From the category archives:

Dangerous Products

A Texas appeals court has ruled that Wyeth must face a lawsuit by a woman who claims her breast cancer was caused by the hormone replacement drug Prempro, according to a Bloomberg article.  The appeals court cited the U.S. Supreme Court’s recent decision in Wyeth v. Levine rejecting Big Pharma’s argument that FDA approval barred lawsuits by people injured by prescription drugs.

Wyeth is defending about 5,000 lawsuits over its menopause drugs Prempro and Premarin. As many as 6 million women took the hormone-replacement therapies to ease menopause symptoms, such as hot flashes and mood swings, before a 2002 study showed a link to cancer.

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Tests of three-year-old children of women who took anti-epilepsy drugs during pregnancy showed that women who took Depacote had children with significantly lower IQs than children whose mothers took other anti-epilepsy drugs, according to a study in today’s New England Journal of Medicine. The study looked at women who had taken one of four epilepsy drugs: valproate (Depakote), lamotrigine (marketed under the name Lamictal), phenytoin (marketed as Phenytek and Dilantin), and carbamazepine (marketed under the names Tegretol, Biston, Calepsin, Carbatrol, Epitol, Equetro, Finlepsin, Sirtal, Stazepine, Telesmin, Teril, Timonil, Trimonil, and Epimaz). On average, the  IQ was 101 for children exposed to lamotrigine, 99 for those exposed to phenytoin, 98 for those exposed to carbamazepine, and 92 for those exposed to valproate.  The study concluded that valproate not be used as a first-choice drug in women of childbearing potential.

Depakote is also commonly prescribed for migraine headaches and bipolar disorder.  There is also a known association between epilepsy drugs and birth defects, with Depakote having risks of birth defects two to four times as high as other epilepsy drugs, according to a WebMD article quoting Kimford J. Meador, MD, the study’s lead author and professor of neurology at Emory University in Atlanta.

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The FDA announced yesterday that Genentech was withdrawing the psoriasis drug Raptiva because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system.  There is no known effective treatment for PML. About 2,000 people in the U.S. are believed to be taking the drug.

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One of the projects in which I am involved is the ATV Attorney Alliance, a national network of law firms we organized to pursue ATV accidents–primarily the Yamaha Rhino, an incredibly unstable vehicle which can roll over at low speeds on flat ground. To make matters worse for Rhino owners, many of the Rhinos were sold without adequate protection to keep riders’ arms and legs in the vehicles. We have used an online marketing campaign for about a year in an effort to: (1) educate consumers to the dangers of the Rhino, (2) put pressure on Yamaha to recall the Rhino, and (3) obtain clients who have been injured or lost family members due to Rhino rollover accidents.

We started calling for a Yamaha Rhino recall in blog posts almost a year before the recall came.

1) On May 17, 2008, after the death of an Arizona teenager, we requested a Yamaha Rhino recall.

2) On August 19, 2008, after the death of a Texas boy on a Rhino, we again made a request for a Yamaha Rhino recall.

3) On August 25, 2008, after the death of a 3 year-old Wisconsin boy, we again requested a Yamaha Rhino recall.

4) On November 27, 2008 after the death of 2 Mississippi girls, we took our Rhino recall campaign in a different direction, this time producing a video for YouTube explaining how dangerous Rhinos are and why they roll over so easily.
5) And finally, due to the lack of response by Yamaha to the requests for a Rhino recall, on March 13, 2009, we launched an Internet campaign which included producing and distributing the video satire that appears in my March 26, 2009, blog post below on this site. That video was designed to dramatize Yamaha’s callous failure to issue a Rhino recall.

On March 31, 2009, the Consumer Product Safety Commission (“CPSC”) and Yamaha announced that all Yamaha Rhino models are being recalled. Owners were told to immediately stop using the Rhinos. All Rhinos are to be returned to Yamaha dealers to have repairs that are intended to solve the Rhinos’ problems, and no new Rhinos will be sold until the repairs have been made on them. (Forgive me, but I believe I’ll take a wait-and-see attitude before deciding whether the newly repaired Rhinos are safe for their intended use.) I have to admit, after trying to get Rhinos recalled for almost a year, it was gratifying to see these dangerous vehicles recalled. I hope the repairs are adeqate to render the vehicles safe for future riders.

Unfortunately for the hundreds of people who have been permanently injured or killed in Yamaha Rhino rollovers, the Yamaha Rhino recall came too late.

For more information about the recall, check out Yamaha Rhino recall blog I started over the weekend.

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According to an article in today’s LawyersUSA, at least two class actions have been filed over allegedly defective Chinese drywall used in thousands of homes. The Chinese drywall allegedly emits a sulfur gas that makes the homes uninhabitable, with an unbearable “rotten egg” smell. The gas also allegedly corrodes electrical wiring, plumbing, air conditioning units and other metals in the homes. A plaintiff’s attorney estimates the damages in the hundred million dollar range.

One plaintiffs’ attorney, Ervin A. Gonzalez of Colson Hicks in Coral Gables, Florida, predicted that there may be 65,000 plaintiffs around the country. Both lawsuits are filed on behalf of Florida residents. Jordan Chaikin, another attorney for the plaintiffs, said suits are likely to spread to other states where the drywall was used, including Alabama, California, the Carolinas, Louisiana, New Jersey, New York and Virginia. [click to continue…]

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Today Bloomberg reports that heart patients taking the anti-clotting drug Plavix were 25% more likely to die or be readmitted to a hospital if they also took pills to prevent stomach bleeding. This conclusion came from a study of 8,205 acute coronary syndrome patients given Plavix after being discharged from Veterans Affairs hospitals from October 2003 to January 2006. About 30 percent of patients taking the stomach medicines, known as proton pump inhibitors, died or were readmitted, compared with 21 percent of those given only Plavix. The information was contained in a report issued today by the Journal of the American Medical Association.

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The U.S. Supreme Court has ruled 6-3 that FDA approval of a prescription drug label does not preempt state tort claims by persons injured by the drug, according to Bloomberg and other sources. “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,” Justice John Paul Stevens wrote for the court. The ruling affirmed a $7 million award to a musician who lost her arm after being injected with Wyeth’s Phenergan nausea treatment.

This settles an issue which has hung over consumers and the plaintiffs’ bar for several years. The Bush administration had agressively pushed for FDA preemption, as well as preemption in a number of other areas.

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