event (for example, 21 days after service of a motion) and the deadline falls on a weekend or holiday; and how to count backward when the period measured is before an event (for example, 14 days before a scheduled hearing) and the deadline falls on a weekend or holiday. The proposed amendments also provide for computing hourly time periods, to address recent legislation affecting court proceedings in which deadlines are expressed in hours (for example, 72 hours for action)."

Here is a list:

* The one-day period in Rule 6(c)(2) becomes seven days. The adjustment would extend the time for a party to serve any affidavit opposing a motion to seven days before a hearing.
* The one-day period in Rule 54(d) becomes 14 days. The increased time period corrects an unrealistic short time period for the clerk to give notice before taxing costs.
* The three-day period in Rule 55 becomes seven days.
* Five-day periods in Rules 32, 54, and 81 become seven days.
* The five-day period in Rule 6(c)(1) becomes 14 days. The adjustment extends the time for a party to serve a written motion and notice of hearing before the scheduled hearing date.
* Ten-day periods in Rules 12, 14, 15, 23, 38, 59(c), 62, 65, 68, 72, 81, and Supplemental Rule C become 14 days.
* Ten-day periods in Rules 50, 52, and 59(b), (d), and (e) become 28-day periods. The adjustment extends the present inadequate time allowed to prepare and file postjudgment motions. To prevent unfair results from these unrealistic short time periods, courts have avoided the rule by delaying entry of judgment or permitting timely filing of a barebones motion but permitting the brief to expand the stated grounds.
* The less-than-11-day period in Rule 32 becomes less than 14 days.
* Twenty-day periods in Rules 12, 15, 27, 53, 71.1, 81, Forms 3, 4, and 60, and Supplemental Rules B, C and G become 21 days.
* Rule 6(b)’s reference to provisions for extending the times set by enumerated provisions in Rules 50, 52, 59, and 60, and Rule 59(c)’s reference to a 20-day extension are eliminated.
* The timing provisions in Rules 56(a) and (c) are replaced by new provisions that recognize authority to set deadlines for summary-judgment motions by local rule or by court order and, in default of a local rule or court order, that allow a motion to be made at any time until 30 days after the close of all discovery. The new provisions also establish default times for response and reply.

Vicks Nasal Spray Recall

The Procter & Gamble Company has announced it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries: the United States, Germany and the United Kingdom.

The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. B. cepacia poses little medical risk to healthy individuals.

P&G detected this problem during routine quality control at the plant and promptly took action. The company's analysis to date shows this problem is limited to a single batch of raw material mixture involving three lots of product. These three lots were sold only in the United States, Germany and the United Kingdom

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries. P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 (Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml., Nasal Spray) and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

Anyone who has these specific lots of this product can call P&G for a replacement coupon or refund at 877-876-7881

FDA Recalls Dietary Supplement

The FDA recalled three types of dietary supplements known as RockHard Weekend after the supplements were found to contain ingredients related to the active ingredients found in Viagra. The ingredient, sulfoaildenfil, was not listed by the company on the packaging label.

Sulfoaildenfil could cause serious injury or even death in some individuals. Sulfoaildenfil may interact with nitrates, an ingredient found in medicines that treat diabetes, heart disease, high blood pressure, and other conditions. This interaction may cause the person’s blood pressure to drop to dangerously low levels and could result in death.

RockHard Weekend is made by RockHard Laboratories and distributed nationwide. The products involved in the recall could have been purchased at several national retailers, gas stations and local markets. They were sold in both pill and liquid form. The Food and Drug Administration (FDA) recall includes the Blister Pack, 3ct. Bottle and 8ct Bottle.

Blair Expands Recall of Robes, Jackets and Tops

A Pennsylvania clothing company has expanded a recall of highly flammable bathrobes, as a Connecticut woman says the company's negligence led directly to her mother's fiery death. Blair LLC, based in Warren, Pa., initially recalled 162,000 of its chenille robes in April, as it announced that it had received reports of three deaths blamed on the robes' extreme flammability.


Blair and the Consumer Product Safety Commission (CPSC) have expanded that recall, as six additional deaths are linked to at least four types of chenille robes and other chenille products produced by the same manufacturer.

The expanded recall covers around 300,000 items. Products covered by the recall include full length women's chenille robes, women's chenille jacket, women's chenille lounge jackets, and women's chenille tops.

Recalled robes bear the item numbers 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. According to the CPSC, the items are one-piece garments made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robes have a full-button front with seven matching button closures.

Affected items were sold both in Blair catalogs and on the company's website, as well as Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009.

Vertebral Body Replacement Recall - Georgia/Florida News

I wrote about the recall in a prior post. Here's the lot information:

The recall applies to devices manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009. The devices included are:

• Part No. 04.808.001; Description: Ti Synex (TM) II Central Body 14 mm – 19 mm
• Part No. 04.808.002; Description: Ti Synex (TM) II Central Body 17 mm – 25 mm
• Part No. 04.808.003; Description: Ti Synex (TM) II Central Body 21 mm – 29 mm
• Part. No.04.808.004; Description: Ti Synex (TM) II Central Body 25 mm – 33 mm
• Part No. 04.808.005; Description: Ti Synex (TM) II Central Body 29 mm – 44 mm
• Part No. 04.808.006; Description: Ti Synex (TM) II Central Body 37 mm – 52 mm
• Part No. 04.808.007; Description: Ti Synex (TM) II Central Body 45 mm – 71 mm
• Part No. 04.808.008; Description: Ti Synex (TM) II Central Body 58 mm – 84 mm
• Part No. 04.808.009; Description: Ti Synex (TM) II Central Body 71 mm – 97 mm
• Part No. 04.808.010; Description: Ti Synex (TM) II Central Body 84 mm -110 mm
• Part No. 04.808.011; Description: Ti Synex (TM) II Central Body 97 mm -123 mm

Class 1 recalls are the FDA’s most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.

Vertebral Body Replacement Recall

Our office is investigating these claims:

FDA has notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ at six to fifteen months post implantation were received. Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery.


Surgeons and hospitals in possession of the subject devices must stop implanting them immediately. This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.



The recall involves part numbers 04.808.001-011, Synex II Central Body, Titanium (all lots).

FDA: Alcohol and Caffiene -Safe Together?

The FDA has contacted nearly 30 makers of caffeinated alcoholic beverages that it will look into the legality and safety of the products.

The FDA has not approved the use of caffeine in alcoholic drinks, so the drinks can only be lawfully marketed if the substance is "Generally Recognized As Safe," or GRAS. For a substance to be GRAS, there has to be evidence of it's safety.

Source here.

My question- what happens to Bourbon and Cokes? Irish Coffee? Will some be relegated to seeking out Rum and Caffeine Free Diet Coke?

FDA issues Class I recall of Edwards Lifesciences aortic catheter

The FDA has issued a Class I recall of Edwards Lifesciences CardioVations EndoClamp aortic catheter, after reports that the device can rupture during cardiac procedures.

The device is a balloon catheter used during bypass operations to block and monitor pressure within the aorta and deliver a drug to stop the heart, "may spontaneously rupture during surgery," according to the FDA recall.

The recalled devices, model numbers EC1001 and EC65, were manufactured between August, 2008 and August, 2009 and distributed from November, 2008 through September, 2009.


Source here.

Thank you Veterans

Today I hope folks will take a moment to say thank you to those veterans who have served our country in good times and bad, in the USA and elsewhere. They stand ready to make the ultimate sacrifice for our country.

In our groups of friends, I'm lucky to call one of our active military a friend. Whether it's a simply greeting, or something more elaborate is up to you.

Thank you from our family to those who served and serve now.



The above photo is from this article -

The State of Georgia is moving aggressively to help refugees of the nation of Georgia who suffered because of the recent hostilities with Russia. Twelve hundred pounds of emergency supplies were packed at Dobbins Air Reserve Base, destined for the more than 9,000 permanently displaced refugees living in tents and makeshift shelters in Georgia.

The supplies consist of medicines and medical supplies, medical protective clothing, and landmine first aid kits. The humanitarian assistance supplies are being donated by US Aid for International Development, US Public Health Service, and the Georgia National Guard.

This delivery is made possible by the coordinated effort of the Atlanta-Tbilisi Sister City Committee with the help of the Georgia National Guard.

Assisting in the packaging of the humanitarian aid was Letha Nesbitt, Subcommittee Chairman for Humanitarian Aid for the Atlanta-Tbilisi Sister City Committee and members of the Georgia Army and Air National Guard.

Recall of Certain Lots of Tylenol Arthritis

Good to see the folks at McNeil Consumer Healthcare taking a pro-active stance. From their site:

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is initiating a voluntary recall of a limited number of product lots of TYLENOL® Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP. McNeil is initiating the recall after identifying an uncharacteristic smell or taste associated with these lots that led to a small number of consumers reporting nausea and related symptoms. This recall includes five product lots only (Full list of lot numbers provided below), and does not include any other lots of TYLENOL® Arthritis Pain Caplet 100 count with EZ-OPEN CAP or any other TYLENOL® Arthritis Pain products. McNeil is implementing this recall as a precaution.

Consumers who purchased TYLENOL® Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) or log on to the internet at www.tylenol.com. Consumers who have medical concerns or questions should contact their healthcare provider.

Link: http://www.jnj.com/connect/news/all/20091106_120000

Last week, the Georgia Court of Appeals issued an opinion holding that State Farm, as a UIM carrier could pursue UM subro against a tortfeasor even though the insured had
signed a Limited Release.

Will this decision make it more difficult to settle a claim if the UM carrier doesn't waive subrogation? Stay tuned.

Excerpts from the decision:

The issue in this case is whether an uninsured motorist insurer can sue a tortfeasor for subrogation after the tortfeasor has been released from personal liability except to the extent that insurance coverage, other than the tortfeasor's personal liability policy, exists. Because we answer this question in the affirmative, we affirm the judgment of the trial court.

Accusure Insulin Syrine Recall

Accusure insulin syringes (Qualitest Pharmaceuticals, Inc) distributed nationwide from January 2002 through October 2009 are being voluntary recalled because of the possibility of detachment of the needles from the syringes.

The current recall is an expansion of a recall made in August for syringes produced between January 2007 and June 2008 as a result of the manufacturer receiving a complaint about a syringe not included in the first recall.

According to Carole Ben-Maimon, MD, senior vice president of corporate strategy for the manufacturer, the recall affects about 250 million syringes, although she told Medscape Medical News that many of those syringes have already been used. "It is not clear how many are still in circulation," she said.

"If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection," according to a statement from MedWatch, the FDA's safety information and adverse event reporting program.

"All Accusure Insulin Syringes regardless of lot number are subject to this recall," a company press release states. Lot numbers are found on the white paper backing of each individual syringe, according to the US Food and Drug Administration report.

The distributed syringes are of the following descriptions and NDC numbers: 28 G, 1/2 cc, NDC 0603-6995-21; 28 G, 1 cc, NDC 0603-6996-21; 29 G, 1/2 cc, NDC 0603-6997-21; 29 G, 1 cc, NDC 0603-6998-21; 30 G, 1/2 cc, NDC 0603-999-21; 30 G, 1 cc, NDC 0603-7000-21; 31 G, 1/2 cc, NDC 0603-7001-21; and 31 G, 1 cc, NDC 0603-7002-21.

For more go here.

Recall: Madol,Tren, Turinsabol and Andro

The business Bodybuilding.com has recalled 65 dietary supplement products sold online that may contain steroids, says the U.S. Food and Drug Administration.

The national and international recalls announced by the Boise, Idaho-based company include all lots and expiration dates of dietary supplements that might contain ingredients that are or should be classified as steroids, including "Superdrol," "Madol," "Tren," "Turinabol," and "Androstenedione."

From emaxhealth.com:

The FDA states they have conducted a two-year investigation in which products bought from bodybuilding.com were later tested positive for steroids. Unlike foods and drug products, dietary supplements are not approved for safety or efficacy by the FDA before they hit the market. Instead, under the Dietary Supplement Health and Education Act of 1994 (DSHEA), it is up to the manufacturer to make sure the product is safe. The FDA can only take action after the products are on store shelves.

The FDA conducted an investigation on September 24 at the Boise, ID warehouse and informed the company that that it believes that the recalled products may contain anabolic steroids. The following ingredients were called into question: superdrol, madol, tren, androstenedione, and turinabol. Anabolic steroids are considered controlled substances in the United States.

Most of the recalled items are taken for body mass and muscle building, and include brand names such as Advanced Muscle Science, Competitive Edge Labs, Diabolic Labs, IDS, Kilo Sports, and Myogenix. A full list of recalled lots is available on the both the FDA website and on bodybuilding.com.

Bodybuilding.com says that it has not yet had an opportunity to independently confirm the FDA’s concerns, but that they are focused conducting the voluntary recall as a precaution to protect the health of its customers. The company also states that it has contacted the manufacturers of the products and has received assurances that each is in compliance with federal law and do not contain unlawful ingredients.

Link here.

Prempro Verdict Appeal

Pfizer Inc. doesn’t have to pay more than $27 million in punitive damages to an Arkansas woman who blamed her breast cancer on the company’s menopause drugs, an appeals court ruled in ordering a new trial on the award.

The U.S. Court of Appeals in St. Louis today upheld a jury’s March 2008 finding that the hormone-replacement drugs helped cause Donna Scroggin’s cancer and its award of actual damages. The three-judge panel also backed a judge’s decision to throw out the punitive award to Scroggin, who alleged two Pfizer units ignored or downplayed the risks of the drugs.

“Scroggin presented sufficient evidence to submit the question of punitive damages to the jury,” the appeals court said in its 41-page ruling. “The evidence presented could allow a jury to find or infer that Wyeth was guilty of malicious conduct within the meaning of Arkansas law.”

Source and more at the link.

Levaquin

You may have seen more information about Levaquin®, which is an Ortho-McNeil-Janssen pharmaceutical, also called a fluoroquinolone, prescribed for the treatment of lung, sinus, skin and urinary tract infections in adults. Levaquin® has been associated with medical complications serious enough to have required FDA involvement.


Reports of Levaquin® Complications

Although the increased risk of tendonitis and tendon rupture has been noted on fluoroquinolone drug labeling for several years, the FDA has continued to receive reports of tendon disorders and ruptures among patients, and incidents of side effects often go unreported or are misdiagnosed as rheumatoid arthritis. In July 2008, the FDA announced a mandatory black box warning label for fluoroquinolone drugs, including Levaquin®, that highlights and strengthens the warning for increased risk of tendonitis and tendon rupture.

The reported symptoms related to the use of Levaquin® include:
· pain
· swelling
· inflammation
· bruising and tears in tendons such as the Achilles,
shoulder, hand or legs

The risk of developing fluoroquinolone-associated tendon disorders or tendon rupture increases in individuals over the age of 60, individuals taking corticosteroid drugs and recipients of kidney, heart and lung transplants. Tendon ruptures and injuries are often debilitating and may affect use of the injured limb.

Prempro Verdict - Don't Ask I Can't Tell You

A Philadelphia jury awarded punitive damages to an Illinois woman who said Wyeth's Prempro hormone replacement therapy caused her breast cancer, but the world will have to wait at least another month before anyone knows how much.

As the jury in Common Pleas Court was nearing a verdict on how much to award to punish Wyeth, which last week completed a merger with Pfizer Inc., company lawyers asked Judge Sandra Mazer Moss to seal the amount until a verdict is reached in a similar case also being tried in Philadelphia. The judge agreed.



Wyeth's attorneys George McDavid and Michael Scott argued that a public announcement of punitive damages in the Barton case could bias jurors in the other case, referred to as Kendall v. Wyeth.

Barton's attorney, Zoe Littlepage, argued that the public's right to know outweighed those concerns and that Wyeth had failed to prove damage, not just speculate that it could occur. Littlepage also said she feared that Wyeth would use the tactic to delay repeatedly as 9,000 cases involving Pfizer/Wyeth menopause drugs make their way through the courts.

Source is right here.

Friday Link: New Georgia Family Law

I don't usually link to others' blogs, but my good friend C.J. Remboldt has a family law blog that is worth a read. You can find her blog here.

Here's a post from her blog:

GA Trial Court Lacks Authority to Modify Terms of Child Support Order

A GA trial court may not deny a child support contempt hearing because the Temporary Protective Order, ordering father to pay child support, would expire before the hearing date because a trial court lacks authority to modify the terms of a child support order nor may it forgive any child support in arrears.

To find her mediation practice, go here.

Georgia Supreme Court rules against State Senator in Accident Case

State Sen. Cecil Staton did not prevail before the Georgia Supreme Court this week.

The court said Staton, a Republican from Macon, was not entitled to additional coverage ($200,000) in coverage after a truck accident near Rome that broke his leg. Staton contended he should be allowed to “stack” $100,000 policies on three vehicles owned by his company, Smyth & Helwys Publishing, even though only one of the three cars was actually in the crash.

Read the opinion here.

Zometa Verdict in Montana

A Missoula jury on Wednesday awarded $3.2 million to a woman suing the maker of a bone-strengthening drug in a decision that could have a bearing on hundreds of cases against the company nationwide.

Peggy L. Stevens, 57, of Missoula filed suit against Novartis Pharmaceuticals Corp., alleging the company should have disclosed health risks associated with the bone-strengthening drug called Zometa.

Stevens developed dental and jaw-related problems after taking the drug for several years.

Stevens' attorneys said the company knew patients taking Zometa were vulnerable to a degenerative jaw disorder called osteonecrosis, particularly those patients who undergo invasive dental procedures. Symptoms include pain, loosening of teeth, exposed bone and infection.

Source here.

Safety Investigation of Certain Medical Device Power Cords

The power cords on a variety of medical devices may cause sparking, charring, and fires, according to reports received by the FDA.

Device manufacturer Hospira has recalled all affected power cords, while Abbott Nutrition has recalled its Flexiflo Quantum Entreal Pumps, used for feeding patients through tubes.

To date, the FDA has received 122 reports of faulty power cords involving devices manufactured by these two companies, whose investigators found that the power cord prongs contain a black bridge, which may crack and fail at or inside the plug.

Additional risks from the device failure include electrical shock, delay in setup and therapy, interruption of therapy, and device failure.

The FDA said the cords, manufactured by the Electri-cord Manufacturing Company, are used on other devices made by other companies, and the agency has launched an investigation to identify them.

The FDA warned practitioners to monitor the condition and make of their devices' electrical cords, particularly in oxygen-rich environments where device sparking may cause fires.

Source here.

FDA Checking Claims on Food Labels

U.S. regulators are
examining the growing number of nutrition claims found on the
front of food packages after complaints that they give a
misleading picture of their health benefits, officials said in
a warning to food companies on Tuesday.

The Food and Drug Administration is trying to determine if
any claims violate federal food labeling rules and "will take
enforcement action against any egregious examples," FDA
Commissioner Margaret Hamburg told reporters.

FDA officials also are developing a proposed regulation to
define nutritional criteria for claims made on the front of
food packages, Hamburg said.

The FDA is acting as companies increasingly add nutrition
claims to the front of packages to catch the attention of
hurried shoppers who might not read the detailed facts about a
food's content on the back, she added.

"Some nutritionists have questioned whether this
information is more marketing-oriented than health-oriented,
and judging from some of the labels that we have seen, we think
this is a valid concern," Hamburg said.

Link to the source here.

Defective Women's Robes Recalled (Blair LLC)

Blair LLC. has reported 162,000 of its defective products -- women's robes -- after six women reportedly died when the chenille robes caught fire. Some of the robes caught fire while cooking, according to an MSNBC news report. The U.S. Consumer Product Safety Commission (CPSC) issued an alert stating that women who own these robes should stop using them. CPSC and Blair initially announced their voluntary recall in April citing three reports of robes catching fire, including one report of second-degree burn injuries. This second product recall notice comes now after the company received reports of six deaths due to the robes catching fire.

The recalled Blair robes were made in Pakistan and include the following item numbers -- 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. They were sold through Blair catalogs and on the company's Web site as well as Blair stores in Pennsylvania and Delaware from January 2003 through March 2009.

We're investigating these awful tragedies.

Vytorin Litigation

An amended lawsuit filed over the Schering-Plough pension plan alleges that executives at the company suspected as early as 2005 that the “Enhance” Vytorin trial was a bust. Citing a “confidential informant,” it also names.

The Plaintiffs claim: "Defendants had intimate knowledge of, or an active role in, improper business activities that allowed Schering-Plough to artificially inflate and manipulate the Company’s earnings."

More at bnet, here.

Trials

I've been a little scarce on here for the past couple of weeks. Was preparing for multiple trials, and actually went to trial last week on a case. I'll discuss the trial in a later post.

