Patients injured by faulty medical devices want laws to hold manufacturers accountable

-Cleveland.com

05/13/2009 - Two summers ago, Bill Storms of Delaware, Ohio, says he got 138 electrical jolts over a five-hour period when the wires to his pacemaker went haywire. The 38-year-old truck driver had to visit several emergency rooms before the device could be turned off.

"It felt like having a horse inside you trying to kick its way out of your chest," said Storms, whose lawsuit against the maker of his Sprint Fidelis pacemaker wires was thrown out of court this year along with hundreds of similar cases by a judge who cited a 2008 Supreme Court precedent.

Storms and others who say they were injured by faulty medical devices want Congress to pass legislation that would override the Supreme Court decision in Riegel v. Medtronic, which found that consumers can't sue medical device companies over medical devices that have been approved by the Food and Drug Administration.

The House Commerce Committee's health subcommittee will hold a hearing on the issue today.

Its chairman, New Jersey's Frank Pallone, a Democrat, is co-author of the Medical Device Safety Act, which would enable injured patients to sue medical device makers. A Pennsylvania woman who got 31 shocks from a Sprint Fidelis lead is scheduled to testify at the hearing.

"They should not just be able to get a free pass to market a subpar product," said Storms, whose lawsuit could proceed if the bill is passed.

Medical device makers, including Medtronic, which made the pacemaker wires at issue in Storms' lawsuit, and Mentor-based Steris Corp., say passage of the bill would stifle innovation, compromise the safety of American consumers, and destroy the international competitiveness of U.S. medical device industry.

"This bill does not in any way improve patient safety," said Steris spokesman Stephen Norton. "It will, however, restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits, and ultimately result in higher health-care costs for all Americans."

Medtronic spokesman Rob Clark wouldn't discuss specifics of Storms' case, but acknowledged that some of the company's Sprint Fidelis pacemaker leads developed tiny fractures that led to an October 2007 recall. He said the company gave affected patients free replacements and paid up to $1,200 in unreimbursed medical expenses associated with any problems.

Although the Supreme Court has upheld the rights of patients to sue pharmaceutical companies for injuries caused by drugs, Clark said medical devices should be handled differently. While people experiencing problems with medications can stop taking them, he noted it's harder to remove a medical device, like a pacemaker wire, that's implanted in a patient's body.

"When you regulate through litigation, which is the recipe the Medical Device Safety Act is aimed at, it places decisions in the hands of a 12-person jury that's only looking at one particular patient, and one particular situation and not evaluating the safety and efficacy and risk benefit of that device for everyone," Clark said.

Storms' lawyer, Rhett Klok, dismisses such arguments, and said it's unfair to burden individuals like Storms with the financial and emotional costs of coping with a faulty device.

"The courts act as a powerful deterrent to insure that medical products put in the stream of commerce in the U.S. are safe and effective for the use they are authorized and marketed to perform," Klok said.

Gerie Voss of the American Association for Justice, a trial lawyers group promoting the bill, says it's unclear when the bill will go through, given Congress' packed schedule.

"We are hopeful we can move on this sooner rather than later so no other patient loses the right to hold manufacturers accountable," Voss said.

Ennis & Ennis, P.A. is representing individuals that have been harmed by defective medical devices such as the Medtronic defibrillator and pacemaker. If you or a loved one have suffered as a result of a defective Medtronic pacemaker or defibrillator or if you need more information about the Medtronic recall or class action lawsuit click here for a free, confidential case evaluation .