COURTS MULL OVER PREEMPTION ISSUE CRITICAL TO RIGHTS OF THOSE INJURED BY DRUGS AND MEDICAL DEVICES

Now we wait. Currently pending before the Supreme Court and the Third Circuit are two critical cases involving the issue of federal preemption of state law claims against manufacturers of medical devices and pharmaceuticals.

The Supreme Court case is  Riegel v. Medtronic, Inc. In that case, the widow of Charles Riegel filed suit against Medtronic after the catheter inserted inside Mr. Reigel burst during a coronary angioplasty because it had been inflated beyond the recommended pressure. Medtronic moved for summary judgment on the ground that the state common law claims were preempted by the Medical Device Amendments to the Food, Drug and Cosmetics Act ("FDCA"), 21 U.S.C. § 360k(a).

The Second Circuit affirmed dismissal of the case holding that because the design of the device was approved by the FDA, any state claim alleging faulty design was preempted; only claims alleging negligent manufacturing could survive.

The Third Circuit case argued just a few days ago is Colacicco v. Apotex, in which the widow of a suicide filed suit against the manufacturer of the antidepressant her husband was taking alleging a failure to warn. Like in the device case, the company argued that state law claims should be preempted because they conflict with FDA's approval of the warnings accompanying the drugs.

The wrong decisions in these cases will be a setback to the rights of individuals to seek justice against large manufacturers who have injured them. The history of tort law reflects the fact that government regulators have not always been correct about the safety of the products they have approved. Perhaps the best example is the Thalidomide scandal of the late fifties. Here was a drug approved by the FDA as safe and yet it wasn't and thousands of children suffered severe deformities as a result.

If a product or device is proved defective or unreasonably dangerous, the issue alleged by the plaintiffs in these two cases, it should not matter that the FDA had once thought otherwise, particularly when the basis of such a decision is information supplied by the manufacturer. We will keep you posted.