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 Consumers who have medical concerns or questions should contact their healthcare provider.


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 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."


The FDA states they have conducted a two-year investigation in which products bought from 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 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.