The U.S. Supreme Court has held that the “preemption clause” of the federal Medical Device Amendements of 1976 prevents a patient from suing for products liability for a failed catheter. See Reigel v. Medtronic, Inc. 128 S. Ct. 999 (2008).
In this case the family of the patient, who died, filed a products liability suit in New York. Riegel was injured by a Medtronic catheter which had a design defect and inadequate warnings. Riegel survived the procedure to unclog an artery, but he suffered permanent injuries. The federal court in New York held that the federal statute preempts a state court based products liability case. The Supreme Court agreed.
Essentially, the medical device was cleared by the federal regulators, and the federal statute preempted state law on the issue of the product’s safety. Riegel’s estate argued that although the manufacturer can use U.S. Food and Drug Administration approval as a defense and an issue for consideration by the jury, the F.D.A. approval should not block a product lawsuits altogether.
Under the doctrine of “preemption”, the federal courts have blocked product liability in state courts under state common law under the thinking that the federal government has decided to “preempt” the states on certain products, such as medical devices. Ordinarily, lawsuits involving defective and dangerous products are regulated by the states’ common law of negligence and personal injuries.
About 10 years ago we had a case involving a dangerous, household pesticide which was ironically called La Bomba. The client was seriously burned when it exploded while she was fumigating her kitchen. We filed suit alleging defective design, negligent manufacture, and failure to warn. The failure to warn part of the case was dismissed on federal preemption because the contents and form of the warning on the spray can were in conformity with a federal statute governing warnings on insecticides. However, fortunately, the guts of the case, i.e., dangerous design, was allowed to proceed to trial. A favorable settlement was obtained during trial.
However, under the Riegel case, the U.S. Supreme Court is blocked the entire case because the FDA had approved the medical device. This is a great setback for people injured by medical devices and other products. The decision is not unexpected because the Supreme Court has been very pro-business.
If you have been injured by a defective medical device or product, please fee free to call us a 800-244-9313.
Mark E. Seitelman, 8/31/08, www.seitelman.com.