Federal Pre-emption Defense Under Fire In Draft House Bills
This article was originally published in The Tan Sheet
Executive Summary
A one-sentence provision tucked into draft House legislation renewing FDA's drug user fee program seeks to weaken manufacturers' ability to use FDA approval as a defense in state product liability lawsuits
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A one-sentence provision tucked into draft House legislation renewing FDA's drug user fee program seeks to weaken manufacturers' ability to use FDA approval as a defense in state product liability lawsuits. The section, entitled "Rule of Construction Regarding Federal Pre-emption," 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 "Act" referred to is the Food, Drug & Cosmetic Act, which defines FDA's legal authorities. The provision in the draft "is supposed to deal with pre-emption that has been successful in some state courts," according to an Energy & Commerce committee staffer. Federal pre-emption, the concept of federal law trumping state tort law in a liability suit, is a perennial point of contention between the drug and medical device industries and plaintiffs' attorneys. Manufacturers have argued FDA approval of products should preclude the need for them to include additional warnings about it. The concept has seen legislative action before, with previous Congresses under Republican control attempting to codify the "FDA defense" as a shield against state suits (1 (Also see "Product Liability “FDA Defense” Prospects Hampered By Vioxx Shrapnel" - Pink Sheet, 29 Nov, 2004.), p. 9). Dan Troy, Sidley Austin law firm partner and former FDA chief counsel said 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," Troy said. The pre-emption language is in each of nine draft bills addressing various FDA safety and approval authorities issued by Energy & Commerce Health Subcommittee Chairman Frank Pallone, D-N.J. The legislation will be considered at a June 12 subcommittee hearing and marked up on June 14 (see 2 (Also see "FDA Reform Bill Goes Back To The Future In House With Tighter Safety Rules" - Pink Sheet, 11 Jun, 2007.)). - David Filmore ([email protected]), "The Gray Sheet" |