Dangerous Preemption Could Victimize Again
In a frightening trend among defective drug and medical devices, pharmaceutical companies are trying to argue in court cases that if the U.S. Food and Drug Administration approve a drug or medical device then the approval preempts any efforts to seek retribution for victims of companies’ products. In a recent Wall Street Journal article the case of Wyeth v. Levine was cited. Diana Levine lost an arm to gangrene because a nausea drug was improperly administered to her arm. She was a musician by trade and she lost her ability to ply her trade. In her case she argued that the drug maker should have put stronger warnings on the label. A Vermont jury agreed and awarded her $6.7 million in damages. The drug manufacturer appealed saying that the drug’s labeling was approved by the FDA thus overruling state law on issues of product safety. “This case is worth tens of billions to the pharmaceutical industry,” said Richard Rubin, Ms. Levine's lawyer. In January, the Supreme Court ruled in favor of pre-emption in a medical-device case involving Medtronic Inc. of Minneapolis. If pre-emption is upheld than drug makers will be given a firmer footing in many lawsuits. Johnson & Johnson has so far paid $68 million to settle cases involving its Ortho Evra contraceptive patch. Settlements over the anti-psychotic drug Zyprexa have cost Eli Lilly & Co. more than $1 billion. Merck & Co.'s Vioxx has cost them $4 billion so far, and Wyeth's fen-phen-related diet pills have reached $20 billion. Consumer advocacy groups argue otherwise. They say patients’ right to sue is the only deterrent to corporate irresponsibility and deceit and argue that the FDA makes mistakes and companies hide information. This is a dangerous trend and if preemption is upheld legal recourse would be almost non-existant.
