Makers of medical devices can be sued in state courts over alleged defects in their products, the Supreme Court ruled Wednesday.
Compliance with federal laws and regulations does not protect a medical device from product-liability lawsuits filed under state laws, the justices said in a splintered decision.The ruling was a victory for a Florida woman who says she was almost killed by a defect in her heart pacemaker.
The case has been closely watched by product manufacturers and consumer advocates. Earlier this spring, a federal trial judge in Birmingham, Ala., said the high court's ruling could "significantly affect" the many silicone breast-implant lawsuits pending in his court.
Led by Justice John Paul Stevens, the court ruled unanimously that a 1976 federal law called the Medical Device Amendments allows consumers to file state lawsuits claiming a product had a design defect.
But the justices split 5-4 in ruling that the law also does not preclude lawsuits alleging faulty manufacturing or labeling of a medical device.
All three claims had been raised in a lawsuit filed by Lora Lohr of Jacksonville, Fla., who was 27 when she had a pacemaker implanted in 1987. The federal Food and Drug Administration had authorized the sale of the pacemaker, and it never was recalled.
But three years later, the pacemaker's wire that delivered the electrical impulse to Lohr's heart failed.
She underwent emergency surgery and has needed four more operations since then. Earlier this year, she said, "The device that was supposed to save me but nearly killed me has made me paranoid."
Lohr and her husband, Michael, sued Minneapolis-based Medtronic Inc., the world's largest pacemaker manufacturer, alleging faulty design, manufacturing and labeling of her pacemaker.
Part of the lawsuit had been dismissed in lower courts. Wednesday's decision revived all of Lohr's legal claims.
Joining all of Stevens' opinion for the court were Justices Anthony M. Kennedy, David H. Souter and Ruth Bader Ginsburg.
The sweep of the decision - and what impact it will have on other products that can be marketed only after federal approval - was not easy to measure because of a key fifth vote for Lohr cast by Justice Stephen G. Breyer.
Breyer did not join all of Stevens' opinion, and in his own concurring opinion said there may be instances in which the federal law does preclude some state court lawsuits.
But Breyer concluded that the Medical Device Amendments law "does not pre-empt the tort claims here at issue." He added: "I am not convinced that future incidents of MDA's pre-emption of common-law claims will be few or rare."
Chief Justice William H. Rehnquist and Justices Sandra Day O'Connor, Antonin Scalia and Clarence Thomas dissented from that part of the ruling that lets Lohr sue in state court over her claims of defective manufacturing and labeling.