Witnesses Want Device Firms Held Accountable

A subcommittee of the House of Representatives’ Energy and Commerce Committee heard testimony Tuesday from witnesses who are in favor of the Medical Device Safety Act, which would provide patients with legal recourse if they are injured by a malfunctioning implanted device and overturn a Supreme Court decision..

A 2008 decision by the Supreme Court, Riegel v. Medtronic, protects device manufacturers from liability if a device that has been granted premarket approval malfunctions.

This ruling is in contrast to the pharmaceutical industry. In March, the high court ruled in Wyeth v. Levine that premarket approval by the U.S. Food and Drug Administration (FDA) of a drug does not shield its maker from lawsuits brought by patients injured by use of the drug.

Dr. William Maisel, chairman of the FDA’s Circulatory Devices Committee, warned at the hearing that devices can still malfunction after approval by the FDA.

“Unanswered questions regarding device safety and effectiveness often remain at the time of FDA approval. It is apparent additional consumer safeguards are needed,” Maisel said.

Stephen, J. Ubl, president and CEO of the Advanced Medical Technology Association, wants patients’ stories to be heard.

“Every day millions of patients’ lives are saved or enhanced thanks to innovative and safe medical technology. Unfortunately, you are not likely to hear these patients’ stories in tomorrow’ hearing,” he said Monday, one day before the hearing.

Patients from across the country came to Washington, D.C., this week to share their stories with lawmakers about how medical technology has helped improve or save their lives.

No representatives from the device industry were on the witness panel.