Health Subcommittee considers bill to eliminate pre-emption for medical devices

May 14 2009

The House Energy and Commerce Health Subcommittee on Tuesday heard testimony on the Medical Device Safety Act of 2009 (HR 1346), which would allow consumers to sue medical device manufacturers in state courts, CQ HealthBeat reports.

The bill responds to last year's Supreme Court ruling that says medical devices with FDA pre-marketing approval can be pre-empted from lawsuits under state law, in accordance with the Medical Device Amendments of 1976.

Rep. Frank Pallone (D-N.Y.), who introduced the bill, said that the 2008 Supreme Court ruling "ignor[ed] congressional intent" by providing blanket immunity for medical device makers. According to Rep. John Dingell (D-Mich.), a co-sponsor of the bill, the original 1976 law sought to grant regulatory authority to FDA for medical devices, but it did not aim to eliminate state liability. Committee Chair Rep. Henry Waxman (D-Calif.), another co-sponsor, said last year's ruling already has caused 1,400 injury cases to be thrown out of court, adding that the threat of litigation provides manufacturers with additional safety incentives. David Vladeck -- a law professor at Georgetown University Law Center who testified at the hearing -- added that immunity from lawsuits "removes incentive to manufacturers to fix devices quickly and get defective devices off the market."

Rep. Nathan Deal (R-Ga.) said the class of device that must obtain pre-marketing approval -- which includes pacemakers and replacement heart valves -- represents only 2% of all approved medical devices each year. Rep. Michael Burgess (R-Texas) added that the measure could create an inconsistent system that allows both FDA experts and jurors in various states to make decisions on medical device safety standards. In addition, Rep. Joe Pitts (R-Pa.) cautioned that the bill might encourage manufacturers to limit distribution of their devices to certain states (Kim, CQ HealthBeat, 5/13).

Related Editorial

The Medical Device Safety Act would allow consumers to "reap financial awards" from medical device safety lawsuits, even though FDA "approved the labeling used on the devices," a Washington Times editorial states. It continues that although the bill's supporters "cite horror stories about injured patients," opponents contend that "manufacturers should not be held hostage to inexpert juries in 50 different states under 50 different state laws when the experts at the FDA already have told them what the labels must say."

The editorial states that the proposed legislation would "kill innovation" because manufacturers would be "far less likely" to market a medical device if they "know they will be subject not just to regulation by the FDA but to uncertain justice under 50 different state standards." The editorial concludes, "The Medical Device Safety Act favors litigious trial lawyers over sick patients. Its passage would amount to serious legislative malpractice" (Washington Times, 5/14).

Broadcast Coverage

NPR's "Morning Edition" on Wednesday reported on issues related to medical device safety and lawsuits against manufacturers (Silberner, "Morning Edition," NPR, 5/13).