Hard cases make GOOD law.

The U.S. Supreme Court ruled today that Wyeth is liable to Diana Levine (pdf) for $7 million, the amount (reduced from $7.4 million by the judge) that a Vermont jury had awarded her (and that the Vermont Supreme Court had affirmed) based on the jury’s conclusion that Wyeth had been negligent under Vermont tort law in failing to provide a strong enough warning against intravenous injection of the drug Phenergan. As a result of being injected with Phenergan, an anti-nausea drug manufactured by Wyeth, Levine’s right arm had to be amputated. Wyeth’s warning warning regarding the safety of injecting Phenergan stated:

When administering any irritant drug intravenously, it is usually preferable to inject it through the tubing of an intravenous infusion set that is known to be functioning satisfactorily.

As Justice Stevens observed in his majority opinion, “The evidence presented during the 5-day jury trial showed that the risk of intra-arterial injection . . . can be almost entirely eliminated” by administering the drug by IV rather than by injection. The jury concluded “Wyeth was negligent, that Phenergan was a defective product as a result of inadequate warnings and instructions, and that no intervening cause had brokenthe causal connection between the product defects and the plaintiff’s injury.”

The principal argument Wyeth made is that since the warnings it provided along with the drug were in compliance with the FDA’s requirements, the Court should have concluded that there can be no enforceable state law that requires stricter requirements. The argument would mean that as long as Wyeth had satisfied the FDA it had done everything right, no one could sue Wyeth, not even if, as the jury in Levine’s case concluded, Wyeth had been negligent and that negligence had caused the loss of Levine’s arm. In legalese, this argument is that the Federal regulation of these warnings “preempts” any state regulations on the same subject.

Whether federal law preempts state law turns on whether, in the Court’s opinion, Congress intended the federal law to do so. As Justice Stevens explains, there is good reason to believe Congress intended state tort law to supplement FDA regulation of drug safety, and there is very good reason that should be the case. Over the decades Congress has enacted laws governing the FDA, it has made clear its understanding federal regulation of drugs has needs to be supplemented by state tort law. Nevertheless, Congress has sometimes intended certain FDA regulations to preempt state law — on those occasions Congress expressly so stated in the legislation regarding those regulations. Thus, it is reasonable to conclude that congressional silence on preemption in the legislation at issue in Levine’s case indicates no intent to preempt.

Moreover, it would be foolish to shift exclusive responsibility for all responsibility for drug safety to the FDA. The FDA does not have the resources to make all determinations necessary to maintain drug safety. The drug makers do. Without state tort liability, the drug companies would be absolved of any responsibility for the safety of drug labeling. Thus, Stevens points out that

Wyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet through many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times.

Stevens even points out that the FDA has traditionally been in favor of having state law complement their own regulation of drug safety:

The FDA traditionally regarded state law as a complementary form of drug regulation. The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.

The dissenting opinion, written by Justice Alito on behalf of himself, Chief Justice Roberts, and Justice Scalia, opened with a variation on one of my most hated legal clichés — “Hard cases make bad law.” Alito’s cute variation? “This case illustrates that tragic facts make bad law.”

Why do I hate this sentiment? As I’ve written before, the ultimate point of our justice system is to do justice. The cliché that “hard cases make bad law” expresses the idea that one harms the law if one goes out of one’s way to interpret it in favor of someone you know should, if real justice rather than law applied, prevail. The jury concluded that Wyeth should have given a stronger warning against injection of Phenergan and that it’s failure to do so caused Levine to lose her arm. Those determinations could not have been overturned by the Supreme Court — they are the type of determinations left to the jury who saw the evidence. So, in the absence of explicit Congressional statements that the statute is intended to preempt state law and thus shield Wyeth from any liability, justice would seem to require  Wyeth to be responsible for the harm its negligence caused to Levine.

Since the dissenters concluded the law requires otherwise, they believe, despite their stated sympathy for Levine’s “tragedy,” that the Court’s hands have been tied and, sadly, it must find that Levine is not entitled to sue Wyeth.

Typically, as in this case, such reasoning rejects perfectly reasonable reasons to find that the “tragic victim” should prevail. Thus, it seems, typically when a court hauls out that old “hard cases” line, it is really not acting in the interests of either law or justice, but, rather in the service of a cause that remains largely hidden.

That cause, in this case, is the conservative campaign against state tort lawsuits (in the name of “tort reform”).

Why do we have such safe drugs? Such high standards in the quality of our medical care? Cars enormously safer now than just a couple of decades ago?

Because the people and organizations most responsible for that safety and most capable of maintaining it are held responsible if they don’t provide for that safety. Tort regulation isn’t perfect, but it’s a lot better than governmental regulation alone. (No regulation at all, of course, would lead to drugs we could have no confidence in.)

But Alito, Steven, and Scalia are clearly acting in the service of the interests that would get rid of state tort suits — in this case, the pharmaceutical industry. This case isn’t a result of the majority’s effort to make people happy for Levine; it’s a case that both does justice to her and is consistent with existing law and sound national policy that Stevens has persuasively explained. Alito isn’t sorry that Levine lost her arm. He’s sorry Wyeth can be sued for its negligence.