Healthy Skepticism Library item: 13020

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Stout D.
Justices Make It Tougher to Sue Medical Device Makers
The New York Times 2008 Feb 20
http://www.nytimes.com/2008/02/20/washington/20cnd-device.html?_r=1&oref=slogin

Full text:

In a case with huge implications for the health care-technology industry, the Supreme Court ruled on Wednesday that the manufacturer of a federally approved medical device cannot be sued under state law if the device causes an injury.

The 8-to-1 ruling in favor of Medtronic, the Minneapolis-based maker of cardiovascular devices, made it much more difficult for patients and their families to sue makers of medical devices that have been granted federal approval.

In 1996, a balloon catheter burst and severely injured Charles R. Riegel while he was undergoing an angioplasty. Mr. Riegel and his wife, Donna, sued the company in federal court, contending that the catheter had been designed, labeled and manufactured in a way that violated New York state law, and that those defects had caused severe and permanent injuries to Mr. Riegel.

But a federal district court and the United States Court of Appeals for the Second Circuit, in Manhattan, dismissed the Riegels’s suit on the ground that the catheter had been given pre-market approval by the Food and Drug Administration, thus protecting the manufacturer from liability under state law. (The case of Riegel v. Medtronic was tried in federal court because the plaintiffs and defendant were based in different states.)

The Supreme Court upheld the lower federal courts on Wednesday, with Justice Antonin Scalia writing for the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, or in addition to, any requirement applicable under this chapter.”

But the justices’ ruling was hardly the last word on when F.D.A. approval bars patients from suing. They are already considering at least three cases involving drugs and drug-labeling.

In 1996, when there was a different lineup of justices, the Supreme Court ruled that medical devices approved by the F.D.A. under a different, more expedited process were not shielded from state liability. At the time, the federal government took that position.

But in 2004, the Bush administration reversed the government’s position and began to take the side of manufacturers. In the Medtronic case, the administration argued that there would be “serious undermining of F.D.A.’s approval authority and its balancing of the risks and benefits” if juries could second-guess the agency.

Justice Scalia wrote that the F.D.A. spends an average of 1,200 hours reviewing each device application and grants pre-market approval only if it finds there is a “reasonable assurance” of its “safety and effectiveness.”

“It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives,” Justice Scalia wrote, noting that the F.D.A. approved a ventricular assist device for children with failing hearts “even though the survival rate of children using the device was less than 50 percent.”

Justice Scalia said jurors would probably not be in a position to weigh the benefits and dangers of medical devices as well as agency experts. A jury, he wrote, “sees only the cost of a more dangerous designed, and is not concerned with its benefits; the patient who reaped those benefits are not represented in court.”

The majority was apparently persuaded by Theodore B. Olson, the lawyer for Medtronic, who argued before the justices on Dec. 4 that the F.D.A. and not the courts was the right forum for imposing requirements on cutting-edge medical devices. Arguing that “nothing is perfectly safe,” Mr. Olson said it would harm patients and future patients to “discourage the marketing of products that might save our lives.”

Medtronic, which makes a wide variety of medical products and is one of the world’s largest manufacturers of cardiovascular devices, no longer makes the type of catheter used on Mr. Riegel, who died several years after the operation. As part of its defense, the company maintained that the doctor involved failed to heed a warning not to use the device on a patient who had calcified arteries, as Mr. Riegel did. Founded in 1949, Medtronic has more than 37,000 employees and had revenues of $12.3 billion in its last fiscal year, according to the company’s Web site.

Justice Ruth Bader Ginsburg was the lone dissenter on Wednesday, asserting that the majority had adopted an unnecessary “constriction of state authority.” Justice Ginsburg said she did not believe that Congress had intended to bring about “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.”

Allison M. Zieve, the lawyer for Donna Riegel, expressed her disappointment to Bloomberg News. “Pretty bad for patients, pretty good for industry profits,” she said.

Leading Congressional Democrats criticized the high court’s decision and issued statements vowing to enact legislation to allow lawsuits against medical device makers.

“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” said Representative Henry A. Waxman of California, the chairman of the House Committee on Oversight and Government Reform. “This isn’t what Congress intended and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

Senator Edward M. Kennedy of Massachusetts, the chairman of the Senate Health, Education, Labor and Pensions Committee, agreed, saying: “Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, F.D.A. approval will become a green light for shoddy practices by manufacturers.”