"Patients are best protected by a single, strong, uniform regulatory authority that is the sole arbiter of the benefits and risks of medicines," says Ken Johnson, senior vice president with the industry trade group Pharmaceutical Research and Manufacturers of America.
Critics say FDA protects drug companies
Levine disagrees. She says the FDA is protecting the drug companies from lawsuits, rather than protecting consumers from dangerous drugs. "I had no idea what the risks were," she says of her ordeal with the Wyeth-produced antinausea drug.
Lawyers for Wyeth say Levine's lawsuit is preempted by federal law and federal regulations. They say the antinausea drug, Phenergan, is approved by the FDA and that the agency authorized the content of the company's warning about the possible negative effects of the drug. The warning label said that if the drug was improperly injected it could lead to the onset of gangrene and the necessary amputation of a limb.
"FDA concluded that Phenergan was safe and effective for use under the conditions described in the approved labeling," writes Washington lawyer Seth Waxman in Wyeth's brief to the court. "That labeling included specific cautionary language" related to the intravenous injection of the drug.
Levine's lawyers say the FDA approved a general warning for Phenergan, but did not conduct a detailed assessment of the dangers and benefits of the intravenous injection of Phenergan.
The Vermont jury found that Wyeth had violated state law by failing to adequately warn of the dangers of intravenous injection.