For those lawyers who read this blog, I will tell you a few key items from the trial: Always prepare a Trial Notebook for the Judge. Include in it a Trial Brief. A short statement of the facts, the key statutes and cases, with a copy of all. It helped once again for me. An informal poll seems to suggest that less than 2/3's of lawyers I know prepare one. Big mistake.

Another: Submit only those Jury Instructions you absolutely need. The Court has its standard ones, of course. I submitted seven, and the Court agreed to read six of them. Opposing counsel submitted more than 40.

More later.

MDL Update: Hydroxycut, Chantix, and Yasmin

The MDL Joint Panel has been busy the last couple of weeks. The JPML had ordered the Iovate (Hydroxycut) MDL to the Southern District of California. The Order may be found here. It's MDL 2087.


An MDL as to Chantix will be sent to Judge I. Johnson in the USDCT of Alabama. The Order may be found at the same link as above. MDL 2092 is the number.

For Yasmin, the MDL is in Ohio.

McDonald's Hot Coffee Documentary 10/13/09 in Atlanta

Remember the film Super-Size Me? That film opened up the eyes of consumers. More people than ever found themselves concerned with the nutritional content—or lack thereof—in fast food. Six weeks after the film premiered, McDonald’s discontinued their “Super-Size” option. The fast-food chain began offering more salads and an adult happy meal in an attempt to appear healthier.



The film was the 10th highest grossing documentary film of all time. Millions saw it. And it changed minds.



Tomorrow’s film screening of “Hot Coffee” also involves McDonalds… but in a different way. Stella, of the now infamous Stella Awards based on the hot coffee McDonalds case, is actually interviewed in this film as it completely debunks the myths surrounding the case. Through additional personal stories, interviews and hard facts, the film illustrates how the media distorted the truth about the McDonald's coffee case, duped the American public and protected corporate interests, endangering our civil justice system.



This 26 minute short of what will be a feature film was chosen by IFP as a Spotlight documentary and is showing around the nation. The film is made by a Trial Lawyer/filmmaker in Oregon. And most importantly, on a grand scale, the film could change hearts and minds.



Please make every effort to attend the screening at tomorrow, Tuesday October 13th at 7:30 at LandMark Theaters in Midtown

Georgia Supreme Court holds SOL Tolled while Traffic Citation Pending

The Supreme Court held yesterday that O.C.G.A. § 9-3-99 tolls the statute of limitations for any tort action from the date of the defendant’s traffic offense until the prosecution of the traffic offense becomes final or is terminated, as long as that time does not exceed six years. See Benke v. Parker, S08G2078, S08G2082, Sept. 28, 2009.

A violation of one of the Uniform Rules of the Road, such as the rule that a OCGA § 16-2-1 (a) provides that “[a] ‘crime’ is a violation of a statute of this state in which there is a joint operation of an act or omission to act and intention or criminal negligence.” A driver must not follow another vehicle too closely. Doing so is a is a misdemeanor, OCGA §40-6-1 (a), and a misdemeanor is “any crime other than a felony.”

To impose a more stringent definition of “crime” within the context of the statute would render superfluous its language that the statute of limitation is tolled from the date of the alleged crime “or the act giving rise to such action in tort” until the prosecution or other termination of such crime “or act.”

Find the opinion online here.

Exjade and the FDA

The US Food and Drug Administration (FDA) is reviewing adverse event information for Exjade from a database that tracks all patients who are prescribed deferasirox (Exjade). This information suggests there may be a greater risk for adverse events such as kidney failure, gastrointestinal haemorrhage, and deaths in patients with myelodysplastic syndrome (MDS) compared with patients without these conditions.

Source here.

Januvia/Sitagliptin: Pancreatitis Risk?

The Food and Drug Administration said on Friday that there may be a connection between Merck & Co.'s diabetes treatment Januvia/Sitagliptin and occurrences of acute pancreatitis, the same issue that sunk sales of Amylin Pharmaceuticals Inc.'s Byetta.

From the FDA site:


FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009.

It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis.

Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided.



More from the source, at Forbes:Here.

Tylenol Infants and Children Recall (Certain Lots)/More

It’s a voluntary recall, which according to NY Pediatrician Dr. Seth Gordon came because “examination of bulk raw material detected that one of the inactive ingredients contained gram-negative bacteria Burkholderia cepacia (B. cepacia). The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product.”

There are also raised that the carton labeling for Junior TYLENOL® Meltaways (160mg) may be confusing to some consumers in determining the proper dosage. This labeling says that each dose provides 160 mg of acetaminophen. Consumers should know that each tablet of Junior TYLENOL Meltaways contains 160 mg of acetaminophen. Some may assume two tablets are standard and this is not the case.

In addition, some Children’s TYLENOL® Meltaways 80mg are packaged in a bottle. The bottle is packaged in a carton. Concerns have been raised that the information on the front panel of the carton for Children’s TYLENOL® Meltaways 80mg may be confusing to some consumers in determining the proper dosage. The carton labeling says that each dose provides 80 mg of acetaminophen. Consumers should know that each tablet of Children’s TYLENOL Meltaways contains 80 mg of acetaminophen. Caregivers should be guided by the dosage directions on the bottle label for the correct number of individual tablets to be given based on the child’s age and weight.

Source here.

Tylenol Infants and Children Recall (Certain Lots)

From tylenol.com

You may have heard that McNeil Consumer Healthcare (the makers of Tylenol) is voluntarily recalling certain lots of Children's and Infants' TYLENOL® liquid products that were manufactured between April, 2008 and June, 2008 in consultation with the U.S. Food and Drug Administration (FDA). The company is implementing this voluntary recall at the warehouse and retail levels, because examination of one of the inactive ingredients did not meet internal testing requirements. However, the packaged product, shipped to retailers by the company, has met all specifications.

These actions do not apply to Children's Tylenol Meltaways and Junior Strength Tylenol Meltaways. The voluntary recall applies only to select lots of Children's and Infants' TYLENOL® liquid products.

If you have any of the potentially affected products in your home and have questions you can contact the McNeil Consumer Call Care Center at 1-800-962-5357 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time.)

Parents and caregivers who have given the product to their child or infant and have concerns should contact their child's health care provider.

The full list of affected products is below. Consumers can find the lot numbers on the bottom of the box containing the product and also on the sticker that surrounds the product bottle. If you have more questions, please contact our consumer call center at 1-800-962-5357.
UPC # Code # Lot # Product Description
300450391049 3910400 SBM041, SBM067, SCM037, SDM027, SEM109 Children's Tylenol Plus Cold MS Suspension 4 oz. Grape
300450296047 2960400 SBM042, SCM015, SCM036, SDM034 Children's Tylenol Suspension 4oz. Grape
300450407047 4070400 SBM043, SBM044, SCM029 Children's Tylenol Suspension 4oz. Bubble Gum
300450493040 4930400 SBM045, SCM011, SCM030, SDM035 Children's Tylenol Suspension 4oz. Strawberry
300450122407 1224000 SBM064, SCM033, SDM020 Infant’s Tylenol Grape Suspension Drops 1/4oz.
300450186157 1861500 SBM065, SCM005, SCM006, SDM032 Infant's Tylenol Suspension 1/2oz. Cherry
300450166043 1660400 SBM066, SCM068 Children's Dye Free Suspension 4oz. Cherry
300450123046 1230400 SBM068, SCM035, SCM070, SCM080, SDM005 Children's Tylenol Suspension 4oz. Cherry
300450249043 2490400 SBM069, SBM070, SCM081, SDM006 Children's Tylenol Plus Cough & Runny Nose 4oz. Cherry
300450122155 1221500 SCM012, SCM067, SDM007, SDM068 Infant's Tylenol Suspension Drops 1/2oz. Grape
300450386045 3860400 SCM013, SCM014, SCM069 Children's Tylenol Plus Flu 4oz. Bubble Gum
300450387042 3870400 SCM016, SFM024 Children's Tylenol Plus Cold Suspension 4oz. Grape
300450247049 2470400 SCM017 Children's Tylenol Plus Cough/ST Suspension 4oz. Cherry
300450122018 1220100 SCM082, SDM039, SDM040 Infant's Tylenol Suspension Drops 1oz. Grape
300450167019 1670100 SCM083, SCM084, SDM008 Infant's Tylenol Dye Free Suspension 1oz. Cherry
300450123015 1230100 SDM064 Children’s Tylenol Pediatric Suspension 1oz. Cherry
300450186300 1863000 SDM038, SDM009 Infant's Tylenol Suspension Drops 1oz. Cherry
300450390042 3900400 SDM033 Children's Tylenol Plus Cold/Allergy 4oz. Bubble Gum
300450122100 1221000 SDM078 Infant's Tylenol Drops 1oz. Grape
350580144183 1221800 SCM034 Infant’s Tylenol Grape Suspension Drops H/G 1/2oz.
350580123034 1230300 SDM028 Children's Tylenol Suspension 4oz. Cherry, Hospital Govt.

Seroquel Litigation News

A federal judge in Orlando, Florida, ordered AstraZeneca to unseal certain sales-call notes by Sept. 11 after Bloomberg News filed a motion to gain access to company files turned over in Seroquel litigation. The judge allowed AstraZeneca to withhold physicians’ names on privacy grounds.

For more, go to the Bloomberg site here.

FDA Bans Flavored Cigarettes

The FDA this week banned cigarettes with fruit, candy or clove flavors.

Authorized by the Family Smoking Prevention and Tobacco Control Act enacted in June, the ban represents an effort to reduce an easy entry point for youth into smoking and tobacco addiction. Some cigarette makers favored and others opposed giving the FDA this new authority.

Smoking is the leading preventable cause of death in the U.S., the government says.

The FDA also is considering bans on menthol cigarettes and other flavored tobacco.

Source here.

Flooding in Atlanta

It's bad here. Real bad. A North Georgia city has been evacuated because of levee failure fears. The above pic is of downtown Atlanta during rush hour today.

Study Finds a Possible Link Between Denture Cream and Imbalance

From ABC.com:

Thirty- four million Americans rely on dentures to replace their missing teeth. But a small number of denture wearers have had difficulty with balance and walking -- a medical mystery that some experts have linked to their denture creams.

More here.

Necrosis Caused by Intra-arterial Injection of Promethazine: Case Report

I found this report after hearing more about the recent black box warning issued by the FDA regarding Promethazine:

"The first reported cases of intra-arterial promethazine (Phenergan) injection causing complications were in the late 1960s." There have been literature reports of adverse outcomes after accidental intra-arterial injections of drugs since the 1940s.

The study presented two cases of intra-arterial promethazine injection that led to digital necrosis. Both cases eventually led to amputations.


The study may be found here.

STLA Meeting in Asheville Sept. 24 and 25, 2009

This week the Southern Trial Lawyers Association meets in Asheville, N.C.

The essential mission of the Southern Trial Lawyers Association is as simple as it is straightforward: To promote fellowship, learning, and networking among trial lawyers throughout the 13 southern states. We do not engage in political activity or fundraising of any kind.

STLA here.

FDA warns about eyelash thickener claims

The FDA has warned Allergan Inc. that the Web site for its eyelash thickener Latisse is misleading because it avoids or downplays risks associated with the product.

In a letter dated Sept. 10 and posted to the FDA Web site Wednesday, the agency said the Latisse site either doesn't mention potential side effects including bacterial eye infection, allergic reactions, excess hair growth outside the intended treatment area, and permanent changes in iris and eyelid pigmentation, or presents them in small text that is much less prominent than statements about the product's effectiveness.

For more, go to fda.gov.

Promethazine Gets Black Box Warning for Tissue Damage/Amputation Risk

Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, the Food and Drug Administration said Wednesday.

The drug, previously sold by Wyeth Pharmaceuticals Inc. under the brand name Phenergan, was at the heart of a U.S. Supreme Court case this spring that ended in a ruling that consumers harmed by a medication approved by the FDA still have the right to sue the manufacturer.

More here.

GA Supreme Court to Hear Oral Argument on Damages Caps on 9/14

Supreme Court to Hear Oral Arguments on Caps on Damages
Statute is challenged after a medical malpractice victim’s face
literally falls off after surgery

Atlanta, GA-- On Tuesday, September 15, 2009, the Georgia Supreme Court will hear oral arguments regarding the constitutionality of the provision that caps the amount of damages a victim of medical malpractice can secure from a jury. The plaintiffs in the case of Betty Nestlehutt and Bruce Nestlehutt v. Atlanta Oculoplastic Surgery, P.C., will argue that the Georgia Supreme Court should uphold the trial court judge’s finding that O.C.G.A. § 51-13-1, as enacted in 2005, is unconstitutional.

The case arose from a medical malpractice claim filed by Adam Malone and Frank Ilardi on behalf of their clients Betty Nestlehutt and her husband Bruce Nestlehutt in the Fulton County State Court in October of 2008. Married for over 50 years, the Nestlehutts raised two children and they shared a real estate business. Bruce handled the behind-the-scenes work, and Betty, a people-person by nature, focused on client and public interaction. Competition was tough and as Betty aged she found that more and more clients seemed to prefer younger agents. So, at seventy-one years of age, Betty Nestlehutt, after much thought and consideration, sought consultation with Dr. Harvey P. Cole of Atlanta Oculoplastic Surgery, P.C. concerning bags under her eyes and lines around her mouth. Dr. Cole recommended she undergo several surgical procedures including a simultaneous CO2 laser resurfacing and full facelift.

Having both the CO2 laser resurfacing and full facelift done together is well-known by practicing cosmetic surgeons to be risky, as the chance of damaging the facial blood supply is greatly increased on a patient of Betty’s age and complexion. However, based on her doctor’s recommendation, Betty went through the combination of procedures and the blood supply to her face was, in fact, severely damaged.

After the surgery, the skin on Betty’s face struggled to live without its usual blood supply and after a 3-week period, died completely, leaving the once fair-skinned wife and mother with huge, gaping wounds from her temple to her jaw line, covering both sides of her face and over both of her cheeks to her chin. Betty Nestlehutt’s face, quite literally, fell off.

“Betty Nestlehutt was the face of her real estate business,” said Malone. “Her face was so horrifically disfigured that she was no longer able to even leave her house. Photographs of her disfigurement are even too gruesome for public distribution. The damage is permanent. Years later she has to wear layers of special makeup to try to give the appearance of normalcy.”

After hearing the testimony and considering all of the evidence, a jury of 12 returned with a verdict in the Nestlehutts’ favor which included a recovery of money damages for her past and future medical expenses, for damage to her relationship with her husband and $900,000 in “non-economic” damages for the devastation of her quality of life. The verdict exceeded the $350,000 cap on noneconomic damages enacted as part of SB 3 in 2005. Judge Diane Bessen declared unconstitutional the statute capping a jury’s verdict and now her decision, upon the defendant’s appeal, is before the Supreme Court.

“Judge Bessen’s order appropriately concluded that a one-size fits all predetermined cap on damages violates several protections guaranteed by the Georgia Constitution,” said Malone. “Her order balances the rights of all Georgians, young and old, rich and poor, and restores the guarantees set forth by our Constitution that were stripped away in 2005.”

Judge Bessen’s order declares the caps on damages provision unconstitutional because it violates three basic constitutional tenets: the right to trial by jury, the separation of powers doctrine and equal protection of the laws.

Under SB 3, the jury’s deliberation regarding the amount of damages to be awarded is preempted by a legislatively imposed cap—no matter how severe or catastrophic the case before them. Historically, a jury had the ability to decide the fate of its peers constrained only by the particular facts of an individual’s case, as the Founding Fathers intended. Thomas Jefferson once said, “I consider trial by jury as the only anchor yet imagined by man, by which a government can be held to the principles of its Constitution.”

In her order, Judge Bessen wrote:

A limit or cap on noneconomic damages, however, invades the right to a jury trial by usurping one of the fact-finding responsibilities of the jury. If the amount of noneconomic damages awarded by the jury exceeds the statutory cap, this Code section automatically and arbitrarily reduces the verdict, without consideration of the evidence, the record, or any other fact produced at trial and found by the jury. The limitations imposed by O.C.G.A. 51-13-1 render the right of the jury to assess damages meaningless… The cap so interferes with the determination of the jury that it renders the right of a jury trial wholly unavailable.

Additionally, Judge Bessen also found that the cap on damages violates the Separation of Powers Doctrine contained in the Georgia Constitution. Three other states’ supreme courts, with similar constitutional provisions, also have struck down caps on damages on this basis. The Georgia Constitution states that: “The legislative, judicial and executive powers shall forever remain separate and distinct, and no person discharging the duties of one, shall, at the same time, exercise the functions of either of the others.” One distinct function of the judicial branch is that judges have the exclusive right to award to a party a “remittitur” – or a new trial – if a judge finds that a verdict is either excessive or inadequate. Judge Bessen’s order declares the cap on damages statute to be a “legislative remittitur” and that the legislature has unconstitutionally invaded the exclusive role of the judiciary to find facts and control judgments.

“Equally important,” the judge writes, “it does so without the option of a new trial for the injured plaintiff. As such, it unduly encroaches upon the judiciary’s constitutional right and prerogative to determine whether a jury’s assessment of damages is either too excessive or too inadequate within the meaning of the law.”

The third violation of the Constitution Judge Bessen found was that a cap on damages violates the Equal Protection provisions of the Georgia Constitution which state: “No persons shall be denied the equal protection of the laws.” To examine this violation, Judge Bessen explored whether there was a “rational relationship” between the government’s purpose and its enacted statute which treats similar parties in very different, unequal ways.

The rational relationship test basically states that a statute may be valid as long as it has a rational relationship to a governmental purpose. In the case of SB 3, the government’s stated purpose was to “promote predictability and improvement in the provision of quality health care services and the resolution of healthcare claims..., assist in promoting the provision of healthcare liability insurance by insurance providers…, [and addressed concerns about] medical providers and facilities leaving the state and the cost of malpractice awards.” For a law to be valid, a rational relationship to those goals must be proven. Judge Bessen found that the cap on damages failed the rational relationship test completely.

In holding the cap on damages provision unconstitutional, Judge Bessen wrote:

After review, this Court finds that there is no rational relationship between statute and the expressed government interest. Most obviously, it is a complete contradiction to state that the overall quality of healthcare would be improved by shielding negligent healthcare providers from liability. In fact, as recognized by other courts, a cap on noneconomic damages actually diminishes tort liability for healthcare providers and diminishes the deterrent effect of tort law… There is absolutely no evidence that these objectives are achieved by imposing a financial burden on the most victimized of plaintiffs… Based on current statistics, limiting noneconomic damage caps is not rationally related to the state purpose of reducing medical malpractice insurance rates… it appears that this statute was enacted arbitrarily, based upon speculation and conjecture rather than empirical data.

Finally, Judge Bessen found that the cap on damages violates Equal Protection because it creates different classes of victims—those injured by healthcare providers and those injured by others and those who are catastrophically injured and those who are less severely injured. Judge Bessen penned, “The cap’s greatest impact falls on those who are most severely injured, and creates classes of fully compensated victims and those only partially compensated… Similarly, the noneconomic damages cap discriminates against low-income individuals who are unable to prove large economic damages but nonetheless may sustain large noneconomic damages.”

The President of the Georgia Trial Lawyers Association, Chris Clark, has been following this case closely.

“As a trial lawyer, I represent the person, who, through no fault of their own, has been injured—sometimes severely. They miss work, accrue medical bills and—often most important to them—they suffer a loss of the quality of life that they once had,” said Clark. “Betty Nestlehutt’s severe disfigurement – which she had no part in creating – has diminished her quality of life and, in turn her husband’s and her family’s. Judge Bessen’s order was fair, upheld our Constitution, and reflected the rule of law that has stood firm since the inception of this nation.”

The argument on Tuesday was prepared by Malone and attorneys Darren Summerville of Bird Law Group, P.C. and Michael Terry of Bondurant, Mixson & Elmore, LLP. AARP, Voices for Georgia’s Children, Georgia Women for a Change and Georgia Watch all filed Amicus Briefs in support of Betty and Bruce Nestlehutt.

Conmed Recall of Surgical Instruments

Medical device maker Conmed Corp. on Wednesday issued a voluntary recall of certain surgical instrument products, saying the devices may self-activate and cause injury in rare cases.

Conmed said the recall affects certain model numbers of its PRO5 and PRO6 series battery hand pieces manufactured before May 31, 2008.

The recall also affects certain lots of the MC5057 Universal Cable manufactured before Dec. 1, 2006, the company said.

