By Sylvia Hsieh
The Daily Record Newswire
BOSTON, MA — Litigation over the blood thinner Plavix is picking up momentum.
About forty cases have been filed in New Jersey state court, and drug makers Bristol-Myers Squibb and Sanofi-Aventis are seeking mass tort treatment and consolidation of the cases.
Thousands more wait in the wings and are expected to be filed in federal court in the coming months, according to plaintiffs’ attorneys.
“I think it’s going to pick up a lot of steam in the next six months,” said Michael Miller of The Miller Firm in Orange, Va., who has filed a number of the cases.
Mark Burton, a plaintiffs’ attorney at Hersh & Hersh in San Francisco, said he has seen an uptick in calls from potential plaintiffs since March of last year when the Food and Drug Administration slapped a black box warning on the drug.
Plavix, a popular drug generating $8 billion per year in sales, is commonly prescribed for patients at risk of heart attacks.
Plaintiffs allege that the drug is no more effective than aspirin, but carries much greater risks.
They argue the manufacturers failed to warn about the increased risk of heart attack, stroke and potentially fatal blood disorders.
According to a complaint filed on behalf of 11 plaintiffs in Illinois state court, defendants heavily marketed Plavix in television ads touting it as a “super-aspirin,” while their own studies showed that the risks to patients far outweighed any benefits.
“We’re arguing Plavix has less efficacy than aspirin which is the generic and much cheaper and safer alternative that costs 4 cents a pill, compared to Plavix that sells for 4 dollars a pill,” said Miller, who does not represent the plaintiffs in the Illinois case, but makes identical allegations in other filings.
Miller also alleges that the drug makers over-marketed Plavix by defying FDA warnings beginning in 1998 not to market it as better than aspirin.
David Harris of Lowenstein Sandler in Roseland, N.J., who represents the defendants in the consolidation motion, did not return calls to his office seeking comment.
Another reason Plavix litigation is gaining traction now is the statute of limitations, which began to run when the FDA issued its March 2010 warning.
In jurisdictions with a two-year statute of limitations, plaintiffs’ lawyers would have to file by early 2012.
“I’m expecting to see litigation in several states all over the country before April 2012, when most statutes of limitations kick in,” said Burton.
The cases recently got back on track after they stalled for years in anticipation of the U.S. Supreme Court’s decision in Wyeth v. Levine on the issue of preemption.
The stays were initiated by defendants, but plaintiffs claim the delay helped them.
“During that time, more science and more studies came out showing Plavix is not safe and not effective,” said Nance Hersh, also of Hersh & Hersh in San Francisco.
A discovery order by a U.S. District Court in New Jersey creates an obstacle for some plaintiffs in federal court. That order says that plaintiffs who filed cases before 2007 cannot get documents after 2007, that include such as communications between the drug manufacturers and the FDA.
The order deprives plaintiffs of evidence that would show that the drug makers knew or should have known about risks to the public, said Hersh, who added that the ruling will not affect cases filed after 2007.
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