The Role of Lawsuits in Regulating the Drug Industry

Vioxx, Fen-Phen, Bextra are just some of the drugs that have been recalled or withdrawn in recent years. Each year, drug companies introduce many new prescription medications to the market. These prescription medications may have adverse effects in the patients who take them.

Patients have long been able to file product liability lawsuits against drug manufacturers to recover money damages for the injuries suffered as a result of defective or improperly labeled medication.

The drug industry is a multi-billion dollar business, one regulated by the United States Food and Drug Administration (FDA). The FDA does not have the capability or the resources to monitor or police each aspect of this enormous enterprise.

In its upcoming term, the U.S. Supreme Court will hear and decide Wyeth v. Levine, the case of a woman from Vermont suing the drug manufacturer known as Wyeth. Ms. Levine lost her right arm to a Phenergan injection, a Wyeth product. She was never notified or warned that such an adverse risk was involved with the use of the drug. What is particularly concerning is that the drug company is denying any responsibility, and is claiming, instead, immunity, that is, complete protection from suit. Wyeth argues that the FDA was aware of the risks of its medication, and had final approval of Phenergan's warnings. Wyeth is claiming that, by virtue of FDA (federal) approval for the drug and its accompanying warnings and instructions, it enjoys total immunity from any claim a patient might make under state law.

There are many who believe that such claims, based upon state law, are an adjunct to federal laws. These product liability lawsuits , like federal regulations, protect the consuming public from unsafe products. There is only so much an agency such as the FDA can do in protecting us. Holding drug companies responsible in damage suits complements federal regulatory efforts.