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.