Once the FDA approves a drug or medical device, state judges and juries will not be permitted to hear cases alleging defects in these products, nor will they have authority to hold manufacturers accountable for the injuries caused by their defective (but FDA-approved) products.

At least that?s what pharmaceutical manufacturers hope will be the case when the United States Supreme Court issues a decision in Riegel vs. Medtronic.

Charles Riegel sued Medtronic Inc. over an allegedly faulty catheter manufactured by the company. While the lawsuit was filed in federal court, the basis for Riegel?s claims is found in state law. The suit was thrown out, as the lower court ruled that if Riegel got to trial and won, it would be the equivalent of the states imposing additional ?requirements? on the manufacturer beyond those established by the FDA during its pre-market approval process for medical devices such as the Medtronic product in question.

The theory behind the court?s decision is called ?preemption? ? namely, while individual states have authority to govern themselves, they may not impose additional (or more stringent) guidelines in an area already legislated by the federal government.

Riegel appealed the decision and oral arguments were heard by the Supreme Court during the first week of December 2007. The court is now left to decide whether FDA pre-market approval of a medical device means parties injured by that device may not seek remedies under state law.

State liability poses a “Catch-22 [for pharmaceutical companies] between complying with FDA regulations on the one hand and still being subject to state liability on the other,” said Rob Clark, a government affairs director for Medtronic.

Consumer-advocate groups are outraged, arguing that state courts offer the chance for those injured by faulty medical drugs and devices to receive compensation for the harm suffered. They argue the FDA sometimes makes decisions based on inaccurate or insufficient information, which makes the state courts a second (and often last) chance venue for consumer protection.

Either way the Court rules, the decision will likely have a dramatic and far-reaching impact on current and future product liability claims in the United States.

Source: Molly Selvin, ?High court may bar claims for FDA-approved drugs,? Los Angeles Times, December 4, 2007.