WASHINGTON, May 12 — A cardiologist who chairs an FDA advisory panel joined a lineup of witnesses asking Congress to eliminate manufacturers’ blanket immunity from lawsuits over faulty medical devices that were preapproved by the FDA.

“Unanswered questions regarding device safety and effectiveness often remain at the time of FDA approval,” William Maisel, M.D., chairman of the agency’s Circulatory Devices Committee, testified on Tuesday.

Dr. Maisel, of Beth Israel Deaconess Medical Center in Boston, said FDA approval doesn’t mean a device won’t malfunction.

Noting that 10 million patients have these implanted devices, he said, “It is apparent additional consumer safeguards are needed.”

He testified before a House Energy and Commerce Subcommittee in favor of the Medical Devices Safety Act of 2009, which would provide patients with legal recourse if they are injured by a malfunctioning implanted device.

Under an odd twist of U.S. law, drug companies are liable for damages if their products cause harm, but many device makers are not.

In fact, if a medical device received premarket approval from the FDA, the manufacturer is protected from liability, thanks to a 2008 Supreme Court interpretation of a 30-year-old law making the FDA the final arbiter of device safety.

In that 8-1 decision (Reigel v. Medtronic), the Supreme Court ruled that if a device received premarket approval from the FDA, individuals injured by the device may not sue the manufacturer for damages.

As a result, lower courts threw out 1,400 lawsuits against device makers, according to Rep. Henry A. Waxman (D-Calif.), chairman of the full House Energy and Commerce committee.

“It is time for Congress to act properly to correct this clear judicial overreach,” added Rep. John D. Dingell (D-Mich.).

Drug companies do not enjoy the same immunity. In March, the Supreme Court ruled 6-3 in Wyeth v. Levine that FDA approval of a drug does not shield its maker from lawsuits brought by patients injured by use of the drug.

(See Supreme Court Tells Drugmakers ‘Label Is No Shield’)

The bill heard Tuesday, sponsored by Rep. Frank Pallone (D-N.J.), would put the two industries on a level liability playing field.

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

But Republicans on the committee and a representative from the Advanced Medical Technology Association (AdvaMed) said device companies do not have true “blanket immunity” from legal action.

They are still subject to criminal penalties in certain cases, Brett Loper, director of government affairs for AdvaMed, told MedPage Today after the hearing.

Rep. Nathan Deal (R-Ga.) argued that the majority of state claims are still allowed because the current law shields only device companies that received premarket approval. They account for just 2% of all devices on the market, he said.

Most devices are approved through a process known as 510(k), which grants approval if a device is “substantially similar” to one already on the market. Their manufacturers are not shielded from liability even if they are identical to products that are.

Although devices that are shielded from lawsuits represent only a small proportion of the total market, their 10 million owners deserve legal protection in the event a “manufacturer fails to produce a product that is as reliable as it should be,” said Dr. Maisel.

Democrats on the panel said legislation is necessary because without a risk of liability, makers of the highest-risk devices — the class III devices which require premarket approval — have no incentive to report device malfunctions to the FDA.

But Republicans on the panel said the bill would stifle innovation because device companies would operate in fear of lawsuits.

“No company would ever create a device if one error meant total ruin for the company,” said Rep. Michael Burgess, M.D. (R-Tex.), an obstetrician-gynecologist.

Related Article(s):

• Supreme Court Tells Drugmakers ‘Label Is No Shield’

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