We will now take a closer look at the involvement of the U.S. Supreme Court in the preemption fight from a legal perspective. Many legal scholars don’t believe that an ultra-conservative Supreme Court will judicially legislate away 100 years of well-interpreted black letter law and specifically laws that were intended to protect states’ rights. Others, however, having seen first hand what judicial activists at least three members of this Court have become, believe that the Justices are on the verge of dealing the most vicious blow ever dealt to the civil justice system. And if they do, it will certainly be the first of many to come. Hopefully, there are enough Justices on the Court who believe in the Constitution and states’ rights to do the right thing.
The case before the Court is Wyeth v. Levine. Interestingly and perhaps by chance, the Court will hear oral argument on November 3rd, the day before Election Day. The Plaintiff in the case, Diana Levine, was a professional musician before her right arm was amputated below the elbow. The debilitating injury was caused by the administration of Wyeth’s drug Phenergan® by an intravenous push (an injection into an IV line). Wyeth had warned physicians not to inject the drug into an artery, but did not warn against the IV push method even though such a technique could inadvertently result in the drug reaching arterial blood, as it did when administered to Ms. Levine. Ms. Levine won at the trial level and also before the Delaware Supreme Court.
As we have reported, the U.S. Supreme Court recently addressed preemption in the context of a medical device (not a prescription drug case) in Reigel v. Medtronic. In that case, the Court held that the preemption language contained in the Medical Device Act precluded lawsuits against manufacturers for devices that had undergone the FDA’s most thorough review process: Pre-Market Approval. Unlike in Reigel, the portion of the Food, Drug, and Cosmetic Act (FDCA) which establishes the FDA’s oversight regarding pharmaceuticals, contains no preemption clause. Therefore, the only way the Court can find federal preemption is to determine that Congress intended for the FDCA to preempt all state laws that allow patients injured by defective drugs to file a lawsuit against a drug’s manufacturer in federal or state court. A clear legislative record suggests that Congress had no such intent when enacting the FDCA.
In 1933 when the revised Foods and Drug Act (precursor to FDCA) was first introduced in Congress, it contained a provision that created a federal cause of action for those injured by violations of the Act. Congressional history makes clear that this provision was removed because injured parties were already able to seek recovery for their injuries under state law. Therefore, a federal cause of action was not needed. When Congress amended the FDCA in 1962 it included language which explicitly precluded preemption unless the state law provided a “direct and positive conflict” with the FDCA. This was done to prevent manufactures from asserting preemption as a defense; and it worked until the mid 1980’s.
Finally, from the inception of the FDA until after George W. Bush became President, the FDA historically and repeatedly took the position that state tort laws “play an important role in consumer protection” and that “FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection.” Unfortunately, the Bush Administration has abandoned “consumer protection” in favor of corporate protection and it has used the FDA as its main vehicle for change. It has charged the FDA and the Solicitor General with doing everything in their power (and perhaps beyond) to disenfranchise injured citizens from seeking redress in the courts against the largest, wealthiest, and most powerful corporations in America. Thus far, the Bush Administration has attempted preemption through regulatory fiat with medical devices and pharmaceuticals. The Bush Administration clearly has broader ambitions — the pharmaceutical field is only the beginning. The Administration and the U.S. Chamber of Commerce have already signaled that they will seek the preemption of state law claims by anyone injured from a defective car and any other industry with even the slightest level of regulatory oversight.
On the bright side, over 60% of the American public, according to recent public opinion polls, understand that granting immunity to drug makers will only force insurance companies and the American taxpayer to foot the bill for the injuries and damages caused by defective drugs. Giving immunity to corporate wrongdoers is simply wrong. It’s in the best interests of all Americans for the Supreme Court to rule that state law claims are not preempted by the FDCA, but are vital to the protection of all people who are injured by defective and dangerous drugs.
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