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Plavix Lawsuits Moving Forward Towards Trial

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After months of delay awaiting a Supreme Court decision about whether FDA approval preempts cases against drug makers for failing to warn about dangerous side effects, a U.S. District Judge in New Jersey has reinstated dozens of Plavix lawsuits pending against Bristol-Myers and Sanofi Aventis, allowing the claims to move closer to trial.

Plavix (clopidogrel) is a blood thinner that prevents blood platelets sticking together to form clots. It is prescribed for stroke reduction, heart attack prevention and to prevent clotting when drug coated stents are used in patients with arteriosclerosis. It is a blockbuster medication, generating annual sales of over $6 billion for Bristol Myers Squibb Co. and Sanofi-Aventis.

Hundreds of patients who previously used the drug have filed or are planning to file a complaint alleging that the manufacturers failed to warn about an increased risk of serious and potentially life-threatening Plavix side effects.

The manufacturers promoted Plavix as a safer alternative to aspirin, which reduces the risk of gastrointestinal problems. However, the lawsuits allege that Plavix actually provides no benefits over taking aspirin alone and could actually increase the risk of heart attacks, strokes, gastrointestinal bleeding, severe ulcers and a rare blood disorder known as TTP, or thrombotic thrombocytopenic purpora.

At least 27 Plavix lawsuits pending in the U.S. District Court for the District of New Jersey before Judge Freda Wolfson, have been on hold for over a year pending the outcome of a Supreme Court decision that was handed down in March 2009.

The lawsuits involve allegations that the drug makers failed to provide adequate warnings and information to doctors about the potential Plavix problems. The drug makers had taken the position that those claims were preempted by federal law, since the FDA approved the warning label that was contained on the medications.

The U.S. Supreme Court issued a ruling in the case of Wyeth v. Levine on March 4, 2009, which directly addressed this argument. In that case, the majority opinion held that FDA approval does not preempt drug lawsuits filed under state law, as the manufacturer bears the ultimate responsibility for the content of its label at all times.

On April 2, 2009, Judge Wolfson reinstated that Plavix lawsuits pending before her, allowing the cases to proceed with further pretrial litigation.

According to a report by Bloomberg News, there are thousands of other cases which are now likely to be filed by Plavix lawyers who have been holding off on bringing lawsuits pending the outcome of the Supreme Court decision in Wyeth.

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Image via: Art Konovalov / Shutterstock.com

152 comments

  1. Rebecca Reply

    I was on Plavix for two years . During that time I had severe bouts of high blood pressure abd dizziness. My blood pressure would suddenly get very high. My cardiologist would prescribe me different meds. They would work for a few days and then the blood pressure would become erratic again. I finally suggested that I stop taking Plavix. When I did, my blood pressure stabilized . I think this drug is very dangerous!!!

  2. Betsy Reply

    My 73 year old mother passed away on February 3, 2012 because she fell asleep on the couch I still can’t believe it, 7 inches from the floor, all because she had been on plavix it had caused a brain bleed and they couldn’t operate because she would have bleed out befor they could have finished. You see she was a very strong woman she survived 2 kidney transplants, cancer three times and fell down a flight of stairs and broke both her wrist and more, but not from this and this is what the Surgeon told us they can’t operate because of the plavix but then again she wouldn’t have a brain bleed from such a minor fall if it were not for the plavix she never woke back up they said her brain was not responding so after a week of prayers and crying and trying to make the hardest decision of our life i told my dad we need to do what she would have wanted she always said she didn’t want to have machines keeping her alive so we took her off life support and she passed a day later. So please if you have a loved one on plavix please get them off find something else for them.

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