Thursday, December 31, 2009

Gov't Panel seeks Blackbox Warning for MRI Drugs

MRI imaging drugs from GE Healthcare (GE.N) and Covidien (COV.N) appear linked to a higher risk of a potentially fatal skin disease for some patients than similar products.

'A majority of the Food and Drug Administration panel felt current data showed GE's Omniscan and Covidien's Optimark were associated with a higher risk of nephrogenic systemic fibrosis (NSF) for patients with severe kidney disease, panel chairman Robert Harrington said.' Source.

Nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. Its cause is not fully understood, but it seems to be associated with exposure to gadolinium (which is frequently used as a contrast substance for MRIs) in patients with severe kidney failure. It does not have a genetic basis.

In NSF, patients develop large areas of hardened skin with fibrotic nodules and plaques. Flexion contractures with an accompanying limitation of range of motion can also occur. NSF resembles scleromyxedema at the histologic (microscopic) level; it shows a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers, and deposits of mucin.

A black box warning is a notice on the packaging of a prescription drug which warns patients and prescribers that the drug has potentially dangerous side effects. This warning system is primarily used by the Food and Drug Administration (FDA), an American regulatory agency which oversees the safety of pharmaceuticals produced and sold in the United States. Other national regulatory agencies may use different systems to indicate that drugs are potentially dangerous.

When a drug receives a black box warning, it means that studies on the drug have suggested that it can have dangerous or even deadly side effects. Black box warnings are often added retrospectively as the result of information about a drug which has been uncovered in the course of routine usage. When doctors start reporting high levels of dangerous side effects for a prescription drug, the FDA may hold a review to decide whether or not the drug requires a black box warning.

The “black box” in “black box warning” refers to the bold black border which is drawn around the warning. The border is designed to draw attention to the warning, and to offset it from other information which may be present in pharmaceutical packaging. Thanks to widespread public awareness of the implications of a black box warning, a black box on drug packaging serves as an alert that the drug is dangerous even before people read the text of the warning.

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OsmoPrep Lawsuits Filed

Four plaintiffs filed a complaint in North Carolina claiming that the use of a Salix Pharmaceuticals drug led to kidney damage.

The case revolves around the drug OsmoPrep, which is used to cleanse the intestines in preparation for a colonoscopy. A statement claims the parties sustained a variety of serious kidney injuries and that some of the injuries resulted in the need for dialysis. The statement says that the medical name for the plaintiffs’ condition is called acute phosphate nephropathy.

The U.S. Food and Drug Administration placed a “black box” warning – the most severe admonition possible – on OsmoPrep in December 2008. The FDA said that OsmoPrep and another Salix bowel cleanser, Visicol, carry the risk of kidney damage.

Source here.

Wednesday, December 30, 2009

Twitter: Value for your Law Practice?

Image representing Twitter as depicted in Crun...Image via CrunchBase

I just completed my first year using Twitter.com. Twitter is -- reduced to its most basic - a real time scroller (like the ones you see on FOX News and CNN) for the goings on in life - news, rumors, gossip, etc. That holds true today. The news on Urban Meyer's resignation came to me via Tweet on my iPhone.

I had heard and read from many who said Twitter was an "absolute must" for a law firm or lawyer. After one year, I can't say it's a must. I am able to assess it and make these conclusions:

1.Twitter as a breaking news source: Quite good. I follow Anderson Cooper and others. On Twitter you were able to get a near ring-side seat for events ranging from the attacks in Mumbai to the ridiculous balloon boy.

2.Twitter for expanding your blog's visibility: For me, this one gets a partial grade of a C, as I think it's to be developed. This blog is ranked highly among lawyer blogs in terms of popularity (even in my niche). Twitter has given my blog a little push when I 'tweet' about a new blog post. Increasing my visibility as a lawyer is of course a goal. Where the end result for me and my firm's visibility is Google results. I have seen a small uptick.

3.Twitter for gaining new clients or potential clients:I practice consumer law - helping those who were injured because someone else was at fault in some act. I can tell you that Twitter had zero effect in developing clients. I first started - naively to be candid - to believe that Twitter would be mechanism for business development. Not so. In the future? Maybe. Just not now for me at least. If you're a personal injury lawyer who has actually developed clients from Twitter, I want to hear from you. If you're a personal injury lawyer, you make a mistake if you think Twitter will increase your client base.

