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Congress Must Pass Medical Device Safety Act, Restore Patient Access to Courts

March 5, 2009

Congress Must Pass Medical Device Safety Act, Restore Patient Access to Courts

Bill Would Allow Patients Hurt by Faulty Medical Devices To Hold Manufacturers Accountable

WASHINGTON, D.C. – Congress should quickly pass legislation introduced today that would restore the rights of patients injured by defective or poorly labeled medical devices to hold manufacturers accountable in court, Public Citizen said today.

The Medical Device Safety Act is sponsored by Sen. Edward Kennedy (D-Mass.) and Reps. Henry Waxman (D-Calif.) and Frank Pallone (D-N.J.). Public Citizen and nine other public interest groups sent letters to Kennedy, Waxman and Pallone urging prompt action on the bills.

The act would overrule the U.S. Supreme Court’s February 2008 decision in Riegel v. Medtronic, which held that the Food and Drug Administration’s (FDA) authority to regulate medical devices severely limits the right of injured patients to sue device manufacturers.

For example, a Minnesota court recently relied on Riegel to dismiss the claims of thousands of patients who were injured or died from a defective implantable defibrillator made by Medtronic. Medtronic reportedly continued to sell the product for nine months after it became aware of the defect. However, the court held that because the FDA approved the product before it went on the market (and before the defect was known), Medtronic cannot be held liable for selling the device, even after it knew that the device was defective.

The Supreme Court reached the opposite conclusion Wednesday in Wyeth v. Levine, holding that state-law suits against drug manufacturers can peacefully co-exist with FDA regulation of drugs.

“The Supreme Court’s decision in Riegel removed a significant incentive for manufacturers to make their products as safe as possible and to remove unsafe or mislabeled products from the market,” said Public Citizen lawyer Allison Zieve, who argued for the Riegels in the Supreme Court case. “By enacting the Medical Device Safety Act, Congress can restore this important layer of consumer protection.”

“Congress should put the safety of consumers above the profits of medical device makers. This law will do that by restoring patients’ access to the courts,” said David Arkush, director of Pubic Citizen’s Congress Watch division. “Litigation creates important incentives for manufacturers to make products that are as safe as possible and to remove hazardous products from the market when undue risks are discovered. For these and other reasons, the continued availability of state-law remedies is essential.”

To read the letter to Waxman and Pallone, go to https://www.citizen.org/our-work/government-reform/articles/house-mdsa-letter.

To read the letter to Kennedy, go to http://www.citizen.org/congress/civjus/preemption/articles.cfm?ID=18436