Patient Medical-Device Suits Curbed by Top U.S. Court (Update6)

Feb. 20 (Bloomberg) -- The U.S. 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 suit that claimed a New York man suffered permanent injury when a Medtronic heart catheter burst during a 1996 angioplasty. The U.S. Food and Drug Administration had permitted the product under its so-called pre- market 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, Massachusetts-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. ``Clearly a lot of people will lose their ability to have even the possibility of getting any compensation for injuries caused by medical devices.''

Drugmaker Cases

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. Today's ruling is the latest in a series of business victories at the Supreme Court.

Medtronic's Supreme Court lawyer, Theodore Olson, hailed the ruling, saying it will help patients by ensuring that juries don't second-guess the decisions of the FDA.

``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.

Medtronic rose 26 cents to $49.41 as of 4:03 p.m. in New York Stock Exchange trading. Boston Scientific slipped 14 cents to $12.61.

Congressional Action

U.S. Representative Henry Waxman, a California Democrat who is chairman of the House Oversight and Government Reform Committee, vowed to move quickly to pass legislation that would reverse the high court ruling. ``This isn't what Congress intended,'' he said in a statement.

The ruling will affect the medical devices most frequently targeted in lawsuits, cutting-edge products such as bone screws and defibrillator wires that undergo the FDA'S pre-market approval process. Because that process typically takes almost a year, companies use it relatively sparingly, filing only 43 new applications with the FDA in 2005.

By contrast, companies that year filed 3,130 applications under rules that provide for fast-track review of devices similar to those already on the market.

In 1996, in another case involving Medtronic, a splintered Supreme Court allowed some product-liability suits over devices cleared under the fast-track process.

In the latest case, device makers and the Bush administration argued that the more rigorous pre-market review should preclude state-law claims that companies ought to have done more to ensure safety. In his opinion for the court, Scalia adopted those contentions, saying product-liability suits would be disruptive to the federal system for approving devices.

A jury ``sees only the cost of a more dangerous design, and it is not concerned with its benefits,'' Scalia wrote. ``The patients who reaped those benefits are not represented in court.''

Ginsburg's Dissent

In dissent, Ginsburg wrote that ``it is difficult to believe that Congress would, without comment, remove all means of judicial recourse for large numbers of consumers injured by defective medical devices.''

Because most federal appeals courts that considered the issue had restricted patient suits, a ruling against Medtronic would have marked a change in much of the country.

The legal question was when the ``pre-emption'' provision in the 1976 Medical Device Amendments kicks in to bar state-law suits that claim a product is defective or that a manufacturer failed to warn of risks. The law bars states from imposing ``any requirement'' on top of those mandated by the federal government.

Scalia's opinion left room for patients to sue under state rules that are ``parallel'' to federal requirements.

That avenue is an important one, said Hunter Shkolnik, a lawyer who secured a $114 million settlement from Medtronic over its Marquis line of defibrillators. That accord came after a federal judge permitted claims including an accusation that the company violated FDA regulations.

`Pleasantly Surprised'

``We were pleasantly surprised that the court left open claims that can be brought alleging violations that are parallel to federal regulations such as those upheld in the Medtronic litigation,'' Shkolnik said in an e-mail.

Whether claims of noncompliance with FDA rules can go forward will be ``the next huge battleground,'' said Mark Herrmann, a lawyer at Jones Day in Chicago who represents companies and co-writes a blog on drug and medical-device law. He called today's ruling ``a great win for industry.''

Charles Riegel underwent an angioplasty to dilate his coronary artery in 1996. When the device burst, he lost consciousness and developed a complete blockage, forcing emergency bypass surgery. Riegel died three years ago, and the case was being pressed by his widow, Donna.

The lawsuit accused Medtronic of breaching a warranty on the device and negligently designing, manufacturing and labeling the catheter.

Medtronic said the surgeon didn't follow guidance on the device's FDA-approved label not to use the catheter on patients with calcified arteries.

The case is Riegel v. Medtronic, 06-179.

To contact the reporter on this story: Greg Stohr in Washington at gstohr@bloomberg.net.

To contact the editor responsible for this story: Michael Forsythe at mforsythe@bloomberg.net.