News

Lawmakers Seek to Return Right to Sue Device Makers

February 19, 2009
By Barry Meier

On the same day last month that a federal judge in St. Paul threw out hundreds of lawsuits against the maker of a faulty heart device, a man entered a nearby hospital to have one of those flawed products surgically removed.

The risky operation went terribly wrong. As doctors extracted the device, a thin electronic cable, from the patient's heart, a vessel was punctured, causing extensive bleeding. The 33-year-old patient, Mark Turnidge, died two days later, leaving behind a wife and two young sons.

" They told me he had suffered massive brain damage," said his wife, Wendy Turnidge.

She is considering suing the doctors, as well as the device's maker, Medtronic, which she said bore blame for her husband's death. But a Supreme Court decision last year stands as a barrier against suing medical device companies — an obstacle that some members of Congress want to remove.

At issue is a February 2008 court ruling that barred patients or their survivors from suing makers of complex medical devices — like the Medtronic product — if the Food and Drug Administration has approved their sale. Since that ruling judges nationwide, including the one in St. Paul, have cited it to dismiss cases against a wide range of manufacturers, including Medtronic. The most recent dismissal was this past Tuesday, by the Wisconsin Supreme Court.

But now, some members of Congress want to give potential plaintiffs like Ms. Turnidge a chance for legal recourse. Two House Democrats, Henry A. Waxman of California, the chairman of the House Energy and Commerce Committee, and Frank Pallone Jr. of New Jersey, the head of its health subcommittee, plan to reintroduce soon legislation that would effectively nullify the Supreme Court decision.

A similar Senate bill, sponsored last year by Edward M. Kennedy, Democrat of Massachusetts, and Patrick J. Leahy, Democrat of Vermont, is expected to be reintroduced in coming months.

The lawmakers, as well as patient advocates and others, say the Supreme Court's medical device decision has left patients legally powerless against what they criticize as spotty oversight of products by the F.D.A.

" Consumers face the worse of all possible worlds," said David C. Vladeck, a professor at Georgetown University Law Center and a medical industry watchdog. "The F.D.A. has shown itself incapable of keeping dangerous products off the market, and now the Supreme Court has said patients can't sue companies for redress."

Those with lawsuits dismissed since the Supreme Court ruling include a woman burned internally by a device meant to reduce menstrual bleeding; a man who sustained internal injuries from a prostrate treatment device; and numerous patients who say they were injured by faulty joints or heart implants.

Mr. Pallone says he also expects the House Energy and Commerce Committee to hold hearings this session to question whether the F.D.A. process for approving devices is adequate. "The F.D.A. has limited resources and can't assess all the risks that a device poses once it gets on the market," he said.

Medical device producers and some conservative legal groups have lined up to oppose the legislation, which is supported by plaintiffs' lawyers. Last year, at a Congressional hearing, the Advanced Medical Technology Association, a device industry trade group, said that the F.D.A. was the appropriate body to set nationwide safety standards and that allowing juries to second-guess such decisions would stifle product innovation.

" We are clearly very troubled by this legislation," Christopher White, the trade group's general counsel said in an interview. "Our concern is that it would undermine the F.D.A. process."

The Supreme Court, in a case argued last fall, is now weighing whether to give the same type of legal protections to drug manufacturers. In that case, like the one decided in February 2008, the Bush administration supported pre-empting many product liability suits against F.D.A.-approved products.

In the 2008 decision, the court held that the Medical Devices Amendments of 1976 — the statute that created a classification system under which the F.D.A. reviews medical devices — specifically pre-empted product liability lawsuits against so-called Class III devices. Such devices are the ones receiving the F.D.A.'s highest level of safety scrutiny before the agency approves them for sale. Mr. Pallone argues that the Supreme Court misread the intent of Congress in passing the 1976 law. For consumer advocates like Professor Vladeck, at Georgetown, it is cases like Mr. Turnidge's that highlight why the absolutes of the Supreme Court's decision do not reflect the vagaries of the F.D.A. review process.

The Medtronic component involved was a slender electrical cable, or lead, that connects an implanted defibrillator to a patient's heart. The faulty model, known as the Sprint Fidelis lead, was a follow-up product based on a Medtronic lead that was originally approved a decade earlier.

But the Fidelis lead, approved in 2004, was much thinner than any of its predecessors and was never tested in humans before it went on the market. By the time Medtronic recalled it in 2007, after discovering a high rate of fractures, the Fidelis had been implanted in more than 235,000 patients.

The flaw caused some defibrillators to deliver unnecessary shocks to a patient's heart or to not fire when needed to send a life-saving jolt. When Medtronic recalled the Fidelis, it said it knew of five cases in which patients might have died because of the problem.

Earlier this year, Mr. Turnidge's doctors determined his lead was fractured and decided to remove it.

The surgical procedure to remove a lead has risks because the cables, which are threaded through blood vessels, can become ingrown. But in younger patients like Mr. Turnidge, doctors may nonetheless choose to remove a faulty lead — rather than simply disconnect it and install a new one alongside it — to make future procedures easier as the person ages.

In Mr. Turnidge's case, those risks became all too real.

Both Medtronic and the facility where the procedure occurred, North Memorial Medical Center in Robbinsdale, Minn., declined to comment on his case, citing patient confidentiality.

Before her husband's surgery, Ms. Turnidge said Medtronic told her that, as a matter of policy, it would pay up to $800 to help offset out-of-pocket expenses like a portion of her husband's $4,000 insurance deductible. She declined to take that money. Ms. Turnidge's lawyer, Fred Pritzker, said he was considering suing the hospital and might sue Medtronic in a Minnesota state court, where he has filed claims for other Sprint Fidelis patients. He said the Supreme Court ruling made it likely that a state judge would reject such cases.

Mr. Pallone said patients needed more legal leverage when medical devices harm patients.

"Tort actions serve as backstop to the F.D.A. and provide another level of protection," he said.

Source: http://www.nytimes.com/2009/03/03/health/03zion.html?_r=1&scp=1&sq=barron%20lerner&st=cse

Sheldon J. Schlesinger, P.A. represents clients throughout the state of Florida including the cities of Boca Raton, Boynton Beach, Carol City, Cooper City, Coral Gables, Coral Springs, Davie, Deerfield Beach, Delray Beach, Fort Lauderdale, Hialeah, Hollywood, Jupiter, Lake Worth, Miramar, Miami, Oakland Park, Palm Beach, Palm Beach Gardens, Palm Springs, Pompano Beach, and Rivera Beach

Broward County • Miami-Dade County • Palm Beach County