On Tuesday, January 19, 2016, the US Supreme Court declined to hear an appeal filed by Johnson & Johnson over a lawsuit involving the company’s fever and pain medication Children’s Motrin, reports Reuters. The lawsuit, filed by Samantha Reckis in 2007, claims patients were not adequately warned about the link between Children’s Motrin and two life-threatening skin conditions: Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome.
Reckis lost 95% of her skin’s epidermis after being Motrin when she was 7, and was awarded $63 million by a jury in Massachusetts. Johnson & Johnson, however, thinks her case should have been dismissed, since the FDA had already rejected a petition from doctors advocating to have the skin rashes added to Motrin’s warning label. By the company’s lights, that’s sufficient evidence the warnings aren’t necessary.
When State & Federal Law Conflict
For pharmaceutical manufacturers, the question at issue here is a big one.
In drug liability lawsuits, plaintiffs often argue that a company should have warned patients of a product’s risks, but since it failed to do so, it should be held accountable when patients suffer those side effects. Then they usually demand that the FDA put stronger warnings on a drug’s label to notify future patients of the risks in question. Warning patients about risks that are supported by adequate science is a legal requirement, but it’s one enshrined in state laws, rather than federal law.
Drug companies usually fire back: if those allegations were true, the FDA would have already put those warning labels on our products. In some sense, a lack of prior FDA action is being used as evidence that the risks aren’t as high as plaintiffs think. The FDA, of course, is a federal agency, so at bottom here, is a question of state versus federal authority. That’s why you’ll often here about this issue in terms of “federal preemption.” The idea is that following some federal laws makes it extremely difficult to follow state laws to the letter. That’s okay, and it’s constitutional. In Article 6 of the US Constitution, you’ll read:
“This Constitution, and the laws of the United States which shall be made in pursuance thereof; and all treaties made, or which shall be made, under the authority of the United States, 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“
The Supreme Court has upheld a rigid interpretation of this statement time and again. When state and federal law conflict, federal law eclipses state law. Thus it’s not surprising that the Supreme Court has entertained the principle of federal preemption in the context of drug warning labels. In practice, federal preemption is a little more complicated.
Wyeth v. Levine: The Standard Of “Clear Evidence”
In 2008, the Supreme Court heard the case of Wyeth v. Levine, a textbook example of pharmaceutical company liability. In Vermont, Diana Levine sued Wyeth Pharmaceuticals over injuries she suffered after being injected with the company’s nausea drug Phenergan. Physicians used the “IV-push” technique to infuse Phenergan into Levine’s arm, but the drug entered her artery, leading to gangrene and ultimately, amputation. Levine sued Wyeth, saying the company had failed to warn patients and health care professionals about the risks of administering Phenergan with the IV-push method. A Vermont jury agreed, awarding Levine a substantial amount of compensation.
Wyeth shot back, appealing the jury’s decision to a state trial court, and insisting that Levine’s failure-to-warn argument was “preempted” by federal law, since the US Food & Drug Administration had approved Phenergan’s labeling. The trial court didn’t buy that, declining to overturn the lower court’s verdict. Neither did Vermont’s Supreme Court, which also affirmed Wyeth’s liability in the case. Eventually, the case made its way to the nation’s Supreme Court.
The Supreme Court held that Wyeth’s state-law duty to adequately warn patients of a drug’s risks were not preempted by federal law, since:
- the FDA allows drug companies to strengthen their warning labels without preapproval, so Wyeth could have done so if it thought making a change would have benefited public safety, and
- there was no clear evidence that the FDA would have rejected that labeling change.
In its Opinion, authored by then-Justice John Paul Stevens, the Court affirmed the principle that drug manufacturers, not the FDA, bear responsibility for the “content” of their labeling “at all times.” But the Court left some leeway for drug companies, by insisting on a standard of “clear evidence.” If a drug company can show clear evidence that the FDA would have rejected a labeling change, federal preemption may apply (although it would still be a case-by-case decision).
What Does “Clear Evidence” Look Like?
What “clear evidence” means, however, isn’t exactly clear. How do you know what an agency would have done, when they haven’t done it? The Court does offer several guidelines:
- If Wyeth had tried to have a labeling change approved, and the FDA had rejected that change, the rejection would constitute clear evidence.
- Stevens’ Opinion suggests that drug companies need to show that the FDA gave more than “passing attention” to the issue at hand.
- If Wyeth had submitted scientific research on the risk, but the FDA had done nothing, that might be clear evidence, too.
Even with those guidelines, drug companies continue to argue that the Court’s “clear evidence” standard is murky at best.
The question has proved contentious throughout numerous lawsuits, including a current Multi-District Litigation surrounding the anti-nausea drug Zofran. More than 200 families have filed lawsuits against Zofran’s manufacturer, GlaxoSmithKline, claiming the drug can cause birth defects.
Glaxo just brought up the “federal preemption argument,” filing a motion to dismiss the lawsuits in the Boston court where they’ve been consolidated. Plaintiffs responded, saying Glaxo hasn’t provided clear evidence that the FDA would have rejected a birth defect warning, since the company never applied to have Zofran approved as a morning sickness treatment. But without a clear answer from the Supreme Court on what “clear evidence” actually looks like, the argument will have to be hashed out in the US District Court of Massachusetts.