Almost two decades ago, a professional guitarist named Diana Levine received an injection of a drug called Phenergan. It was supposed to relieve nausea from a migraine. Instead, it triggered irreversible gangrene.
Levine lost her right forearm and her livelihood. With just one hand, she could no longer play the guitar.
Levine’s lawsuit against the drug’s manufacture, Wyeth v. Levine, triggered a minor panic in the consumer rights community when it reached the Supreme Court a decade ago. The business-friendly Roberts Court seemed likely to absolve Wyeth of liability and leave Levine with nothing.
Instead, the Court broke 6-3 in Levine’s favor, with Justices Anthony Kennedy and Clarence Thomas crossing over to vote with the Court’s liberal bloc.
Ten years later, a similar case involving closely related legal questions is before the Supreme Court in Merck Sharp & Dohme Corp. v. Albrecht, which will be argued on Monday. But the Court itself looks very different. Justices John Paul Stevens, David Souter, and most significantly Kennedy, are all retired — and all of them were in the majority in Levine. Kennedy’s replacement is a hardline conservative likely to join the dissenters from Levine.
That means that the fate of thousands of Americans who face injuries similar to Levine is in jeopardy. And the question of whether the drug companies that injured this individuals will ever be held accountable could rest a man who is ordinarily the Court’s most conservative voice — Justice Thomas.
Both Merck and Levine deal with a doctrine known as “impossibility preemption.” Under Article VI of the Constitution, acts of Congress “shall be the supreme law of the land; and the judges in every state shall be bound thereby, anything in the Constitution or laws of any State to the contrary notwithstanding.” Thus, if it is “impossible for a private party to comply with both state and federal requirements,” the federal law prevails and the state law can be ignored.
Imagine, for example, a federal law that required all shirts to be made entirely out of cotton. If Texas also had a law requiring shirts to be made completely out of polyester, that law would be void, because it is impossible for a shirt to simultaneously be 100% cotton and 100% polyester.
The federal Food and Drug Administration requires drug manufacturers to comply with certain labeling requirements before they are allowed to sell a drug. Often, these labels are very detailed. They frequently offer health providers lengthy instructions on a drug’s risks, and of possible adverse consequences that can result from taking it.
Typically, these labels are drafted by the drug companies themselves, but must be approved by the FDA before the drug can go on the market. If a company discovers new risks arising from one of their drugs, it has an obligation to notify the FDA and potentially to update its label. As the Court explained in Levine, “the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.”
When a company determines that its existing label is inadequate, the FDA offers two different processes that can be used to notify the agency and to update the label. In both cases, however, the FDA has the power to reject proposed changes — possibly due to concerns that an overly alarmist label will discourage too many patients from availing themselves of a beneficial drug.
Meanwhile, state tort law typically requires manufacturers to warn consumers about non-obvious dangers arising from their products. This is a major reason why so many ordinary products come with warning labels. The question in both Levine and Merck is whether it was impossible for the drug companies in those cases to provide adequate warnings to escape liability under state tort law, while also complying with the FDA’s labeling regime.
In Levine, the Supreme Court said it was not impossible to both provide adequate warnings about Phenergan’s potential to cause gangrene, and to comply with the FDA’s requirements. “When the risk of gangrene from IV-push injection of Phenergan became apparent,” Justice Stevens wrote for the Court, “Wyeth had a duty to provide a warning that adequately described that risk, and the CBE regulation permitted it to provide such a warning before receiving the FDA’s approval.”
According to Levine, Wyeth should have updated its label, notified the FDA, and given the FDA the opportunity to reject the new label if it deemed that to be the proper response. “Absent clear evidence that the FDA would not have approved a change to Phenergan’s label,” Levine held, “we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.”
A harder case
While Merck involves many of the same legal questions that arose in Levine, it is a much more marginal case. Indeed, Merck Sharp & Dohme appears to have acted fairly responsibly in this case, notifying the FDA of new evidence suggesting that one of their drugs can cause broken bones, and even requesting that the FDA permit it to change the drug’s label to add additional warnings.
The drug at the heart of Merck is called Fosamax, and it is supposed to help postmenopausal women retain bone density. In some patients, however, Fosamax allegedly increases the risk of “atypical femoral fractures,” a severe break in the upper leg bone. Several hundred patients filed suits against Merck, claiming that Fosamax caused them to suffer such fractures.
As the appeals court explained in Merck, “between 1995 and 2010, scores of case studies, reports, and articles were published documenting possible connections between [drugs like Fosamax] and atypical femoral fractures.” Merck “kept the FDA informed of these and other studies.” And in September of 2008, it submitted an official request to the FDA asking that Fosamax’s label be change to warn health providers of this potential risk.
In May of 2009, the FDA rejected most of Merck’s suggested changes to Fosamax’s label — though there is an important dispute regarding why the FDA rejected these changes. The plaintiffs claim that the FDA merely objected to imprecise language in the proposed new label and “would have approved a proposed warning that specifically discussed the risk of atypical femoral fractures while eliminating the general references to stress fractures.” Merck claims that the FDA simply rejected the idea that a new label was needed outright.
In any event, the FDA reversed this position in 2010, requiring Merck “to add information regarding the risk of atypical femoral fractures to the Warnings and Precautions section of the drug label.”
The dispute over why the FDA initially rejected the proposed new label matters, because it speaks to whether it would have been impossible for Merck to update its label prior to 2010. If the FDA outright rejected the request for a label change, that would constitute the kind of “clear evidence that the FDA would not have approved” a new label which the Supreme Court alluded to in Levine. If the FDA merely wanted Merck to fix some imprecise language, that suggests that it could have fixed its label sooner — and thus provided adequate warning to patients who took Fosamax before 2010.
Since the factual question of what the FDA required of Merck remains unresolved, it is possible — likely even — that after this case goes to a full trial Merck will prevail. There is a very good chance that it was actually impossible for Merck to comply with both federal and state law. And if that is the case, Levine provides that Merck should not be liable.
What’s really at stake
The danger from the Merck case is not that this one drug company may eventually escape liability for the alleged dangers of Fosamax. The danger from Merck is that it offers a much more conservative Court the opportunity to reconsider Levine, or at least to limit Levine‘s holding so that it no longer provides an adequate safeguard for patients.
Given the rather complicated series of FDA hoops that Merck had to jump through, one doesn’t have to be the most pro-business judge on the planet to be sympathetic to their pleas that it is difficult to comply with federal rules and also meet their obligations under state law. But looking at cases like Merck and Levine entirely through the lens of a drug company misses the essential human element.
Diana Levine did nothing wrong. Yet she lost much of her arm, as well as her ability to work.
The question in cases like Merck and Levine is whether someone in her unfortunate position should have to bear this burden alone. Or whether it is fair to ask a company that has profited handsomely off a particular drug to give up some small portion of those profits to ensure that someone injured by that drug should not be left destitute.
As the California Supreme Court explained in a famous and more rudimentary case, in an ideal world, “the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market rather than by the injured persons who are powerless to protect themselves.”
Justice Thomas, for his part, was not moved by these humanitarian arguments. His separate opinion in Levine was rooted largely in states’ rights. State governments, he reasoned, should not have to set aside their own tort law lightly because of a perceived conflict with federal law.
In Merck, we are likely to discover whether that esoteric objection to an aggressive preemption doctrine will be enough to save the Diane Levines of the future.