Supreme Court Decision issued in Levine v. Wyeth Pharmaceuticals

Earlier today the United States Supreme Court issued a 6-3 decision in Levine v. Wyeth. This is fantastic news for consumers, patients, and victims of pharmaceutical misconduct. The text of the opinion can be found here.

The legal issue under scrutiny was whether approval by the Food and Drug Administration (“FDA”) of a drug’s warning label should preempt state court lawsuits.

The plaintiff in the original case in state court in Vermont, Diana Levine, had been prescribed and administered an anti-nausea drug manufactured by Wyeth Pharmaceuticals. As a result of the method of administration of the drug (an “IV Push” rather than an intramuscular injection), she developed gangrene in her arm and it had to be amputated. She sued Wyeth Pharmaceuticals, claiming that the product packaging failed provide adequate warning about the risks of using the IV Push method and the consequences of the drug’s exposure to arterial blood.

Wyeth had countered that because its warning label had been approved by the FDA, state lawsuits should be preempted. Wyeth lost this argument at the state trial court level and again in 2006 in its losing appeal to the Vermont State Supreme Court. Wyeth then appealed to the U.S. Supreme Court.

Justice Stevens wrote the majority decision, and was joined by Justices Kennedy, Souter, Ginsberg, and Breyer. Further - and perhaps surprisingly - Justice Thomas concurred with the majority decision but elected to write his own opinion. Justices Alito, Scalia and Roberts dissented.

Justice Stevens’ Opinion concluded that federal approval provides a regulatory floor below which the company cannot go, not a ceiling above which it may not be forced to go by other jurisdictions. In essence, Justice Stevens said, state court lawsuits such as the one Ms. Levine filed in Vermont are a complement – not a hindrance – to regulatory approvals such as those issued by the FDA.

In light of poor staffing, budget cuts and other severe structural limitations placed on the FDA’s powers (and those of other federal regulatory agencies’ such as the Consumer Product Safety Commission and the National Highway Traffic Safety Administration) over the past 20 years, this is an important and laudable decision. Otherwise, if a pharmaceutical company simply manages to get away with pulling the wool over the FDA’s proverbial eyes (something which Wyeth accomplished when it obtained FDA approval for Vioxx), it would have carte blanche to act with impunity. The FDA simply doesn’t have the power, the staff or the resources to do the job on its own.

Reading today’s decision, I am reminded of Ben Wallace Wells’ excellent article in the January 28, 2009 issue of Rolling Stone. In the piece, he discusses at length Eli Lilly’s marketing of its schizophrenia drug Zyprexa for off-label uses, namely for mild depression, vague anxieties, and even for use on rambunctious children. In doing so, Eli Lilly raked in about $16 billion, but in the process deceived thousands of doctors with partial, misleading and often falsified data. Also, those prescribed Zyprexa endured a host of devastating and largely unnecessary side-effects, such as cardiac arrest in teenagers, rapid and profound weight gain, diabetes and serious compromises to overall cardiovascular health.

This is what happens when pharmaceutical companies driven exclusively by profit run amok unchecked in the marketplace. Fortunately, today’s decision in Levine v. Wyeth affirms that the state tort law system remains at least one way to keep the predatory tactics of big pharma in check.