Bettendorf man testifies in Washington about medical device failure

- Quad City Times

08/05/2009 - Two years ago, Michael Mulvihill was driving through a construction zone in western Ohio when he saw a blue flash and felt a jolt.

At first, the Bettendorf man said, he thought that he had hit something in the road.

Instead, he said, it was something in his chest - the defibrillator that had been implanted a little more than a year earlier for an irregular heart beat and pulse rate.

"I was scared to death," Mulvihill said.

Twenty-two times over nearly the next hour, he said, the defibrillator shocked him, sending spasms of pain through his body.

Mulvihill managed to get his car to the side of the road, while his wife summoned help.

In the hospital, he said, one of the shocks was so intense, "it lifted me up from the gurney and dropped me back down."

Mulvihill, who is 64, told his story Tuesday at a U.S. Senate committee hearing, where Democratic lawmakers are pushing for a bill that would make it easier for patients to sue medical device makers.

The bill is sponsored by U.S. Sen. Ted Kennedy, D-Mass. U.S. Sen. Tom Harkin is a co-sponsor. The Iowa Democrat presided at the hearing of the Senate Health, Education, Labor and Pensions Committee.

The legislation Kennedy introduced would revise a 1976 law that limited state courts from oversight over medical devices.

The law was cited in a U.S. Supreme Court ruling last year that rejected a claim by the estate of a New York man who had sued claiming a balloon catheter made by Medtronic Inc. was defective.

The court, by an 8-1 decision, said the lawsuit in state court was pre-empted by the 1976 law, noting the catheter had undergone a rigorous review by the U.S. Food and Drug Administration.

Medtronic also makes the defibrillator implanted in Mulvihill.

Harkin said the rules are tilted too heavily in favor of medical device makers and it's impossible for injured patients to sue.

"For a patient to undergo a device malfunction and then learn that they have no legal resource against the device manufacturer after it fails them is a one-two punch. And it is unfair," he said.

During the hearing, he said the FDA makes mistakes, often is strapped for resources and isn't an adequate backstop. Access to courts, he said, is often vital to "exposing dangers and bringing about remedies."

Medtronic declined to answer questions about Mulvihill's case specifically. However, the company said implantable defibrillators have saved more than 70,000 lives over the past five years.

"These devices are highly reliable, and they save lives," said Christopher Garland, a Medtronic spokesman. "Inappropriate shocks are unpleasant, they're difficult, and we understand that. And we're doing everything we can to eliminate inappropriate shocks. But that same shock could save that patient's life someday."

Critics of the Kennedy legislation say it will stifle innovation, supplant FDA experts with juries and, ultimately, endanger patients.

"I believe it is the patients who are going to suffer," said Sen. Orrin Hatch, R-Utah, the ranking Republican on the panel.

Industry officials add that only a small number of devices are given protection from lawsuits, and they are for the most complex devices.

Mulvihill was one of two patients scheduled to testify Tuesday. There also were others who have expertise about the law as it applies to medical devices.

After surgery to replace a lead on the device, Mulvihill said, he became so anxious about a recurrence that he found he was afraid to drive. He said he's sought medical help repeatedly and began seeing a psychologist, too.

"Psychologically, it's definitely affected me," he said in an interview.

Mulvihill said he had to retire early from his job as a golf irrigation specialist and developed ulcers. He said he hopes nobody else will experience what he did. "It's not a fun way to live," he testified.

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