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Different standards for name-brand, generic drugs

WASHINGTON — The Supreme Court decision late last month that state-law failure-to-warn claims against generic drug makers are preempted by federal law — handed down just two years after the Court held that brand-name drug makers could face such suits — creates a legal discrepancy that leaves the majority of patients without recourse, some advocates say.

“It creates an absolutely untenable distinction in the law between name-brand and generic drugs,” said Louis Bograd, senior litigation counsel for the Washington-based Center for Constitutional Litigation, who argued on behalf of the plaintiffs in PLIVA, Inc. v. Mensing.

But business-side attorneys say the ruling provides much needed clarification of preemption law in the drug litigation context.

The case involved a suit brought against the makers of the drug metoclopramide, the generic form of the diabetes drug Reglan.

The plaintiffs claimed the drug caused them to develop tardive dyskinesia, a severe neurological movement disorder. They claimed that the drug makers took no steps to strengthen warning labels despite evidence indicating a risk of developing tardive dyskinesia from the drug was far greater than indicated on the label.

The district court granted summary judgment for the defendants on preemption grounds, but the 8th U.S. Circuit Court of Appeals reversed, holding that the plaintiffs had stated a viable claim against the generic manufacturers.

In a 5-4 ruling, the U.S. Supreme Court reversed, holding that the claim was preempted by federal drug labeling laws.

Unlike name-brand drugs — like the one at issue in the 2009 opinion in Wyeth v. Levine, where the Court held that failure-to-warn-claims were not preempted — generic drugs have more restrictive label requirements. Specifically, the label of a generic drug must match its brand-name counterpart.

“The statute covering generics said you have to have the same labels as the name-brand drugs,” said Patricia Ann Millett, partner in the Washington office of Akin Gump, where she heads the firm’s Supreme Court practice and co-heads its national appellate practice.

While generic drug makers can — and must, under federal rules — report information about drug risks to the FDA, and ask the agency to change labeling to reflect such risks, they cannot place more stringent warnings on drugs if those warnings would deviate from those of the name-brand drug.

Writing for the Court’s five-member majority, Justice Clarence Thomas found the state failure-to-warn law would have held generic drug makers to a different standard than that of federal law, and that they could not comply with both.

“If the manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law,” Thomas wrote. “[S]tate law imposed on the manufacturers a duty to attach a safer label to their generic metoclopramide. Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels. Thus, it was impossible for the manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.”

The ruling means that the majority of drugs on the market — generics make up about 70 percent of all prescription drugs in the country — cannot be subject to suits based on warning labels. About 2.6 billion generic drug prescriptions are filled for patients each year, according to the American Association for Justice.

“What I find more disturbing is that the Court accepts the premise [that] under federal law generic drug companies had the legal obligation to go to the FDA and seek stronger labels” should they learn of adverse risks, Bograd said. “The Court said that despite the fact that they had breached that federal-law obligation, they are absolutely immunized from state tort liability.”

Tort liability, Bograd said, provides an “important complement” to the federal regulatory system, serving to protect consumers and spur companies to update safety information in a timely manner.

That sentiment was echoed by Gibson Vance, shareholder in the Fort Valley, Ga., office of Beasley Allen and president of the AAJ.

“Patients will now be taking generic drugs at their own risk,” said Vance in a statement following the Court’s ruling. ”It is absurd that doctors and patients will have to make medical decisions knowing that only brand-name drug manufacturers — not generics — can be held accountable for their drugs’ dangerous side effects.”

Generic drug makers applauded the ruling, and claimed that generic drugs are just as safe as their brand-name counterparts under the FDA regulatory scheme.

“When used as directed by FDA-approved labeling, generic prescription drugs provide the same safety and efficacy as the counterpart brand product and patients can expect the same therapeutic benefit,” said Bob Billings, executive director of the Generic Pharmaceutical Association, in a statement after the ruling. “The generic pharmaceutical industry will continue to scrupulously comply with all laws and regulations to provide patients with the safe, effective and affordable medications they have come to rely on.”

The question of whether patients who took generic drugs may bring an action against the makers of the equivalent brand-name drug for improper labeling remains open, Bograd said. The plaintiffs in Mensing raised and lost that issue in the lower courts, but courts in general are split, he said.

“This decision will provide a powerful impetus for courts to revisit those rulings,” Bograd said.

Lawyers USA is a sister publication of The Daily Record.