The company estimated the pretax cost of the recall at $6 million. The expense will be factored into the company's financial results during the quarter ending Sept. 30.

Source here.

Penumbra Catheter Recall

Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death. The device was distributed from May 5, 2009 through June 12, 2009.

Source here.

Window Blinds Recall

The Consumer Product Safety Commission is announcing a major recall on several types of winder blinds and shades. Here are three of the largest recalls.

The first set of shades on our recall list is the kind that rolls up. It's called the Oval Roll-Up Blinds. There is the potential for a child to be strangled in the pull cord.

The Consumer Product Safety commission is recalling more than four million of the blinds.They were sold national retail stores across the country.

The second recall is for bamboo shades called Matchstick Bamboo Roman Shades. They too could strangle a young child if that child gets caught in the inner cord. They were sold at Target stores nationwide.

The third recall is for the Melina Roman Blind which can also catch a child around the neck. The problem here is the exposed inner cord. These shades were sold at IKEA stores.

go to the cpsc site for more.

Levaquin and Link to Vision Problems?

From the journal Opthamology:

According to World Health Organization criteria, the relationship between fluoroquinolone therapy and diplopia is “possible.” This causality assessment is based on the time relationship of drug administration and ADR development, the multiple positive dechallenge and rechallenge reports, and the plausible mechanism by which diplopia could occur: Possible tendinitis of the extraocular muscles.

Link here:

http://www.ophsource.org/periodicals/ophtha/article/S0161-6420%2809%2900655-1/abstract

Zyprexa: Allegations that Lilly Paid Docs to Prescribe it

From Bloomberg:

Eli Lilly & Co. paid doctors in South Carolina for participating in a speakers’ program in exchange for prescribing the antipsychotic Zyprexa, and used golf bets to get more patients on the drug, according to notes by sales representatives.

During a golf game, one doctor agreed to start new patients on Zyprexa for each time a sales representative parred, or put the ball in a hole within a predetermined number of strokes, according to the notes.

“I got four pars out of nine holes,” Lilly salesman Vince Sullivan said in a February 2002 note. “I said I wanted my four new patients.”

More at the link above.

Fosamax: Jury Deliberations Marked by Threats and Intimidation?

From CNNMoney.com I can tell you I've never heard of any Judge offering to have court officers escort jurors home:

A U.S. judge called for a daylong "cooling off" period in a product-liability case over Merck & Co.'s (MRK) osteoporosis drug Fosamax after jury deliberations became tense on Wednesday.

U.S. District Judge John F. Keenan suspended deliberations until 11:15 a.m. EDT Friday and offered to have court security officers escort individual jurors to the subway after two separate notes were sent out of the jury room Wednesday afternoon about the tenor of the deliberations.


Outside the presence of the jury, the judge said that he would declare a mistrial in the case if a verdict isn't reached by 5:30 p.m. EDT Friday.

The article notes that one juror had complained of threats.

Actiq Deaths

Actiq is a powerful narcotic painkiller in the form of a lollipop that is manufactured by Cephalon, Inc. The drug is delivered to the bloodstream by a lollipop-like lozenge; when placed against the inner cheek, pain is relieved in minutes. Actiq is also administered by transdermal patches and by injection. The active ingredient, fentanyl citrate, is a highly addictive narcotic which is approximately 80 times more potent than morphine.

The FDA approved the Actiq lollipop in 1998 for treatment of severe pain in cancer patients. However, Actiq is apparently being prescribed to thousands of people for off label treatment of non-cancer related pain. It has been estimated that in the first half of 2006 approximately 99% of the 187,076 Actiq prescriptions filled in the U.S. were not for cancer patients.

The Actiq lollipop has been associated with the deaths of at least 127 people. There have been another 91 FDA reported incidents of severe side effects. Side effects have ranged from dehydration to respiratory problems along with further issues associated with the highly addictive nature of the narcotic. Forty-seven of the deaths have been linked to addiction, misuse, or overdose. Two deaths have reportedly involved children who mistook the Actiq lollipop for candy.

College Football Arrives

Tailgating at Ole Miss in the Grove

My passions are typically every day ones - my labs, the outdoors. This week (Thursday, actually) is the start of the real passion/religion 'down here' in the South - big time college football. My team? The Gators.



What's it like for me and others in SEC Country? Here is a comparison of North v. South College Football:


Stadium size
North: College football stadiums hold 20,000.
South: High school football stadiums hold 20,000.

Fathers
North: Expect their daughters to understand Sylvia Plath.
South: Expect their daughters to understand pass interference.

Campus décor
North: Statues of Founding Fathers.
South: Statues of Former Coaches.

Homecoming queen
North: Also a physics major.
South: Also Miss America.

Heroes
North: Rudy Guiliani.
South: Bear Bryant, Steve Spurrier, Eli Manning.

Getting tickets
North: Five days before the game, you walk into the ticket office on campus and purchase tickets.
South: Five months before the game, you walk into ticket office on campus and put your name on waiting list for tickets.

Parking
North: An hour before game time, the university opens the campus for game parking.
South: RVs sporting their school flags begin arriving on Wednesday for the weekend festivities.

Game day
North: A few students party in the dorm and watch ESPN on TV.
South: Every student wakes up and rushes over to where ESPN is broadcasting “GameDay Live” to get on camera and wave to the fans up North who wonder why “GameDay Live” is never broadcast from their campus.

Tailgating
North: Raw meat on a grill, beer with lime in it, listening to local radio show with truck tailgate down.
South: 30-foot, custom pig-shaped smoker fires up at dawn. Cooking accompanied by live performance by Dave Matthews Band, who come over during breaks.

Getting to the stadium
North: You ask, “Where’s the stadium?” When you find it, you walk right in.
South: When you’re near it, you’ll hear it. On game day, it becomes the state’s third largest city.

When National Anthem is played
North: Stands are less than half full, and less than half of them stand up.
South: 93,000 fans, all standing, sing along in perfect four-part harmony.

Announcer
North: Neutral and paid.
South: Announcer harmonizes with the crowd in the fight song, with a tear in his eye because he is so proud of his team.

After the game
North: The stadium is empty way before the game ends.
South: Another rack of ribs goes on the smoker. Planning begins for next week’s game.

Fans
North: Women comment "My, what a rough sport."
South: Women scream "DON'T JUST TOUCH HIM, TAKE HIM DOWN!"

Womens' Attire

North: Chapstick in their back pocket and a
$20 bill in their front pocket.

South: Louis Vuitton bag and a fifth of bourbon, barnoculars.

North: Fans wear a team tshirt.
South: Fans wear a team tshirt, pants, shoes, face paint, and sunglasses.

Vehicles:
North: Cars and trucks have a removal window flag.
South: Cars and trucks are custom painted w/ team colors, Flat screen TV, portable
satellite, and Honda generator.

Alumni
North: Take prospects on sailing trips
before they join the law firm.
South: Take prospects on fishing trips so
they don't leave for the NFL their senior year.


In case you have made it this far, a special lagniappe, this video:

Steam Dietary Supplement Recalled

Nutracoastal Trading LLC announced today that it is expanding its July 28th, 2009 voluntary nationwide recall of the company's dietary supplement product sold under the following name: STEAM.

The Company has found by lab analysis that Lot 90260 contains Tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM DIETARY SUPPLEMENT an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.

The recalled product listed below was distributed in white plastic bottles to retail stores nationwide.

Brand Name Size Lot EXP. UPC

STEAM 1 Bottle – 5 Capsules 90260 6 11 8 52263 30033 1

No illnesses have been reported to the company to date in connection with this product.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

The FDA has been apprised of this action.

Stella Awards, Part II

Good stuff from my friend Jere Beasley:

The annual Stella Awards list, a list of the years seven “most outlandish lawsuits and verdicts in the U.S.,” is nothing more than a fraud on the public. The so-called awards deal primarily with fiction, and many of the lawsuits listed never happened. The examples of what they describe as frivolous lawsuits are at best gross misstatements. The Stella Awards are just part and parcel of the carefully planned efforts designed to destroy the civil justice system. Once these awards are announced, they take on a life of their own. That’s because of the Internet. Unfortunately, the media never bothers to investigate the validity of the cases mentioned in the awards, and then write stories that keep the myths alive.

An example of how these myths orginate is this year’s runaway First Place Stella Award winner. Mrs. Merv Grazinski, of Oklahoma City, Oklahoma, who supposedly purchased a new 32-foot Winnebago motor home, was the winner. On her first trip home, from a football game, having driven on to the freeway, she set the cruise control at 70 mph and calmly left the driver’s seat to go to the back of the Winnebago to make herself a sandwich. Not surprisingly, the motor home left the freeway, crashed and overturned. Also not surprisingly, Mrs. Grazinski was supposed to have sued Winnebago for not putting in the owner’s manual that she couldn’t actually leave the driver’s seat while the cruise control was set. It was reported that an Oklahoma jury had awarded the woman $1,750,000 plus a new motor home. It was also said that Winnebago actually changed their manuals as a result of this suit, just in case Mrs. Grazinski has any relatives who might also buy a motor home. The e-mail that announced the award concludes: “Are we, as a society, getting more stupid?”

The truth is that this sort of nonsense relating to a Winnebago lawsuit never even happened. But, the media bought the story hook, line, and sinker, and never even bothered to check it out. Scores of articles – the vast majority buying the Winnebago story as gospel truth – resulted across the country. Apparently, few journalists bothered to do any research to determine whether they were true. Among outlets falling for the hoax were the New York Daily News, CNN and U.S. News & World Report. In fact, the story actually spread around the world. Readers in Canada, England, Australia, Ireland, New Zealand and even Vietnam heard about this fictitious lawsuit that never happened. To his credit, Los Angeles Times reporter Myron Levin, who wanted to learn more about the lawsuit, called Winnebago and found out there was no Grazinski lawsuit. He also learned that the company had not changed the owner’s manual to avoid a swarm of copycat claims as claimed by the Stella awards.

The next time an “Internet tale” makes you believe things are even worse than you thought, check it out. Especially when the story suggests that the American court system is stacked against wealthy Corporate America. If you want to check out the “Stella Awards” and decide for yourself whether they are on the level, a good place to go is www.snopes.com, an excellent site that investigates urban myths. Simply search for “Stella Awards” and find out if the lawsuit stories are true or false.

Stella Awards -Fabricated

The Stella Awards® were inspired by Stella Liebeck, the Plaintiff in the McDonald's coffee case. Some folks may know that The sweatpants Liebeck was wearing absorbed the coffee and held it next to her skin. A vascular surgeon determined that Liebeck suffered full thickness burns (or third-degree burns) over 6 percent of her body,
including her inner thighs, perineum, buttocks, and genital and groin areas. She was hospitalized for eight days, during which time she underwent skin grafting. Liebeck, who also underwent debridement treatments, sought to settle her claim for $20,000, but McDonalds refused.

There are many debunked jury "award" reports linked to the claimed awards.

From their own site:

"Many stories are going around the 'net saying they are "The Stella Awards". Many of these stories are false, made-up, or (sometimes) true stories with false elements added to them.

The sad part: despite these stories having been debunked years ago, they not only still circulate, but many reporters, columnists and radio "personalities" still talk about them as if they were true, which says a lot about their professionalism. In many outrageous cases, these lazy "news" people will even link to this site as the source of these silly lies."


Claimed Cases -Status:

Kathleen Robertson of Austin, Texas, was awarded $780,000 by a jury after breaking her ankle tripping over a toddler who was running amuck inside a furniture store. The owners of the store were understandably surprised at the verdict, considering the misbehaving tyke was Ms. Robertson's son. Fabricated.

Carl Truman, 19, of Los Angeles won $74,000 and medical expenses when his neighbor ran his hand over with a Honda Accord. Mr. Truman apparently didn't notice someone was at the wheel of the car whose hubcap he was trying to steal. Fabricated.

Terrence Dickson of Bristol, Penn., was exiting a house he finished robbing by way of the garage. He was not able to get the garage door to go up because the automatic door opener was malfunctioning. He couldn't re-enter the house because the door connecting the house and garage locked when he pulled it shut. The family was on vacation, so Mr. Dickson found himself locked in the garage for eight days. He subsisted on a case of Pepsi he found, and a large bag of dry dog food. Dickson sued the homeowner's insurance claiming the situation caused him undue mental anguish. The jury agreed to the tune of half a million dollars and change.Fabricated.

Jerry Williams of Little Rock, Arkansas, was awarded $14,500 and medical expenses after being bitten on the buttocks by his next door neighbor's beagle. The beagle was on a chain in its owner's fenced-in yard, as was Mr. Williams. The award was less than sought after because the jury felt the dog may have been provoked by Mr. Williams who, at the time, was shooting it repeatedly with a pellet gun. Fabricated.

A Philadelphia restaurant was ordered to pay Amber Carson of Lancaster, Pennsylvania $113,500 after she slipped on a spilled soft drink and broke her coccyx. The beverage was on the floor because Ms. Carson threw it at her boyfriend 30 seconds earlier during an argument. Fabricated.

Kara Walton of Claymont, Delaware, successfully sued the owner of a nightclub in a neighboring city when she fell from the bathroom window to the floor and knocked out her two front teeth. This occurred while Ms. Walton was trying to sneak through the window in the ladies room to avoid paying the $3.50 cover charge. She was awarded $12,000 and dental expenses. Fabricated.

The "winner" every year: In November, Mr. Grazinski purchased a brand new 32 foot Winnebago motor home. On his first trip home, having joined the freeway, he set the cruise control at 70 mph and calmly left the drivers seat to go into the back and make himself a cup of coffee. Not surprisingly, the Winnie left the freeway, crashed and overturned. Mr. Grazinski sued Winnebago for not advising him in the handbook that he could not actually do this. He was awarded $1,750,000 plus a new Winnebago. Fabricated.

Don't be fooled into believing all that you read on the web.

Katrina: New Orleans Four Years Later

It's easy for many to simply forget that Katrina hurt much more than New Orleans. It devastated parts of lower Mississippi and damaged coastal Alabama as well.

I flew out of New Orleans the weekend before Katrina hit. I was there this weekend, on the 4th Anniversary of the storm's passing. In between, I have been back to New Orleans more than 25 times in the last four years. I was there for the first Mardi Gras post storm, and walked the fairgrounds for the 1st Jazz Fest after the storm.

I spent time reading about the city. Reading about its history, about the history of the French Quarter. I walked (and ran) its streets post storm. I went to St. Bernard Parish, saw the Lower 9th's destruction, as well as that of East New Orleans.

This is a city that deserves to be rebuilt just as much - more so - than the cities being rebuilt in Iraq by the US Military. Sure, the politics of the city are god awful. The spirit of the people though, is coming back. At least in areas away from where the flooding was at its worst.

In case you are wondering, the Central Business District is coming back. Surely the economy has hurt the rebuilding of the CBD. The Garden District is looking much better, where thankfully the damage was not as severe. The Quarter is seemingly back to its nearly normal tawdry self.

The area between the Port and the edges near Canal Street are hit and miss, but there is development.

I won't rant about what happened, didn't happen, or which politician was most incompetent (not on these pages, anyway). I will simply say this: Go. Visit the city. Eat at its 100+ year old restaurants. Take a walking tour of the Quarter, which while universally known as the French Quarter, has most of its standing buildings being of Spanish origin. Have a two hour plus dinner at Antoine's, or Bayona. Drive - like I just did - from the edge of the city out to the south and west, taking Highway 90 through cajun country.

I'll be back to my favorite city in America soon. Join me?

Image via Wikipedia

Diet Drug Reviewed by FDA: Orlistat (Xenical)

The FDA said it has received 32 reports of serious liver injury -- including six cases of liver failure -- among users of diet drug orlistat, which is sold as a prescription drug under the trade name Xenical and as an over-the-counter diet aid under the name Alli.

As a result of those reports, the FDA said it had initiated a safety review of the product, which works by blocking the absorption of ingested dietary fats.

Orlistat 120 mg (Xenical) was approved in 1999 for weight loss in conjunction with a reduced caloric diet and for prevention of rebound weight gain after weight loss. The OTC version, orlistat 60 mg, was approved in 2007 for use by overweight adults ages 18 and older.

The FDA said that in addition to the 32 reported cases, orlistat safety "was discussed at the CDER Drug Safety Oversight Board in April 2009, and the FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA's analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time."

Source here.

Tamifoxen News

A report recently released suggests that a drug used to prevent the recurrence of breast cancer may have a rare but dangerous side effect: increasing the odds that long-term users may develop an uncommon but aggressive new tumor.

The report was called into question right away, noting clinical trials had repeatedly found that the drug, tamoxifen, reduced the recurrence and spread of common breast cancers and that its benefits exceeded any possible risks.

For more, go here.

Sports and the Law

A few items of interest for me, given my love of sports. Always a fun read when law intersects with Sports:

Delaware Lottery and NFL? Scratch that.

"In a rare move, the appellate court not only found that a lower court judge had erred in refusing to issue a preliminary injunction, but declared that the answer to the ultimate question in the case was indisputably clear -- and that a permanent injunction must be issued.

Lawyers for Delaware had urged the appellate court to greenlight the new lottery, arguing that it was protected under a PASPA exemption that grandfathered in the existing sports betting statutes in four states.

But lawyers for the sports leagues argued that Delaware was strictly limited to restarting the sort of sports betting it had conducted for a few months in the mid-1970s -- a multi-game football pool limited to betting on at least three NFL games at once.

Delaware should be blocked from launching a sports lottery at three racetracks or "racinos" that allows for single-game betting on any sport other than games played by Delaware college teams."

Read more here at the source.

FSU and NCAA: Judge says NCAA must publicly release FSU documents

Circuit Judge John C. Cooper said he'd give the NCAA two days from when he signs a written order next week to turn the documents over to The Associated Press and other media, which filed a public records lawsuit.

NCAA lawyers said they will appeal to block the release.

The documents focus on Florida State's appeal of an NCAA plan to strip coaches and athletes of wins in 10 sports.

That includes football coach Bobby Bowden, who stands to lose 14 victories. It would dim his chances of again becoming major college football's winningest coach. Bowden has 382 victories -- one behind Penn State's Joe Paterno.

The NCAA said in a statement it was "very disappointed this court has determined the NCAA's private records could be transformed to public records."

Source here.

Atlanta Spirit Lawsuit:

"Boston-based partner Steve Belkin had asked his Atlanta Spirit partners to buy out his 30 percent stake in the two teams back in August 2005, a process that was supposed to take 125 days. Ever since, the Spirit has been embroiled in a high-profile legal battle that has lasted nearly four years and earned the group a reputation as the most fractious ownership in North American professional sports.

Their arguments wound through the Maryland circuit court system and finally to the Maryland Court of Special Appeals, which overturned the lower court’s ruling as too vague.

The ruling, issued Monday afternoon, tossed out the initial purchase and sale agreement to buy out Belkin and keeps him in the partnership as a minority owner. The partners are now placed back in precisely the same position they were in before August 2005. The judge’s decision came after a trial that began in February and wrapped in early May.

“We won on every single point,” Spirit co-owner and NBA Governor Michael Gearon Jr. said in a statement released by the team. “The court did exactly what we asked it to do. We are back under the operating agreement which we think is a good agreement. We no longer have any obligation to buy out Belkin nor does Belkin have any right to purchase the Hawks and Thrashers.”

Read the whole story here at the AJC site.

Yaz & Yasmin Injury, Georgia

Our office is investigating claims of injury related to the birth control pills known as Yaz or Yasmin:

Yasmin and Yaz are two types of birth control pills manufactured by Bayer Healthcare, and the generic, Ocella, is marketed and distributed by Barr Laboratories, Inc. Yasmin and Yaz contain the same estrogenic compound, ethinyl estradiol, that has been used in “The Pill” since the 1970s, but the progestin in Yasmin and Yaz is new. Yasmin and Yaz both contain drospirenone, a “fourth generation” progestin – no other birth control pills contain drospirenone, except for a recently approved generic version, Ocella.




Side Effects of Yaz/Yasmin Birth Control Pills

Yaz/Yasmin was approved by the Food and Drug Administration (FDA) in 2006 as an oral contraceptive, and was marketed by its manufacturer, Bayer. Once the drug hit the market, however, the FDA started to receive reports of side effects when taking Yaz/Yasmin, including:

* Deep Vein Thrombosis (DVT): Deep vein thrombosis commonly affects the leg veins (such as the femoral vein or the popliteal vein) or the deep veins of the pelvis. Occasionally the veins of the arm are affected (if spontaneous, this is known as Paget-Schrötter disease). The most serious complication of a DVT is that the clot could dislodge and travel to the lungs, which is called a pulmonary embolism (PE). DVT is a medical emergency, present in the lower extremity there is 3% chance of a PE killing the patient.

