Wyeth Preemption Bid Denied By NJ Judge
2 CommentsBy Ed Silverman // June 27th, 2007 // 3:54 pm
A New Jersey state judge who oversees more than 200 Prempro cases has tossed aside the drugmaker’s argument that an FDA rule pre-empts the right to file a product liability lawsuit.
In reaching his decision, Superior Court Judge Bryan Garruto cited rulings by judges overseeing Vioxx and Zyprexa litigation, and wrote that the US Food, Drug & Cosmetic Act “does not preempt state law tort claims based on a pharmaceutical company’s inadequate warnings of the risks involved in ingesting FDA-approved product.”
Preemption is a hot topic in pharma these days. Essentially, preemption gives companies some immunity against product liability claims, because the FDA has already deemed a product to be safe. An exception would occur when, say, a company knowingly hid or falsified info that would have led the FDA to make a different decision about approving a drug. Drugmakers have been pushing preemption nationally and many lawyers expect the US Supreme Court to eventually take up the issue.
“This ruling is extremely significant,” says Esther Berezofsky, a plaintiffs attorney in NJ. “Essentially, what the judge has done is made it possible for people to bring tort claims in New Jersey. And it has wider implications than Prempro hormone replacement litigation. This is the same judge presiding over mass torts involving Ortho-Evra, Risperdal and Seroquel.” The Ortho-Evra birth control patch and Risperdal antipsychotic are made by Johnson & Johnson, while AstraZeneca sells the Seroquel antipsychotic.
Hank
As someone who has followed the preemptions issue in some detail, I think this is very good news. Indeed, most courts who have ruled on the FDA preemption defense have rejected it.
However, it is important to know that there are a few cases based on preemption that will almost certainly end up in the US Supreme Ct. (one involving a device already there for next winter). Given the current make-up of the court, it is more likley than not that preemption would be withheld. Crazy as it will sound to many, that will, indeed, mean that drugs that have received FDA approval and our “in compliance” will be immune from civil liability. As it turns out, that has been the law in my own state, Michigan, for ten years. As a result, Michigan citizens (or their survivors) who believe they were harmed by drugs like fen-phen, rezulin, baycol, vioxx, et. al. have been _entirely_ shut out of court - at both the state and federal levels (because fed. cts deferred to state law for Michigan citizens).
Also important for people to know that the “fraud exception,” mentioned above, is illusory. How would one know if a drug would or would not have been approved? There is no agency anywhere that could make such a determination. Second, as the law now stands, the exception would come into play only if FDA has been _intentionally_ defrauded. This means (a) FDA itself would have to bring the charges, no citizen could (that comes from a couple of related rulings) and (b) FDA, in conjunction with Justice, would have to successfully prosecute felony fraud (in order to prove intent).
Guess how many cases in the past twenty years meet those criteria?
Zero.
stan Russell
Hank, My wife and I also live in michigan, as a result of her taking prempro made by weyth pharm. developed beast cancer. I’m trying to locate a law firm willing to bring suit againest weyth in this state, any advice in this matter?