Supreme Court prepares to hear pre-emption case that could give pharmaceutical companies protection against liability

The case of a Vermont women who won a $6 million award from Wyeth for failure to adequately warn her of the risk of one of its products is the "latest in a brisk parade of similar ones" in which the U.S. Supreme Court will examine the principle of pre-emption, which states that FDA approval of drugs or medical devices pre-empts the ability for individuals to sue manufacturers for liability in state courts, the New York Times reports.

Catherine Sharkey, a professor at New York University School of Law, said, "Federal pre-emption is the fiercest battle in products liability law today." She added, "The court clearly recognizes this, as it has agreed to hear so many cases and seems eager to give clarity to what has been, to date, an indisputably muddled area of law." The Times reports that business groups and the Bush administration have "vigorously pursued pre-emption arguments, hoping to build a barrier against many kinds of injury suits." However, plaintiff lawyers say broad pre-emption doctrines "short circuit valid claims arising from terrible injuries," according to the Times.

An eight-justice majority of the U.S. Supreme Court in February ruled, in Riegel v. Medtronic, that many suits regarding injuries caused by medical devices are pre-empted by a 1976 federal law. The Vermont case, which will be heard starting in November, centers on Diana Levine, who had her arm amputated after being treated with Wyeth's nausea drug Phenergan. Levine was administered the treatment via a method known as "IV push," during which the nurse mistakenly injected the drug into an artery, rather than a vein. The drug's label warns that "inadvertent intra-arterial injection" can result in "gangrene requiring amputation," but did not mention IV push. Levine said that no one discussed with her the risks of this method and that the drug's label should include a more comprehensive warning. Wyeth claims it could not change the label to indicate this risk without violating federal law.

According to the Times, the "crux of the issue" is whether FDA and federal regulators' standards represent a minimum to which states are permitted to add or if FDA and federal officials decide on the "optimal balance between risks and benefits" to which states must adhere. Sharkey said the Riegel case "boiled down to a statutory interpretation," adding, "Levine challenges the court to define the parameters of pre-emption outside the safe confines of the legislators' text."

In Levine's case, the Vermont Supreme Court rejected the argument of Wyeth and FDA that the company could not simultaneously comply with both federal law, to use agency-approved labeling, and the verdict of a jury in a lower court, which punished Wyeth for not using a different label. The agency and Wyeth argued that this amounts to "implied pre-emption." The majority opinion stated that federal law "provides a floor, not a ceiling, for state regulation." In a dissenting opinion, Vermont Chief Justice Paul Reiber wrote, "FDA balances the risks of a drug against its benefits to maximize the availability of beneficial treatments," adding, "A jury does not engage in a measured and multifaceted policy analysis. Rather, a jury views the safety of the drug through the lens of a single patient who has already been catastrophically injured" (Liptak, New York Times, 9/19).

Waxman Letter

House Oversight and Government Reform Committee Chair Henry Waxman (D-Calif.) on Wednesday sent a letter to FDA asking that the agency explain its priorities and alleges that it has attempted to restructure rules in favor of the drug and medical device industries. He wrote, "At a time in which FDA's own Science Board warns that 'American lives are at risk' due to chronic underfunding of the agency, I am deeply concerned that ... industry priorities are being promoted at the expense of the agency's core public health mission."

In the letter, Waxman focuses on the issue of pre-emption, as well as the potential loosening of rules concerning the way drugmakers use articles from medical journals to promote off-label use of their products. An FDA spokesperson said agency officials have not seen the letter (Mundy, "Health Blog," Wall Street Journal, 9/17).