* Pulmonary Embolism (PE): Pulmonary embolism (PE) is a blockage of the main artery of the lung or one of its branches by a substance that has travelled from elsewhere in the body through the bloodstream (embolism). Usually this is due to embolism of a thrombus (blood clot) from the deep veins in the legs, a process termed venous thromboembolism. A small proportion is due to the embolization of air, fat or amniotic fluid.

* Heart Arrhythmia: An irregular heartbeat is an arrhythmia (also called dysrhythmia). Heart rates can also be irregular. A normal heart rate is 50 to 100 beats per minute. Arrhythmias and abnormal heart rates don't necessarily occur together. Arrhythmias can occur with a normal heart rate, or with heart rates that are slow (called bradyarrhythmias -- less than 60 beats per minute). arrhythmias can also occur with rapid heart rates (called tachyarrhythmias -- faster than 100 beats per minute). In the United States more than 850,000 people are hospitalized for an arrhythmia each year. There are types of this condition:

Premature atrial contractions; Premature ventricular contractions (PVCs); Atrial fibrillation; and Atrial flutter, among others.

* Heart Attack/Myocardial Infarctions and
* Stroke and Transient Ischemic Attacks

What is in the pill:

Yaz/Yasmin contains a synthetic progestin called drospirenone, which some claim will raise blood potassium levels. Doing so may result in a dangerous condition known as hyperkalemia. Hyperkalemia can lead to life-threatening heart problems.

Xolair- Investigate for Link to Cardiac Problems?

In Canada news:

The safety of the asthma drug Xolair is under review to investigate a potential link to cardiovascular problems.

The probe was triggered by interim findings in an ongoing U.S. study into the long-term safety of Xolair, known generically as omalizumab.

The early data point to a disproportionate increase in cardiovascular problems among people treated with Xolair compared with those who did not take the drug. The reported problems include heart attacks, abnormal heart rhythms, heart failure, fainting, mini-strokes and blood clots.

That's part of an article you can find here.

Cellcept Warning Label Updated

A warning of a risk of pure red cell aplasia (PRCA) has been added to the label and prescribing information for mycophenolate mofetil (CellCept).

Drug manufacturer Roche reported 41 cases of PRCA in patients given mycophenolate mofetil. In 16 of the cases, reduction of the dose or discontinuation resolved the condition.

The mechanism causing the side effect is unknown, but the manufacturer noted that some of the cases were also receiving other immunosuppressants, which may have contributed to the aplasia's development.

"When PRCA occurs in a patient on multiple immunosuppressants, the relative contribution of the drugs to PRCA and the prophylaxis of rejection must be considered before a decision is made to discontinue a drug," according to the letter to healthcare professionals sent by Roche announcing the new warning.

Other adverse effects reported with mycophenolate mofetil include increased likelihood of opportunistic infection, fetal damage in pregnant women, and lymphoma in patients taking the drug as part of an immunosuppressive regimen.

From Medpage Today.

What Should a Solo/Small Firm Focus on to build a practice?

I have been reading on several sites the opinions of what a solo lawyer or small law office should do when it comes to building a client base. There can never be a set list of what is important, but I do shudder when (at least in the consumer law/personal injury field) I see people blindly touting Social Networks as the key to all things, or a key building block. They're wrong.

On twitter, someone posted this: Solo/small should focus on social networking, blogging, thought leadership and niche focus more than "advertising." Doing so is folly. What matters on any list, at least for my areas of law noted above?

1.Competency: Knowing the area of the law- Really knowing it. Because if you say you do, and you don't, a potential client will learn of it. Sometimes, while you talk to that person at an event.

2.Networking: Live, real world networking. Not Twitter, not Facebook. Affinity groups, volunteering, law associations, meetings, conventions. Shaking hands, taking people to lunch or breakfast.

3a.Web presence- Each day I am amazed/appalled at what some lawyers/firms try to pass off as a web site. No phone number on page one. Impossible to locate office address. Spend the time building a website. Keep it current. One firm's website I saw listed under "Recent News" an article from April ... of 2008 ... as the lead news story.

3b.Learning Google Adwords: Most lawyers will mention how many hours are spent preparing for a deposition in a case, but simply slough off Google and internet advertising. Learn it. Google Adwords training can be done over time. Even if all you do is put up a google ad with your name or firm name, limited to your state, you must do it. I bet that what one Gen Y staffer calls a "kick ass" website for your firm, with Google, will generate more work than all SN sites you work on combined.

4.Blogging- This site for me is an outlet, sort of my office without the suit jacket and tie. I blog about law, pharma, and more - even the loss of my beloved dog. After three years, it's not uncommon for our office to receive 50+ emails or calls a month from the blog. With zero cost (thanks blogger!) to run and zero advertising.

5.Marketing to current clients:Good work is nice, but the last thing I need to hear is a person telling me, "I didn't know you practiced that type of law, or I would have told my brother/neighbor/pastor about you." We send out to every client a glossy "important papers" folder, a current (and not cheap) 8 1/2 by 11 Calendar, and more. Each year, new Calendar. In fact, when we miss a couple, I get the call asking "Where's my calendar?" We're working a birthday cards now.

6.List Servers: Speaking only for trial lawyers, our list servers are terrific sources of information as well as work. I contribute from time to time, I read daily, and I offer to assist. If you don't have one for your practice, dig. ABA and a State Bar may be a good start.

Way down on my list is Social Networks like Facebook and others. I no longer use two of them to build my office's work.

The Twitter post mentioning "thought leadership." Jargon. Worthless. How many of you reading this blog post even know what that means. That makes no list. For now.

Social Networks? Sure. I spend 1-5% now on it. I like Twitter- For the rapid rush of information. In certain areas- news, entertainment - great. For law? Not so much at least in my vast area - consumer law and injury practice. I spend time on it.

The point of all this is - learn by doing. I think SN will perhaps be like a yellow pages ad- a good but small part of your practice.

If you think I am wrong when it comes to SN on any list, I'd love to hear from you. Tell me your area of practice, and please - PLEASE- don't merely mention how you now have 1 or 2 clients from SN. If you have a practice where more than 15% have come from SN, my guess is you're a lawyer in tech, IP, or Entertainment.

Actos and Avandia News

A large study from British Columbia, Canada is pointing to an increased fracture risk with thiazolidinediones (TZDs), used in the treatment of type 2 diabetes [1]. The study, which reviewed fracture risk in more than 84 000 patients receiving either rosiglitazone (Avandia, GlaxoSmithKline) or pioglitazone (Actos, Takeda) vs a sulfonylurea, found that both men and women are at increased risk of broken bones when taking a TZD and hints that pioglitazone may be more strongly associated with fracture risk. Two years ago, the FDA requested that a warning on fracture risk be added to the pioglitazone labeling.

The study appears in the August 10/24, 2009 issue of the Archives of Internal Medicine.

"Larger observational studies are needed, and fracture data from clinical trials need to be fully published so that fracture risks can be known with greater certainty," Dr Colin R Dormuth (University of British Columbia, Vancouver) and colleagues write.

Dormuth et al point out that the research linking fractures to TZD use has not been entirely consistent, with some trials (but not all) suggesting different effects for the two commercially available TZDs and others pointing to a different degree of risk according to gender.

www.segeorgialaw.com

Permax Information

Earlier in 2007, the FDA announced that Permax (generic: pergolide) was withdrawn. There are additional drugs in the same class that can be substituted.


Studies had been released linking Permax with heart valve damage. A study by Italian researchers found that approximately one-fourth of Parkinson's patients taking Permax had moderate to severe heart valve troubles. An additional study, by German doctors, established that users of Permax were five to seven times more likely to have leaky heart valves than those on other types of Parkinson's medications. Both studies can be found in the New England Journal of Medicine.

Avandia - Diabetes Drug- Heart Attack Link?

Avandia is manufactured by GlaxoSmithKline for type 2 diabetes. It was first approved for use in 1999. Since then more than 6 million people worldwide have taken this drug. Avandia helps sensitize the body to insulin and helps control blood sugar. According to a recent study by the New England Journal of Medicine, patients taking Avandia have a 43% higher rate of heart attacks.

Several published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.

The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

If you believe you were injured because of your use of Avandia, talk with me.

Fosamax: First Trial Approaches

Merck & Co., the drugmaker facing 900 lawsuits over claims that its osteoporosis drug Fosamax causes the death of jawbone tissue, goes to trial this week. The trial in New York of the first case of the group, filed by Shirley Boles, 71, will be one of three cases to go this summer.


The Fosamax plaintiffs claim Merck misrepresented the drug’s safety and failed to warn doctors and patients that it might hamper blood flow to the jaw, causing jawbone-tissue death and leading to partial removal in some patients. Jawbone tissue death is called osteonecrosis of the jaw, or ONJ.

The patients claim Merck didn’t sufficiently warn about the drug’s risks when it changed the label in 2005. “They were the only drug company not to use the language that the FDA requested,” O’Brien said, referring to the U.S. Food and Drug Administration.

Merck says the drug is safe and effective.

Fentanyl Patch Recall News

Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that one lot of 100 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies. The recalled patches are from Lot Number 145287A, have expiration dates of February 2011 and were manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma, Inc. The affected lot of Fentanyl Transdermal System patches was shipped to customers between April 2, 2009 and May 20, 2009. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall. The Company has notified the U.S. Food and Drug Administration (FDA) of the recall.

A small number of patches leaking fentanyl gel have been detected in this lot, potentially exposing patients or caregivers directly to fentanyl gel. Fentanyl patches that are leaking should not be used. No serious injuries have been reported in connection with the recalled lot. However, exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.

Anyone who has 100 mcg/hr Fentanyl Transdermal System patches should check the box or foil pouch for the lot number and expiration date to see if they have patches that are being recalled. Affected patches should not be handled directly. Anyone with 100 mcg/hr Fentanyl Transdermal System patches being recalled should call 888-345-2656, Monday through Friday, 8:00 a.m.-5:00 p.m. EDT, for instructions on how to return affected product.

Patients using fentanyl patches who have medical questions should contact their healthcare providers.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

Source here.

Courts: Remand Order Worth a Read

Below is a link to a recent US District Court Order regarding a case that had been removed from a State Court (in Alabama) to a Federal Court based on diversity as well as Defendants' claim that the jurisdictional amount had been met.

The Federal Court Judge assigned to the case wrote:

"The question [before the Court[ is whether this specific settlement demand, given all the evidence presented, established by a preponderance of that evidence that the amount in controversy exceeds $75,000 ... The defendants insist that the plaintiffs’ demand of $155,000 must meet this standard simply because the demand was made. The proper assessment of settlement offers is not so facile. “While [a] settlement offer, by itself, may not be determinative, it counts for something.” Burns v. Windsor Insurance Co., 31 F.3d 1092, 1097 (11th Cir. 1994). What it counts for, however, depends on the circumstances."

The case may be found here.

What Should a Solo/Small Firm Focus on to build a practice?

From the FDA:

The U.S. Food and Drug Administration announced an update to a previous safety alert on four botulinum toxin drug products, noting that all of them now have boxed warnings on their labels and have developed Medication Guides for patients, as directed by the agency in April 2009.

The boxed warning cautions that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include potentially life-threatening swallowing and breathing difficulties and even death.

These symptoms have mostly been reported in children with cerebral palsy being treated with botulinum toxin for muscle spasticity, a use of the drugs that has not been approved by FDA. Symptoms have also been reported in adults treated both for approved and unapproved uses.

The affected products are:
- Botox (new established name: onabotulinumtoxinA)
- Botox Cosmetic (new established name: onabotulinumtoxinA)
- Myobloc (new established name: rimabotulinumtoxinB)
- Dysport (abobotulinumtoxinA) was approved in April 2009 with the boxed warning and is not making any name or label changes at this time.

No definitive serious adverse event reports of distant spread of toxin effect have been associated with dermatologic use of Botox/Botox Cosmetic at the recommended doses (for frown lines between the eyebrows or severe underarm sweating). As well, no definitive serious adverse event reports of distant spread of toxin effect have been associated with Botox when used at approved doses for eyelid twitches or for crossed eyes.

The revised labels also emphasize that the different botulinum toxin products are not interchangeable, because the units used to measure the products are different. To help reduce the potential for dosing errors, the botulinum toxin products have changed their established drug names (often referred to as the drug’s “generic” name). Neither the brand names nor the formulations of the products have changed.

Tort Reform Champion Loses Med Mal Case

I pulled this from my good friend Chris Hellum's blog, analabamalawyer

"Elliott Kaplan is a prominent Kansas City attorney. For years, he railed against judges, juries, and trial attorneys. He was well known as one of the founders of the modern tort reform movement in America. He was named "Legal Reform Champion" by the American Tort Reform Association.

In a cruel twist of fate, it appears he may have reaped what he sowed.

According to its website, The American Tort Reform Association was founded in 1986 by the American Council of Engineering Companies and shortly thereafter, the American Medical Association followed them. They have worked to enact tort reform legislation in 45 states. They have led grassroots efforts which have resulted (they claim) in 85% of Americans believing that frivolous lawsuits clog our courts.

Their efforts have paid off, perhaps to the detriment of one of their own. According to the National Practitioner Data Bank, the number of U.S. malpractice payments in 2008 was the lowest since creation of the federal National Practitioner Data Bank, which has tracked payments since 1990.

WHAT HAPPENED TO LAWYER KAPLAN

Lawyer Kaplan was diagnosed in 2003 with pancreatic cancer by his doctor in Kansas City. Kaplan sought the best care money could buy. He went to the Mayo Clinic in Rochester, MN. There he was again diagnosed with pancreatic cancer.

To save his life, he underwent a Whipple resection, a highly invasive surgery that can cause more harm than good. It was only after the surgery that the diagnosis was determined to be wrong, that he only suffered from pancreatitis, and that the Whipple resection made the condition worse, leaving him debilitated and a broken man.

Believing that the doctor had committed malpractice, Kaplan sued the pathologist alleging negligence in the diagnosis. He assembled an army of attorneys to represent him. Unfortunately, the jury found against Kaplan and awarded him no damages. He has moved for a new trial. The motion is currently pending.

I certainly feel for Lawyer Kaplan. Unfortunately, he and the organization which he was a "Champion", foster the belief that all lawsuits are frivolous and that they compromise access to affordable health care, punish consumers by raising the cost of goods and services, chill innovation, and undermine the notion of personal responsibility.

I don't know if his lawsuit was meritorious or not. If it is, then I pray that justice will prevail. I do know that his organization, the American Tort Reform Association, has perpetuated the belief among most Americans that all lawsuits are frivolous. The beneficiaries of this belief are not injured or defrauded people, but the insurance companies and large corporations who fund these organizations."


Chris Hellums can be reached at Chrish@pdkhlaw.com

Denture Cream Issues: Fixodent and Poligrip

Approximately 35 million Americans use denture creams and several of the popular adhesives, such as Fixodent and Super PoliGrip, have been linked to serious and debilitating injuries caused by excess levels of zinc contained in the products that may enter the body.

Some users may have suffered from neuropathy or other injuries caused by zinc poisoning, which could cause symptoms like:

* Paralysis
* Numbness
* Loss of Sensation
* Tingling or Pain in Hands or Feet
* Muscle Weakness
* Loss of Balance
* Difficulty Walking
* Unexplained Pain or Weakness

The makers of each product believe their products work as advertised.

Blair Robe Recall - Important News

Women’s Chenille Robes Recalled by Blair Due to Burn Hazard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Full Length Women’s Chenille Robes

Units: About 162,000

Retailer: Blair LLC, of Warren, Pa.

Hazard: Some robes fail to meet federal flammability requirements and present a risk of serious burns to consumers if they are exposed to an open flame.

Incidents/Injuries: Blair has received three reports of the robes catching on fire, including one report of second-degree burns.

Description: The recall involves the Full Length Women’s Chenille Robe with the following item numbers: 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. The item number is identified on a label in the garment’s neckline. This is a one-piece garment made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robe has a full-button front with seven matching button closures, long sleeves with self cuffs, a straight bottom with self hem, and two sideseam pockets. The robe’s sewn in label states: “100% Cotton, RN 81700, Made in Pakistan”. Robes with other item numbers are not included in the recall.

Sold at: Blair catalogs and Web site, and Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009 from about $20 to $40.

Manufactured in: Pakistan

Remedy: Consumers should stop wearing the garment immediately. Contact Blair LLC for information on returning the robe and to receive a refund or a $50 gift card for Blair merchandise.

Court Decisions: Sealed Container Defense Rejected in AL as to Retailers

News regarding an Alabama Supreme Court decision, and cases are before the Court on a certified question from the United States District Court for the Northern District of Alabama. The USDCT concluded that it was not clear under Alabama law whether claims alleging the breach of the implied warranties of merchantability and fitness for a
particular purpose are subject to the defense of the sealed-container doctrine.

Supreme Court held that they were not. Opinion here.

Medtronic Recalls Lots of Paradigm® Quick-Set® Infusion Sets in the United States

Medtronic, Inc. has initiated a recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” Medtronic recently discovered that approximately two percent of “Lot 8” Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly. The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death.

Patients should discontinue using “Lot 8” Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Visit the Medtronic Diabetes website at www.medtronicdiabetes.com/lot8 to view the labels of “Lot 8” Quick-set infusion sets. Customers are being asked to return any affected infusion sets to the company. Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge.

More about the recall here.

segeorgialawblog.com

Image by TeecNosPos via Flickr

I'm working on a new blog for Southeast Georgia. I've been litigating in Brunswick, Glynn County, Woodbine, Folkson, Camden County and other cities there for nearly a half decade, and have opened an office there.

For a dose of segeorgia flavor, visit that blog.

News from A Friend's Firm: Lawsuit in MD

I count Rick Kuykendall as one of those lawyers whom I trust. He's with the Murphy Firm in Baltimore, and there is this news this week:

The Murphy Firm of Baltimore and Henry & Associates of Largo have announced the filing of a 12-count civil suit that charges Prince George's county officials and some of the County's correctional and law enforcement officers with responsibility for the 2008 death of 19-year-old Ronnie L. White, who, the suit states, was “assaulted and killed by the very same correctional officers who were supposed to be there to insure his safety.”

White died of a broken neck and asphyxiation 34 hours after he was received in custody by the Prince George's County Correctional Center. Following an autopsy, the Office of the Chief Medial Examiner for the State of Maryland ruled that White's death was a homicide.

The suit, filed on behalf of White's mother, Angela L. White, states that Ronnie White’s death was “the direct result” of excessive force and gross negligence by County officials, and that his constitutional and civil rights were violated. The suit is seeking $153,600,000 in compensatory and punitive damages.

Link here
.

We talked this morning, and he said his real issue front and center today is making sure his daughter Amalee Kuykendall gets to college on time. I worry about that day as well!

Weight Loss Supplements Recalled

The U.S. Food and Drug Administration (FDA) www.fda.gov alerts Universal ABC Beauty Supply International, Inc., a Brooklyn based dietary supplement manufacturer, found the illegal, unapproved, and undeclared drug, Sibutramine, in the products the company distributes. Sibutramine, an FDA approved medication used as an appetite suppressant for weight loss, is a prescription approved medication by the federal government. The FDA has not approved the use of this prescription medication ingredient in 34 different Universal ABC Beauty Supply’s products.

