Wyeth v. Levine: A Conflicted Roberts Didn't Recuse Himself; Ruling Encourages Unilateral Label Changes

There are three interesting things about the U.S. Supreme Court’s ruling against Wyeth’s preemption claim. (The case was about whether the FDA preempts state courts from ruling on drug safety.)

First, Chief Justice John Roberts took part in the decision even though he owns Pfizer stock (Pfizer just bought Wyeth and thus gives him in a financial interest in the decision).

Second, the language in the ruling is not merely a technical rejection of Big Pharma’s preemption arguments — it’s a strong refusal of the entire doctrine and a significant vote of confidence in state tort laws.

Third, the ruling sends a signal to drug companies to not wait to tighten their warning labels just because they haven’t heard from the FDA. We could be in for an era of much quicker unilateral label changes than we’ve seen in the past.

Let’s take Chief Justice Roberts first. BNET noted on Feb. 9 that Roberts owned Pfizer stock and that some lawyers felt he should recuse himself from the decision. (Thus Roberts doesn’t have the “Oops! I wasn’t paying attention!” excuse that Pfizer board director James Kilts came up with recently.)

With preemption now re-opening the door to state tort claims against drug manufacturers, Pfizer-Wyeth, the largest drug company on the planet, will bear proportionately the largest number of those claims, and the legal expenses that depress net income — and thus returns to stock holders, like Roberts. So the Roberts dissent is, viewed from this angle, squarely a vote for his own IRA.

Roberts, of course, doesn’t frame it that way in the ruling. He joins with Justice Samuel Alito’s dissent. That dissent is outright hostile to juries:

… that ignores the antecedent question of who — the FDA or a jury in Vermont — has the authority and responsibility for determining the “adequacy” of Phenergan’s warnings.

The dissent starts with its best argument, which is that the plaintiff was really the victim of medical malpractice by her doctor (not product injury by Wyeth), who should have taken more care injecting the Wyeth drug that caused her arm to become gangrenous and require amputation:

… it is unclear how a “stronger” warning could have helped respondent … after all, the physician’s assistant who treated her disregarded at least six separate warnings that are already on Phenergan’s labeling, so respondent would be hard pressed to prove that a seventh would have made a difference.

Then Alito and Roberts get back to their hatred of juries in medical cases:

By their very nature, juries are ill-equipped to perform the FDA’s cost-benefit-balancing function. … juries tend to focus on the risk of a particular product’s design or warning label that arguably contributed to a particular plaintiff’s injury, not on the overall benefits of that design or label; “the patients who reaped those benefits are not represented in court.” … Indeed, patients like respondent are the only ones whom tort juries ever see, and for a patient like respondent — who has already suffered a tragic accident — Phenergan’s risks are no longer a matter of probabilities and potentialities.

That’s not quite true, is it? Juries and their families are patients themselves. Everyone visits a doctor and takes a drug at some point in their lives. Jurors with drug injuries are weeded out in jury selection, so most juries are composed of 12 individuals who have had good or neutral outcomes with drugs.

Here’s the Supremes holding on preemption. It’s worth quoting at length:

Held: Federal law does not pre-empt Levine’s claim that Phenergan’slabel did not contain an adequate warning about the IV-push method of administration. … The argument that Levine’s state-law claims are pre-empted because it is impossible for Wyeth to comply with both the state-lawduties underlying those claims and its federal labeling duties is re-jected.

Although a manufacturer generally may change a drug labelonly after the FDA approves a supplemental application, the agency’s“changes being effected” (CBE) regulation permits certain preap-proval labeling changes that add or strengthen a warning to improve drug safety.

Pursuant to the CBE regulation, Wyeth could have uni-laterally added a stronger warning about IV-push administration,and there is no evidence that the FDA would ultimately have rejected such a labeling change.

Wyeth’s cramped reading of the CBE regulation and its broad assertion that unilaterally changing the Phenerganlabel would have violated federal law governing unauthorized distri-bution and misbranding of drugs are based on the fundamental mis-understanding that the FDA, rather than the manufacturer, bearsprimary responsibility for drug labeling. It is a central premise of theFood, Drug, and Cosmetic Act (FDCA) and the FDA’s regulationsthat the manufacturer bears responsibility for the content of its label at all times.

Wyeth’s argument that requiring it to comply with a state-law duty to provide a stronger warning would interfere with Congress’ purpose of entrusting an expert agency with drug labeling decisions is meritless

Which brings us to point No. 3: There’s no way around this ruling. This isn’t a subtle holding with a narrow application to some obscure set of circumstances. Rather, it’s a green light to sue drug companies that don’t unilaterally tighten their warning labels. Thus, expect to see a flurry of press releases from companies issuing new warnings on their labels without instructions from the FDA.