Focus: Drugs and Devices under Federal Law

Source: The New York Times -Barry Meier and Natasha Singer, 3/5/2009

Drug Ruling puts Devices in Spotlight. The Supreme Court has ruled that federal law does not protect (preempt) drug companies from being sued for product liability in state courts.

The Court previously ruled, as recently as last year, that manufacturers of stents, artificial joints and other medical devices could not be sued for defective products in state courts.

It is anticipated that drug manufacturers will now face additional litigation and may be more inclined to settle cases already brought against them. Congress has signaled intent to introduce legislation that would equal the playing field as to medical device manufacturers. Such devices, known as Class III devices, which include, pacemakers, artificial hips and breast implants have, since 1976 been exempted from state product liability law suits under federal law.

Supporters of the legislation have stated that it is necessary because the FDA has continued to approve faulty and high-risk devices.

posted by David Marc Schwadron, Esq.