With several different websites for my firm, I will tell you that websites (and blogs) will be by far the best way to spend your time if you you hope to develop business from the web for the near future.

On this blog earlier this year, I posted what one lawyer thought of Twitter:

9 Reasons You Need Social Media Marketing in 2009. Among those are:

4. More Social = more Search.
More Search = More Customers.
More customers = More business.


That is simply not the case in the PI area.


I have switched from believing that (in my field) Twitter would work to increase my client base, to one where I decided to follow other lawyers with helpful news and information. This leads to the next item:

4. Twitter as a resource: I have been able to locate vendors and support persons thanks to Twitter. I did so by actively seeking someone to, for example, help me with service of process in a Pacific state.I was able to find a vendor for office products. Could I have used Google to accomplish the very same thing? Probably, but I wanted to see what Twitter could or could not do.

I have tried to use Twitter to refer a number of matters, and it's just not there yet. In my practice, groups like the AAJ and my state bars are the best source for me to find someone to assist on a legal matter. According to Lextweet.com, there are 5856 lawyers with some form (inactive or active) of Twitter account. One list serve I belong to has more than 7,000 member subscribers.

It's probably too early to give Twitter a ringing endorsement, and too early to pan it. For me it's one more piece of my overall business effort. The 'ground war' is going to meetings, having lunches and visits with lawyers, and joining affinity groups in my city. The "air war" is my web presence, and Twitter will likely be a part of that effort.


This is my list of items so far. I'll be updating with more items later.

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Comparison of Free Online Storage Sites

I've been checking out online backup storage for my office, and I have found many possible solutions. Worth checking out is a post on Lifehacker that compares many of the sites.

Take a look here, and good luck with your selection.

Recall of Tylenol Arthritis Pain Caplets

A voluntary recall of Tylenol Arthritis pain caplets is being expanded because of consumer reports of a moldy odor.

The recall affects the 100-count bottles. The FDA says the recall is specific to bottles with the distinctive red "EZ open" cap.

It's based on consumer reports of a foul smell on the medicine associated with nausea, stomach pain, vomiting and diarrhea.

The pills’ musty odor comes from trace amounts of a chemical known as 2, 4, 6-tribromoanisole, according to the company, which is believed to be from the breakdown of another chemical in wooden pallets used to transport and store the drug

Monday, December 28, 2009

From NPR: How A Bone Disease Grew To Fit The Prescription (Fosamax)

Interesting read at NPR about Osteoporosis and Fosamax. Osteoporosis is a disease that causes bones to become thinner, more porous and break more easily. It mostly affects elderly women, who can be devastated by a fall that breaks their hip. One in five elderly women who break a hip will die within a year. Osteopenia, it turns out, is a slight thinning of the bones that occurs naturally as women get older and typically doesn't result in disabling bone breaks.

NPR writes: "This is the story of how pills for osteopenia ended up in one person's
medicine cabinet, and in the medicine cabinets of millions of women like her all over the United States.

Read it here.

FDA: No Cancer Link to Vytorin

The FDA says an extensive data review shows there's no evidence that Merck's cholesterol drug Vytorin causes cancer, a suspicion raised last year by a patient study.

Still, the Food and Drug Administration says it cannot definitively rule out whether Vytorin is linked to a higher risk of cancer or death from cancer.

The FDA says it's examined all of the data from the study that first raised the alarm about a possible risk. It also has reviewed interim data from two very large studies that are still in progress.

Source here.

Nestle Gets FDA Letter Regarding Boost

In an early December letter to Nestle, the FDA told the company that it had mislabeled its Boost drink, which comes in flavors like chocolate, vanilla and strawberry, “as a medical food for the medical condition of ‘failure to thrive’ and also for ‘pre/post surgery, injury or trauma, chronic illnesses.’”

The FDA informed that federal guidelines explain that “medical foods must be for the dietary management of a specific disorder, disease, or condition for which there are distinctive nutritional requirements and must be intended to be used under medical supervision.”



Source here.

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Saturday, December 26, 2009

IKEA High Chair Recall

IKEA Home Furnishings is recalling LEOPARD Highchairs sold exclusively at IKEA stores nationwide from October 2009 to November 2009. The snap locks used to secure the seat to the frame can break and allow the seat and child to drop through the frame, posing a fall hazard. Detached snap locks can pose a choking hazard.

