Speaking at a House Energy and Commerce Health Subcommittee hearing, Rep. Bruce Braley (D-Iowa) said a Supreme Court decision preventing injured patients from suing devicemakers over Food and Drug Administration-approved products is flawed because it results in shifting the cost of caring for injured patients away from companies responsible for the damage and onto taxpayers shoulders.
Braley was among House lawmakers who listened to testimony from experts and patients and argued the merits of the Medical Device Safety Act of 2009. Sponsored by Rep. Frank Pallone Jr. (D-N.J.), the bill would negate the Supreme Courts decision in last years Riegel vs. Medtronic case, which involved a Medtronic-manufactured balloon catheter that ruptured inside the patient during coronary artery surgery.
Arguing against the bill, Rep. Steve Buyer (R-Ind.) said allowing patients to sue devicemakers in state courts could ultimately limit product innovation and force manufacturers to refuse to market their product in states that support patients rights to sue devicemakers with FDA-approved products.
But New England Journal of Medicine Executive Editor Gregory Curfman said such arguments are unsound. Innovation and patient safety are not mutually exclusive. We can and must have both, he said.
The bill is currently being reviewed by Health Subcommittee members. An Energy and Commerce representative was not available at deadline to discuss subsequent steps for the legislation.
See today's Beyond the Headlines for more on medical-device reform legislation.