Representative Henry A. Waxman 30th District of California

Waxman and Pallone Praise Supreme Court Decision Preserving Ability of Injured Patients to Seek Compensation

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Washington, Mar 4, 2009 - U.S. Reps. Henry A. Waxman (D-CA), Chairman of the House Energy and Commerce Committee, and Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, praised the Supreme Court's decision today which preserved the right of patients injured by FDA-approved drugs to seek compensation through lawsuits against drug makers.

The Supreme Court affirmed that, in granting the U.S. Food and Drug Administration (FDA) the authority to regulate drugs, Congress never intended to prevent injured patients from seeking compensation for those injuries in state court. The Court also recognized the critical role that state lawsuits play in uncovering unknown drug hazards and incentivizing manufacturers to disclose safety risks promptly. Finally, the Court emphasized the fundamental premise that the manufacturer—not the FDA—bears ultimate responsibility for the safety of their drug. As the Court notes, the basis for this structure is that the FDA has limited resources with which to monitor drugs once they are on the market and the manufacturers will always have superior access to information about their drugs, especially after they are on the market.

“I am pleased that the Supreme Court has recognized the important right of patients to seek redress in court if harmed by a drug – this is a critical check that helps ensure the safety of pharmaceuticals," said Chairman Waxman. “I hope that the Congress will now move to level the playing field and act swiftly to enact legislation to reverse the Court’s earlier decision regarding medical devices and restore the ability of patients injured by medical devices to have their day in court."

"Today's Supreme Court decision is a giant victory for patients," Chairman Pallone said. "Drug companies must be responsible for the safety of their products, and this decision is likely to make pharmaceuticals safer for all Americans. The decision also highlights the need for Congress to pass legislation giving patients harmed by medical devices the same legal recourse now affirmed for pharmaceuticals. There should not be any distinction between the legal treatment of pharmaceuticals and medical devices, and without action by Congress this unfortunate distinction will continue to exist."

In reference to the Court's February 2008 medical device decision, the two lawmakers plan to introduce legislation that would reverse Riegel v. Medtronic, Inc. in the coming weeks.