Defective Medical Device Question Before Supreme Court

The United States Supreme Court heard arguments yesterday in a case which may have a major impact on lawsuits against medical device makers brought by patients who have been injured by defective products. The Supreme Court will be asked to consider whether patients can bring lawsuits over defective devices which have been cleared for sale by the Food and Drug Administrations’ approval process. In this case, a federal appeals court barred a suit which claims a New York man suffered permanent injury when a Medtronic heart catheter burst during a heart procedure.
The decision of the lower court would undercut thousands of lawsuits, including cases over defibrilators made by Medtronic and Boston Scientific Corp. Guidant unit. The ruling may also shield Medtronic from suits over its recalled Fidelis defibrilator wires. In 1996, a divided Supreme Court allowed lawsuits over products approved through a separate Food and Drug Administration approval process that provided for fast-track reviews of devices. The case before the Supreme Court concerns a pre-market approval process which is a more intensive FDA review.
The Bush administration is not surprisingly backing the medical device makers in their argument that the federal pre-market system should preclude claims that companies ought to have done more to ensure safety.
The current Supreme Court has almost uniformly ruled against plaintiffs in insurance and antitrust, as well as products cases.