YOU ARE AT:Archived ArticlesHIGH COURT PONDERS LAWSUIT FOR MEDICAL DEVICE MALFUNCTIONING

HIGH COURT PONDERS LAWSUIT FOR MEDICAL DEVICE MALFUNCTIONING

WASHINGTON-The Supreme Court’s consideration of whether manufacturers of medical devices that malfunction can be sued in state court potentially adds a new twist to the wireless interference issue.

Up to now, the issue has been largely framed by consumer advocates in terms of what digital pocket telephone manufacturers and wireless carriers should be doing to correct interference from phones to medical devices, like pacemakers, hearing aids and electric wheelchairs.

The Supreme Court case, depending on the outcome two months from now, could shift some of the focus away from the wireless industry and redirect attention to the design of medical devices operating in an expanding digital world.

Supreme Court Justices heard oral arguments last week in a closely watched case that centers around legal liability for medical devices, overseen by the Food and Drug Administration, that fail to operate properly.

The wireless telecommunications industry, prompted by the threat of regulation and legislation, has been working in recent months with the hearing impaired community to identify and implement short- and long-term solutions to hearing aid interference. Remedies range from phone retrofits as a stop-gap measure to shielding phones and hearing aids on a permanent basis.

Research funded by the industry is being conducted at the University of Oklahoma to curb interference from digital wireless phones to medical devices susceptible to radio frequency disruption.

First generation mobile phones using analog technology, which most of the 35 million cellular subscribers have, do not cause interference. But the operation of analog phones nevertheless has raised concern in the public and the scientific community about potential adverse health effects from radiation radio frequency exposure.

The FCC, poised to tighten RF radiation exposure limits this summer, is caught in the middle of a fight between the Environmental Protection Agency and the wireless industry over what the guidelines should be. There, too, the wireless industry has earmarked millions of dollars for research that, with the exception of a recent epidemiology survey, has yielded limited results at the halfway mark of a five-year funding cycle.

“It (the case) has huge implications,” said Frederick Graefe, a Washington, D.C., lawyer who has lobbied the FCC and Congress to make mobile phones hearing-aid compatible.

Graefe said that if the Supreme Court sides with a woman who sued Minneapolis, Minn.-based Medtronic Inc.-the top pacemaker supplier-after her pacemaker failed several years ago, the firm and others that manufacture medical devices overseen by the FDA could be sued in state court.

What is unclear is whether Medtronic could be subject to legal action if a pacemaker malfunctions due to electromagnetic interference from a wireless phone. Could a consumer argue, for instance, that his or her pacemaker should be designed to block emissions from pocket phones and other products.

Graefe said that if the high court rules against Medtronic, the medical equipment supplier as well as the wireless phone vendor and service provider could potentially all be held liable for damages were a pacemaker to malfunction due to phone interference, though the plaintiff would likely pursue most aggressively the defendant with the deepest pockets. That could turn out to be pocket phone manufacturers.

As such, manufacturers of pacemakers, hearing aids and other medical equipment whose products are susceptible to electromagnetic interference from mobile phones may take a more active role in the wireless interference issue if they believe that operation of increasingly popular digital pocket phones makes their equipment more vulnerable to product liability suits.

Medtronic believes a 1976 law gives the federal government total jurisdiction over pacemakers and other medical devices and that it preempts product liability suits involving such products in state courts.

If the Supreme Court agrees with the company, though, Medtronic and other firms in the same field could be insulated from lawsuits in states.

The case revolves around Lora Lohr, of Jacksonville, Fla., whose pacemaker failed three years after being implanted in 1987, when she was 27.

“The device that was supposed to save me but nearly killed me has made me paranoid,” Lohr told the Associated Press. Lohr has undergone four more heart surgeries since 1990.

ABOUT AUTHOR

Editorial Reports

White Papers

Webinars

Featured Content