WASHINGTON - The US Supreme Court put new limits on lawsuits against Medtronic Inc. and other medical-device makers, saying patients generally can't sue over products cleared for sale under the most intensive federal review process.
The justices, voting 8-1, barred a lawsuit that claimed a New York man suffered permanent injury when a Medtronic heart catheter burst during a 1996 angioplasty. The Food and Drug Administration had permitted the product under its so-called premarket approval process.
Writing for the court, Justice Antonin Scalia said the FDA's review was a "rigorous" one that precluded imposition of any additional requirements under state product-liability law. Justice Ruth Bader Ginsburg was the lone dissenter.
The ruling gives device makers a new weapon in thousands of lawsuits, including claims over heart devices made by Medtronic and Boston Scientific Corp.'s Guidant unit. Minneapolis-based Medtronic and Natick-based Boston Scientific are the world's largest makers of cardiovascular devices.
"Pretty bad for patients, pretty good for industry profits," said Allison Zieve, the lawyer who represented the widow of patient Charles Riegel, who died three years ago.
The decision also may bode well for drugmakers, which are fighting in two Supreme Court cases of their own to restrict the ability of patients to sue over FDA-approved pharmaceuticals. Yesterday's ruling is the latest in a series of business victories at the Supreme Court.
Medtronic's lawyer, Theodore Olson, hailed the ruling, saying it will help patients by ensuring that juries don't second-guess FDA decisions.
"What the FDA does is examine in a comprehensive way medical devices to be sure they are as safe as possible, as effective as possible, and as available to as many people as possible," he said.
Separately, the Supreme Court sided with business in another case yesterday, unanimously invalidating Maine regulations of package delivery companies that bar online tobacco sales to minors.
The justices said the state cannot impose a regulatory scheme on transportation companies delivering tobacco products directly to consumers. The justices said federal transportation law prevents state-by-state regulation.
"Despite the importance of the public health objective, we cannot agree" with Maine's approach, Justice Stephen Breyer wrote.
Thirty-one states besides Maine have cigarette delivery laws targeting the problem of underage smokers.
Yesterday's ruling could enable the industry to argue that similar laws in other states are invalid.
Business groups were on the losing end of another unanimous ruling, allowing individual participants in the most common type of retirement plan to sue under a pension protection law to recover their losses.
The decision has implications for 50 million workers with $2.7 trillion invested in 401(k) plans.
James LaRue of Southlake, Texas, said the value of his stock market holdings plunged $150,000 when administrators at his retirement plan failed to follow his instructions to switch to safer investments. The issue was whether the Employee Retirement Income Security Act permits an individual account holder to sue plan administrators for breaching their fiduciary duties.
The language of the law refers to recovering money for the "plan" rather than for an individual, raising the question of whether a participant can sue solely for himself.
Business groups argued that ERISA is aimed at encouraging employers to set up pension plans, while guarding against administrative abuses involving the plan as a whole.
Material from Bloomberg News and the Associated Press was used in this report.
