Imagine that you or your loved one takes prescription medication that you later find out is responsible for the devastating side effects you have been suffering from, and that the manufacturer knew about but failed to disclose not only to you, but to your doctors, and possibly even the FDA during the course of trying to get approval for the drug.
Consider the case of Diane Levine. In April of 2000, Diana Levine went to a clinic for treatment of a severe migraine headache and associated nausea. She was originally treated with intramuscular injections of Demerol (for headache) and Wyeth’s drug, Phenergan (for nausea). Intramuscular injection was the preferred method for administering Phenergan identified in the product’s labeling. Following Levine’s treatment, she developed the symptoms of arterial exposure and gangrene, and was forced to undergo amputation of her forearm. Levine sued Wyeth (the drug manufacturer) in state court in Vermont, pleading state law claims for inadequate warning, and argued that Wyeth should have warned of the contraindicated intravenous injection of Phenergan on the drug’s label, and should have forbid that method of administration. Wyeth argued that the FDA was aware of this issue, but never required such a contraindication warning, and that Wyeth used only the language the FDA had approved. Thus, the issue is not whether the drug manufacturer was aware of this potential risk and complication, but whether it should warn about that risk or simply warn of those matters required to be disclosed by the FDA.
The Supreme Court has in the Wyeth v. Levine case that drug manufacturers are not necessarily entitled to this protection of pre-emption. The Court stated:
State tort suits uncover unknown drug hazards and pro-vide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come for-ward with information.
Wyeth has not persuaded us that failure-to-warn claims like Levine’s obstruct the federal regulation of drug labeling. Congress has repeatedly declined to pre-empt state law, and the FDA’s recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight. Although we recognize that some state-law claims might well frustrate the achievement of congressional objectives, this is not such a case.
We conclude that it is not impossible for Wyeth to comply with its state and federal law obligations and that Levine’s common-law claims do not stand as an obstacle to the accomplishment of Congress’ purposes in the FDCA. Accordingly, the judgment of the Vermont Supreme Court is affirmed.
For years, the FDA took the approach that lawsuits against these drug manufacturers were extremely helpful in discovering and encouraging drug manufacturers to remove dangerous drugs from the market, and that these lawsuits were helpful to the FDA in carrying out its mission in protecting the public. At Montes Herald Law Group, L.L.P., we believe drug manufacturers should be held accountable for the products they design, and distribute and for the warnings that need to be given for their product so that doctors and patients can make informed medical decisions about whether or not to prescribe or to take a drug. Over the past few years, drug manufacturers have been increasingly claiming that if the FDA approves a drug, that the manufacturer of the drug cannot be sued in state courts because of a legal concept known as “pre-emption.” In short, these drug manufacturers claim that federal law exclusively governs their practice, and therefore they should only have to meet minimum federal standards and should not be held accountable under state law for the harm their drugs do to people even if knew about the side effect and failed to warn of those dangers. At Montes Herald Law Group, L.L.P., we believe that the FDA was correct that these lawsuits against these giant drug manufacturers are beneficial not only to compensate individuals for the injuries they have sustained, but that these lawsuits also serve an important role in our society to ensure that manufacturers are held accountable to develop and to distribute safe products.