Medtronic, Medical-Device Makers Seek to Block Suits

- Bloomberg

12/04/2007 - Medtronic Inc. and other medical- device makers have a chance to win a new shield from patient lawsuits in a case before the U.S. Supreme Court.

In arguments today in Washington, the justices will consider whether patients can press product-liability lawsuits over devices cleared for sale by the Food and Drug Administration's most rigorous approval process. A federal appeals court barred a suit that claims a New York man suffered permanent injury when a Medtronic heart catheter burst during an angioplasty.

The lower court's approach would undercut thousands of lawsuits, including cases over defibrillators made by Medtronic and Boston Scientific Corp.'s Guidant unit. Such a ruling might also shield Medtronic from suits over its withdrawn Fidelis defibrillator wires. Minneapolis-based Medtronic and Natick, Massachusetts-based Boston Scientific are the world's largest makers of cardiovascular devices.

``There's a significant concern that the court's ruling may alter the landscape and make it either impossible or difficult to bring these claims,'' said Edward E. Angwin, a Birmingham, Alabama, lawyer who is suing Johnson & Johnson over its Duragesic pain-killing patch. J&J, the world's largest health-products maker, is based in New Brunswick, New Jersey.

A divided Supreme Court, in a 1996 case that also involved Medtronic, allowed lawsuits over products approved through separate FDA rules that provide for fast-track review of devices similar to those already on the market. The latest case concerns ``pre-market approval,'' a more intensive FDA review that typically takes close to a year.

Patient Safety

Device makers, backed by the Bush administration, say the rigorous federal pre-market system should preclude state-law claims that companies ought to have done more to ensure safety. Companies also say suits invoking state laws would subject them to different legal standards around the country.

``The industry here is just asking for uniformity,'' said Mark Herrmann, a lawyer at Jones Day in Chicago who represents companies and co-writes a blog on drug and medical-device law. ``Just give us one set of rules.''

Because of the intense review, companies seek pre-market approval sparingly, filing 43 new applications with the FDA in 2005 compared with 3,130 under the fast-track rules. Products that undergo pre-market approval tend to be cutting-edge devices, and often are targeted in lawsuits.

`Ripe for Litigation'

``It's a relatively small number of products a year, but they're the most ripe for litigation,'' said William Schultz, a former FDA official and now a lawyer at Zuckerman Spaeder in Washington. Schultz filed a brief backing the lawsuit on behalf of Senator Edward Kennedy of Massachusetts and Representative Henry Waxman of California, both Democrats.

Because most federal appeals courts that have considered the issue have restricted patient suits, a ruling against Medtronic would mark a change in much of the country. That ``could have an adverse long-term effect on the overall medical-device industry,'' said Kristen Stewart, a Credit Suisse Group analyst who has ``neutral'' ratings on Medtronic and Boston Scientific.

The dispute will be resolved by a Supreme Court that in its most recent term ruled against plaintiffs' lawyers in insurance, antitrust and securities cases.

To continue that winning streak, business groups will have to win over at least one of the five justices who formed the majority in the 1996 case -- John Paul Stevens, Ruth Bader Ginsburg, David Souter, Anthony Kennedy and Stephen Breyer.

Switching Sides

Breyer may be most likely to switch sides. He wrote separately in 1996 to say that a 1976 law ``will sometimes pre- empt a state-law tort suit.''

That law, known as the Medical Device Amendments, says pre- emption applies when the U.S. government imposes a ``requirement.'' The statute doesn't specify whether that term includes FDA approval.

The Supreme Court could let only some types of claims go to trial, such as those alleging a manufacturing defect or a failure to provide a better warning about potential hazards.

Later in the court's 2007-08 term, the justices consider shielding drugmakers from some patient lawsuits. The court will decide both cases by July.

In the Medtronic case, 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.

Widow's Appeal

Riegel died three years ago, and the case is being pressed by his widow, Donna. In October, the Supreme Court rejected Medtronic's contention that Riegel's death required dismissing the appeal.

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

``What's at stake is patients' ability to seek compensation for injuries caused by the most dangerous medical devices,'' said Allison Zieve, who will represent Donna Riegel at the high court.

Medtronic says the surgeon didn't follow guidance on the device's FDA-approved label not to use the catheter on patients with calcified arteries. The company is represented by Theodore Olson, a former U.S. solicitor general and now a lawyer at Gibson, Dunn & Crutcher in Washington.

Olson told the justices in court papers that Donna Riegel is ``directly challenging the FDA's expert judgment that the Evergreen Balloon Catheter is safe and effective.''

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