Bush: FDA's word shields against lawsuits

Preempt away. That's what the Bush Administration told the Supreme Court yesterday, supporting Medtronic's contention that its FDA-approved products shouldn't be subject to liability claims in state court. By throwing its weight behind Medtronic, of course, the administration is really supporting a sweeping change to patients' rights that could affect hundreds of outstanding lawsuits.
As we reported yesterday, the Supreme Court is hearing two cases that deal with the public's right to sue drug and device makers over FDA-approved products. Industry types, plus tort-reform activists, would like the court to say the agency's approval preempts state law. In other words, if the FDA says a product is safe, then patients potentially damaged by drugs or devices have no right to argue in state court.
"Even serious problems are exempt from state tort liabilities," Deputy U.S. Solicitor General Edwin Kneedler told the court. In fact, Kneedler said, companies are shielded from lawsuits even if they continue to sell a product that's mislabeled. Several justices, though, seemed to question whether manufacturers should be shielded after they've discovered safety problems with their own products, but before the FDA takes action. A decision is expected by July.

Tratto da: FiercePharma, December 5, 2007, http://www.fiercepharma.com/