This recall involves all colors of the LEOPARD highchairs sold as a seat and a frame individually. The seat and tray has an adhesive label affixed to the underside with the words LEOPARD and “Made in Italy,” an eight-digit article number and a five-digit supplier number (19589).

Consumers should return the highchairs to any IKEA store for a full refund.

Consumers can also contact IKEA at (888) 966-4532 anytime, or visit at www.ikea-usa.com. More info at www.recalls.org.

Polaris ATV Recall

Polaris Industries Inc. is recalling 2009-2010 Polaris All-Terrain Vehicles (ATVs) sold nationwide from February 2009 to November 2009. The front suspension ball joint stem can separate from the steering knuckle and cause the rider to lose steering control, posing a risk of injury or death.

This recall involves model year 2009 and 2010 Polaris Sportsman ATVs with certain VIN numbers. A list of the recalled ATVs can be found at www.recalls.org.

AstraZeneca’s Swine Flu Nasal Spray Recalled for Lower Potency

AstraZeneca Plc recalled 4.7 million doses of its nasal spray version of the swine flu vaccine after routine tests showed a decline in potency, U.S. regulators said.

The doses remain safe, and people who have already been inoculated don’t need to get vaccinated again, said Norman Baylor, director of vaccines research and review for the U.S. Food and Drug Administration. About 3,000 of the affected doses remain in warehouses, and AstraZeneca will send recall notices to clinics that may have unused vials of the vaccine.


The link is here.

Prempro Verdict: $8 Million

A Philadelphia jury in January 2007 awarded Mary Daniel compensatory damages of $1.5 million in her lawsuit against Pfizer’s Wyeth subsidiary over its Prempro menopause treatment. The panel recommended she get more than $8 million in punitive damages if an appeals court found she was entitled to such an award because of bad conduct by the company, people with direct knowledge of the figure said.

The $8 million figure was sealed pending an appeal. A judge in Philadelphia refused last month to make it public. A Pennsylvania appellate court heard arguments in Wyeth’s challenge to the verdict on Dec. 1. Wyeth wants the jury’s $1.5 million compensatory award thrown out. Daniel’s lawyers are seeking to have punitive damages added to it.

Source and more here.

Monday, December 21, 2009

Does Chelation Therapy Cause Heart Injuries?

Chelation therapy is a recognized treatment for heavy metal (such as lead) poisoning. EDTA (Ethylenediamine tetraacetic acid) is injected into the blood and binds the metals, allowing them to be removed from the body in the urine.A potent chelator of cations, especially calcium, it is FDA-approved only for rapid, emergency treatments of hypercalcemia or digitalis toxicity,and for those indications it has long been obsolete. Source.

Na2EDTA is specifically contraindicated for “generalized arteriosclerosis.” Its labeling includes a “black box” warning: “The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy." You can find the warning here: http://www.circare.org/foia2/endrate_ppi19740716.pdf



Chelation therapy is not approved by the FDA to treat coronary artery disease, but some physicians and alternative medicine practitioners use it for this purpose.

In August 2002, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI), which are both components of the National Institutes of Health (NIH), announced the launch of the Trial to Assess Chelation Therapy (TACT). This placebo-controlled, double-blind study involves participants age 50 years and older who’ve had a heart attack, and is expected to reach a total enrollment of 1,950. Participants are representative of the U.S. population.

Last August, the federal Office of Human Research Protections began a probe into whether the people in the study were being fully informed of risks and adequately protected. Researchers then suspended enrollment.

The most common immediate side effects of oral chelation therapy include: skin rashes, redness and swelling, headaches, diarrhea, nausea, fainting, fatigue, joint pain, body aches, cramps and convulsions.

Kidney damage from chelation therapy has resulted in permanent damage requiring ongoing dialysis. Deaths have also occurred during chelation therapy from kidney failure and cardiac arrhythmia.

Death and permanent injury have resulted from chelation therapy, even in doctor-supervised clinical trials. The American Heart Association warns of severe and life-threatening side effects and does not endorse chelation as a treatment for heart disease.

Other observers have reported cases of hypocalcemia leading to cardiac arrhythmias and tetany; kidney damage; decreased blood clotting ability with abnormal bleeding; thrombophlebitis and embolism; hypoglycemia and insulin shock; severe vasculitis and autoimmune related hemolytic anemia, dermatitis with pruritus and generalized eczema; and extensive clumping of platelets in the blood of some patients with atherosclerosis and other chronic diseases.


