Pharmaceutical Companies Hiding Behind Federal Preemption

David Mittleman

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Diana Levine, a 62-year old woman who suffered from migraines, took prescription drugs Demerol and Phenergan to cope with associated pain and nausea. While the drugs are both FDA approved when administered in the "right way", Phenergan may cause irreversible gangrene when exposed to arterial blood. Phenergan is typically administered by intramuscular injection or an intravenous drip; however, Ms. Levine’s received a third method of Phenergan injection, an IV push, by a physician’s assistant. Unfortunately for Ms. Levine, the physician’s assistant missed. Consequently, Ms. Levine’s forearm and hand turned purple and black, and both were amputated.

While the FDA did not rule out the risks of an IV push, it did warn against the potential for gangrene amputation as a consequence of an inadvertent intra-arterial injection. Ms. Levine stated that no one discussed the risk of an IV push with her prior to receiving the treatment. She said that only the benefits of having an intravenous administration were explained to her, and thus she was assured that an IV push would result in faster anti-nausea relief. In hindsight, Ms. Levine stated that had she known about the risks associated with an IV push, she would have never consented to the injection. "The benefit-risk is just outrageously ridiculous, [a]ny child could figure this out." Levine said. Faster nausea relief is hardly worth the loss of an arm.

A Vermont jury awarded Ms. Levine six-million dollars for her injuries. The jury found that Wyeth, Phenergan’s drug manufacturer, should have added a more detailed label to the drug outlining the risks. Wyeth argued that putting such a label on the drug while complying with Vermont law, would violate federal law. However, Ms. Levine’s attorneys argued that a tougher label is always permissible within in the confines of federal law. On appeal, the Vermont Supreme Court agreed with the jury finding that federal law "provides a floor, not a ceiling, for state regulation." Essentially, this means that states are permitted to implement more stringent labeling requirements than are required by federal law.

In what is shaping to be the most important business case of the term, the United States Supreme Court is scheduled to hear the case in November. The Supreme Court will address the following issue:

Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration ("FDA") pursuant to FDA's comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.

The Vermont Supreme Court dissenting justice, Chief Justice Paul L. Reiber , who believed the Phenergan label was accurate, wrote that "no drug is without risks. The F.D.A. balances the risks of a drug against its benefits to maximize the availability of beneficial treatment." The majority decision, however, believed that the FDA sets minimal safety floors and states are free to impose more stringent standards as they see fit.

The FDA was created to protect the public from the carelessness and recklessness of drug companies. Unfortunately, millions of lobbyist dollars from these pharmaceutical giants have turned this governmental watchdog into a shield of immunity.