From the June 11, 2007, issue of "The Gray Sheet"
A one-sentence provision tucked into draft legislation circulating in a House subcommittee seeks to weaken device and drug manufacturers' ability to claim FDA approval as a defense in state product liability lawsuits.
On June 6, the House Energy & Commerce Health Subcommittee released "discussion drafts" for nine FDA-related bills, including the reauthorization of medical device and drug user fee programs, and legislation relating to pediatric product development, drug safety, clinical trial registries and FDA advisory panel conflicts of interest.
Each of the drafts includes an identical section, entitled "Rule of Construction Regarding Federal Preemption." The section reads, "Nothing in this Act or the amendments made by this Act may be construed as having any legal effect on any cause of action for damages under the law of any State (including statutes, regulations, and common law)."
The provision in the drafts "is supposed to deal with preemption that has been successful in some state courts," according to an Energy & Commerce committee staffer.
Federal preemption, the concept of federal law trumping state tort law in a liability suit, is a perennial point of contention between device and drug manufacturers and plaintiffs' attorneys. In the device arena, manufacturers commonly use the preemption defense in liability suits and have been successful more often than not on appeal when PMA-approved products are involved.
Six out of seven federal appeals courts that have considered the matter favored preemption, ruling against a patient's right to sue in state courts over complications with a PMA-approved device as long as the product continues to adhere to FDA regulations. Further, FDA has filed briefs backing device companies' preemption claims in several specific lawsuits.
The U.S. Supreme Court, however, ruled in 1996 that the 510(k) premarket notification process did not preempt state liability law. The high court has not elected to rule on a case involving a PMA product. To support the case for preemption, device manufacturers point to a section in the 1976 Medical Device Amendments stipulating that states may not establish device requirements that are "different from or in addition to" federal requirements.
Device companies were taken by surprise by the House language, but industry lobbyists have already mobilized against the measure.
"Clearly, above and beyond all of the other issues that we have concerns about in the draft, ... preemption is absolutely critical to our industry and that is the one we are spending the most time on," stated a high-level industry insider who did not wish to be identified. "We think the implications are very strong and very concerning."
Although industry lawyers are still completing analysis of the provision, the source added, Hill staffers seem to be giving the language a more "narrow" read.
Dan Troy, Sidley Austin law firm partner and former FDA chief counsel, said that under at least one interpretation, the provision "would completely undercut FDA's authority ... If you read it literally, even if FDA has commanded you to do something or FDA has prohibited you from doing something, you can still be liable for damages in a state court suit."
Trial lawyers represented by the American Association for Justice are a primary lobby against federal preemption. A spokesperson for the group was not aware of the draft provision in the House bills, but reiterated the organization's position that "federal preemption is nothing more than a back door attack on the civil justice system."
The nine draft bills, issued by Energy & Commerce Health Subcommittee Chair Rep. Frank Pallone, D-N.J., will be considered at a June 12 subcommittee hearing. Pallone says he anticipates marking up legislation on June 14.
The user fee reauthorization and the other bills mostly reflect the language that the Senate passed last month in broad-based FDA legislation, though there are a few areas of divergence with which device stakeholders have concerns. The Senate bill did not contain the preemption language.
- David Filmore
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