It's rare that a doctor feels moved to disagree with the executive editor, managing editor, and editor-in-chief of the
New England Journal of Medicine, not to mention the editorial board of the
Gray Lady, the
New York Times. For that matter, it's not often that I'm inclined to side with Big Pharma, the Bush Administration, and (probably) Judge
Antonin Scalia. But the stakes are high in a case now before the U. S. Supreme Court, and to my mind the bad guys have it right, and the good guys have it wrong. What's at issue, indirectly, is the funding of health care reform.
The human story behind the lawsuit is heart-rending. Suffering from migraine, Diana Levine, a musician, went to a clinic in Vermont for treatment. She was given the painkiller Demerol along with an intramuscular injection of Phenergan, an anti-nausea drug. When the headache persisted, she returned and was administered Phenergan by intravenous "push." A physician's assistant inadvertently injected an artery, rather than a vein. Ms. Levine suffered gangrene and, in time, an amputation of her hand and lower arm. She sued the sued the PA, supervising doctor, and clinic, winning an out-of-court settlement. Then Ms. Levine went after Wyeth, Phenergan's manufacturer, and won, to the tune of $6.7 million, a verdict upheld by the Vermont Supreme Court and now being considered on appeal.
Ms. Levine has asserted that Wyeth failed to warn doctors, via the standard informational literature, of the dangers of an IV push, in comparison to a safer infusion of Phenergan by a dilute IV drip. Wyeth's defense is that it had negotiated its warnings with the Food and Drug Administration in a manner that satisfies Federal law. That process, Wyeth argues, should pre-empt state law. Their case is summed up by a comment Justice Scalia made during the verbal arguments: "If you're telling me the F.D.A. acted irresponsibly, then sue the F.D.A."
The Times and the Journal want Wyeth's appeal to fail.
Preemption is a major topic in business law. The question is whether a corporation can work out a safety standard with the Federal government and so avoid liability down the road. Preemption was at issue in Silkwood v. Kerr-McGee Corporation, the 1984 case (involving workplace exposure to radiation in a Federally licensed nuclear facility) featured in a Hollywood movie. In Silkwood, the Court overrode preemption. But this year, preemption prevailed in Riegel v. Medtronic. There, the Court ruled that a medical device manufacturer was shielded from lawsuits by an explicit provision in Federal law governing the FDA.
Wyeth v. Levine turns on technical issues. For drugs, preemption is not spelled out in legislation; the manufacturer says it is implicit. Experts are predicting that the case will be decided on narrow grounds. But the Times and Journal (published by the Massachusetts Medical Society) are arguing broad principles, saying that preemption harms citizens' rights to seek legal redress for injury. This line of appeal strikes me as wrong-headed, especially for an organization representing doctors. The Journal wants Congress to pass legislation preventing preemption.
But isn't preemption the basis of rational health care? Government experts sit down with providers of - whatever, devices, medication, professional services - and decide what level of precaution is in the public interest. That way, policy is not set on the basis of emotional pleas in courtrooms or fears of the result of that process. Policy is set on the basis of utility, the greatest good for the greatest number.
One of the premises of the Obama health care plan is that the country can save money by rationalizing the delivery of services. For instance, in many hospitals, when doctors order, say, an MRI, they must make a request via a computer protocol that walks them through standard indications for the scan. If the circumstance does not meet criteria, doctors need to justify an override. The Obama team wants most medical treatment to take place in group settings where this sort of waste-fighting technology would play a role.
Of course, a competing consideration for doctors is malpractice liability. No one knows how much "defensive medicine" costs the country, but the losses may well run into the billions of dollars. Certainly, on a colloquial basis, doctors confess to "treating the chart" rather than the patient, and ordering tests to preclude lawsuits even when the odds of discovering relevant information are long. Excess testing can then lead to excess care, especially if doctors feel compelled to respond to lab values rather than clinical judgment.
One resolution to this tug-of-war is preemption - stipulating, for example, that if a doctor follows a public health algorithm that deems a test unnecessary, then a patient cannot sue for consequences of that omission. Citizens would, quite sensibly, give up individual rights to sue in exchange for less unnecessary care and more universal coverage, through cost savings attributable to the controls on testing. The operating value here is public health. The change might be accompanied by no-fault insurance for bad medical outcomes (in effect, the FDA and similar agencies would back their decisions with cash) and by funding for re-education and supervision of doctors who would otherwise have been sued. At the core of any such system is preemption. However much we might enjoy the idea of punishing physicians (and drug companies) in the course of compensating injured patients, we might conclude that the arrangement is too expensive in terms of the public good.
That's my interest in preemption. It stands on the side of rational decision-making. The arena where preemption would be easiest is informed consent. Experts and citizens would agree on what patients need to know. In non-emergency situations, and with patients who are of normal intelligence and not demented, on-line videos about the risks of surgery, medication, psychotherapy, or other interventions would convey the necessary facts. The relevant videos might be accessed via forking paths, with different information called up for patients with different risk factors - and periodic updating of warnings. I don't mean that good doctors might not do more. But whatever goes on in each consulting room, a preemption system would remove a non-medical expense, anxiety over liability, from the health care budget.
I have no brief for Wyeth, no opinion finally about whether Ms. Levine or the drug company should prevail in the case at hand. For me, as for jury members, Ms. Levine is the more appealing litigant; I would like to see her lead as good a life as she would have led without her injury. What does exercise me is the notion that doctors and opinion leaders should oppose preemption. In the long run, the opposite of preemption is chaos.
Conflict of interest notation: Seth Waxman, a Solicitor General in the Clinton Administration, is an old friend. Seth argued the appeal for Wyeth; he and I have not discussed the case.
