Supreme Court Rules In Favor Of Preemption Of Medical Device State Tort Claims
On February 20, 2008, the United States Supreme Court issued a decision in Riegel v. Medtronic that was a victory for both medical device manufacturers and federalists. The Court ruled 8 to 1 that tort claims based on state regulations or restrictions for medical devices that are different from the Food, Drug and Cosmetic Act requirements and restrictions for medical devices are barred by the preemption provisions of Section 360k(a) of the Medical Device Amendments of 1976 for devises that have gone through the FDA’s premarket approval process. In writing the opinion for the majority, Justice Scalia stated such a finding “is exactly what a preemption clause for medical devices does by its terms . . . .” Based on this ruling, plaintiffs can no longer sue medical device manufacturers for claims such as strict liability, breach of implied warranty, design defect, etc. under state law for devices that have passed the FDA’s premarket approval process. This ruling may greatly affect the number of medical device claims brought against manufacturers. Although, some experts believe the impact will not be as far reaching as expected because the decision does not discuss preemption for devices that have obtained approval through the abbreviated 510(k) approval process, which the vast majority of products use for approval over the full FDA premarket approval process.
In addition to being a win for device manufacturers, the decision is a big win for federalism. This decision has increased the FDA’s authority as the ultimate body established by Congress to regulate this industry. Since products such as medical devices are marketed and sold on a national level, making the FDA the ultimate authority on these products will ensure consistency in the review of and approval process for medical devices. In the decision, Justice Scalia stated that jurors would most likely not be in as good a position as the FDA to weigh the benefits and dangers of medical devices.
Although this ruling only governs medical devices, the Supreme Court currently has a case pending before it that raises similar arguments and issues for prescription drugs approved by the FDA. In the case of Wyeth v. Levine, the Supreme Court will decide whether state law failure to warn claims are preempted when a prescription drug obtains FDA premarket approval for the drug and its label warning of potential side-effects associated with the drug. The FDA weighed in on this issue and issued a preamble in the Federal Register stating that it believes state court claims regarding failure to warn should be preempted and barred for any prescription drug that passes FDA approval. Based on the 8 to1 decision in favor of medical device preemption, one has to think there is a good likelihood that the Supreme Court will reach a similar decision for prescription drugs on state law failure to warn claims.