The FDA issued a strong advisory to U.S. Consumers about the undeclared , Sibutramine, because the medication is known to cause the following harmful side effects:

-Substantially increase blood pressure and/or pulse rate in some patients
-High risk for patients with a history of coronary artery disease
-Harmful to consumers with congestive heart failure
-May be risky for patients who have arrhythmias
-Possible injury to patients with a medical history of stroke

Here's the product list:

PRODUCT NAME

1. ProSlim Plus, 60 capsules, bottle in box
2. 3 DAYS fit, 60 capsules, bottle in box
3. EIGHT FACTOR DIET, 60 capsules, 3 pouches/box
4. 24hours Diet, 60 capsules
5. Slim 3in1 M-18 ROYAL DIET, 90 capsules, 3 pouches/box
6. 3X SLIMMING POWER, 60 capsules, bottle in box
7. Extrim Plus 24 Hours RE-BURN Formula, 60 capsules
8. Slim 3in1 EXTRA SLIM FORMULA, 90 capsules, 3 pouches/box
9. Slim 3in1 EXTRA SLIM WAIST FORMULA, 90 capsules, 3 pouches/box
10. SLIM EXPRESS 360º C
11. SLIM EXPRESS 4in1, 60 capsules, bottle in box
12. ROYAL SLIMMING FORMULA, 60 capsules, bottle/box
13. BODY CREATOR, 90 capsules, 3 pouches/box
14. Slim Waistline (labeling written in Chinese)
15. BODY SHAPING, 90 capsules, 3 pouches/box
16. PERFECT SLIM, 90 capsules, 3 pouches/box
17. Perfect Slim 100% Natural Herbal Essence
18. IMELDA Perfect Slim
19. Slim Waist Formula, 32 capsules, 2 pouches/box
20. Super Slimming, 60 capsules, bottle in box
21. 2 DAY DIET
22. Powerful Slim
23. BODY SHAPING
24. SUPER FAT BURNER, 60 capsules, bottle in box
25. SLIMMING FORMULA
26. SLIM FAST 2, 32 capsules, 2 pouches/box
27. SLIM FAST, 60 capsules, 3 pouches/box
28. Slim up, 120 capsules, bottle in box
29. 7 DAYS DIET, 60 capsules, 3 pouches/box
30. Perfect Slim Up, 60 capsules, bottle in box
31. JM Fat Reducer
32. SlimBurn
33. 21 Double SLIM
34. TRIM PLUS 2

Dietary Supplement Recall

Hi-Tech Pharmaceuticals and the FDA have notified healthcare professionals and consumers of a nationwide recall of all products sold under the name Stamina-Rx.

An FDA lab analysis found that the product contained the undeclared ingredient, benzamidenafil. Benzamidenafil is in the same pharmacologic class as the phosphodiesterase type 5 (PDE5) inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED). Benzamidenafil is not FDA-approved and poses a threat to consumers because it may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels. Patients with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the most susceptible to adverse effects from this product.

Source here.

FDA To Discuss Liver Risks With Tylenol,Other Painkillers

Image via Wikipedia

The FDA will be taking a look at painkillers such as Tylenol next week.




The issue front and center relates to acetaminophen, a drug found in Excedrin as well as NyQuil and Theraflu, that can cause liver damage. Acetaminophen is the most widely used drug in America.


Acetaminophen is found in more than 100 products, including many prescription drugs administered by pharmacies. Much of its popularity is because - when taken at recommended doses - acetaminophen does not cause stomach discomfort or bleeding, unlike other drugs commonly used to reduce pain and fever, such as aspirin, ibuprofen and naproxen.

When, however, it's taken over the maximum amount of 4 grams per day, acetaminophen can cause liver damage, ranging from abnormalities in blood tests used to assess liver function to acute liver failure (ALF), and even death; a problem not caused by other over-the-counter painkillers.

Despite efforts since the early 1990s to reduce the incidence of acetaminophen-related liver damage, liver injury from acetaminophen overdose remains a serious public health problem. Source.



You'll be able to see the FDA at work by logging on to FDAAdvisoryCommittee.com


Source here.

Problems With Homeopathic Remedies?

An Associated Press analysis of the FDA's side effect reports has found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide.


According to reports:

The AP also found that the FDA has set limits for alcohol in medicine, especially for small children, but they don't apply to homeopathic remedies. At least 20 ingredients used in conventional prescription drugs, such as morphine for pain, are used in homeopathic remedies.

Source here.

Given recent recalls of over the counter products, it's imperative that consumers carefully read the label of products like Zicam and others.

Zicam Recalled

Intranasal spray Zicam is being recalled as the FDA warns of 130 cases of anosmia- loss of the sense of smell.

Some Zicam users reporting anosmia say that the condition started with the first dose, while others indicate the symptoms did not appear until multiple doses had been administered. Officials have not yet determined if the condition is permanent, and fear the intranasal gel spray may be damaging nerves. The FDA expressed concern that consumers are using Zicam for a minor, “self-limiting condition” (such as a cold) and inadvertently risk damaging their quality of life permanently.

The affected products have been pulled from store shelves across the country and the FDA have advised that all remaining product should be discarded and not used for any reason.

Source here.

Zyprexa news

From Public Citizen and other sources:

Eli Lilly urged doctors to prescribe Zyprexa for elderly patients with dementia, an unapproved use for the antipsychotic, even though the drugmaker had evidence the medicine didn’t work for such patients, according to unsealed internal company documents.

In 1999, four years after Lilly sent study results to the FDA showing Zyprexa was not effectively alleviate dementia symptoms in older patients, the company started to market the drug to such patients, so says documents unsealed in insurer suits against the company.

Lilly has pleaded pleaded guilty earlier this year to a federal misdemeanor charge of illegally marketing Zyprexa for off-label uses to elderly consumers. The company admitted illegal promotions from September 1999 through March 2001, while denying such practices beyond that date.

Source here.

Liberty National Life Insurance News: Florida Licensure At Risk?

Liberty National Life Insurance could have its license suspended or revoked in Florida for refusing to write life policies based on nationality or travel to certain countries, state insurance regulators said Thursday.

Investigators from Florida's Office of Insurance Regulation spent nearly five months reviewing life insurance policy applications from Florida residents and found that consumers of Haitian descent were more likely than others to have their applications denied.

The OIR order to Liberty National gives the company 21 days to provide proof that it didn't violate state laws that prohibit discrimination.

Liberty National, based in Birmingham, Ala., didn't return a call from The Miami Herald asking for comment on Thursday's order.

According to OIR's order, 52.6 percent of Haitian applicants were denied compared to 18.2 percent of other foreign-born applications. For instance, although Liberty National's life insurance application asks if consumers have lived in the United States for more than a year, it applied a selective 10-year residency requirement to customers born in certain countries such as Haiti or Colombia.

TRAVEL CONCERN

Applicants with plans to travel to such countries as Haiti, Liberia or Honduras were also denied.

Investigators reviewed some 7,000 applications and found 1,149 violations, including 1,053 involving discriminatory practices.

Read more here.

Calrcon Skin Product: Partial Recall and Warning

he Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon because of high levels of disease-causing bacteria found during a recent inspection.

Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, issued a voluntary recall of some skin sanitizers and skin protectants marketed under several different brand names, the FDA said in a statement.

Consumers should not use any Clarcon products and should throw them away, the FDA said.

Analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions, according to the agency. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage.

Examples of products that should be discarded include Citrushield Lotion, Dermasentials DermaBarrier, Dermassentials by Clarcon, Antimicrobial Hand Sanitizer, Iron Fist Barrier Hand Treatment, Skin Shield Restaurant, Skin Shield Industrial, Skin Shield Beauty Salon Lotion, Total Skin Care Beauty and Total Skin Care Work.

Link here.

Recent Avandia Medical Article

Avandia doesn't increase overall heart risks, according to final results of a large clinical study sponsored by the world's second largest drugmaker.

The study does seem to confirm that the medicine doubles the risk of heart failure -- a chronic condition where the heart struggles to pump enough blood around the body -- and also increases the danger of bone fractures.


You can find the article here.

Graves Disease Drug: Increased Risk for Liver Injury?

The FDA warned physicians that a drug used for 62 years to treat Graves' disease -- propylthiouracil, or PTU -- carries an increased risk for life-threatening liver injury.

The FDA said it has received 32 adverse event reports -- 22 in adults and 10 in children -- including 12 deaths and six transplants among adult users of the medication. In the pediatric population, the FDA said there were one death and six transplants linked to PTU use.

"Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy," the FDA said.

Source here.

Reglan: No MDL For Litigation

The JPML heard argument last week regarding a request by Plaintiffs' lawyers to consolidate proceedings involving Reglan. Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders.

The Petition was opposed by several drug maker of metoclopramide including Teva Pharmaceuticals USA, Actavis Elizabeth, Barr Pharmaceuticals and Pliva.

What's next? Likely a mess of results or rulings in multiple courts, both State and Federal.

412(i) Tax Shelter Litigation

My friend Alabama attorney Chris Hellums is investigating abusive tax shelter creation. Here's his post from his blog:

Typically, these transactions will include an Insurance company, accountant, tax attorney, and a promoter (someone with an insurance background, perhaps an actuary, who knows how to structure the policy itself). These groups will use insurance brokerages and sub-agents (licensed in the various states) to sell the policies themselves.

HOW THESE PLANS WORK:

In the late 1990’s, the individuals and groups above devised a scheme to sell abusive tax shelters under the auspices of Section 412(i) of the tax code. A 412(i) is a defined benefit pension plan. It provides specific retirement benefits to participants once they reach retirement and must contain assets sufficient to pay those benefits. A 412(i) plan differs from other defined benefit pension plans in that it must be funded exclusively by the purchase of individual life insurance products. To create a 412(i) plan, there must be a trust to hold the assets.

The employer funds the plan by making cash contributions to the trust, and the Code allows the employer to take a tax deduction in the amount of the contributions, i.e. the entire amount. The trust uses the contributed funds to purchase some combination of life insurance products (insurance or annuities) for the plan. As the plan participants retire, the trust will usually sell the policies for their present cash value and purchase annuities with the proceeds.

The revenue stream from the annuities pays the specified retirement benefit to plan participants. These defendants (with the aid and knowledge of the insurance companies) used the traditional structure and sold life insurance policies with excessively high premiums. The trust then uses the large cash contributions to pay high insurance premiums and the employer takes a deduction for the sum of those large contributions. As you might expect, these policies were designed with excessively high fees or “loads” which provided exorbitant commissions to the insurance companies and the agents who sold the products.

The policies that were sold were termed Springing Cash Value Policies. They had no cash value for the first 5-7 years, after which they had significant cash value. Under this scheme, after 5-7 years, and just before the cash value sprung, the participant purchases the policy from the trust for the policy’s surrender value. In theory, you have a tax free transaction.

The IRS does not recognize the tax benefit of such a plan and has repeatedly issued announcements indicating that such plans are contrary to federal tax laws and regulations. These plans were targeted to high net worth individuals, including doctors, dentists, corporate executives, and professional athletes.

Read more at his blog, here.

Bausch and Lomb Settles Fungal Infection Lawsuits

Image via Wikipedia

Contact lens maker Bausch & Lomb Inc. had an overriding reason for going private in 2007: It wanted to handle a devastating recall of its flagship lens cleaner, its chief executive said, "without a lot of outside distraction."

Over the past year, away from the glare of public scrutiny, the optical products company has quietly settled nearly 600 fungal-infection lawsuits — with dozens more individual claims yet to be resolved. The cost so far: Upward of $250 million.

Read more from this article here.

Reglan: JPML Hearing held in Louisville, KY

A motion to form an MDL, or Multidistrict Litigation, was argued yesterday before the JPML sitting in Louisville, Kentucky. There are at least 15 Reglan lawsuits pending in 11 different district courts throughout the United States.

Reglan is prescribed to treat gastrointestinal disorders like diabetic gastroparesis, GERD (gastroesphageal reflux and delayed gastrict emptying.

Request for Reglan lawsuit consolidation was opposed by the attorneys for companies involved in the litigation, including Wyeth, who manufactured the brand name Reglan products, and several manufacturers of generic versions, such as Baxter, Pliva, Barr, Duramed, Actavis, Teva and Scwarz Pharma.

Life Investors Insurance Class Action: Deadline Looms

Our firm is currently representing consumers who have cancer insurance policies with Life Investors Insurance Company of America as well as Transamerica.

Good and honest people bought cancer policies for a simple reason - To provide for a reimbursement amount of “actual charges” to be paid when incurred or billed. When claims were submitted, we believe that these two companies do not pay the “actual charges.” Instead, these insurers will pay a discounted amount for those same cancer treatments, contrary to the terms of the policy. We are pursuing individual cases.

Many people who bought a cancer insurance policy may have a received recently a class action notice in the case of Runyan v. Life Investors Insurance Company of America / Transamerica. The time period that applies to any policy bought during the years 2004 - 2006.

In our experience, the class action relief asked for is simply not an adequate remedy. As we see it, the Runyan class settlement is inadequate relief for policyholders.

We believe that “opting out” of the class action may be more appropriate to protect their individual rights. Alternatively, filing an objection to the class may be even more appropriate. We are currently evaluating both of these options for these policyowners, but we are nonetheless accepting cases for those who wish to either opt out or object to the class settlement in its entirety. The deadline to exclude yourself from this class is June 29, 2009.

The deadline to object to the settlement is June 29. 2009.

Tech: PDF For Lawyers

The site, that is. http://www.pdfforlawyers.com/ Is worth a look. Tips include: "Using Acrobat to put Exhibit stamps on digital documents." Also, learn how to OCR with the ScanSnap to create searchable PDF files at just the push of the “scan” button…


Worth your time. We use the Scansnap at work, and it's a must have.

Hydroxycut Lawsuit; Hypertensive retinopathy associated with Hydroxycut Usage

Here's a report on the use of performance-enhancing and weight-loss supplements is prevalent in the United States. The report notes that with new restrictions placed on such products, companies have been marketing caffeine-based ephedra-free herbal supplements.


The report notes, "less is known about the potential side effects of these products. We present the case of a 42-year-old, previously healthy man who developed malignant hypertension and hypertensive retinopathy while taking Hydroxycut, a caffeine-based ephedra-free supplement."

Find the abstract here.

Flomax and Cataracts

Men taking Flomax to treat an enlarged prostate face more than double the risk for serious complications should they need cataract surgery, a new Canadian study has found.

It's not the first time that Flomax (tamsulosin) has been linked to cataract complications. A study in 2005 found that men taking Flomax or other alpha-blockers before cataract surgery had complications during and immediately after the procedure. The U.S. Food and Drug Administration called for stronger warnings about the drug, and Boehringer Ingelheim Pharmaceuticals, which makes Flomax, sent warning letters to doctors about the potential problems.

In the new study, 7.5 percent of the men who had taken Flomax in the two weeks before cataract surgery had a serious complication, compared with 2.7 percent of those who had not taken the drug, for a 2.3 times greater risk.

Read more at this source, here.

Reglan: FDA Video from YouTube

Interesting that the FDA now uploads video to youtube.com

Hydroxycut Lawsuit Filed in Georgia State Court

Our office filed in Georgia State Court a lawsuit where a consumer claims she suffered an injury related to her use of Hydroxycut. The multi-count lawsuit claims, among other things, what most would expect: Negligence, Breach of Warranty, and other claims of wrongdoing.

We don't file class actions in my office, believing that the best way to seek some measure of justice for someone is to make a specific claim for each person in separate lawsuits. Other lawyers may go the class action route; it's just not for me.

I will post a few pages of the Complaint filed in the next day or so.

Reno Article: Reglan (Georgia, Alabama)

"It's wonderful when prescription medications cure ailments, but what happens when they cause adverse medical side effects?" The article goes on to note:


"I'm angry because I appear to be suffering from permanent central nervous system damage associated with the prescribed drug Reglan (brand name for "metoclopramide"), prescribed over a year ago for a digestive disorder.

I received a letter dated April 30 from my GI's office noting the FDA has placed a "Black Box Warning" on Reglan, explaining, it's possibly linked "with the development of a condition known as "tardive dyskinesia," a permanent CNS condition that's untreatable.

TD is a disorder of the tongue, mouth and jaw, causing them to move uncontrollably in abnormal ways.

The drug can also cause face jerking or involuntary body movements, including:

"Repetitive movements of the extremities

"Lip smacking, pursing, puckering

"Grimacing

"Tongue protrusion

"Rapid eye movements

"Impaired movement of fingers

"The movements are pretty much constant, except during sleep," reported Dr. Jeff Bronstein in a Los Angeles Times article. He's with the UCLA David Gaffen School of Medicine.

If you have taken Reglan, or are taking it now, the FDA says it's time to call your physician, whether you are experiencing side effects or not."

Read the rest here.

David Hodge: $17 Million Dollar Verdict in AL on 5/13/09

A guy who I consider a friend is David Hodge, a Birmingham, Alabama lawyer. Not too excitable, loves Bama football, family man, dog man like me.

David went to Hale County, which is right here:





His firm's client was Chapman Logging. The case involved the sale of a defective logging skidder equipped with a Cummins engine. David's firm is found here pdkhlaw.com. A skidder looks like this:

Image via Wikipedia

I know what you're thinking: How in the world did the jury come back with that verdict? I'm thinking the same thing, but will have to hear more about it tomorrow. Well done. I will tell you this - if you run across David Hodge in any case, take a get ready pill.

That Pesky Drug known as Cheerios

Image via Wikipedia

Sometimes you just shake your head in amazement. This warning letter from the FDA to the CEO of General Mills (never mind that people are getting ill or dying from bad foods):

(FDA source)

Ken Powell
Chairman of the Board and CEO
General Mills
One General Mills Boulevard
Minneapolis, Minnesota 55426

Dear Mr. Powell:

The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA's home page at http://www.fda.gov.

Unapproved New Drug

Based on claims made on your product's label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims on its label:

• "you can Lower Your Cholesterol 4% in 6 weeks" "
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application.

If you can ...ummm ...stomach the rest of that letter, you are a better person than I.

Lawyer Etiquette: Is Your Blackberry Use Hurting your Reputation?

Image by Getty Images via Daylife

I attended a meeting of lawyers this month, and when about 5-6 of us were sitting together talking shop, one member of the group brought up a good subject. As we talked, that same person started typing away on his Blackberry. He was so distracted, he missed two questions posed to him. I was to be candid appalled. It was rude and insensitive. I didn't know this person very well, but I will remember him now for that mistake.

I went searching on the web for a quick list of suggestions that I lawyers could read to help them when using a Blackberry, since at least 50% of its users forget basic courtesies:

From the Legalease Blog:


1. If you are attending an event, meal, meeting or presentation, turn off your electronic devices. If you put MUST keep them on, turn them to silent or vibrate, do not place them on the table so that the vibration disturbs those around you;

2. If you are awaiting an important call or email, consider not attending the event so that you can attend to your important business;

3. If it is imperative that you attend the event, be sure that you keep your focus or attention on the event. Advise your companions at the outset that you are waiting for an urgent call, and sit near the door. Leave the room or the table discreetly if you absolutely MUST check your email or voice mail or return a call or email;

4. Remember that those around you are forming an impression of you AT ALL TIMES; if you are with a client and are checking your BlackBerry, reading emails, surfing the web, the client is going to think that you don't care about them and that they are not important to you;

5. Be aware that if you are replying to important emails while at dinner, a networking event or another meeting, you are not presenting your best self either at the event or in the email. Not only are you unable to devote your complete attention to the event and the people you are with, but you are also unable to devote your full attention to the email message. You may be making a poor impression on two groups of people at the same time.

6. Even if your device is under the table or you think you are being discreet others in the room are well aware of what you are doing. Regardless of what you think, you are NOT getting away with it!

7. The smaller the meeting, the more noticeable your behavior. But even in large meetings, be mindful of those around you, since they will certainly be aware of your behavior, so if your boss or an important client or colleague is sitting near you, refrain from checking your BlackBerry. And if the presenter, meeting facilitator or your boss is standing, seated on a dais or is behind you, they will be aware of your behavior even in a large room.

8. Reconsider your definition of what is an 'urgent' matter and what can wait. Think about your priorities, not just in the short term (answering this email immediately as opposed to 10 minutes from now), but also in the long term (if the client thinks I'm rude, I may lose the account).

There's more at the link above.

Take heed, lawyers!

Autism: Are Children able to "Recover?"

A close friend has a child with autism, and the frustrations, worries and concerns are etched on his face when we get together. I could never imagine what he and his family must address each day.

From several sources, including Yahoo, this article:

"Leo Lytel was diagnosed with autism as a toddler. But by age 9 he had overcome the disorder. His progress is part of a growing body of research that suggests at least 10 percent of children with autism can "recover" from it — most of them after undergoing years of intensive behavioral therapy.

Skeptics question the phenomenon, but University of Connecticut psychology professor Deborah Fein is among those convinced it's real.

She presented research this week at an autism conference in Chicago that included 20 children who, according to rigorous analysis, got a correct diagnosis but years later were no longer considered autistic.

Among them was Leo, a boy in Washington, D.C., who once made no eye contact, who echoed words said to him and often spun around in circles — all classic autism symptoms. Now he is an articulate, social third-grader. His mother, Jayne Lytel, says his teachers call Leo a leader.

The study, funded by the National Institute of Mental Health, involves children ages 9 to 18.

Autism researcher Geraldine Dawson, chief science officer of the advocacy group Autism Speaks, called Fein's research a breakthrough."

Read the rest here.