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Saturday, December 19, 2009

M-Drol and P-Plex -Link to Liver Injuries?




Both M-Drol and P-Plex were supplements were marketed on the Internet by a company in Galveston, Texas called TF Supplements.

Some say that the main ingredients in M-Drol and P-Plex are methylated compounds known to cause liver damage. It has been claimed that the supplements were manufactured by a company called Competitive Edge Labs, a foreign corporation working in Virginia. Making and distributing the supplements is not against the law.

If you took either or both of these and have liver injuries now, call us.

Friday, December 18, 2009

Law Tech: 2009's Most Useful Tech Items

Here are tech apps/hardware that I think are "best" when it comes to helping my office in the practice and business of law:

1.iPhone- I'm old enough to remember when computers for lawyers were a rarity. In 1991 I remember an older partner literally yelling at me that "computers are for secretaries!" when he saw a PC on my desk. Could anyone today imagine practicing law without one?

I'd put the iPhone on the list of essential tools. If you don't have one, in my opinion you are at a disadvantage. Apps for it are key - Dragon dictate, access to key documents, email with PDF capability, the ability to fill out, sign and annotate any PDF document while away from the office (Zosh), and more. The blog iPhoneJD.com is a must read. If you're one of those dinosaurs who proudly proclaims that you only use your phone to make calls, well, the meteor is headed your way, and it has an Apple logo on it. If you have a smart phone like a BBerry, at least you're getting closer.


2.Speak Write: This is a transcription service. A transcript is processed by trained professionals located in the U.S. and Canada, without the use of voice recognition software. You can dictate from anywhere and receive your completed work via email, 24 hours a day, 7 days a week, in about 3 hours. Since you can dictate using a variety of methods, no special equipment or software is required; you can be signed up and dictating within minutes. Speak-write.com


3.Scansnap:


Especially for smaller firms like ours, the Fujitsu ScanSnap scanner takes the complication out of document imaging with one-touch ease of use. It's the size of a football, is sturdy (I've dropped it twice), lightning fast, and relatively inexpensive. I've taking it to document reviews and have been able to have 1000's of pages scanned while reviewing papers.



4.Google Desktop: Google Desktop is desktop search software made by Google for Mac OS X, Linux, and Microsoft Windows. The program allows text searches of a user's e-mails, computer files, music, photos, chats, and Web pages viewed.

We have indexed the documents on our servers, and now can search our "google-style" for items. Cost? Free.





5.Dual Monitors: More and more you are seeing dual monitors. I have two, and it helps a great deal. Using dual monitors allows you to eliminate scrolling and window switching. You may not even be aware of how often you are moving things around now. It’s very easy to get used to two monitors and to determine the best way for you to work with them.

On my desk, our client database and contacts are on one monitor, and my work items are on another.

I also have two 23" monitors, and that's been a great help as well.

6.RingCentral: RingCentral Office delivers a virtual PBX, VoIP phone service and IP phone as one complete system. It's cheap, and here is how I use it: I sign up for an account, and then use that number to track any google ad words buy we use. At any one time, I may have 2-4 web sites active with either google ad buys or simply as informational sites. It helps me measure the success of the site separate and apart from any emails or forms filled out. It's cheap, easy to use and yes, there's a free app for that for the iPhone. On the iPhone it looks like this:



7.Phonetag: From their site: PhoneTag automatically converts your voicemail into text and delivers it directly to your mobile phone, Blackberry, Goodlink enabled phone and/or your email account; so you can read your voicemail.

I love it.

There you have it. Email me if any of those help.

Tuesday, December 15, 2009

SCOTUS to review Texting Privacy Ruling

The Supreme Court has granted certiorari regaarding a federal appeals court in California that reading text messages sent on devices provided by the employer violated the worker's privacy rights and amounted to an "unreasonable search" barred by the U.S. Constitution. The case is City of Ontario v. Quon, 08-1332.

The city appealed to the Supreme Court, saying employers typically have policies in place establishing that workers have no expectation of privacy in electronic communications on employer-owned equipment.

The PDF opinion may be found here.

Source here.

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Roman Blind Recall

The federal government - via the CPSC - has issued a recall of Roman Blinds that they could suffocate kids.

