Monday, March 9, 2009


In Greek mythology, both Odysseus and Jason had to navigate the perilous waters between two the horrible sea monsters Scylla and Charybdis.

Pharmaceutical manufacturers in America now face a similarly hazardous path - between succumbing to crippling tort lawsuits and adopting drug contraindications injurious to public health - after the Supreme Court ruled in Wyeth v. Levine that state juries can, in essence, override the Food and Drug Administration‘s considered safety judgments.

A Congress in the grip of trial lawyers is unlikely to act, so the Levine decision is likely to have an adverse effect on drug innovation. There is a way out that would both protect innovation and offer real victims a remedy, were Congress to pre-empt drug lawsuits broadly but establish an alternative compensation program for parties injured by unknown drug side effects.

The facts in Levine are tragic. In 2000, professional guitarist Diana Levine had to have her arm amputated below the elbow after developing gangrene, caused by an arterial injection of Wyeth´s anti-nausea drug Phenergan. The injection into Mrs. Levine’s artery was inadvertent: A physician´s assistant at a Vermont clinic had attempted to administer the product into Mrs. Levine’s vein.

The risk of the injury Mrs. Levine suffered was neither new nor unknown: Phenergan’s label detailed the risk of intravenous (”IV-push”) injection in four specific FDA-mandated warnings that were collaboratively developed over a 30-year period. The label clearly explained that “inadvertent intra-arterial injection” could lead to “resultant gangrene requiring amputation.” Twice more, in bold, upper-case letters, the label emphasized: INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY.

Failing to take proper account of such warnings, Mrs. Levine’s physician’s assistant administered the drug via IV-push at twice the maximum dosage specified on the label, even after the patient complained of severe pain. In addition to Wyeth, Mrs. Levine sued the physician’s assistant, her doctor and the clinic for malpractice; after the case settled, the physician’s assistant wrote Mrs. Levine a letter admitting “responsibility” for the tragedy.

Rather than wrestle with the label’s specificity and the decades-long history over which the Food and Drug Administration and Wyeth developed the warnings at issue, the Supreme Court’s majority opinion simply made up facts of its own. Implausibly, the court asserted that “the labeling did not contain a specific warning about the risks of IV-push administration.”

The court also relied heavily on the notion that Congress did not “intend” to pre-empt state tort claims in the Food, Drug, and Cosmetic Act. Looking to Congress’ intent misses the point, however, since the 1938 law and its 1962 amendments predated the revolution in product liability law that made “failure to warn” suits like Mrs. Levine’s possible in the first place, a change ushered in by the California Supreme Court´s landmark 1963 decision, Greenman v. Yuba Power Products. Congress simply did not and could not have known what was coming in state courts when it developed the FDA’s regime of drug regulation.

Though the FDA’s reasons for permitting Phenergan injection by IV-push are not publicly known, one can surmise it may be because the effective onset time for IV-push administration is 3 to 5 minutes, versus 20 minutes for the normally preferred IM-push method; in some circumstances, that time difference could literally be a matter of life and death. Notwithstanding the FDA’s judgment, Mrs. Levine´s attorney argued to the jury that the Phenergan label “should not have allowed IV push” under any circumstances - and thus asked the jury to reach a judgment in direct conflict with the FDA’s.

The outcome in Levine imperils the public health by promoting more litigation, higher prices, and reduced innovation. Juries only consider the case before them, rather than weighing social costs and benefits of drugs and their side effects (the precise calculus the FDA is asked to undertake).

Moreover, lay juries are simply unable to make complicated scientific judgments, which is why the morning-sickness drug Bendectin was driven from the market by bogus lawsuits, though it is safely available overseas.

The threat of such spurious litigation discourages new drug development, which why there is still not a single morning-sickness drug on the U.S. market. And litigation also drives up health-care prices: in the 1980s, prices for the diphtheria-pertussis-tetanus vaccine rose fortyfold - versus a “mere” doubling of vaccine prices overall - when a wave of lawsuits over the vaccine’s side effects pummeled the vaccine’s manufacturers.

Congress’ reaction to the vaccine crisis offers a roadmap for the proper legislative response to the Supreme Court’s confused pre-emption jurisprudence concerning pharmaceuticals. In 1986, Congress passed the National Childhood Vaccine Injury Act, which pre-empted vaccine lawsuits and established a federal administrative compensation program to process claims from children injured by vaccine side effects.

Congress’ program, while hardly perfect, has won plaudits for quickly meting out justice, with administrative costs only a fraction of those in the tort system, where the majority of payments go to lawyers. Furthermore, whereas juries often buy into dubious scientific claims, the congressional program has tended to reach the right answers. Just last month, the special master in charge of the vaccine program jettisoned the thousands of junk-science claims filed by plaintiffs’ lawyers that had asserted a link between the vaccine preservative thimerosal and autism.

The existing vaccine system would have to be adjusted if applied to all drugs, as we spell out in a forthcoming white paper, but it could serve as a valuable template. We harbor no illusions that the current Congress will work to enact a program along the lines we prescribe, but it is the better choice. For now, manufacturers, consumers, and the broader public health will merely have to suffer.

Jim Copland, director of the Center for Legal Policy and Paul Howard, director of the Center for Medical Progress at the Manhattan Institute for Policy Research, have a forthcoming paper, “The Case for FDA Pre-emption and Administrative Compensation.&#8221.

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