Fighting a Tort Plague

By: The Editorial Board

The Supreme Court’s inconsistent rulings on federal pre-emption of state law have often produced unintended side effects. On Monday the Justices hear a case that could partly remedy one of their muddled decisions that sanctioned state lawsuits against drug manufacturers for label warnings approved by the Food and Drug Administration.

In Merck v. Albrecht, plaintiffs are suing the drug maker for not adequately warning patients of upper-leg fracture risk from its osteoporosis drug Fosamax. Merck ’s proposal to include a warning on its drug label was rejected by the FDA, but plaintiffs argue this should not preclude a lawsuit in state court.

The Federal Food, Drug, and Cosmetic Act doesn’t expressly pre-empt state torts, and the Court has long held that there is a presumption against federal pre-emption of state laws. But one exception is when it is “physically impossible” to comply with both federal and state regulations. The Court has inconsistently applied this exception, which has produced confusion and a tort epidemic.

Consider the Court’s Levine (2009) decision, which involved a label warning for an anti-nausea drug. Plaintiffs sued a drug manufacturer, arguing it should have provided a stronger warning about “IV push injection” though the FDA had approved its label. A 6-3 majority including the Court’s four liberals joined by Anthony Kennedy and Clarence Thomas concluded FDA approval doesn’t protect manufacturers from state torts.

Defendants must provide “clear evidence” that “the FDA would not have approved” the label warning to avoid liability, the Court ruled. In other words, drug makers can be sued for warnings that the FDA deemed were accurate and adequate. This allows the scientific judgments of juries to overrule those of federal drug regulators.

As Justice Samuel Alito explained in his dissent joined by Chief Justice John Roberts and Antonin Scalia, “the FDA conveys its warnings with one voice, rather than whipsawing the medical community with 50 (or more) potentially conflicting ones.” He concluded: “Turning a common-law tort suit into a ‘frontal assault’ on the FDA’s regulatory regime for drug labeling upsets the well-settled meaning of the Supremacy Clause and our conflict pre-emption jurisprudence.”

The Court’s liberals are typically sympathetic to trial lawyers, though Justices Kennedy and Thomas appear to have joined for federalism reasons. In his concurrence, Justice Thomas rebuked the “majority’s implicit endorsement of far-reaching implied pre-emption doctrines” and the Court’s practice of invalidating state laws “based on perceived conflicts with broad federal policy objections.”

But he and Justice Kennedy have since joined the Court’s conservatives in two major cases involving federal pre-emption of state drug torts when conflicts were clearer. Albrecht provides an important opportunity for the Court to clarify its jurisprudence.

Starting in 2008, Merck provided the FDA with periodic safety updates on studies linking long-term use of bisphosphonate (the major compound in Fosamax) with atypical femoral fractures and sought to revise its label. But the FDA concluded there was insufficient data to merit a stronger warning. Only after an FDA task force discerned a strong link did the agency support a label revision.

The Third Circuit Court of Appeals ruled for the plaintiffs, holding that a jury might conclude that the FDA rejected Merck’s proposed label warning because of a semantic disagreement. But the FDA said that was not the case. Had Merck heeded the plaintiffs’ demands, it would have violated federal regulations.

Justice Thomas is right that the Court in the past has pre-empted state laws willy-nilly. And as Justice Alito noted in his Levine dissent, “state tort suits can peacefully coexist with the FDA’s labeling regime, and they have done so for decades.” But businesses shouldn’t be looted for complying with federal regulations.