As many readers know, the Supreme Court is considering the case of a Vermont musician, Diana Levine, who lost an arm when a physician assistant didn’t fully consider the label on a Wyeth anti-nausea drug. The legal debate is stark: can the FDA’s approval take precedence, or “preempt,” state courts hearing liability cases?
Earlier this year, we spoke with an attorney, Tom Lamb. His view is that given an FDA that is not functioning at its best, state courts can provide important insights into medications. Such insights, he feels, supplement the secret conversations between FDA and industry and augment physician understanding. Lamb’s view is the one prevailing in Congress.
Industry, needless to say, feels otherwise. It wants a single system to regulate drugs, not one in each of the 50 states.
According to the Wall Street Journal and other publications, the FDA is divided on the preemption issue. High level FDA officials like preemption and prefer having one coherent system for drug regulation. Theirs. But lower-level staffers at the agency recognize the occasional contribution of state drug lawsuits in illuminating the limits of FDA oversight. Just to keep things spicy next year, the memos of lower-level officials have been leaked to the media.
The Supreme Court transcript provides a glimpse of the thinking on both sides. Most observers of the court expect it to rule in favor of FDA preemption for state lawsuits. Why? Because the court recently did just that with regard to medical device litigation. Our reading of the transcript is not a legally sophisticated one. But it suggests unexpected high court frustration with the present system.
Seth Waxman, the lawyer for Wyeth, was able to utter a single paragraph before the grilling from the justices began. The topic: could one label comply with state and federal law? Said Justice Anthony Kennedy: “I think I could design a label that’s completely consistent and that meets the requirements that the Respondents wish to urge.”
Really? We wonder about Justice Kennedy’s label-making prowess. What if the FDA and courts in Hawaii and Alabama disagreed? Do we want people in Wyoming figuring out if antidepressants are safe and effective? There are mind-boggling practical complications of designing labels that reconcile state and federal law. These were pointed out to the court, and eventually appeared to sink in.
Justice Ruth Bader Ginsburg did not say much. But she was clearly hoping for a better system. She sounded incredulous at the prospect of the FDA being on top of its responsibilities: “There are 11,000 drugs that have this approval. Is the FDA really monitoring every one of those to see if there is some new information that should change the label?”
At that point, the Bush administration’s representative chimed in. Attorney Edwin Kneedler noted that the FDA, under the 2007 FDAAA legislation, has required 21 additional clinical trials; four label changes; and hired 430 people to address drugs in the post-marketing arena. Translation: we’re on top of this.
But those numbers did not impress the court. The justices were puzzled about why the Wyeth label had not been updated to reflect the risk of a particular type of administration of the Wyeth drug, a method called “IV push.” The hearing suggested a divergence of opinion on whether (and when) the FDA had seen Wyeth data on “IV push.”
Said Justice Stephen Breyer: “Why isn’t the fact that some certain number of people are getting gangrene, why isn’t that new information?” Gangrene is a tough public relations issue, we have to say.
Even Justice Antonin Scalia sounded impatient about the status quo. He asked: “What you mean is whether or not new drug risks become apparent, they have to change [the label], right?” The rejoinder from David Frederick, a lawyer for the Vermont plaintiff: “The question is what did the manufacturer know and when did this manufacturer know it.” Which (for younger readers) is a reference to Richard Nixon’s staff and the Watergate scandal of the 1970s.
Frederick maintains it’s clear that Pfizer stopped using the IV push administration for a similar drug several decades ago. If true, it’s an explosive fact. Crucially, however, it may not be relevant to a completely different drug from another company.
Much of the remaining time in the court was devoted to discussing five proposed Wyeth labels that the FDA rejected, and whether those efforts show good faith on Wyeth’s part—or didn’t directly address the risks of the IV push method.
Then the court began to understand the practical considerations of frequent label changes. Said Justice Scalia: “How many—you mentioned a number of—of times that—that label alterations are—are proposed. I mean, this is going to be a massive operation for the FDA.”
Frederick, the lawyer for the Vermont plaintiff, appears to nearly concede the difficulty of having all 50 states regulate the industry. But then, in a moment out of Hollywood, he says something which appears to silence that line of questioning. “The FDA was never put to the test of deciding comparative risks and benefits of IV push verses IV drip. And it’s that point that is crucial, because the catastrophic risks of IV push are so dramatic,” Frederick says.
According to him, there is no record that Wyeth and the FDA ever corresponded specifically about the risks of IV push. And it turns out the original label for the Wyeth drug cannot be located. Hmmm. That missing document brought to mind a key section of audio tape from Watergate; it was erased under dicey circumstances. “We don’t know where the original label was, Justice Souter,” Frederick says at one point.
Of course, the sheer age of the Wyeth drug, which was first approved in 1955, offers many utterly innocent explanations for no one being able to find the original label. But we would not want to be a Wyeth CEO and face questions on that point from Congress. Some of the evidence about IV push goes back to the 1950s and 1960s; some to the 1970s. It will be hard to argue a 1988 or 1998 label couldn’t have included such information.
The Supreme Court transcript reinforces one of the recurring themes of criticism of the industry. To wit: unflattering scientific information about drugs is easily withheld from the public and the medical community. Fair or not, that impression fuels lawsuits, newspaper editorials and unprecedented public cynicism.
Not dealing with that impression is common. It is similar to Detroit’s car companies not dealing with perceptions of low vehicle quality. It’s easy to postpone that conversation with the public for so many years that no one will have any interest in having it.
In the end, much of the discussion at the court seemed to be circling around two different drug labels.
The first label is a Platonic ideal, containing every bit of the latest scientific data from industry and beyond. This Platonic label would appropriately balance the risks and benefits of a medicine, and be updated instantly with each new development in the medical literature. It would be published in type large enough for people to read. Clinicians could inspect it with the benefit of professional training, and absorb the necessary information.
This Platonic label is admittedly imaginary. A fantasy. But we raise it as a possibility because: a) technology could make such labels possible today and b) such labels would defuse much of the deep confusion about drug safety for medical professionals—and the high risk of litigation that hangs over every major company in the life sciences.
The second label is the one in the actual world. It has tiny, invisible typography. It may not have up-to-date information. This is the label present in our own medicine cabinets (or bathroom waste baskets). This label is imperfect, negotiated, a patchwork of what real people could agree on. By definition, this second label is a compromise.
To some degree, the Wyeth-Levine case is about whether the second label is good enough. Is it adequate? Or is it something so flawed that state courts must have the authority to supercede it?
Ultimately, that could be decided in the legislative environment, in Congress. Not the courts. Our own inspection of the transcript suggests considerable Supreme Court frustration with the real world label, and some fondness and longing for a more Platonic ideal. The Supreme Court’s decision will be announced by next summer.