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As the number of lawsuits centralized in the Plavix MDL continues to increase, with complaints involving more than 1,000 plaintiffs transferred into the coordinated federal proceedings this week, the U.S. District Judge presiding over the federal Plavix litigation delayed the first organizational conference until next month.
Earlier this year, the U.S. Judicial Panel on Multidistrict Litigation (MDL) centralized all Plavix lawsuits filed in the federal court system before U.S. District Judge Freda L. Wolfson in the District of New Jersey for coordinated pretrial proceedings.
At that time, 21 different complaints filed in U.S. District Courts throughout the country were transferred to the new multidistrict litigation or MDL. The process is designed to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
Late last month, Judge Wolfson scheduled an initial conference in the Plavix MDL for June 10, to discuss the organizational structure of the litigation. Parties were directed to provide status reports on each case, which were submitted late last week.
On June 6, a letter (pdf) was sent to all parties by Judge Wolfson, notifying them that the conference was rescheduled for July 12 at 10:00 a.m.
The conference was postponed after the U.S. JPML ordered the transfer (PDF) of at least 16 additional lawsuits pending in the U.S. District Court for the Northern District of California, after determining that the actions involve common questions of fact with actions already pending in the Plavix litigation.
According to a status report (PDF) provided by lawyers for the makers of Plavix, Bristol-Myers Squibb and Sanofi-Aventis, the recently transferred complaints each involve multiple plaintiffs, with a total of 1,036 individual claims contained in those lawsuits.
The Plavix cases were originally filed in California state court, and a dispute exists over whether the claims were properly removed to the federal court system under diversity jurisdiction, as the complaints include non-diverse plaintiffs and a California drug wholesaler is listed as a Defendant, which plaintiffs maintain should have prevented the removal of the cases from state court.
“Defendants believe that a key threshold issue in this multidistrict litigation is determining whether federal jurisdiction exists over the multi-plaintiff cases removed to the Northern District of California, which include the substantial majority of the plaintiffs in [this] MDL,” wrote attorneys for the drug makers, asking the Court to approve a plan to file a coordinated set of briefs on the jurisdictional issues.
Resolving the issue of whether these lawsuits and the hundreds of plaintiffs involved in the Plavix cases will remain in the federal court system will substantially affect the discovery plan in the MDL, according to the Defendants’ status letter.
Plavix Efficacy, Safety Problems
The Plavix lawsuits involved in the MDL all involve similar allegations that Bristol-Myers Squibb and Sanofi-Aventis failed to adequately warn consumers or the medical community about the potential side effects of Plavix, which has been linked to a risk of gastrointestinal bleeding, severe ulcers, a rare blood disorder known as thrombotic thrombocytopenic pupura (TTP) and other injuries.
Plavix (clopidrogrel) has been used by millions of people in the United States and is commonly prescribed to prevent blood platelets from sticking together and forming clots. There are between 2.5 million and 3 million Plavix prescriptions handed out each month in the U.S., and concerns have emerged in recent years that many of these may be unnecessary due to genetic resistance to Plavix.
While Plavix has been promoted as being better at its job than aspirin, with a cost that is many times higher than aspirin, questions have been raised about the effectiveness of Plavix for many patients and whether it actually provides any benefit over aspirin.
In August 2009, researchers from the University of Maryland identified a gene variant found in about one-third of the population that may signal a reduced effectiveness of Plavix. People with the CYP2C19 variant have reduced functioning of a liver enzyme that is supposed to convert Plavix from its inactive form to its active form, potentially making Plavix ineffective at reducing the risk of blood clots.