Hydroxycut: UPC Codes Released today (Georgia, Alabama, Florida)

Here's news on the Universal Product Codes related to the Hydroxycut products:

Iovate Health Sciences U.S.A., Inc. Adds Hydroxycut-Branded Product Universal Product Codes to its Voluntary Nationwide Recall

Contact:
Jamie Moss
201-493-1027

FOR IMMEDIATE RELEASE -- (May 7, 2009) -- Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is adding Universal Product Codes (UPCs) with respect to the Hydroxycut-branded products sold in the United States and subject to the voluntary recall. These additions all involve additional packages and sizes of products previously referenced.

The UPC numbers being added to the May 1 list are as follows:

631656800265 Hydroxycut Hardcore 8 fl. oz. Grape Explosion
631656800210 Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
631656001501 Hydroxycut 280ct-3 Pak Kit *Discontinued*
631656001563 Hydroxycut 280ct-6 Pak Kit *Discontinued*
631656000658 Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit
631656600896 Hydroxycut 2x60ct Club Pack US Kit
631656000672 Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit *Discontinued*
631656874693 Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
631656000665 Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit *Discontinued*
631656002362 Hydroxycut Sachet Twin Pack US Kit
631656860498 Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit
631656660623 Hydroxycut Hardcore Shredded Stack Kit120ct
631656500585 Hydroxycut 60 Rapid Release Caplets



On May 1, 2009, the FDA issued an advisory which states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.” The number of adverse event reports described by the FDA is small relative to the many millions of people who have used Hydroxycut products over the 7 years referenced by the FDA.

Iovate’s own assessment of the potential risk associated with the use of these products differs from that expressed by the Agency. Every product marketed by Iovate is evaluated during its development for the safety of its individual ingredients. Additionally, independent third-party experts from the leading independent scientific firm specializing in ingredient assessment, toxicology and product safety for the nutritional and pharmaceutical industry review the safety of Iovate’s ingredients and formulas before products are introduced in the marketplace. Only after this external review is completed does Iovate release a formula.

Source here.

FDA: Testosterone Gel Puts Children at Risk

From various sources, including the AP:

The FDA issued a statement that adults using prescription testosterone gel should be cautious and avoid its contact with children to avoid causing serious side effects. This week a black box warning was added to several products, AndroGel and Testim.

AndroGel is approved to be applied to the abdomen and shoulders and arms, while Testim can only be applied to the arms and shoulders. An FDA rep. has informed that in a few reports people had applied the product to their chest and then held their children without wearing shirts.

As of December 2008, the agency had received eight cases of secondary exposure to the products in children ranging in age from nine months to five years. Other reports have since come in, the FDA said. In most cases the side effects in children regressed after they weren't exposed to the product, but in a few instances enlarged genitalia didn't fully return to age-appropriate size and bone age remained modestly greater than the child's chronological age. Source here.

Certain Epilepsy Drugs Get a Suicide Warning

the FDA has approved new labels for epilepsy drugs that include warnings about an increased risk of suicidal thoughts and behaviors associated with the medicines.

The labeling for the epilepsy drugs Topamax, Lamictal, Tegretol and Trileptal come after the FDA ordered the drugs' labels be updated with warnings about suicidal risks with the medications.

In December, the FDA issued a public-health advisory about the drugs, saying a review of clinical studies showed there was one additional case of suicidal thoughts or behaviors for every 500 patients treated with an anti-epileptic drugs compared with a placebo, or fake pill.

Source here.

Botox Warnings

Allergan Inc.will work with the Food and Drug Administration to appropriately update labeling for its Botox and Botox cosmetic products.

"We are pleased that the FDA has emphasized that the dosing units are different between the products," Chairman and Chief Executive David Pyott said on the earnings call, adding he was happy with Botox's first-quarter sales, which declined 5.8%.

Last week the FDA said it was strengthening warnings on Allergan's Botox and similar products about the possibility of life-threatening breathing and swallowing problems.

Link here.

Hydroxycut Recall: TV Report (Georgia, Alabama, Florida)

Image by size8jeans via Flickr

From NBC and Tom Costello and NBC: The government issued an urgent warning to immediately stop using the dieting supplement after reports surfaced of liver damage and at least one death. FDA's limited ability to oversee is discussed. Report notes that 114 million people use OTC supplements.

Hydroxycut Lawsuit from 2003

Found this from 2003, a press release from the then Missouri A.G.:


Attorney General Jay Nixon today filed a lawsuit in St. Louis against the maker of Hydroxycut, marketed to consumers as a safe and tested over-the-counter way to lose bodyfat rapidly. Hydroxycut is sold in several retail store chains, through television ads and on several Web sites.

Nixon said manufacturer MuscleTech Research and Development Inc., based in Mississauga, Ontario, did not disclose safety risks associated with Hydroxycut containing ephedra, and that claims that Hydroxycut was "clinically proven" to be a "fat-burner" were false.

"MuscleTech's own consultants had serious concerns about the safety of Hydroxycut, but the company continued to market the product," Nixon said. "The disclaimers and warnings on the bottle label are so small as to be useless to many consumers, so they would not be able to read that the disclaimers would preclude use of Hydroxycut by most of the adult population of the United States, including anyone who drinks coffee or cola containing caffeine."

The lawsuit claims that in order to obtain the research results it sought, MuscleTech would replace research subjects who had to drop out of the company's studies because they could no longer tolerate the Hydroxycut or because it became too dangerous for them to continue. In at least one study, Nixon said, those dropouts were concealed and not treated as an adverse effect of Hydroxycut. In another study cited in the lawsuit, one subject was rushed to the hospital due to a serious change in heartbeat. This incident was not treated as an adverse reaction in the final study.

From the Complaint:

JEREMIAH W. (JAY) NIXON,
Attorney General of the State of Missouri
Plaintiff

Vs

MUSCLETECH RESEARCH &
DEVELOPMENT, INC.,
Defendant.


1. Defendant MuscleTech Research and Development, Inc. (“MuscleTech”) has made and sold purported weight loss products under the name “Hydroxycut” containing ephedra alkaloids. Such products continue to be sold at least at the retail level. The product is not “clinically proven” to be a “fat-burner,” as MuscleTech claims. MuscleTech’s own study showed that Hydroxycut has no efficacy as compared to placebo with the possible exception of an appetite-suppressing effect. Moreover, the serious adverse health risks of Hydroxycut with ephedra – including death – were not adequately described or disclosed in marketing and labeling of the product. This conduct violated the Missouri Merchandising
Practices Act.

16. MuscleTech used deception, misrepresentation, unfair practice and/or the concealment, suppression, or omission of material fact in connection with the sale and advertisement of MuscleTech in regard to Hydroxycut’s safety – or lack of safety – including but not limited to the following:

a. MuscleTech’s web site and advertisements [b]did not adequately disclose safety risks associated with Hydroxycut.[b/] Some advertisements or material supplied by MuscleTech to magazine publishers specifically stated that Hydroxycut is effective in reducing bodyfat “without any unwanted side effects,” that it is “extremely safe” and that “studies” have shown the herbal equivalents to ephedrine and caffeine to be “very safe,” that potential users can be “reassured” that Hydroxycut is “safe,” and that even prescription drugs do not yield as much fat loss as the ingredients in Hydroxycut “with as little negative side effects.”

iii. In at least one instance, a subject was rushed to a hospital for atrial fibrillation, which is a precursor to ventricular fibrillation (a lethal arrythmia that results in sudden cardiac death). The study of which he was a subject did not treat this event as an adverse event for purposes of its statistical analysis.


However, the results of MuscleTech’s studies regarding safety did not accurately indicate the safety risks for most consumers of Hydroxycut because MuscleTech carefully screened all study subjects for health risks. This screening meant that there was no testing done on persons with physical and health characteristics of many consumers purchasing Hydroxycut over the counter (such as high blood pressure), making the results of such studies misleading for those consumers. Moreover, even after this screening was performed, MuscleTech’s studies were still tainted in at least the following respects:

c. MuscleTech has not disclosed in any of its marketing or advertising materials that its own consultants believe there are serious concerns as to the safety of Hydroxycut. At least one person whom MuscleTech hired as an expert in litigation stated under oath that he believes people should not take products with ephedra and caffeine, such as Hydroxycut, and that he cautions people not to take these “drugs.” Both he and another expert hired by MuscleTech testified separately that they would not recommend Hydroxycut to anyone.

17. a) Another study commissioned by MuscleTech showed that the subjects using a “new and improved” version of Hydroxycut showed no statistically significant weight loss that was greater than the placebo group, and even lost less weight than the placebo group. MuscleTech misrepresented the true results of this study by having one of its marketing persons submit a letter to the researcher suggesting that the researcher attribute the study’s result to the horrific events of 9-11-01. The researcher complied, without explaining why the events of 9-11-01 would affect the placebo group differently.

b) b. MuscleTech ran advertisements using deceptive “before” and “after” pictures. The pictures are deceptive in that, among other things:

i. The pictures use different lighting to convey an artificial fattening and slimming effect.

ii. The models in the pictures use different poses to convey an artificial fattening and slimming effect.

iii. The pictures and the accompanying copy do not fully disclose the extent of weight loss and muscle toning activities used by the models in conjunction with the use of Hydroxycut.

iv. MuscleTech has used one picture (in multiple advertisements) showing a “before” photograph of a woman with a much larger abdomen than in the after picture. A copy of one such advertisement is attached as Exhibit B. [b]The advertisements identify the woman as Marla Duncan and tout that she lost 35 pounds. At least some advertisements did not indicate that the “before” picture reflected post-pregnancy weight. Nor did the advertisements state that Marla Duncan has been a swimsuit and fitness model since at least 1983 (when she was 19 years old), has appeared on more than 100 magazine covers, and was Miss Fitness USA in 1990.

Hydroxycut News Part 2/Background

Herbs that have been associated with liver disease include:

- Black Cohosh

• Buckthorn (Rhamnus cathartica).

- Callilepsis laureola ( Impila)

- Cascara Sagrada

- Celandine ( also known as greater celandine) (Chelidonium majus)

• Chaparral (also known as creosote bush or greasewood) (Larrea taridentata).

• Comfrey and other herbs containing pyrrolizidine alkaloids (heliotropium, senecio, crotalaria, symphytum)

- Doxidan ( Danthron 1,8-hydroxyanthroquinone and dioctyl calcium sulfosuccinate)

• Germander (Teucrium chamaedrys).

- Green tea leaf

• Groundsel (Senecio vulgaris).

- Impila root

• Jin Bu Huan.

- Kava ( also known as kava kava or Piper methysticum)

- Kombucha

• Lobelia (Lobelia inflata).

• Ma huang (ephedra).

• Mate (also known as paraquay tea) (Ilex paraguariensis).

• Mistletoe (Viscum album).

• Nutmeg (Myristica fragrans).

• Pau d’arco (La pachol).

• Pennyroyal (Mentha pulegium).

• Poke root (Phytolacca americana).

• Ragwort (Senecio jacoboea).

• Sarsparilla (Smilax species).

• Sassafras (Sassafras albidum).

• Saw palmetto – the main ingredient of the herbal preparation known as “Prostata”.

• Senna (Casio acutifolia).

• Skullcap (Scutellaria laterifolia).

- Soy phytoestrogen

• Sweet clover (Melilotus officinalis).

• Tansy (Tanacetum vulgare).

• T’u-san-chi.

• Valerian (Valeriana offinalis).

• Woodruff (Galium odorata).













Found this article posted a while back by a "doctor" who commented on Hydroxycut:

"Hydroxycut made headlines for over a controversial compound that it contained called Ephedra. This compound is banned by FDA. Now you can get a Ephedra-free product that claims to increase your metabolism and energy while suppressing your appetite, therefore cutting caloric intake and hence causing weight loss. Claims made by there manufacturers are pretty bold. They say that Hydroxycut can decrease body fat by 8%, and increase norinephrine by 40%. Among the most important ingredients in this product are:

Hydroxagen™: This is a compound which has been shown to decrease the activity of the enzyme which is responsible for the conversion of excess carbohydrates into fat. This subsequently makes it extremely effective for low fat diets. There may some added advantage of it curbing hunger and cravings.

Guarana Extract: Guarana, is the herbal form of caffeine and this has been shown to stimulate fat stores and resulting in fat being utilized as energy. Caffeine also facilitates the effectiveness of ephedrine, thus making it a more potent.

L-Carnitine: This is an amino acid that has been reported to carry fats to the interior of cells where it can be metabolized as energy. The addition of L-carnitine is an absolute necessity to get fat burning.

Chromium Picolinate: It has been shown that dosages of chromium as that contained in Hydroxycut can cause fat reduction and increases in muscle tone.



It should be understood that many people do experience side effects with these “stimulating” medications. Some say that feel anxious, others complain of increased libido. If you have heart condition, hyperthyroidism etc you should stay clear from this product (see all contraindications before starting)."

Source here.



Firm handling it is: www.bunchandjames.com/hydroxycut/

FDA Recalls Hydroxycut

Government health officials are announcing the recall of popular weight loss pill Hydroxycut, after reports of liver damage and other health problems.

The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural



Food and Drug Administration officials said Friday the manufacturer of Hydroxycut has launched a nationwide recall of the dietary supplement, used by people trying to shed pounds and by body builders to sharpen their muscles.

Hydroxycut is advertised as made from natural ingredients. It accounts for about 90 percent of the market for weight loss supplements, with sales of about 1 million bottles a year.

Dietary supplements are not as tightly regulated by the government as medications. Manufacturers don't need FDA approval ahead of time before marketing their products.

Sources include: AP and FDA.

Reglan: MDL Petition to be Heard on 5/28 in Louisville, KY

Link to the Order here.

I mentioned last week that counsel on cases (friends of mine) had file the Petition - looks like it will be argued next month.

Early indications? Plaintiffs' lawyers want it in Las Vegas.

Botox - Unapproved Use Warning

Health officials are warning doctors and patients about potentially deadly risks of using anti-wrinkle drug Botox and similar drugs for unapproved uses to treat muscle spasms.

The Food and Drug Administration says Botox and two other injections have been linked to rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

While Botox is best known for clearing wrinkles by paralyzing facial muscles, the botulism-based drug also is widely used for muscle-spasm conditions.

Regulators say the majority of deaths are in children with cerebral palsy taking the drugs for spasticity in their legs.

Botox and competitors Myobloc and Dysport will carry a boxed warning, the most serious type available.

Link here.

Accu-Chek Insuling Pump Recall

Another day another recall - how is the public expected to know about these nearly once a day recalls?

Roche Holding AG(RHHBY) unit is recalling Accu-Chek Spirit insulin pumps that were sent to the U.S., the Food and Drug Administration said Thursday noted in a recall notice posted on its Web site.

Also, we are working on a SE Georga Law Blog, and you can find more online.

Excessive Selenium Kills 21 Polo Ponies

My office is investigating the damage selenium has caused to people who took an over the counter supplement known as Total Body Formula. This week there is news that selenium killed nearly two dozen horses:

The 21 polo horses that died last week shortly before they were to compete in the U.S. Open polo tournament fell victim to a fatal overdose of selenium, a mineral ingredient in a medication meant to help them recover from exhaustion, according to Florida's state veterinarian.

"Signs exhibited by the horses and their rapid deaths were consistent with toxic doses of selenium," Dr. Thomas J. Holt said today of the circumstances surrounding the loss of the horses, which were all owned by the Venezuela-based Lechuza Caracas team.

The medication was prepared by an Ocala, Fla., retail and compounding pharmacy called Franck's Pharmacy at the request of the veterinarian who treated Lechuza's horses while in Florida. Franck's Pharmacy announced last week that an internal review prompted by the horses' deaths showed that the compound, a substitute for a medication called Biodyl that is unapproved for use in the U.S., was mixed incorrectly.

Sources are many, including here.

Nail Polish Remover Recall

The U.S. Food and Drug Administration announced a nationwide recall of Personal Care-brand non-acetone nail polish remover because of a claimed safety hazard.

The FDA said Personal Care Products Inc. of Bingham Farms, Mich., initiated the recall of the polish remover-conditioner enriched with gelatin because it doesn't meet product specifications and might cause chemical burns to the fingers of users.

Treanda and Stevens Johnson Syndrome

The cancer drug Treanda, in combination with another therapy, may have caused two people taking it to develop a serious skin condition known as Stevens Johnson Syndrome and one has died.


The patients developed a severe form of the condition known as toxic epidermal necrolysis, which is characterized by a blistering and peeling of the top layer of skin, causing it to peel off, leaving damaged areas which can become infected.

Both patients were also taking a drug called allopurinol, which is often used in patients taking chemotherapy to lower high levels of uric acid in the body. The drug is already known to be associated with Stevens Johnson Syndrome/toxic epidermal necrolysis.

Source here.

NSAIDS: Increase Risk of Dementia?

Those who use non-steroidal anti-inflammatory drugs (NSAIDs), such as naproxen and ibuprofen, shouldn't bank on the drugs helping them ward off dementia.

A study in Neurology suggests that NSAID users do not have lower rates of dementia and that increased use of the pain relievers may actually raise the risk of cognitive decline.

Read the article here.

Golimumab Approved, with a Black Box Warning

Image via Wikipedia

Simponi Approved for Immune-Related Arthritis



From HealthDay News:

Simponi (golimumab) has been approved by the FDA to treat three forms of arthritis that occur when the body's immune system attacks the joints.


The injected drug will be prescribed to treat moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

It arrives on the market with a black box warning in place: Users will face an increased risk of tuberculosis and invasive fungal infections.

Reglan: Generic Drug Makers and Metoclopramide

Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders.

Four generic drug makers named as Defendants in a Reglan lawsuit that is pending in a USDCT in Vermont won't be granted an immediate appellate appeal the Trial Court’s decision not to grant a pending motion for summary judgment. The argument was that the generic makers did not develop the drug’s warning label.

The lawsuit was filed against Wyeth, which manufactured the drug metoclopramide under the brand name Reglan, and others including Teva Pharmaceuticals USA, Actavis Elizabeth, Barr Pharmaceuticals and Pliva.

You can read the opinion here, in PDF format. (D and B blog)





My office is investigating claims of injury related to Reglan, www.markzamora.com

Advanced Bionics Cochlear Implant Recall

Update on a cochlear implant recall:

In 2004, Advanced Bionics issued a recall for the Clarion CII-x HiResolution 90k (HiRes90k) bionic ear system. Advanced Bionics eventually began to distribute the HiRes90k. The FDA had, however, written to the company about the product.
Advanced Bionics then had a 2nd recall on Vendor B HiRes90k implants.

What we are hearing: As many as 20% of HiRes90k vendor B units may fail.

What are the symptoms of a failed or failing Advanced Bionics HiRes 90k or Clarion Cochlear Implant?

*Delays in hearing

*Popping sounds

*Crackling sounds

*Shocks/pain in the head/face

*The implant turns on/off without warning

*Your child is not telling you that the batteries on the implant need charging

*Your child is turning the implant off

What amazes me is how little the news has been out on this recall.Talk to us, on the web at: http://www.markzamora.com/Implant/index.html

Digoxin Recall

Caraco Pharmaceutical Laboratories, has issued a nationwide recall of DIGOXIN, a medicine used to treat heart failure and abnormal heart rhythms. The tablets are being recalled because they may differ in size and could have more or less of the active ingredient, digoxin.

This recall includes all lots of Caraco brand digoxin tablets distributed before March 31, 2009:

Digoxin 0.125 mg tablets - NDC# 57664-437-88 or NDC# 57664-437-18

Digoxin 0.25 mg tablets NDC# 57664-441-88 or NDC# 57664-441-18

Digoxin tablets from other manufacturers are not included in this recall. Last year a similar problem was reported with another manufacturer’s brand of digoxin. At the time this resulted in a massive recall of the heart drug, affecting 60% of the nation's supply. It also helped spur reports of at least 650 patient deaths. However, a direct link to defective tablets was difficult to assess click here.

This source comes from the FDA and other sites.

We're investigating this recalled drug. You can always reach us at markzamora.com/contact

Late 2008 - Adverse Drug Event Reports Reach Record Numbers

In 2008, one site reports that there were a record number of reports submitted to the US Food and Drug Administration (FDA) about serious injuries, disabilities, and deaths associated with drug therapy.

Almost 23,000 cases of serious ADEs—including 1,397 cases attributed to error—were reported to the FDA in April-June 2008, nearly 40% higher than the average of reported cases during the four quarters in 2007. The increase came about equally in reports originating from health professionals and consumers. Among the 23,000 ADEs were 2,968 deaths and 585 cases of disability or birth defects. The 2,968 reported deaths in this quarter declined from a record 4,824 deaths in the first quarter of 2008, but deaths remained substantially higher in 2008 than in 2007.

Source here.

