The recent Supreme Court decision in the case of Wyeth v. Levine, in which the plaintiff won a tort case against the drug manufacturer for a severe adverse event — despite clear label warnings and a “preemption” defense — will either result in burdensome, unreadable product labels to cover every possible adverse contingency associated with use of drug products ... or it won’t. The court’s decision will either result in FDA receiving a rush of changes being effected (CBE) supplements to product labels as a defensive measure against all possible future tort actions ... or it won’t. The “preemption” defense (based on the concept that a hazard, so long as it is referenced in the FDA-approved label absolves a manufacturer of further liability) is either dead ... or it isn’t. This clash of opinions among legal experts provided attendees at FDLI’s 52^nd Annual Convention 4/23 with a sense of the uncertainty in long-term results that court decisions can generate and, indeed, provides a glimpse into the ambiguities inherent in the legal system — even after a ruling by the court-of-last-resort.

Former FDA chief counsel Sheldon Bradshaw, now partner in the Washington law firm Hunton & Williams, described the court’s decision in Wyeth v. Levine as a “complete disaster, a seismic shift” — one that will inevitably result in an “already-overburdened” FDA becoming “inundated” with CBE supplement requests — labeling amendments that are “problematic for the agency, for physicians, and for consumers.” Based on the court’s opinion, Bradshaw said he has “no idea what additional warning could have been put in the label” that would have made a difference in the outcome of the case. “The Supreme Court ruling is not a very useful tool in aiding FDA in making labeling decisions,” Bradshaw said, asserting that “over-warning is soon to be a problem.”

Public Citizen attorney Allison Zieve denied that Wyeth v. Levine represents a “seismic shift;” rather, she said, it tends simply to “put the brakes” on the notion of “implied preemption.” She pointed out that the states have always had purview over consumer information (the case was on appeal to the Supreme Court from a Vermont court decision, also favoring the plaintiff). Zieve noted that, over the past several years, there has been an “explosion” of companies making implied preemption arguments. She charged that FDA began this trend in legal defense when it opposed California’s efforts to add “suicidality” warnings to a class of drugs, with the agency’s opposition based on preemption and a “lack of scientific evidence” in support of the proposed warning. (In that instance, the courts seemed to uphold FDA’s primacy in labeling matters). Zieve indicated that an alarmist view of Wyeth v. Levine by drug companiesis unwarranted. “Drug manufacturers should continue to do what they have always been doing (with respect to labeling),” she said.

“Reports on the death of preemption are premature,” according to Bert Rein, founding partner in the law firm Wiley Rein. He suggested that a close reading of the court’s opinion opens up the possibility that had Wyeth proposed a label change (for example, strengthening the warning), and had this proposal been rejected by FDA, then a preemption defense might have prevailed. If this legal theory is correct, Rein pointed out that a problem remains: “Who gets to decide what FDA would have done? This poses a difficult issue for the courts,” he said.

Georgetown University law professor David Vladeck, who has been named director of the Federal Trade Commission’s Bureau of Consumer Protection, pointed out that the idea of preemption, as applied to FDA functions, is a policy issue, not a legal one. “There is no preemption in the Food, Drug & Cosmetic Act,” he said. “Congress has considered this matter, and did not give preemptive authority to the agency — and it won’t.” Vladeck said the FDA label is merely a “floor,” but that the states “may go further.” Only in cases where FDA actually writes the label (as, he said, in the case of tampons) would there be a “ceiling” to language in the label (i.e., no additions allowed). “The FDA label is a floor, not a ceiling. Wyeth v. Levine does not imply a new regulatory regime,” he said. “Companies are not going to be allowed to off-load their responsibilities on FDA.”