Most Americans today are completely unaware that there is a movement afoot to abolish personal injury or wrongful death lawsuits against pharmaceutical companies under the doctrine of “Federal Pre-emption.” In the context of pharmaceuticals, this means that if a consumer who takes a prescribed drug and suffers a serious injury or death as a consequence, he/she will have no right to recover against the Pharmaceutical Company, no matter how blameworthy the company was, if the drug was approved by the Food and Drug Administration (FDA).
Over the years, many commentators have been critical of the FDA and its ability to adequately oversee and regulate the pharmaceutical industry. In issuing its approval of drugs, the FDA must rely in large part on the company’s testing of drug performance to determine its efficacy, contraindications, side effects and dangers. The FDA is not an independent lab, and its approvals of drugs and drug warnings cannot help but be strongly influenced by the pharmacetical company’s presentation of the drug and its proclaimed health benefits.
Recently, in a case entitled Riegel v. Medtronic, the United States Supreme Court extended the pre-emption doctrine in the field of medical devices. In that case, Charles Riegel was seriously injured when the ballon catheter used during an angioplasty burst during the operation. In a suit brought against the manufacturer, Medtronic, the Riegels claimed that the device was defective and dangerous. The Supreme Court trumped the case, however, holding that the federal law that authorizes the FDA to regulate medical devices also limited the rights of injured parties to sue. The Riegels were left with no remedy.
In November of this year the issue of pre-emption in the field of pharmaceutical drugs will be taken up by the U.S. Supreme Court in Levine v. Wyeth Industries. In that case Diana Levine, a musician, was admitted to an emergency room for a migraine headache. During her stay a drug called Phenergan was administered through her IV to address nausea. The drug is usually administered intramuscularly through a shot in the rear end. As a direct result of the administration of the drug through her IV, Levine’s arm and hand became gangrene. The hand was amputated first, but she eventually lost her entire arm.
Levine brought a civil action against Wyeth claiming that the labeling instructions were inadequate. A jury awarded her $6 million against the pharmaceutical company. Wyeth Industries has appealed to the U.S.Supreme Court on grounds of pre-emption.
Since the Riegel decision, Congress has proposed the Medical Device Safety Act of 2008 (HR 6381) to overturn the Riegel v. Medtronic decision. In opposition to pre-emption in the upcoming Levine case, nine current and former editors of the prestigious New England Journal of Medicine, along with 47 state attorneys general and two former FDA commissioners have filed a brief asserting that the FDA cannot do an adequate job to protect Americans. Two strong articles concerning these pre-emption fields can be found at injuryboard.com: Part One and Part Two.
The importance of the pre-emption doctrine in the field of pharmaceutical drugs is critical. Today pharmaceutical companies advertise directly to consumers in every form of media, creating demands for drugs never before experienced. If consumers are precluded from going to court to recover when the drug companies are negligent, distribute defective and dangerous products, fail to warn about known or forseeable adverse effects, or misrepresent the need or appropriateness of the drug for certain health conditions, then not only is the individual consumer hurt, but all consumers are hurt. What sends a clearer message to a manufacturer, a money verdict telling them to pay for the wrong they have done, or a “complaint” filed with the FDA that will take years to process, if it is ever processed?
We would urge all consumers to write their congressional representatives to advise them that pre-emption in the field of pharmaceutical drugs is a bad idea. A petition has been circulated on the internet if you chose to go this route.