Retinopathy of Prematurity, and Richard Shapiro

From my good friend Richard Shapiro, information on a specific type of case he handles:

Retinopathy of Prematurity (ROP) is a potentially blinding eye disorder that primarily affects premature infants weighing approximately three pounds or less, born before 31 weeks of gestation (A full-term pregnancy has a gestation of 38–42 weeks). The smaller a baby is at birth, the more likely that baby will develop ROP. This condition is one of the most common causes of visual loss in childhood and can lead to lifelong vision impairment and blindness.

There is established medical proof that if ROP is treated timely (within 36-38 weeks of gestation or approximately at 6 weeks of age), it is likely that blindness will be prevented. Without proper care, the delay in diagnosis or treatment will often lead to permanent blindness.

What causes Retinopathy of Prematurity?

ROP occurs when abnormal blood vessels grow and spread throughout the retina, the tissue that lines the back of the eye. These abnormal blood vessels are fragile and can leak, scarring the retina and pulling it out of position. This causes a retinal detachment. Retinal detachment is the main cause of visual impairment and blindness in ROP.

Medical experts believe that the periphery of the retina sends out signals to other areas of the retina for nourishment. As a result, new abnormal vessels begin to grow. These new blood vessels are fragile, weak, and can bleed, leading to retinal scarring. When these scars shrink, they pull on the retina, causing it to detach from the back of the eye.

Most premature infants are either born/or treated at children’s hospitals or other pediatric hospital units within general hospitals.

How is ROP treated?

The most effective proven treatments for ROP are laser therapy or cryotherapy. Laser therapy "burns away" the periphery of the retina, which has no normal blood vessels. With cryotherapy, physicians use an instrument that generates freezing temperatures to briefly touch spots on the surface of the eye that overlie the periphery of the retina. Both laser treatment and cryotherapy destroy the peripheral areas of the retina, slowing or reversing the abnormal growth of blood vessels. Unfortunately, the treatments also destroy some side vision. This is done to save the most important part of our sight—the sharp, central vision we need for "straight ahead" activities such as reading, sewing, and driving.

Both laser treatments and cryotherapy are performed only on infants with advanced ROP, particularly stage III with "plus disease." Both treatments are considered invasive surgeries on the eye, and doctors don't know the long-term side effects of each.

In the later stages of ROP, other treatment options include:

* Scleral buckle. This involves placing a silicone band around the eye and tightening it. Infants who have had a sclera buckle need to have the band removed months or years later, since the eye continues to grow; otherwise they will become nearsighted. Sclera buckles are usually performed on infants with stage IV or V.

* Vitrectomy. Vitrectomy involves removing the vitreous and replacing it with a saline solution. After the vitreous has been removed, the scar tissue on the retina can be peeled back or cut away, allowing the retina to relax and lay back down against the eye wall. Vitrectomy is performed only at stage V.

Richard Shapiro may be reached here.

Tysabri and PML

I wrote an earlier post this week on PML. Today, there is this report:


Biogen revealed another new case of progressive multifocal leukoencephalopathy in a multiple sclerosis patient being treated with Tysabri.

That means that six patients have developed the potentially deadly brain infection since Tysabri (natalizumab), which is partnered with Ireland’s Elan Corp, was reintroduced to the market in July 2006. The case was confirmed late last week.


In the latest case, the patient had been on the drug for 31 months, the longest duration so far. The previous high had been 26 months and the average now is 19 months.

Source here.

U.S. Supreme Court: Tuna/Mercury Poisoning Case

Image via Wikipedia

An interesting case, and the SCOTUS' decision to let stand a lower court ruling (thanks to the WSJ.com site):

The Supreme Court left in place a lower court ruling that allowed a New Jersey woman to sue a tuna-fish producer over the mercury poisoning she allegedly suffered after her diet consisted almost exclusively of canned tuna for five years.

The woman, Deborah Fellner, said Tri-Union Seafoods LLC, the maker of Chicken of the Sea brand tuna, failed to warn her of the risks of consuming tuna fish.

Tri-Union said U.S. Food and Drug Administration regulations prevented it from placing a mercury warning label on its products. The company said that Fellner's suit should be thrown out because it conflicted with the FDA's regulatory regime.

A federal trial judge had tossed Fellner's lawsuit, but an appeals court in Philadelphia reinstated it, saying the FDA had taken no regulatory action that preempted her legal claims.


"Tri-Union argued that the appeals court ruling put it in the untenable position of facing legal liability under state law for not including a warning label that would have rendered its products misbranded under federal law."

More at the source.

Reglan News: Lawyers seeking to Consolidate in Nevada

What we are hearing: Lawyers have filed a Motion with the JPML, asking that all of the filed Reglan cases be consolidated and moved to a US District Court in Nevada.

Reglan (metoclopramide) is a drug which is only approved for short-term use to treat gastrointestinal disorders like diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, because those conditions are usually chronic problems, it is often prescribed for longer periods of time. Illnesses include essential tremors, Tardive Dyskinesia, and other movement disorders.

We're investigating this drug and how it may have harmed Georgia consumers. Go here for more information.

Raptiva pulled; An explanation of PML

Raptiva is used to control moderate to severe cases of plaque psoriasis, the most common form of the autoimmune disease, which causes red scaly patches on the skin that can itch and hurt.

PML is a serious infection of the nervous system caused by a virus. It's referred to as the JC virus. This virus attacks the brain's white matter and disrupts nervous system activity.

What are the symptoms? Look to where in the brain the virus hits. Common symptoms include deficits in speech, vision, movement and thought processes. The disease progresses rapidly and inexorably toward serious disability and death.

It's important to note that PML is also seen in those with HIV. PML also does not occur without some underlying risk. The highest risk comes from HIV infection.

With Raptiva off the market, is there another treatment for psoriaris?

There is. The drugs Enbrel, Humira and Remicade are medications for its treatment. None has been linked to PML and all three act in a way different from Raptiva.

Sources are here, as well as here and here.

Law Review Articles: Using Facebook in Litigation, and the Daubert Revolution

From the Torts Prof Blog, links to a recent law review articles worth reading.

Facebook:

Here is an article worth reading on how Facebook.com's pages are deemed discovery in the context of Canadian Court. In the U.S., expect the same treatment.

A quote from the article:Canadian courts have considered web-based networking sites such as Facebook and MySpace pages to be ‘documents’ subject to discovery.

I always ask my client if he/she uses Facebook, Myspace, or other S.M. If you're not, be ready for a surprise at your client's deposition, and I don't mean surprise as in surprise party - I mean it as in, "Wow, is that really you doing a tequila body shot at a Panama City Beach bar? I thought you needed back surgery."


Daubert:

A paper addresses Daubert's limitations and suggests that the relevant problems demand resolution before one can conclude that the Daubert revolution is complete.

Download it here.

Trucking: CVSA Out of Service Criteria Handbook

Attending a lawyer convention this week, I had a chance to hear from a Public Safety Officer regarding truck inspections.

The bible for an officer when conducting an inspection? A book called the North American Standard Out-of-Service Criteria.

Part I details violations which place a driver out-of-service.

Part II identifies critical vehicle inspection items and criteria for placing a vehicle out-of-service.

Part III details unsafe hazardous materials transportation, including both conditions which fail to communicate a hazard and those which are themselves hazards.

Part IV outlines the criteria for placing a motor carrier out-of-service.

If you investigate wrecks involving tractor trailers, it's worth buying. Get it
here.

Intra Aortic Balloon Pump Recall

Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters Recalled.

The FDA announced a Class 1 recall for Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) catheters, a component of the Intra-Aortic Pump System which is designed to provide cardiac assist therapy to critically ill people to increase blood flow to the heart.

The recall is being conducted because of a fault in the connector of the pump tubing assembly may result in failure of the system to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.



http://www.fda.gov/medwatch/safety/2009/safety09.htm#Arrow

FDA stops firm marketing unapproved cold medicines

Federal regulators have secured a court order barring a New Jersey pharmaceutical company from distributing more than 50 unapproved cough and cold medicines.

The Food and Drug Administration said Advent Pharmaceuticals continued to market the medications despite prior warnings from regulators. The company also failed to correct numerous manufacturing problems identified by FDA inspectors.

Drug manufacturers in the U.S. are required to submit their products to the FDA for premarket approval to guarantee they are safe and effective. The unapproved products marketed by Advent and its subsidiary Neilgen Pharmaceuticals include: BP Allergy Junior Suspension, RE All 12 Suspension and many others.

Source here.

Raptiva Recalled

There will be a phased voluntary withdrawal of psoriasis drug Raptiva from the U.S. market due to its link to a brain infection.

Raptiva has recently been associated with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.

Authorities in Europe, where Raptiva is sold by Merck KGaA (MRCG.DE), recommended in February that the drug be suspended in light of the PML risk.

The European Commission is expected to follow that advice.

There have been three cases of diagnosed PML in patients receiving Raptiva, two of which were fatal, and a fourth patient who developed progressive neurologic symptoms and died of unknown causes.

Raptiva is approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or light therapy.

PML has also become an issue for patients treated with multiple sclerosis drug Tysabri, which is sold by Biogen Idec Inc (BIIB.O) and Elan Corp Plc (ELN.I).

Related articles by Zemanta

• Genentech withdraws psoriasis drug (money.cnn.com)

Rhino ATV Recall

Yamaha Motor Corp. USA recalled about 145,000 off-highway recreational vehicles Tuesday, after two models were involved in 46 deaths and hundreds of injuries.

The two-passenger Rhino 450, 660 and 700 vehicles are designed for those older than 16 with driver's licenses, though some deaths involved children who were passengers or operated vehicles against recommendations, said the Consumer Product Safety Commission.

All Rhino 450, 660 and 700 model vehicles were recalled to reduce rollover risk and improve handling and keep riders' limbs in the vehicles. Reported deaths occurred between the fall of 2003, when the vehicles were first distributed, through this year.

Nationwide Voluntary Recall of Propafenone HCL Tablets: Oversized Tablets

One lot of Propafenone HCL 225 mg Tablets sold in 100 count bottles in the United States is being voluntarily recalled to the consumer level as a precautionary measure.

The lot is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. The recalled tablets were manufactured by Watson Laboratories, Inc. The affected lot of Propafenone HCL tablets was shipped to customers between October 15, 2008 and November 26, 2008. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall. The Company has notified the U.S. Food and Drug Administration (FDA) of the recall.

Propafenone is a drug product used to treat cardiac arrhythmias (irregular heartbeats). It has a narrow therapeutic index, so some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. Consequently, as a precautionary measure, Watson is recalling this one lot to the consumer level to minimize any potential risk to patients.

Anyone who has 225 mg Propafenone HCL tablets should check the bottle for the lot number and expiration date to see if they have tablets being recalled.

Alabama: Hydroxycut Information

Bunch and James have been investigating Hydroxycut related injury claims; their firm is Alabama. Their # is 888-422-2882, and their site is bunchandjames.com

The product Hydroxycut Max has these ingredients:

The active ingredients in Hydroxycut Max are: green tea extract, caffeine anhydrous, xanthinol nicotinate, yohimblne HCI, black tea extract, wu long tea extract, rooibos tea extract, cissus quadrangularis extract, soy isoflavones, rose hip powder, hibiscus extract, garcinia cambogia extract, L-lysine HCI, diacylglycerol, dandelion powder, juniper powder, terminalia chebula powder, angelica keiskel powder, mangosteen extract, chaste extract, citrus peel, soy phospholipids, raspberry extract, and policosanol. The inactive ingredients include: sesame oil, gelatin, FD&C Red No. 40, caramel color (may contain sulfites and wheat), polysorbate 80, ink (shellac, dehydrated alcohol, isopropyl alcohol, butylalcohol, propylene glycol, sodium hydroxide, povidone, titanium dioxide).

On one site, there are these disadvantages:
Disadvantages

* The product is expensive compared with similar products.
* Hydroxycut Max contains over twenty unexplained ingredients.
* No money-back guarantee is evident on the manufacturer’s website at this time.
* Consumers cannot purchase this product directly from the manufacturer.

Source here.

More on Reglan, Octamide and Maxolon

Some have emailed asking what is Metoclopramide.

Metoclopramide is used to treat the slow stomach-emptying that can occur in diabetes, and as a second-line treatment for heartburn caused by gastroesophageal reflux. It's sometimes used for the nausea and vomiting that accompany cancer treatment, and migraines.

Regulan or its generic stimulates the stomach to move things along, reducing fullness and reflux of the stomach's contents. It also quashes the urge to vomit. It works by blocking dopamine, a neurochemical that induces vomiting and stomach-slowing.

What is TD?

Tardive dyskinesia is a disorder in which the tongue, mouth and jaw move uncontrollably in abnormal ways. Movements can include eye-blinking and face-jerking, and can occur elsewhere on the body. The movements are "pretty much constant," says Dr. Jeff Bronstein, a neurologist at UCLA's David Geffen School of Medicine, except during sleep.

The disorder can persist for months and years, and in some cases appears to be permanent. Severity can vary, Bronstein says. "Some people can get so bad it's hard for them to eat and swallow because of their tongue movements. And obviously, cosmetically, it's horrible."

Tardive dyskinesia occurs as a side effect of drugs that block dopamine. Once diagnosed, patients are usually taken off the drug. In some patients, the symptoms get better. In many cases, it becomes a permanent neurological disorder. No standard therapy exists, but various drugs have been used as treatments.

How big is the risk?

Jankovic analyzed all 443 tardive dyskinesia patients seen over 25 years at his Baylor clinic. Prior to 2000, the antipsychotic Haldol was the main culprit; since then, metoclopramide has moved to first place.

"It is a public health problem," Jankovic says. "Many of these patients who have metoclopramide-induced movement disorders aren't recognized until . . . they're at pretty advanced stages of the disease."

The main way to limit the risk is by limiting how long the drug is used. The drug is already labeled for short-term use, defined as four to 12 weeks. But a 2007 FDA study found that 20% of patients were prescribed the drug for longer than this.

Researcher Faked Data for 21 Studies

Medical journals have been asked to retract 21 studies that touted the benefits of Vioxx, Celebrex and other drugs. According to The Wall Street Journal, Baystate Medical Center, Springfield, Mass. is asking the journals to make the retractions because its former chief of acute pain, Dr. Scott S. Reuben, had faked data used in the studies.

According to The Wall Street Journal, these studies had a great deal of influence on the practice of medicine. Because of Reuben's "research", it had become routine for doctors to combine the use of painkillers like Celebrex and Lyrica for patients undergoing common procedures such as knee and hip replacements, the Journal said.

Related articles by Zemanta

• A New Low in Drug Research: 21 Fabricated Studies (blogs.wsj.com)

Bills Pending In the Georgia Legislature for 2009

Just a few days remain before what is called crossover day - when a proposed bill must crossover to the other chamber. Here is a list of bills pending, with a hat tip to the GTLA blog:



SB 39 and HB 277 - Two approaches to transportation funding are moving through the General Assembly. The Senate passed SB 30 that would allow a one-penny sales tax for transportation (TSPLOST) to be approved for the metro Atlanta region and in individual counties outside metro Atlanta. The legislation was sent to the House, where it has been put on the back burner while House members consider their own transportation funding solution. The House passed HB 277, which provides for a ten-year, statewide sales tax for transportation with specific projects listed in the legislation. Status: It is likely that a conference committee will be formed to work on a consensus proposal for transportation funding before the Governor for signature or veto.
SB 54 - Prohibits abusive home loan practices as part of the Georgia Fair Lending Act. Status: Senate read and referred to committee.

SB 55 - Alters factors to be considered in determining fair market value of real property in relation to ad valorem taxes. Status: Senate passed, read second time in House.

SB 60 - Authorizes each local board of education to determine the maximum age of mandatory education from 16 to 18 for its local school system. Status: Senate read and referred to committee.

SB 71 - Prohibits engaging in certain outdoor sporting activities while under the influence of alcohol, drugs, and other substances. Status: Senate read and referred to committee.

SB 83 - Increases the amount of the statewide homestead exemption for ad valorem taxes. Status: Senate Passed, House Committee favorably reported, passed House vote on March 4, House voted to reconsider on March 5.

SB 84 - revise provisions relating to eligibility for election as a local board of education member; limit the size of local boards of education; revise provisions relating to per diem and expenses of local board of education members; provide for the fundamental roles of local boards of education and local school superintendents; prohibit certain conflicts of interest of board members; provide for a code of ethics for local board of education members. Status: Passed in Senate, read a second time in House.

SB 90 - Establishes vouchers to use taxpayer funds for families to pay private school tuition. Status: Senate committee favorably reported, read a second time in the Senate.

SB 108 - Provides tort reform to allow the charging of attorney fees to plaintiffs when a judge grant's a defendant's motion to dismiss. Status: Senate Committee favorably reported, read a second time in Senate.

SB 142 - Creates the Georgia Family Violence Offender Registry and enhances penalties for an act of family violence. Status: Senate read and referred to committee.

SB 169 - Restricts stem cell research in Georgia; provides that it shall be unlawful for any person or entity to intentionally or knowingly create or attempt to create an in vitro human embryo by any means other than fertilization of a human egg by a human sperm; provides for standards for physicians and facilities performing in vitro fertilizations; defines a living human embryo as a person, not property; prohibits the destruction of a living human embryo for any reason, such as disposal of unwanted frozen embryos kept at a fertility clinic or scientific research. President Barack Obama has announced a lifting of restrictions on federal dollars for such research. Status: Senate Committee favorably reported.

SB 175 - Provides for a moratorium on the administration of a death sentence. Status: Senate read and referred to committee.

SB200 and HB605 - proposed by Governor Perdue with the support of Lieutenant Governor Cagle and Speaker Richardson, would implement sweeping changes in statewide transportation planning, including the merging of the Georgia Regional Transportation Authority (GRTA) and the State Road and Toll way Authority (SRTA) into a new State Transportation Authority (STA), which would be responsible for planning, policy and funding decisions. The current Department of Transportation would remain responsible for operations, maintenance and certain construction projects. SB200 passed the Senate on March 5. HB 605 has been read a second time in the Senate.

HB 39 - Cigarette tax increase in the amount of $1 per pack - currently in the House Ways and Means Committee. Status: Read a second time in the House.

HB 67 - Suspending exemption on sales and use tax on certain food and beverages, reinstating a four-cent sales tax on groceries. Status: House Committee favorably reported.

HB 118 - Mid-year adjustments to the current year's budget, including reinstatement of the Homeowners Tax Relief Grant to local governments. Status: passed both House and Senate, now in conference before going before the Governor for signature or veto.

HB 119 - Fiscal year 2010 budget including a 10 percent cut in spending and a $1.2 billion stimulus package - currently in the House Appropriations Committee.

HB 160 - "Super Speeder" bill to boost fines $200 for drivers exceeding 85 mph on interstates and 75 on other roads. Also increases the fees paid for reinstatement or restoration of suspended or revoked drivers' licenses. Passed the House on Monday (March 9) and headed to the Senate.

HB 209 - Allowing the use of valid student identification cards issue by a public or private college or university in Georgia as proof of identity in order to vote. Status: House Committee favorably reported.

HB 228 - Reorganizing and reestablishing various state health and human services agency and reassign various functions of the Department of Community Health and the Department of Human Resources and abolish the Board of Community Health and the Board of Human Resources and establish the position of State Health Officer and the Behavioral Health Coordinating Council. Status: House Committee favorably reported.

HB 261 - Providing for an income tax credit for a limited period of time for the purchase of one eligible single-family residence. Status: House Committee favorably reported.

HB 277 - Levying a 1 percent sales tax statewide for specific transportation projects over the coming 10 years - passed the House, currently in the Senate Finance Committee. Status: Passed house, read in Senate and referred to Senate Committee.

HB 385 - Repealing the date on which the State Commission on Family Violence shall cease to exist. Status: House Committee favorably reported.

HB 517 - Imposing a cap on property assessment increases at the inflation rate or 3 percent. Status: Read a second time in the House.

51 resolutions under consideration in the Georgia General Assembly. Many are associated with House or Senate Bills currently under consideration. Adopted resolutions are constitutional amendments to the Georgia Constitution and require voter approval following adoption and signature by the Governor. For a complete list of Resolutions and their status, see the link posted above.

FDA - Political Lobbying Drove Process on a Medical Device Application

From the WSJ:

"The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections by scientists within the Food and Drug Administration, agency documents show.

The FDA's internal dissent over Menaflex, which targets the most-common knee injury afflicting everyone from high-school athletes to baby boomers, is straining a government agency that oversees a quarter of the U.S. economy. Some senior FDA staff members complained in documents that the handling of Menaflex, made by ReGen Biologics Inc., shows how political and industry pressure can influence scientific conclusions."

