Motion Filed to Consolidate Plavix Lawsuits in Federal Court

Bristol-Myers Squibb and Sanofi-Aventis are calling for a panel of judges to centralize and consolidate all Plavix lawsuits filed in federal courts throughout the United States on behalf of users of their blockbuster blood thinner who allege that side effects of Plavix resulted in serious personal injuries and even death.

On December 1, the U.S. Judicial Panel on Multidistrict Litigation will hold a hearing to determine whether at least 13 lawsuits over Plavix filed in New Jersey, New York and Arizona should be centralized before one judge for coordinated handling during pretrial proceedings.

The request to consolidate the Plavix litigation was filed by Bristol-Myers Squibb and Sanofi-Aventis, arguing that centralizing the cases before Judge Freda Wolfson in the U.S. District Court for the District of New Jersey would serve the convenience of the parties, prevent duplicative discovery and conflicting pretrial rulings from different judges.

Plaintiffs who have filed the Plavix lawsuits oppose the formation of an MDL, claiming it is another delay tactic by the drug makers that would further slow the progress of the cases, many of which have been pending for more than 5years.

All of the Plavix suits allege that the drug makers failed to adequately research their medication or warn about the risk of Plavix side effects, which could increase the risk of serious and potentially life-threatening bleeding, as well as a rare blood disorder known as thrombotic thrombocytopenic purpura (TTP).

Ten of the 13 cases under consideration were filed in New Jersey in 2006 and 2007, having undergone a lengthy process to finally reach the beginning of discovery. At one point they were all administratively dismissed until the Supreme Court ruled on a major case, Wyeth v. Levine, regarding the responsibility of drug makers to put adequate warning labels on their products. They were reinstated after the Supreme Court found that failure to warn lawsuits against name-brand drug makers were not pre-empted by federal law.

In opposition statements filed with the MDL Panel, plaintiffs gave a number of reasons they feel consolidation would further slow their cases. For one thing, they argue, the New Jersey cases are advanced in their depositions, and combining them with the cases from New York and Arizona would slow things down considerably. They also claim that the non-New Jersey cases are much newer and will involve recent events, like the FDA’s 2010 black box warning that some genetic traits prevent Plavix from being effective, that are irrelevant to the New Jersey cases.

Defendants argue that the cases all involve common fact issues surrounding the drug makers’ research and development of Plavix. They also argue that the timing for consolidation is appropriate, as no single case has reached the phase of depositions of “common” fact and expert witnesses who may have knowledge relevant to all Plavix suits.

Plavix cases filed at the state court level in New Jersey have already been centralized before one judge. However, the Supreme Court of New Jersey stopped just short of giving Plavix lawsuits a mass tort designation, the state-level equivalent to an MDL. Instead, the cases were all simply transferred to Judge Jessica R. Mayer for centralized case management. 

At the time of that decision, there were 40 cases in New Jersey state court, but Plavix lawyers predicted there could be hundreds or thousands of cases filed at the state level against the defendants.

Plavix (clopidogrel) is prescribed to prevent blood platelets from sticking together to form clots. It is often prescribed to reduce the risk of heart attacks, strokes and blood clotting when drug coated stents are used in patients with arteriosclerosis and in other at-risk patients. It is a blockbuster medication, generating more than $6.5 billion in U.S. sales for Bristol Myers Squibb Co. and Sanofi-Aventis in 2010.

Plaintiffs allege that they suffered injuries as a result of their unnecessary use of Plavix, such as gastrointestinal bleeding, severe ulcers and a rare blood disorder known as TTP. Some complaints also allege that Plavix did not provide the promoted benefit of reducing the risk of a heart attack or stroke, raising questions about the effectiveness of Plavix among some users.

In November 2009, the FDA issued a public health advisory warning that side effects of Prilosec may interfere with Plavix effectiveness, increasing the risk of heart attack, death or other injuries for patients.

In March 2010, a Plavix “black box” warning was added to alert patients and healthcare professionals that the anti-clotting drug may not work in some patients due to genetics. The FDA indicated that a genetic test is available to determine whether patients are able to metabolize Plavix efficiently and suggested that doctors should consider another medication for at-risk patients who are confirmed to have the gene variant.