Proposed reg could breathe life into generic drug suits

Following two U.S. Supreme Court decisions that shut the door on state-law failure-to-warn and design-defect claims over generic drugs, the Food and Drug Administration is taking steps that could ultimately open a window for plaintiffs.

The agency has stated its intention to issue a proposed rule that would loosen the federal restriction on generic drug label changes. That change, if adopted, could lead to state law civil suits against generic drug makers that are currently barred by Supreme Court rulings.

The justices’ 2011 ruling in PLIVA Inc. v. Mensing, which nixed lawsuits against generic drug makers based on inadequate warning labels, and their recent decision in Mutual Pharmaceutical Co. v. Bartlett, which barred design-defect claims that also turn on the sufficiency of a generic drug’s warning label, were based on federal laws requiring drug makers to place the same labeling on generic drugs as appears on their brand name equivalents. Because generic drug companies cannot change labeling without running afoul of the federal Food, Drug and Cosmetic Act, state laws could not authorize civil claims based on a failure to do so, the justices reasoned.

But in a notice filed July 3 with the Office of Management and Budget, the FDA advised of a forthcoming proposed regulation that would allow generic drug companies to change labels in some circumstances based on “certain types of newly acquired information in advance of FDA’s review of such change.”

According to the OMB notice, the “proposed revisions to FDA’s regulations would create parity between” generic drug makers and brand name drug makers, which already have the ability to change labels before the FDA authorizes such a change if they receive new information about the drug’s safety. That difference was a factor in the Supreme Court’s decision in the 2009 case Wyeth v. Levine, which held that state-law failure-to-warn drug claims are not automatically preempted by federal law.

The change is supported by members of the plaintiffs’ bar and patient advocates, who argue that the current state of the law gives civil immunity to the makers of some dangerous drugs.

“When finalized, the revisions will fill a regulatory gap that poses a risk to patient safety,” said Sidney Wolfe, founder and senior adviser of the Health Research Group of Public Citizen, a Washington consumer advocacy organization that submitted a citizen petition to the FDA two years ago asking it to revise its labeling rules.

But defense attorneys said the rule, even if adopted, may not stamp out entirely the preemptive effect of existing federal laws. They say that under the court’s holding in the 2001 case Buckman Co. Plaintiffs’ Legal Committee, even when claims are not automatically preempted, they may be barred in cases in which a drug company unilaterally makes a pre-approval labeling change that the FDA would not ultimately condone once the agency considers the new label. Under the new rule, jurors would essentially be tasked with deciding: What would the FDA do?

“There would be an additional element to the plaintiff’s claim,” said David R. Geiger, a partner in the Boston office of Foley Hoag and head of the firm’s product liability and complex tort practice group. “They would have to prove that the FDA would have approved the change. [Otherwise] there could still be preemption.”

Support for the change

According to data from the trial attorney group American Association for Justice, roughly 80 percent of prescriptions written in the country are for generic drugs. And since the court’s ruling in Mensing, hundreds of lawsuits brought by patients claiming injuries for dangerous or defective generic drugs have been dismissed.

A Public Citizen report released in June found that information about the potential dangers of drugs or labeling is often uncovered after the drugs have been on the market for years.

“Yet, currently, generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk,” Wolfe said.

After the Supreme Court’s ruling in Bartlett, several lawmakers sent a letter to FDA Commissioner Margaret Hamburg urging changes to federal regulations.

“These changes are critically important to ensure that the public is adequately informed of the risks and benefits of prescription drugs, and that consumers who are injured by generic drugs have the same legal rights as those who are injured by the brand-name versions of the same drugs,” read the June 24 letter from Reps. Chris Van Hollen, D-Md., Henry Waxman, D-Calif., Matt Cartwright, D-Pa., and Bruce Braley, D-Iowa, and Sens. Patrick Leahy, D-Vt., Tom Harkin, D-Iowa, and Al Franken, D-Minn.

 Preemption analysis not over

A rule change may not be the end of the preemption analysis, Geiger said. Even if generic drug makers are given more wiggle room to make changes to warning labels, many state-law claims still may be deemed to be impliedly preempted by federal law.

“It’s the old Buckman preemption from years ago,” said Geiger, referring to the ruling that federal law preempted a claim against a medical device manufacturer that told the FDA it would market its product for certain uses and then promoted it for others. The suit was barred, the justices held, in cases in which such lawsuits “conflict with the FDA’s responsibility to police fraud consistently with the agency’s judgment and objectives.”

While the new proposed rule would mean cases would not be automatically dismissed based on preemption, plaintiffs would still have to clear a preemption hurdle down the line, and that might not be an easy task. That, Geiger said, is one reason why the Supreme Court has yet to rule on the issue of Buckman preemption in a drug case.

Even in Levine, Buckman preemption could have been an issue for the plaintiff had it been raised.

“It’s likely that the parties just went with the most direct preemption argument,” Geiger said.

But whether Buckman preemption — or another legal theory — limits the applicability of a proposed FDA labeling change remains to be seen in the litigation that lies ahead.

Regardless of the state of the law, drug liability cases “involve stories of such terrible personal tragedy,” Geiger said.  “Because the claims of injury are often so gripping … plaintiffs’ attorneys will always look for legal theories for their clients. And defense attorneys will always respond.”