Supreme Court Decision re: Device Industry

[Cynaburst]

Medical device industry wins in Supreme Court decision

East Bay Business Times - by Mark Hollmer

Medical-device manufacturers came out on top with a Supreme Court decision Wednesday that makes it harder for consumers to sue the makers of federally approved devices.

The court ruled 8 to 1 that a state lawsuit against a device company is barred if federal regulators had already approved the device for sale and determined it was both safe and effective.

Federal law requires the U.S. Food and Drug Administration to sign off on a device before it can be marketed and sold. But the court said state lawsuits, if accepted, would be detrimental because they would impose requirements different from federal requirements.

Justice Ruth Bader Ginsburg dissented saying Congress never intended federal law to trump state lawsuits over injuries caused by "defectively designed or labeled medical devices."

But a Massachusetts medical device industry leader said the decision affirms the meticulous review process that medical device companies go through to get a product approved.

"In bringing a medical product to market in this country, medical device manufacturers comply with the most-rigorous review process in the world," said Thomas Sommer, president of the Massachusetts Medical Device Industry Council. "Approval of medical products and technology by the FDA is considered to be the 'gold standard' in the global marketplace. Today's ruling confirms that the current review system is the most appropriate for establishing the safety and effectiveness of medical devices."

The Supreme Court Case involved a specific lawsuit from a patient who suffered serious injuries when a Medtronic Inc. catheter burst during a medical procedure. The man used the catheter to unclog an artery and was left disabled before dying in 2004, according to press reports.

Boston Business Journal

[Cynaburst]

Justices Make It Tougher to Sue Medical Device Makers

By DAVID STOUT
Published: February 20, 2008

WASHINGTON — 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.

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’ suit on the ground that the catheter had been given premarket 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.

Justice Scalia wrote that the F.D.A. spends an average of 1,200 hours reviewing each device application and grants premarket 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.”

In this case, the Bush administration had taken the side of the medical-device industry, arguing 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.

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.