Health Law

FDA Review to ?Pre-Empt? State Pharmaceutical Litigation?

By Greg Piche'

The United States Supreme Court will soon decide whether state tort actions against drug companies will be "pre-empted" by the FDA?s pre-market regulation of new drug products. The case, Wyeth v. Levine, arose out of a Vermont action by a musician, Diane Levine, who was injected with Wyeth?s anti-nausea drug, Phenergan during hospital treatment for migraine headaches. The drug was mistakenly injected into Ms. Levine?s artery resulting in the necessary amputation of her right arm. Many observers believe the Supreme Court will follow the logic of its recent decision in Riegel v. Medtronic, to pre-empt state law tort actions against drug companies where the drug has received FDA approval.

The FDA does not itself test new drugs, but rather relies on reported results of pre-market studies performed by the drug companies themselves. It may not surprise anybody to learn that these self-reports are not always complete and candid. Further, an overextended and underfunded FDA is not always on top of its game in investigating weaknesses in the studies presented to it.

The pre-emption policy announced by the FDA appears to have been the work product of Daniel Troy, former FDA General Counsel who, prior to joining the Bush Administration, used to regularly file lawsuits on behalf of drug companies against the FDA to loosen restrictions on off-label prescribing and advertising of prescription drugs. He has since returned to his former role of regulatory gadfly.

House Democratic lawmakers Henry Waxman, John Dingell and Sherrod Brown were not amused. In a letter they asserted:

Another case currently pending before the Court, Warner-Lambert v. Kent, is set to decide the question of whether a state law that permits state claims that require a predicate showing of drug company fraud upon the FDA is itself pre-empted by the Food and Drug Act.

The recent revelations of connivance between the FAA and airlines over required safety inspections should give some pause.

FAA officials were quoted as having perceived the airline industry as their "customer" rather than the consumers who fly on the airlines. That is a misguided view of role and responsibility that is likely to return after the elections with an even greater public demand for effective government oversight. There is perhaps no known limit to the potential spread of "pre-emption" doctrine to exclude and limit product liability torts in any number of regulated industries, but the state tort system, with its many unfortunate faults, has served as an important back-up for citizen consumers when government has failed to perform its oversight duties. Wipe that away and the public may well demand real and effective government oversight at a level that will dwarf today?s regulatory environment. After all, even big business has an interest in safe airlines and safe drugs and narrow partisan industry shields will likely generate the seeds of their own destruction or unparalleled government intervention.

Full post as published by Healthcare Law Blog on April 10, 2008 (boomark / email).