FDA Preemption: Another Bush Legacy Wrecking The House

The Bush Administration has consistently sought to undermine consumer-oriented regulatory practices in favor of corporate interests. If it could also take a shot at plaintiffs and their demon trial lawyers, all the better. One of its more spectacular successes was the Supreme Court’s recent decision in a medical devices case, Riegel v. Medtronic, which stands for the proposition that the FDA’s approval of a medical device should preempt any litigation against the manufacturer in state claims by someone the product injures. As expected, every defendant with any conceivable preemption argument is now injecting that defense into products liability and negligence claims all across the country. FDA and Mercury Regulation;FAA Regulation. The Alaska Personal Injury Law Group just defeated a similar move by a defendant arguing that the FAA’s regulation of aircraft should preempt state claims against an air carrier.

The Supreme Court will next consider the application of the preemption doctrine in an injury claim against Wyeth by a Vermont guitarist who lost her arm below the elbow after she was injected with Phenergan, a nausea medicine. Wyeth v. Levine, Docket No. 06-1249. At issue is Wyeth’s claim that it should be immune from suit because of the FDA’s approval of Phenergan’s label. It reasons that the FDA’s regulatory approval should be enough to preempt the plaintiff’s claim that the manufacturer failed to warn about the dangers of IV injection of the drug. Remarkably, The New England Journal of Medicine has joined 47 state attorneys general and two past FDA commissioners in submitting amicus briefs to the Supreme Court warning that the FDA lacks the ability to serve “as the sole guarantor of product safety”.

It is well known that the FDA simply cannot know all the risks of a product or warning label it approves. This is especially true when the manufacturer intentionally skews clinical trial results, Newsday, Annals of Internal Medicine or otherwise keeps product risks from the FDA to achieve the lucrative benefits that come with the approval of a new drug or device, NEJM, Synthes Story. The FDA is not constituted to truly regulate this industry, and it cannot get to bedrock truth the way litigation can. Often, the FDA does not act until litigation proves the product’s dangers and makes public the evidence the manufacturer kept from the FDA when the drug or device was approved. Talbert v. E’ola Products, Inc.. If Big Pharma succeeds in the Wyeth matter, millions of Americans will be at risk from dangerous drugs. Without the protections of the legal system, their claims will be unrepresented, and corporate interests will run roughshod over the FDA. At this juncture, Congress will likely have to act to restore the balance of regulatory and legal interests the courts previously forged in protecting the rights of individuals to pursue state claims when injured by dangerous products approved by the FDA.

It is an extraordinary testament to how far off course the Bush Administration has taken American administrative agencies that a national medical journal must file an amicus brief in the highest court in the land to state the obvious. (Remember, “Well, Mr. President, torture is illegal…) Up has become down in American jurisprudence courtesy of the Bush Legacy. Hopefully, legal analysis and not political agendas will guide the Court when it decides Wyeth.

Oral argument before the Court is to be held on November 3, 2008.