Supreme Court Preserves Ability of Injured Patients to Seek Compensation
The Supreme Court on Wednesday enhanced the ability of people to hold drug companies financially responsible for injuries. In a 6-3 decision, the court ruled that federal law does not block a lawsuit in state court by a woman who lost an arm to gangrene after receiving an injection of an anti-nausea drug.The ruling, a rejection of the Bush administration's position, affirms a Vermont jury's $6.7 million award to Diana Levine, a former guitarist, who sued drugmaker Wyeth for the loss of her arm after she had gone to a local health clinic in April 2000 for treatment of a migraine. A physician's assistant injected Wyeth's anti-nausea drug Phenergan into an artery, rather than a vein, and caused immediate gangrene.
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, praise the Supreme Court decision preserving ability of injured patients to seek compensation:
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.