For the first time, the safety commission now recommends using only cordless window treatments in any home where children live or visit, such as a grandparent's house or day care center.


From USA Today:

HOW TO MAKE KIDS SAFER

1. Install only cordless window treatments in all homes where children live or visit, especially in children's bedrooms.

2. Move all cribs, beds and furniture away from windows.

3. If not using cordless shades, cut the ends of pull cords, so that the loop can't form a noose.

4. Don't allow cords to dangle. Wrap cords around a hook that's high off the floor out of a child's reach.

5. If using Roman shades with hidden strings on the back side, raise the shades high enough so children can't reach them.

Another Recall on an OTC Cold Remedy

The FDA reports that P&G has made a voluntary recall of specific lots of their Vicks brand nasal spray in the US, Germany and the UK.

The recall comes as a result of P&G finding the bacteria B. cepacia in these particular batches. There have been no reports of illness, and most healthy individuals should not be effected from this bacteria; however, the bacteria could cause serious illness in those with compromised immune systems such as those with Cystic Fibrosis or other chronic lung conditions.

The lot number in the US that is being recalled is 9239028831, which is for Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml Nasal Spray.

Antidepressants May Raise Women's Stroke Risk

That, according to a report released this week.You may find the abstract at the Archives of Internal Medicine.

Older women who ingest such antidepressants may have a small but statistically significant increased risk of stroke and death compared to women not on the medications, a new study finds.

"But statistical significance can be different from clinical significance," stressed Dr. Jordan W. Smoller, an associate professor of psychiatry at Harvard Medical School, and lead author of a report in the Dec. 14 issue of Archives of Internal Medicine. "It is possible that a statistically detectable effect may not be a problem for most people." Source.

The Report's conclusion: "In postmenopausal women, there were no significant differences between SSRI and TCA use in risk of CHD, stroke, or mortality."

Monday, December 14, 2009

FDA Warning on Steris Sterilizer

The Food and Drug Administration has warned doctors and hospital administrators that a widely used surgical tool sterilizer made by Mentor-based Steris no longer has the agency's "safe and effective" stamp and should not be used.

The product, called System 1, is used to sterilize medical tools such as endoscopes, bronchoscopes and other devices. It is used in hospitals, outpatient surgical centers and some physicians' offices.

Source here.

Alka Seltzer Recall

Bayer Healthcare is recalling 100,000 packages of Alka-Seltzer cold capsules because some lack warnings of possible drowsiness. The recall applies to Alka-Seltzer Plus Day & Night Liquid Gels. Bayer blamed the label omission on human error and said steps are being taken to prevent this from happening again.

Consumers who purchased packages from lot 296939L can contact Bayer for a refund at (800) 986-3307.


I like the product, and a thumbs up for Bayer's effort to recall the product.





Dietary Supplement Recall

Atlas Operations Inc. is recalling dietary supplements for sexual enhancement sold under about 37 brand names. The products might contain an ingredient not declared on their labels. The undeclared ingredient is similar to a Food and Drug Administration-approved drug used to treat erectile dysfunction, making these recalled products not approved drugs.

The interaction of the ingredient with some prescription drugs could lower blood pressure to dangerous levels. No illnesses or incidents have been reported, according to the Pompano Beach, Fla., company.

The products are being sold as dietary supplements online and in retail stores throughout the nation. Laboratory results found that products tested from certain batches of these brands contain the undeclared ingredient: Rock Hard, 72 Hours, Stamin It, Finally On Demand, Sexual Surge, Staminil and Vierect.

The recalled products have the following numbers in the middle of their lot codes: 494, 520C, 520B, 520A, 520, 521, 705, 706, 779 or 807.

AP source here, FDA here.

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Slim-Fast Recall

Original Slim Fast labelImage via Wikipedia


The Food and Drug Administration (FDA) has issued a nationwide recall on cans of Slim-Fast ready to drink beverages because of a possible contamination with Bacillus cereus, a microorganism that can cause infected people to suffer from diarrhea, nausea and vomiting.


The recall involves all Slim-Fast ready to drink beverages in cans, regardless of flavor, best-by date or UPC number, the FDA said. No other Slim-Fast products are affected by the recall.

The company is in the process of identifying and correcting the production issue and will resume production and shipment as soon as the problem is remedied.

