Supreme Court Limits Lawsuits on FDA-Approved Medical Devices

Defective Medical Devices

In a major decision in favor of the pre-emptive power of the Federal government, the Supreme Court decided on February 20, 2008 that the Medical Device Amendments of 1976 (MDA) created a standard of safety oversight for medical devices that supersedes any requirements for “design, testing, inspection, distribution, labeling, marketing, and sale” of medical devices that might be interpreted as deriving from state law in the case of Riegel v. Medtronic. They decided that under the terms of the law, any medical device that has received FDA approval cannot be held to any higher standard of strict liability, breach of implied warranty, and negligence Furthermore, the Court decided that the FDA requirements provided for “reasonable assurance of safety and effectiveness.”

Apparently, the Supreme Court is considering a different FDA and its process than the one I know. If one looks at devices like the Davol’s Composix Mesh products, there was nothing like “reasonable assurance of safety and effectiveness provided by the FDA.” In fact, the FDA never evaluated the company’s quality control procedures or its manufacturing process until after issuing a Class 1 recall of the company’s hernia patches, indicating that the product posed an imminent health threat. When it did carry out the inspection, it found that the quality control procedures were so ineffectual and the manufacturing so inconsistent that it expanded its recall to encompass all hernia patches produced by the company.

How can the FDA provide “reasonable assurance of safety and effectiveness” if it only carries out inspections of a company AFTER finding out a device is deadly? I agree with the Court that medical product manufacturers should be held to only one standard of quality and not have to deal with numerous conflicting regulations, but I think that this ruling only makes sense in a country where the FDA actually protects us, instead of simply giving medical device manufacturers a merge lane onto the highway of profits.

Note that this ruling only applies to suits involving medical devices. Next term, the court will consider a case involving whether FDA-approved drugs. Of course, we know the FDA’s record in this area, since it responded so quickly to safety concerns about Trasylol, Vioxx, and others.

This ruling does not quite, however, ban defective product lawsuits against manufacturers of medical devices, it only makes the suits more difficult to argue and to win because they have to be argued under federal law only now, whereas many cases have been argued under state law in the past. Because of this restriction, it is even more important that you get a qualified and experienced personal injury lawyer to represent you. If you or someone you love has been injured by a defective medical device, contact today to get in touch with a local personal injury lawyer who can represent your interests under the new restrictions.