Bill Would Eliminate Preemption In Device Suits
1 CommentBy Ed Silverman // March 17th, 2008 // 2:36 pm
This was predictable, yes? Less than a month after the US Supreme Court voted to 8-1 that patients can’t file lawsuits against device makers when their products were approved by the FDA, a Congressman has introduced legislation that would make it possible to file such lawsuits.
Specifically, the bill, which was introduced by Frank Pallone, a New Jersey Democrat who chairs the House Energy & Commerce health subcommittee, would eliminate express preemption under the Medical Device Amendments by adding the following language: “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any state.” (Take a peek).
You may recall that the Supremes reviewed a lawsuit that pitted Medtronic against a woman whose now-deceased husband suffered a disabling injury when a balloon catheter burst during angioplasty. Medtronic argued that the Food, Drug, and Cosmetic Act expressly preempts state law claims brought by patients who were hurt by devices that received premarket FDA approval.
In the decision, Justice Antonin Scalia wrote that the FDA’s approval process was “rigorous” and precluded imposition of any additional requirements under state product-liability law (Please see page 4 of the ruling). Justice Ruth Bader Ginsburg was the only dissenter. The ruling gave device makers an eagerly anticipated defense in product-liability lawsuits.
Unlike medical devices, however, there is no statute providing for preemption for drugs. This separate battle centers on whether decisions by state courts and juries should have the right to trump an FDA rule, which the agency and industry say is the final word on safety and effectiveness. The Supremes will take up this debate in the fall (you can read more here).
Hat tip to Drug & Device Law blog
Justice in Michigan
Coupla things -
The DDL guys (understandably given their clients) blame the “plaintiffs’ lobby” for this legislation. However, precisely this remedy was suggested in the January editorial in NEJM which was as strong a condemnation of FDA preemption as you’ll find. I don’t think the NEJM editorial board view themselves as spokespeople for the trial lawyers!
Second, the same language as the Pallone bill was inserted - and then removed, in compromise - in last year’s FDAAA bill. So it is not at all clear whether a further amendment to the FDCA would not impact preemption in the drug, as in the device, arena. Almost certainly, we will see that debate in the future.
Finally, I say again, that no jury decision has _ever_ “trumped” - or was intended to “trump” - FDA regulation. All decisions about warnings, labels, withdrawal or not are solely within the purview of FDA, and always have been.
What juries decide is whether - given what they knew, when they knew it, what they did - companies ought to be held liable. Not all potentially relevant delinquencies are within the purview of FDA oversight, and some may have occurred entirely outside FDA’s knowledge. Either way, no jury has ever withdrawn a drug or changed a label. (On the other hand, FDA has sometimes done either one _because_ litigation uncovered new facts that the agency had not known).
Once again, then, that’s why FDA itself has alwaysw argued that - in this world of imperfect folks and institutions - having both systems of consumer protection is better than either one alone. The “only FDA” argument (preemption) is a creature of the Bush FDA.