Consumers who have recently purchased ready to drink Slim-Fast beverages in cans are urged to discard them immediately and contact the company at 1-800-896-9479 for a full refund.

Source here.

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FDA Investigating Brain Scans

Federal health regulators are investigating reports of dangerous radiation levels at two more California hospitals, following earlier unsafe medical scans at a Los Angeles facility.

The Food and Drug Administration is probing the use of CT scans at Glendale Adventist Medical Center and Providence St. Joseph Medical Center in Burbank, Calif. The brain scans are used to diagnose strokes.

For more, go here, the NYT Online.

First Gadolinium Trial Set to Begin in early 2010

On Monday a suit against Bayer Healthcare will begin in January, in front of San Francisco Superior Court Judge Curtis Karnow.

Peter Gerber's lawsuit accuses Bayer of negligently designing, testing and marketing Magnevist, a drug used to help doctors read MRIs, is one of hundreds of suits in California and elsewhere alleging that diagnostic drugs containing gadolinium have caused nephrogenic systemic fibrosis. And according to Gerber's lawyer, his suit is the first to be scheduled for trial.

Magnevist is a contrast agent used to improve magnetic resonance imaging. In 2007 the U.S. Food and Drug Administration requested that gadolinium-based agents such as Magnevist carry boxed warnings about the risk of contracting nephrogenic systemic fibrosis for patients with kidney problems.

Nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. Its cause is not fully understood, but it seems to be associated with exposure to gadolinium (which is frequently used as a contrast substance for MRIs) in patients with severe kidney failure. It does not have a genetic basis.

In NSF, patients develop large areas of hardened skin with fibrotic nodules and plaques. Flexion contractures with an accompanying limitation of range of motion can also occur. NSF resembles scleromyxedema at the histologic (microscopic) level; it shows a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers, and deposits of mucin.

Most patients with NSF have undergone hemodialysis for renal failure, some have never undergone dialysis and others have received only peritoneal dialysis. Many patients have taken immunosuppressive medications and have other diseases, such as hepatitis C. Four of the five gadolinium contrast agents approved by the U.S. Food and Drug Administration have been principally implicated in NSF, including Omniscan, Multihance, Magnevist, and OptiMARK.

The first cases of NSF were identified in 1997.

Source here.

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Sunday, December 13, 2009

Trucking: Speed Limits to in crease

Reefer on a truckImage via Wikipedia

A new law takes effect next month increasing the speed limit for semi truck drivers from 55 to 65 miles per hour, but there are differing opinions on whether the new law is a good one.


"If everyone goes the same speed, it has to be safer," he said. "I think it's been proven other states' accident rates went down and I think it will also take a lot of pressure off the drivers. I don't think a lot of people want to go faster because of the threat of a speeding ticket."

More here.

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FDA Fails to make safety changes Post Vioxx

The Food and Drug Administration still hasn't restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal.

That's according to congressional investigators who found that the FDA has yet to follow through on changes suggested in 2006 to help the agency detect problems with drugs taken by millions of Americans. Those recommendations came after the embarrassing and dangerous episode with Vioxx, a blockbuster pain drug the FDA approved in 1999, only to pull from the market in 2004 after linking it to heart attack and stroke.

More from the AP story.

Monday, December 07, 2009

Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes

Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.

Monday, November 30, 2009

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.

Tuesday, November 24, 2009

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 theƂ 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

Monday, November 23, 2009

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.

Wednesday, November 18, 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.

Tuesday, November 17, 2009

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).

Monday, November 16, 2009

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?

Friday, November 13, 2009

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.

Wednesday, November 11, 2009

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.

Tuesday, November 10, 2009

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

Monday, November 09, 2009

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.

Thursday, November 05, 2009

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.

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Wednesday, November 04, 2009

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.

Thursday, October 29, 2009

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.

Wednesday, October 28, 2009

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, October 23, 2009

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.

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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.

Thursday, October 22, 2009

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.

Wednesday, October 21, 2009

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.

Wednesday, October 14, 2009

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.

Tuesday, October 13, 2009

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.

Monday, October 12, 2009

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

Tuesday, September 29, 2009

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.

Friday, September 25, 2009

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.

Thursday, September 24, 2009

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.

Wednesday, September 23, 2009

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.

Monday, September 21, 2009

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.

Friday, September 18, 2009

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.

Thursday, September 17, 2009

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.

Monday, September 14, 2009

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.