While preemption has always been a possible affirmative defense in any products liability suit, recent decisions have raised significant concerns over the new push by industry to use preemption as an avenue to avoid liability. Preemption generally refers to the displacing effect that federal law can have on a conflicting or inconsistent state law. Typically, when preemption is asserted as a defense, it is argued that state law supporting a consumer’s claim is preempted by “requirements” as set forth by the federal government or through federal product safety statutes that specify standards for the safe design or manufacture of products.
The doctrine of preemption has historically been interpreted to apply to limited areas that are not traditionally left to the states to regulate. However, the traditional presumption against preemption appears to be in danger. Several court rulings are challenging these traditional notions and, if upheld, will make it more difficult for consumers to bring tort claims based on state common law when it is possible to argue that federal regulations preempt state tort law.
This issue is expected to be addressed by the U.S. Supreme Court this fall regarding pharmaceutical drugs, and the court’s decision could radically alter consumers’ ability to seek recourse from drug makers. The case, Wyeth v. Levine, may lead to a new interpretation of federal law, which would shield pharmaceutical companies from the most common kind of lawsuits.
Because of the significant impact the Supreme Court’s decision could have on consumers’ ability to seek recourse, the future of product defect claims in pharmaceutical cases remains in question.
Medical Device Claims
Preemption of Medical Device Claims: Riegel v. Medtronics
To understand the concerns raised by preemption, it is important to understand the United States Supreme Court decision in Riegel v. Medtronics which upheld federal preemption in medical device design defect cases.
In Riegel, the plaintiff underwent heart surgery and during the procedure a balloon catheter ruptured while his doctor was attempting to dilate his coronary artery that had been partially blocked. The device was blamed and a question of law arose as to what impact the approval by the Food and Drug Administration (FDA) should have.
Specifically, the Court addressed whether the FDA’s approval of a product preempted state common law tort claims. In an 8-1 decision, the Court held that a state-law-based claim against a manufacturer for a defective medical device was preempted by the Medical Device Amendments of 1976 if the alleged defective product had been approved by the FDA. The Court reasoned that state regulatory laws and state tort law that made devices “safer, but less effective” than the FDA’s approved model would disrupt the federal scheme and should be preempted.
While the ruling is a major setback to consumers, the language of the opinion appears to be limited to “design defect” claims, leaving open the possibility of recovery in cases involving manufacturing defect-based claims, which would remain viable. However, with preemption now recognized, the ability to prosecute these cases has been made much more difficult.
Preemption Case Supporting Glazing Claims: O’Hara v. General Motors Corporation
While preemption arguments continue to find their way before judges, some Court’s have refused to accept the application of the defense. One significant case occurred recently in O’Hara v. General Motors Corporation. In that case, Mr. and Mrs. O’Hara and their daughter were riding in a 2004 Chevrolet Tahoe when it was involved in a rollover accident. During the rollover sequence their daughter was partially ejected from the passenger side window and sustained serious injuries to her arm. The O’Haras filed suit, and alleged in part, that the vehicle was unreasonably dangerous and defective because it had failed to incorporate safety glass or advanced glazing to contain occupants in foreseeable rollovers.
The ensuing litigation resulted in a significant appellate ruling on the issue of whether FMVSS 205, relating to automotive glass, preempted the common law suit brought by the O’Haras against General Motors. After considering whether the right to bring suit under existing state law would conflict with or stand as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress, the Court found that FMVSS 205 did preempt the common law suit for failure to use advanced glazing on the side windows of the 2004 Tahoe. This ruling has been touted as a major victory for those who promote automotive safety. This decision is one of the most consumer friendly preemption rulings in recent history, and is viewed by many as properly limiting preemption to areas where it has been specifically mandated.
Preemption of Pharmaceutical Claims: Wyeth v. Levine
In the face of nationwide debate over preemption, the Supreme Court is now considering the Wyeth v. Levine case. In that case, Diana Levine went to the hospital because she was suffering from a severe headache. She was injected with Phenergan, a drug that treats nausea. After suffering complications from this injection, her hand and forearm were amputated. Ms. Levine alleged that her injuries were caused by misadministration of the drug due to defects in the labeling. The Supreme Court is set to take up the issue of whether the use of FDA approved and mandated labeling would bar the state for claims because of the preemptive effect of the federal labeling laws.