The U.S. Supreme Court’s ruling in Wyeth v. Levine is likely to increase drug costs, decrease invention of new drugs, and cause a surge in state court drug-related lawsuits.
The ruling may also slow down delivery of medical services to patients while medical personnel catch up on their homework. That would be a good thing.
In a 6-3 ruling in early March, the Court held approval of warning label language by the Food and Drug Administration—in this case for Wyeth’s anti-nausea drug Phenergan—does not preempt state personal injury cases based on alleged inadequate warnings. The case was widely watched because the Court had ruled in February 2008 state law tort cases involving medical devices are preempted by FDA pre-market device approval.
The Bush Administration had pushed the preemption argument in various regulatory settings, and pharmaceutical companies hoped the Court would expand it further in FDA-related cases.
‘Tragic Facts, Bad Law’
That didn’t happen, perhaps because “tragic facts make bad law,” as Justices Alito and Scalia and Chief Justice Roberts noted in their dissenting opinion in Wyeth.
The case is perhaps most valuable in illustrating the problems drug companies face in promulgating warning labels and in being forced by juries to compensate patients for unrelated malpractice by the medical personnel who treat them.
The “tragic facts” began when plaintiff Diana Levine went to a Vermont hospital complaining of migraine headaches and accompanying nausea. She was given pain medication and Phenergan for her nausea. The latter was administered by injection into a muscle (a typical “shot” called IM injection).
She returned to the hospital later that day, complaining the migraine was still causing her hours of “terrible pain,” “retching,” and “vomiting.” She received more pain medication and 50 mg of Phenergan, this time injected by IV push in the crook of her elbow. The Phenergan entered an artery and caused gangrene in her arm, ultimately resulting in amputation of the limb.
Physician Ignorance to Blame
The Phenergan label included six conspicuous warnings to medical personnel to be extremely careful when using IV push to avoid injecting the drug into an artery because gangrene could result. The label also warned the dosage should not exceed 25 mg and should cease if the patient complained of pain during injection.
Levine’s own medical expert testified “it is a principle of ‘basic anatomy'” that arteries and veins are close together in the crook of the elbow, as reflected in every medical student’s bible, Gray’s Anatomy. In embarrassing and dangerous admissions, both Levine’s physician and her physician’s assistant testified they didn’t know this.
Levine got twice the recommended dosage of Phenergan, and the assistant continued the injection even though Levine complained of “one of the most extreme pains I’ve ever felt.”
‘Oblivious’ to Warning Label
As the dissent in Wyeth noted, the physician’s assistant was “oblivious” to the warning label. The assistant testified “it would have been ‘just crazy'” to worry about an intra-arterial injection at that time. Levine’s physician testified he chose IV push over IM injection because it would speed relief of the patient’s pain and nausea.
After several months of pain, Levine’s forearm was amputated due to the gangrene. She sued the hospital and medical personnel for malpractice, and they settled for around $750,000. She also sued Wyeth for inadequate labeling, resulting in a judgment against Wyeth for $6.7 million.
The Vermont Supreme Court affirmed the verdict and Wyeth appealed to the U.S. Supreme Court on preemption grounds, which the Court rejected.
Need for Common Sense
The Wyeth case has three lessons. First, no warning label, no matter how detailed, can protect patients if medical personnel don’t read it. Second, the longer the label, the less likely medical personnel are to read it. Third, drug companies should not be targeted as “deep pockets” to compensate patients for other parties’ medical malpractice.
This last lesson may not amount to constitutional preemption, but it does amount to common sense.
Maureen Martin, J.D. ([email protected]) is senior fellow for legal affairs at The Heartland Institute.