The U.S. Senate held a hearing yesterday regarding the Medical Device Safety Act, introduced in March of 2008 and aimed at clarifying that FDA approval doesn't preempt lawsuits against medical device manufacturers.
But "FDA marketing clearance or approval of a medical device does not guarantee its safety," said William Maisel, MD, director of the Medical Device Safety Institute and a cardiologist at Beth Israel Deaconess Medical Center in Boston.
Dr. Maisel -- who chairs the FDA's Circulatory Advisory Committee -- said the FDA does an "exceptional job" of monitoring the safety of medical devices. However, the post-marketing data is an issue. He said it is "simply impossible" for the FDA to continue to monitor the safety of every medical device it has approved.
Sen. Tom Harkin (D-Iowa), who chaired Tuesday's hearing, agreed.
"No matter how diligently and effectively the FDA does its job, it simply cannot guarantee that no defective, dangerous and deadly medical device will reach consumers," Harkin said.
The device company immunity stems from 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.
Drug companies do not enjoy the same protection. 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.
So patients who are injured by a faulty medical device often have to cover the costs of their resulting medical treatment. The federal government would foot the bill if patient was covered by Medicare or Medicaid, Maisel said.
"Some might argue that we have two cash for clunkers program and this is one of them where the government is paying for defective devices," he said.
But Peter Barton Hutt, a food and drug attorney in Washington, disagreed with Maisel's view and said the FDA is in a better position to decide the safety and efficacy of a device than a jury.
"FDA is not perfect, but certainly a jury is going to be less perfect," he said.
Besides, he said, risk is inherent in all medical devices, and small numbers of patient injuries do not mean a device is defective.
"The fact that it hurts someone doesn't mean there's a defect. It may save 999 lives, but hurt the thousandth life. That doesn't mean it's defective," said Hutt, who served as chief counsel for the FDA from 1971 to 1975.
Allowing individuals to sue device companies at the state level -- which is what identical bills in the House and Senate would do -- would not improve device safety, Hutt said.
But giving injured patients the ability to sue provides a "powerful incentive to manufacturers to use the utmost care," Harkin countered.
Sen. Orrin Hatch (R-Utah) argued that exposing device makers to litigation would make the companies, particularly the small companies, afraid to produce new, innovative products.
The witness panel was lacking a representative from the device industry. However, a race car driver from Missouri told the committee how a spinal implant gave him a new lease on life, and urged the committee not to do anything that would stifle such innovation.
In a release, a spokesperson for Advanced Medical Technology Association (AdvaMed) said the bill would not improve patient safety.