Supreme Court Sides with Medical Device Manufacturers
The Supreme Court Wednesday sided with medical device manufacturers in an 8 to 1 ruling protecting medical device manufacturers “that have passed the most rigorous federal review standards from lawsuits by consumers who allege that the devices caused them harm.”
This decision could make it more difficult for product liability litigation, but it is important to remember that the decision only applies to Class III medical devices, which is based on the highest level of FDA scrutiny. The decision also refers to medical devices approved by the FDA and does not include drugs.
In January, we pointed out that a New England Journal of Medicine report concluded that drug-eluting stents were not associated with an increased risk of death, and that the FDA a month before that said they expected to issue new testing requirements for drug-coated stents. (See Drug-coated Stents Considered Safe)
Devices and drugs, such as these stents, may not be covered by this decision unless they fall within the Class III medical device category.
