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Following the centralization of all federal Plavix lawsuits earlier this year as part of an MDL or Multidistrict Litigation, an initial conference will be held early next week for the lawyers involved in the litigation to meet with the judge and review the organizational structure of the pretrial proceedings.
In February, a Plavix MDL was established before U.S. District Judge Freda L. Wolfson in the District of New Jersey, where complaints filed throughout the federal court system involving the blockbuster bloodthinner will be centralized for coordinated management to reduce duplicative discovery in dozens of different cases, avoid conflicting rulings from various judges and to serve the convenience of the parties, witnesses and the courts.
All of the lawsuits 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 have been linked to problems with gastrointestinal bleeding, severe ulcers, a rare blood disorder known as thrombotic thrombocytopenic pupura (TTP) and other injuries.
Judge Wolfson has scheduled an MDL organizational conference for June 10, indicating that she wishes to acquaint herself with the lawyers involved in the litigation and obtain a status of the individual Plavix cases that have been transferred to her court.
According to a letter (PDF) sent to all counsel on May 22, Judge Wolfson has directed the attorneys to submit a Status Report on all cases by the end of this week. The report will indicate the status of discovery, pending motions and whether any Plavix settlement discussions are ongoing in the case.
The lawyers have also been directed to confer and submit a proposed initial case management order, outlining various deadlines in the litigation, a schedule for discovery proceedings, dates for future conferences and possible bellwether Plavix trials that may be scheduled in the MDL to help the parties gauge the relative strengths and weaknesses of there cases.
Following the conference, it is also expected that Judge Wolfson will appoint a group of attorneys to serve in leadership positions in the litigation, taking certain actions that benefit all plaintiffs with lawsuits in the MDL.
Currently, there are only about 16 lawsuits consolidated in the Plavix MDL, but the number of cases is expected to increase dramatically in the coming months as Plavix lawyers continue to file cases. It is ultimately expected that hundreds, if not thousands, of lawsuits will be filed in federal and state courts throughout the country.
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 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, and costs many times more 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.