Juries vs. FDA on drug safety
WITH ORAL arguments due to be heard Monday in the Supreme Court case of Wyeth v. Levine, several members of Congress and patient advocates are raising false alarms that a decision favoring Wyeth will amount to blanket immunity for drug makers from liability for injuries caused by their products. But this distorts what the Wyeth case is about and the implications of the court's decision.
Wyeth does not involve the questions of whether a drug made somebody sick, or whether a company withheld safety information from the public. Instead, at issue is whether a company should have changed a drug label previously approved by the FDA to protect patients from certain known medical risks. These are different questions, and this distinction has important consequences for the availability of safe and effective drugs.
The facts of this case are tragic. Suffering from a severe migraine headache and related nausea, plaintiff Diane Levine went to a community health clinic for treatment. During her first visit, Levine received a deep intramuscular injection of Wyeth's drug, Phenergan. Phenergan is an injected drug that treats nausea, and the FDA has approved its use through either deep intramuscular injection or via intravenous push. Phenergan's labeling clearly states that IV administration produces clinical effects four times faster than intramuscular injection, but comes with additional risks.
Levine returned to the clinic later that day complaining that her first Phenergan treatment did not provide relief. A physician's assistant administered a second dose of Phenergan using an IV push. The physician's assistant mistakenly injected the drug into an artery, rather than a vein. Levine later developed gangrene, which required amputation of her right arm.
Phenergan had been under FDA oversight for 45 years at the time Levine received it. The FDA knew the risks associated with Phenergan mixing with arterial blood, but chose to permit IV injection because of clinical evidence that it delivers faster and stronger relief than intramuscular injection. The FDA, not Wyeth, controls Phenergan's labeling, and the FDA-authorized label clearly warns of the risk of gangrene and provides detailed instructions on how to minimize arterial blood mixing.
After settling a malpractice suit against the physician's assistant and the clinic, Levine sued Wyeth alleging that the company should have provided an instruction on its label stating, "Do not use this drug intravenously." A jury in Vermont agreed and awarded damages of $7.4 million, thus disregarding the FDA's regulatory judgment and ignoring that Wyeth could sell Phenergan only with the precise FDA-approved label allowing IV injection.
But the Wyeth case raises larger issues. In creating the FDA, Congress established a robust system for determining the safety and efficacy of new drugs. To market a new drug, pharmaceutical companies must submit to the FDA results of clinical studies and other extensive documentation. FDA scientists then spend thousands of hours assessing the data involving hundreds of patients before potentially granting a company the right to market the new drug and determining its proper labeling.
Should the Wyeth verdict stand, a jury of six or 12 laypeople with no medical experience would have substituted its judgment about the appropriate labeling of a drug - based upon evidence presented to it in a single case - over the judgment of medical professionals assessing information involving hundreds of patients culled from multi-year clinical trials. An isolated jury is likely to focus on costs to the individual patient to the exclusion of broader societal benefits like the public health. This simply defies all logic.
This case boils down to the question of who should be empowered to make difficult judgments about the safety, effectiveness, and warnings on proper use of a drug. Do we want to legitimate an alternative regulatory system, situated in the courts and operating outside the FDA? If so, companies could face verdicts dictating a different label in each of the 50 states - hardly a formula for bringing safe and effective devices to a national market.
No regulatory system is foolproof. Certainly one can point to cases and studies that have cast doubt on the FDA's ability to ensure the safety, efficacy, and proper labeling of drugs. But the proper remedy for this situation is to strengthen the FDA, not to ask lay citizens to replace the expert judgment of medical professionals.
David Ferrera is a partner with the law firm of Nutter McClennen & Fish LLP, specializing in drug and medical device litigation. 