Tuesday, February 26, 2008

Trial lawyers' ability to second guess the FDA on medical devices "neutered"

The US Supreme Court (SCOTUS) has dramatically shifted the balance of power in product liability lawsuits for makers of medical devices. By an 8-1 margin last week, the Justices decided that the tort system should not be a system that second guesses the scientific evaluations of the FDA on medical device designs. In the "Riegel Case", the Supreme Court concluded that the premarket approval process (PMA) would bar patients from later filing lawsuits.

This week they're hearing similar arguments over pharmaceuticals in Warner-Lambert v. Kent , a case from Michigan, click here to read about. The case was brought by plaintiffs who claim they were injured as a result of taking the diabetes pill, Rezulin, which has since been withdrawn from the US market. The plaintiffs claim the company withheld evidence from the F.D.A. of potential dangers to the liver that might have led the agency to deny an approval. They fighting against existing precedent from a 2001 case where the Supreme Court held that plaintiffs cannot sue based upon claims that a manufacturer defrauded the F.D.A.

While no one would reward fraud by industry, this claim has exploded by trial lawyers in all these cases and frequently comes down to statistical hair-splitting of published data rather then some "smoking gun" company memo. Even liberal jurist Steven Breyer has expressed frustration and skepticism of using state or federal courts to "retry" the FDA approval process before people unqualified to understand or interpret most of the studies and data that will be argued over. He posed the rhetorical question of who should be the arbiter of product safety during oral arguments yesterday,
An expert agency (the FDA) on the one hand or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt and don’t see those who need the drug to cure them?

This whole debate relates a little to the whole breast implant controversy from two decades ago where trial lawyers pulled off a multi-billion dollar shakedown of Dow Corning and others based on innuendo. We now have compelling safety studies from all over the world and universal treatment of these products by every western government health agency. It would appear these recent SCOTUS decisions would put the final stake in product liability cases relating to approved breast implant designs or materials. It's a little moot anyway, as trial lawyers largely haven't taken implant cases for years anyway as they're aware of the consensus body of of literature and know there's no money in it.


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