A Sweet Tort Claim

[from the CV Spectator of 4/1/2009]

It takes two hands to play bass, guitar or piano – and Diana Levine of Marshfield, Vermont had been playing those instruments, making a living as a musician for more than 30 years, when she came down with a severe migraine in April 2000. She headed for her local health clinic, where a physician assistant gave her two drugs – Demerol for pain and Phenergan for nausea.

Wyeth Pharmaceuticals – one of the world’s biggest drug companies – had been producing Phenergan since the 1950s. The drug is intended for injection into the patient’s veins; that’s why it’s called an IV (intravenous) medication. But if Phenergan gets into one of the patient’s arteries, it can cause irreversible gangrene. The drug carries a label, approved by the federal Food and Drug Administration (FDA), warning of this danger and explaining how to avoid it.

Who, as between Levine and Wyeth, should have borne the risk on that day in 2000 that the physician assistant would not get the message that Wyeth intended to communicate? Levine lost her right hand and forearm to gangrene. Was that her responsibility – or Wyeth’s?

It took nearly nine years – and a lawsuit that progressed through the Vermont court system to the U.S. Supreme Court – for Levine to get her answer. Wyeth is responsible. The pharmaceuticals giant could not hide behind the FDA’s approval of the warning label, ruled Associate Justice John Paul Stevens in last month’s 6-3 Wyeth v. Levine decision.

Think of it as a vindication of democracy. You don’t have to be a cynic to conclude that the FDA – and the Congress which oversees the FDA – tend to be dominated by industry. But jurors are just regular folks who do not depend on connections or campaign contributions for their power. Much of the clamor for “tort reform,” and all of the vilification of “trial lawyers,” reduces to the notion that average citizens, as distinct from politicians and experts, shouldn’t be trusted to decide where justice lies between one big company and one little citizen.

Another angle concerns the legal principle upon which the Supreme Court actually ruled – the Supremacy Clause of the U.S. Constitution. The Constitution makes federal law – including the statute that created the FDA – the “supreme law of the land” that trumps anything inconsistent in Vermont law or the law of any other state. The Levine decision may be a sign that the Court is changing course and becoming less inclined to invalidate state law by invoking federal supremacy. This is of special interest to Vermont, which is pondering whether to order Vermont Yankee to shut down when its federal license expires.

Still another view of the Levine case is the apoplectic one adopted by Justice Samuel Alito in his dissent. Alito blames the physician assistant and the doctor who supervised her. He mentioned both by name – information missing from the majority opinion – and pointed out that each reached an out-of-court settlement with Levine, apologized, and then testified on her behalf in her litigation against the drug company. According to Alito, although this may have been an “ideal medical-malpractice case,” it should not have been allowed to become a “frontal assault on the FDA’s regulatory regime for drug labeling.”

What of future patients? The anesthesiologist in the family – I happen to be married to one – reports that Phenergan is the only effective drug for treating major nausea symptoms. She contends that Phenergan can be administered safely, even using the “push” (as distinct from the “drip”) IV method used on Levine. But if providers grow skittish about administering Phenergan, based on the publicity surrounding the Levine case, then seriously nauseated patients will simply have to suffer – or, perhaps, pay a lot more money for the medication.

Tort cases like Wyeth v. Levine pack emotional power. But they ultimately serve civilization as a system for allocating risk among the various participants in a particular convergence of human beings – in this instance, a patient, her caregivers and the owners of a multinational drug company. Here the system allocated none of the risk to Diana Levine – and her entitlement to full compensation from all of the remaining participants for the permanent loss of her arm has the sweet ring of justice.