For the rest of the story, go here.

Reglan Gets a Blackbox Warning: Tardive Dyskinesia

News about Reglan:


What is Reglan? Reglan is used for the short-term treatment of heartburn in patients who have already tried other medications but had no relief of symptoms. The way that Reglan works is that it increases the muscle contractions in the upper digestive tract, which in turn speeds up the rate at which the stomach empties into the intestines. People that suffer from diabetes sometimes suffer from a slow gastric emptying, which can cause nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness after meals, so they take Reglan as well.



In February of 2009, the FDA issued a warning about Reglan:


Agency warns against chronic use of these products to treat gastrointestinal disorders

The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.

Manufacturers will be required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.



Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.



Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

United States Supreme Court Rules for Consumer, against claim of Drug Preemption

Opinion just came in today, and it's worth a read:

http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf

Held: Federal law does not pre-empt Levine’s claim that Phenergan’slabel did not contain an adequate warning about the IV-push method of administration.

Footnote 11 is worth your read alone:

11In 1955, the same year that the agency approved Wyeth’s Phener-gan application, an FDA advisory committee issued a report finding“conclusively” that “the budget and staff of the Food and Drug Admini-stration are inadequate to permit the discharge of its existing responsi-bilities for the protection of the American public.” Citizens AdvisoryCommittee on the FDA, Report to the Secretary of Health, Education,and Welfare, H. R. Doc. No. 227, 84th Cong., 1st Sess., 53.

and ...

(“The [FDA] lacks the resources needed to accomplish its large and complex mission . . . .There is widespread agreement that resources for postmarketing drugsafety work are especially inadequate and that resource limitationshave hobbled the agency’s ability to improve and expand this essentialcomponent of its mission”); GAO, Drug Safety: Improvement Needed inFDA’s Postmarket Decision-making and Oversight Process 5 (GAO–06–402, 2006), http://www.gao.gov/new.items/d06402.pdf (“FDA lacks a clear and effective process for making decisions about, and providingmanagement oversight of, postmarket safety issues”);

FDA; 189,000 Food Plants Worldwide; 96 Inspected

No your eyes are not deceiving you. That's the total of plants inspected in 2007 by the FDA. The FDA is broken.

From the AJC.com

The FDA’s inspection record underscores the need for more regular, comprehensive food inspections. But it also speaks to the importance of prevention and transparency, not crisis management, in protecting the safety of our food supply.

An efficient safety network prevents contamination before food products are shipped to schools, senior centers and grocery stores. An efficient system also tracks illness outbreaks quickly and recalls tainted products with equal speed.

Today, the U.S. food-safety network does not meet those standards, and Americans are literally dying as a result.

For more go here to read the posted opinion.

Seroquel Internal E-mails Unsealed

Documents recently unsealed in a U.S. federal court case showed AstraZeneca may have known about the risk of weight gain and diabetes in 2000.

At least one lawyer prosecuting the cases said internal e-mails and other documents showed AstraZeneca officials had evidence of the drug's link to weight gain but used promotions suggesting Seroquel had no effect on weight or could lead to weight loss. Weight gain is a risk factor for development of diabetes.

The drugmaker believes that the Seroquel label has always provided adequate and appropriate information and warnings based on available data.

Source here.

Alabama: Jury Orders Makers of Sandoz to Pay State $78.4M

News from Alabama yesterday:

Jurors ordered Sandoz Inc. pay the State Government of Alabama $78.4 million for causing the state Medicaid program to pay too much for prescription drugs from 1991 to 2005.

Evidence at trial? The evidence included a company memo that said: "Go forward and take the position of a Roman legion, be greedy and take no prisoners."

Source here.

Vytorin: Cancer Risk for This Heart Drug?

From various sources, link below. Several larger studies say no, one smaller study suggests yes.

Last year, a heart researcher (Terje Pedersen) released a from an 1,800 patient study. According to it, 47% of those taking the cholesterol drug Vytorin were more likely to develop cancer than those taking a placebo.

Pedersen and other scientists conducting two Vytorin studies tried to refute the findings. An analysis of data from two larger but unfinished Vytorin studies showed no increased risk of cancer.

A 18,000-patient larger study, called IMPROVE-IT, which began in October 2005 and is set to continue until 2012, didn't have enough useful information to give any answers. Another 9,000 patient test (which began in June 2003) in patients with kidney issues, code-named SHARP, showed no increased risk of cancer.

Source here.

Happy Mardi Gras - From Our Family to Yours

For my 1,000th post, I'm happy to say to folks today, Happy Mardi Gras. For many, the beads tossed have a less than family oriented connotation, but make no mistake - Carnival in New Orleans is heavily family oriented (Yes, the French Quarter and that certain street are exceptions).

Mardi Gras for families is as much sitting along St. Charles all day, with a ladder for the kids to better catch trinkets as it is a time to laugh, eat, and be with friends. For college students, it's a day/night long tailgate without the football game.

For me, it was a time to dine at great restaurants (Antoine's, NOLA, Mr. B's), to enjoy a lawyer seminar (yes, held this past week, during Carnival), and to talk to folks enjoying the parades.

It's good to see that the City I love is coming back.

Outsourcing of Drug Trials

The most recent issue of the NEJM, here discusses the globalization of clinical trials.

Concerns noted in the article include:

Wide disparities in education, economic and social standing, and health care systems may jeopardize the rights of research participants;

There may be a relative lack of understanding of both the investigational nature of therapeutic products and the use of placebo groups; and

In some places, financial compensation for research participation may exceed participants' annual wages, and participation in a clinical trial may provide the only access to care for persons with the condition under study.

Worth a read.

Tech Talk: Lawyer(s) Suddenly Laid Off? Looking to Set up an Office?

A couple of friends across the USA have either suddenly been let go, or made the decision to depart before the ax fell. Most have the same problems: How to quickly set up an office presence if a lawyers decides to open up shop.

Here are a few quick - perhaps interim only - suggestions:

1.Email: When I left my prior firm, I was sweating the purchase of an email server. After a day of searching, I settled on MailTrust.com.For about $3-$5 per mail box, you get POP, IMAP, & Webmail, Business-class email, sharing, & mobility. I set up my system for $70 a month. Plus, no contract terms to worry about long term. I am able to control the number of users, add or remove mailboxes, and I have an email address with a specific domain.

2.FAX: I signed up and receive faxes through efax.com. I'm able to get a local FAX number, and within about 10 minutes I was ready to go.

3.Phones: Obviously a concern. I am able to tell you that we now use VOIP, but in the beginning we went cell. An attorney I know who was let go suddenly actually only had his personal cell. He went to tossabledigits.com for a disposable phone number.

At the very least, get another cell phone line for the first several days of your new career. You can always forward it to a main number when you're set up.

4.Internet/Website My suggestion to anyone reading this is to acquire and manage your own domain. I'm not talking about building a page, merely about controlling the domain name. That is, don't entrust any internet hosting company to build your site and administer/control the .com name. Why? I can tell you horror stories of a firm passing off its .com to a host, only to have that host go under, and with it the .com name. Another story involves a hosting company getting angry about losing business and refusing to turn over the domain name.

I simply use godaddy.com or yahoo.com, buy the domain name, and forward it to the site that is ultimately built. I can go into detail about modifying an A record, but that is for later.

5. Openoffice and PDF995.com: Openoffice is the free version of the typical office system like MS Word/MS Office. It allows you to create a document and save in .doc or other formats. It also allows you to save as a PDF. Pdf995.com is just that - converts a document into PDF. There is a free version as well.

Reglan and Movement Disorders

Reglan now has a blackbox warning, pursuant to the FDA. We're investigating those who may have been harmed by this drug.

Movement disorders describe a variety of abnormal movements of the body that have a neurological basis. These abnormal movements are characterized by changes in the coordination and speed of voluntary movement. They may also involve the presence of additional movements that are not voluntary.
Description

Movement disorders are sometimes referred to by medical professionals as extrapyramidal diseases because this class of disorders is distinct from the disorders caused by disorders of the pyramidal region of the brain. Researchers have determined that movement disorders are caused by diseases in various parts of the brain, including the substantia nigra, the subthalamic nucleus, the globus pallidus, the striatum, and the basal ganglia.

Movement disorders are usually broken down into two types of movement: hyperkinetic movement and hypokinetic movement. Hyperkinetic movement disorders are characterized by a significant and excessive amount of motor activity. This type also includes cases in which there is a significant amount of abnormal involuntary movement. Hypokinetic movement disorders are those in which there is an abnormally reduced amount of intentional motor activity.

Hyperkinetic movement disorders are characterized by two types of behavior: rhythmical and irregular. Tremor is a rhythmic movement that is further divided into three forms: rest, postural, and intention. Rest tremor is most prominent when an individual is at rest and decreases with voluntary activity. Postural tremor occurs when an individual attempts to support a position against gravity (such as holding an arm outstretched). Intention tremor occurs during voluntary movement toward a specific target.


A side effect is a movement disorder, like Dystonia:


What is Dystonia?

Dystonia is a movement disorder characterized by involuntary muscle contraction leading to abnormal postures and twisting movements. The frequency of this disorder is similar to multiple sclerosis.

Are there different types of dystonia?
Several types are known and they are classified according to age of onset, distribution of dystonia, and cause. The primary dystonias are diseases that are characterized with only dystonia as their clinical feature. They are classified as early onset or adult onset disease.

* Early onset dystonia
The characteristic form of early onset form is called "primary childhood onset dystonia" otherwise known as Oppenheim's dystonia or DYT1 dystonia. This disease begins frequently with dystonia in a limb and with onset under the age of 28. It characteristically progresses to involve other body parts and ultimately becomes generalized.

* Adult onset dystonia
The adult onset dystonias are far more common and cervical distribution (otherwise known as spasmodic torticollis) is the most common type. The adult onset dystonias usually remain localized to specific areas such as neck, face or vocal cords. And they generally do not spread and are much less frequently hereditary.

* Cervical dystonia (or spasmodic torticollis)
For cervical dystonia, typical age of onset is around 40 years and women are more affected than men.

What causes dystonia?
The cause of dystonia is unknown although genetic studies may shed some light on this in the next decade. The genetic nature of this disorder has recently come to light as it is autosomal dominant and a number of genes have been isolated.

How is dystonia treated?
The primary treatment for the focal adult onset dystonias is Botulinum toxin. There are currently two types of toxins - Type A (approved in 1989) and Type B (approved in 1999). The most recent advance in the treatment of dystonia is deep brain stimulation surgery similar to that utilized in Parkinson's disease and essential tremor.

Another side effect is an essential tremor

What is essential tremor?

Essential tremor is probably the most common of movement disorders affecting about 5-10% of the population.

What are its symptoms?
It is characterized by tremors. But unlike Parkinson's disease

* Essential tremor is associated with postural and action tremors, which interfere with such activities as writing, eating and performing fine motor movements.

* With Parkinson's disease, tremors occur while sitting at rest.

Essential tremor can occur at any age. It is sometimes very mild and not troublesome but it can be progressive and result in severe disability.

What causes essential tremor?
The cause of essential tremor is unknown. We do know that it is inherited in an autosomal recessive manner in many cases, meaning that each child of a person with this disease has a 25% chance of inheriting it. Two genes have recently been associated with essential tremor and further research may delineate a cause.

How is it treated?
Currently there are some medications that may be helpful in diminishing the tremor. These include:

Medical Treatments

* Propranolol
* Primidone
* Gabapentin
* Topiramate
* Benzodiazepines

Unfortunately, there is no medicinal treatment that is capable of completely stopping tremor.

Surgical Treatments
In the last 10 years, developments in surgical therapy have helped some to slow the progression of essential tremor. For those who are severely disabled by tremor and do not respond to medicinal treatments, a surgical procedure known as deep brain stimulation may ease symptoms. During deep brain stimulation, a part of the brain is exposed to electrical pulses to help abolish or partially abolish tremor, Patients who undergo deep brain stimulation have continued to experience symptom improvement for years after the procedure for years.

FDA Targets Starcaps and Other Diet Pills

The FDA says that certain weight-loss capsules, including StarCaps are promoted as natural dietary supplements using papaya, but could be hazardous to your health. In violation of the law, the FDA found, the capsules also contained a drug called bumetanide that can have serious side effects.

In a continuing investigation, the FDA has concluuded that dozens of weight-loss supplements, most of them imported from China, contain hidden and potentially harmful drugs.

Expect a detailed list to be published soon.

Our office is investigating alleged wrongdoing by the matkers of StarCaps. The recall information is here.

Source here.

FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs (Fentanyl)

From the FDA's very own site:

Certain ffected opioid drugs will be reviewed, and include brand name and generic products that are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks.

Opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients. Opioid drugs have serious risks when used improperly. The FDA, drug manufacturers, and others have taken a number of steps in the past to prevent misuse, abuse and accidental overdose of these drugs, including providing additional warnings in product labeling, implementing risk management plans, conducting inter-agency collaborations, and issuing direct communications to both prescribers and patients. Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade. The FDA believes that establishing a REMS for opioids will reduce these risks, while still ensuring that patients with legitimate need for these drugs will continue to have appropriate access.

Read more here.

GA: Medical Malpractice Ruled Unconstitutional

In Atlanta, State Court Judge Diane Bessen ruled that the Georgia statute that capped medical malpractice non-economic damages (O.C.G.A. Sec. 51-13-11) violated the Georgia Constitution. Known as the Nestlehutt decision, some highlights of the Order include: "A limit or cap on noneconomic damages ... invades the right to a jury trial by usurping one of the fact-finding responsibilities of the jury... ."

Read the Order here.

Consumers At Risk with Proposed Georgia Legislation

From the GTLA: Governor Perdue wants to place the safety of Georgia’s citizens in the hands of a mismanaged federal bureaucracy

Georgia lawmakers introduced SB 101. Senate Bill 101 would grant new protections from product-liability suits to Georgia companies whose products have Food and Drug Administration approval.

In essence SB 101 seeks to rely on the federal Food and Drug Administration (FDA) amidst grave controversy while giving large pharmaceutical companies who harm Georgians a “Get out of Jail Free” card

Governor Perdue suggests that a federal bureaucracy embroiled in heavy controversy, the FDA, should have all the power in deciding the safety of pharmaceuticals and medical devices. SB 101 bars any Georgia citizen from bringing a products liability claim against a pharmaceutical corporation so long as it is headquartered or has 200 employees in Georgia and the product in question, either a drug or a medical device, is FDA approved.

“Vioxx was an FDA approved drug that harmed at least 139,000 people. If there were to be a drug or medical device made here in Georgia that injured or killed people like Vioxx did, Georgia residents would have absolutely no recourse. A person in Phoenix City, Alabama could pursue justice; a person in Columbus could not,” said Fred Orr, President of the Georgia Trial Lawyers Association. “The Governor believes SB 101 will bring corporations to Georgia. But I don’t think we want the kind of business this legislation would attract as this bill says, “Move to Georgia! You can harm or kill our citizens and you will not be held accountable!”

The Governor stated early in the session that FDA approval “should mean something” and that it should protect corporations from lawsuits.

“The FDA can’t protect us from peanut butter. How can we possibly rely on the FDA to protect us from dangerous drugs and medical devices?” said Orr. “If a pharmaceutical corporation manufactures a drug or medical device that seriously harms or kills an innocent person, that corporation should not, under any circumstance, be shielded from accountability. The Governor has simply gone too far with this proposal.”

On February 2, 2009 President Obama had harsh words for the FDA and he urged Congress to conduct a complete review of the FDA after the agency failed to protect the public from contaminated peanut butter. At this time the contaminated peanut butter has killed 8 people and sickened over 500 people.

In addition to the agency’s failure to protect the public from peanut butter, as recently as the last month, the FDA has been at the center of three other nationally publicized controversies concerning alleged corruption, mismanagement, and claims of serious financial conflicts of interest. First the federal Government Accountability Office (GAO) released a report revealing that the FDA has failed to comply with a congressional mandate set nineteen years ago that requires manufacturers of medical devices to provide proof of rigorous testing and safety analysis to the FDA for all Tier 3 medical devices (classified as those devices that are implanted or that a person relies on for life) prior to approval.

Second, a group of FDA scientists went public with their allegations of corruption, mismanagement and coercion within the FDA. The scientists stated that the scientific review process for medical devices “has been corrupted and distorted by current FDA managers, thereby placing the American people at risk.” They allege that managers at the FDA lacked scientific knowledge and clinical expertise regarding medical devices and that they have ignored the experts and scientists within the FDA. The authors stated that they had been ordered to modify their findings and evaluations of medical devices—allowing for the approval of products that may not be safe.

And third, the Inspector General of the Department of Health and Human Services (HHS) issued a report uncovering a troublesome conflict of interest inherent in the FDA approval system. The FDA failed to collect information on financial ties between those that perform clinical tests and the pharmaceutical companies that manufacture the product being tested in an alarming 42% of the cases. HHS claims that such financial ties may compromise the safety of the people in the clinical trials and the authenticity and integrity of the final research data.

“The scientists working at the FDA think that Americans are in danger. Other governmental entities report that the FDA is inept at keeping the American public safe. Yet Governor Perdue inexplicably thinks we should trust a corrupt federal bureaucracy to keep Georgians safe,” said Andy Childers, an Atlanta attorney.

National leaders in medicine don’t think that FDA approval is enough to keep people safe either. In a friend-of-the-court brief filed in association with the case of Wyeth v Levine, multiple editors of the New England Journal of Medicine stated, “The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety." The doctors went on to say that without civil lawsuits and the discovery they produce, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."


NOTE: For more information on the FDA approval process and other Government reports, please contact Rebecca DeHart at GTLA.



The Georgia Trial Lawyers Association
Protecting the Constitutional Promise of Justice for all by
Guaranteeing the Right to Trial by Jury,
Preserving an Independent Judiciary, and
Providing Access to the Courts for all Georgians

FDA Advisory Committee Hearing Will be Webcast 2/3/09

Te Cardiovascular and Renal Drug Advisory Committee Meeting scheduled for February 3rd, 2009 will be webcast.

The FDA's Cardiovascular and Renal Drug Advisory Committee Meeting is being held to decide whether or not to approve a competitor drug to Plavix, the second-biggest selling drug in the world. The new drug in question is called prasugrel and would be marketed by Eli Lilly & Co with potential co-marketing by Japan's Daiichi Sankyo Co., the drug's discoverer.

Reports issued suggest that prasugrel may be more effective than Plavix in preventing heart attacks, but also a higher risk to cause dangerous bleeding. These are the issues that have been considered and will likely be commented upon as the Advisory Committee decides on approval.

Webcast here.

Source here.

Pres. Obama Weighs in on FDA: Critical Comments

Nice to hear he is going to have a complete review of the agency that is failing Americans every day:

"President Obama had critical words for the Food and Drug Administration yesterday in the midst of a massive recall of peanut products linked to a nationwide outbreak of salmonella illness that has killed eight people and sickened another 550.

"I think the FDA has not been able to catch some of these things as quickly as I expect them to catch them, so we're going to be doing a complete review of FDA operations," Obama told Matt Lauer during an interview broadcast on NBC's "Today" show."

Source here.

Peanut Butter Recall: Peanut Corp. of America

The King Nut Food Supply Company announced an immediate recall of their institutional brands King Nut and Parnell's Pride peanut butter. Minnesota State Health officials linked the country's latest outbreak of Salmonella food poisoning to tainted peanut butter. King Nut is a large scale distributor of peanut butter and other foodservice products to hospitals, schools, and nursing homes. The company does not manufacture their brand of peanut butter.

The peanut butter in question was produced by the Peanut Corporation of America, which issued a statement expressing dismay over the discovery of salmonella bacteria in a King Nut five gallon jar of peanut butter. However, the company instatly struck a defensive position, insisting that the chain of custody of that peanut butter jar had not been fully established, and more conclusive facts needed to be revealed.

Minnesota Health officials established in preliminary laboratory testing that the Salmonella found in a jar of King Nut peanut butter was identical to the strain responsible for the large outbreak of salmonella bacteria food poisoning in the United States since September of 2008. This same salmonella outbreak has been responsible for hundreds of cases of salmonella poisoning and hospitalizations in 42 states.

Peanut Butter Recalls: Save Your Proofs of Purchases

I've been reading (as have most) about the recall of tainted peanut butter products. I think bad advice is being given in an overly simplistic way - that is, advice to simply "throw away" the bad product.

Obviously, most of the producers of the bad product hope most consumers throw away any proof they may have. I suggest you keep the jar lids as a bare minimum. Keep the proof of purchase or the label. You're going to need it later, perhaps.