Senate To Hold Hearings On Preemption
3 CommentsBy Ed Silverman // September 11th, 2007 // 6:43 pm
On Wednesday morning at 11 am EST, the Senate Judiciary Committee wades into this increasingly thorny and contentious issue that pits industry versus trial lawyers and consumer advocates (and other non-combatants). What is preemption? Essentially, preemption gives companies some immunity against product liability claims, because the FDA has already deemed a product to be safe. As a result, drugmakers say state judges and juries don’t have the right to supercede a federal regulatory authority.
The pharmaceutical industry hasn’t been terribly successful in using this argument, but the Supreme Court appears likely to sort this out, anyway. The court, in fact, signaled its interest last May. For insight, try reading this primer from The Drug & Device Law blog (which is written by two attorneys whose firms rep drugmakers). Meanwhile, here is the list of witnesses to appear at tomorrow’s hearing.
Lisa Van Syckel
This should be very interesting!!!…..
Hank
As Ed know, this issue one of my obsessions, in part because I live in a state (Michigan) what has had an FDA-preemption law for twelve years. What that means is that _no_ Michigan citizens (none, nada, zilch) have been able to have a day in court related to Rezulin, fenphen, Vioxx, Baycol, or any of the other drugs withdrawn for safety reasons during this period.
As intended by its proponents, FDA preemption would really grant _total_ immunity from civil liability to drug companies. They will claim there are some exceptions, but they are de facto meaningless (I won’t bore you with the reasons why - at least not yet). In any case, that’s what companies ask for when they file for “summary judgment” based on FDA preemption - the suit should be preemptively thrown out because the product was in compliance with FDA at that time.
So here is what is at stake. Imagine a United States in which _no one_ could bring suit who believed a company inappropriately failed to warn, red flag, follow up, not camoflage, not intimidate researchers, not spin journal articles, miseleadingly advertise, etc. in connection with dangers of which they were aware.
That is the country we could become when the current Supreme Court takes up the issue. And that is not far away.
In my view, this is as serious as it gets.
Theo
Preemption is a trick because it only absolves the guilty: The innocent would get off anyway, but with preemption the wrong-doer gets off too. Imagine you’re crossing a street and a speeding drink driver runs a red light and runs you over; you’ve got pretty serious damages and a good cause of action, right? Preemption would let that driver off the hook because the criminal penalties are exclusive of any civil remedy the victim might have. Is that just? Hell no. Big companies want preemption for one reason - because it gets them off the hook when they’ve been negligent or engaged in misconduct and caused serious injuries and death.