When U.S. District Judge Berle Schiller finalized a $4.5 million settlement on Monday in a class action accusing Impax and Teva of improperly marketing their generic versions of the antidepressant Wellbutrin XL, the Philadelphia judge made it clear he does not agree with a U.S. Supreme Court ruling in 2011, Pliva v. Mensing, that undercut the plaintiffs' case.

The 5-4 ruling -- which held that personal injury claims against generic drugmakers are pre-empted because generics are required to carry the same federally approved labels as their brand-name predecessors -- has provided generic manufacturers with broad protection from litigation over the risks and effectiveness of the drugs they market, even though patients who took the brand-name versions may still bring suits. Schiller said the consequences of the Supreme Court ruling were "absurd."

"An individual's ability to sue for damages caused by prescription medication should not depend on whether the drug was a name-brand or a generic," wrote Schiller, who had previously ruled before Mensing was issued that class claims were not pre-empted. "If drug manufacturers are legally responsible for their products (like every other maker of a good), generic drug makers should not be immune from liability."

Schiller isn't the first judge to voice displeasure with Mensing while also siding with the generics. In a decision that dismissed a decent chunk of the hundreds of suits in New Jersey state court involving generic Reglan, Superior Court Judge Carol Higbee in Atlantic City said she might have ruled differently if it was a brand-name drug, but "precedent constrains this court's decision." Higbee said either the FDA or Congress would need to change the regulations or statutes to allow her to rule differently.

Some public interest groups and members of Congress are trying to get just the type of change in law alluded to by Higbee. Democrats in the U.S. Senate and House of Representatives introduced bills in April to undo Mensing, which Senator Patrick Leahy, a Democrat from Vermont, at the time said "creates a troubling inconsistency in the law governing prescription drugs."

Separately, a petition by the group Public Citizen that seeks a revision in agency guidelines to allow generics to change their labeling is pending before the U.S. Food and Drug Administration. "Although Mensing was about lawsuits, we really see it as a safety issue," said Allison Zieve, the litigation director at Public Citizen. As it stands, she said, generics don't have to change their labels ahead of brand manufacturers even if they become aware of problems.

That's what the plaintiffs contend happened in the case of the generic version of Wellbutrin XL -- or Budeprion XL, as Impax and Teva called it. The generic drug wasn't exactly the same as the brand-name version by GlaxoSmithKline, according to the lawsuit; Impax had designed its version around a Glaxo patent for a membrane-release technology in order to allow for the extended-release action of the brand-name drug. The FDA certified the drug as bioequivalent, but the plaintiffs contended that after the generic version was approved, Impax and Teva (the drug's distributor) became aware that the different release technologies rendered the generic less effective. Consumers complained the drug wasn't as good as Glaxo's and alleged that they experienced side effects.

The nationwide class action was filed on behalf of 2.23 million purchasers of Budeprion XL, who claimed they were duped into purchasing an inferior drug. The stakes were huge: The California consumer rights law the plaintiffs cited calls for statutory damages of $5,000 per plaintiff, or $11.2 billion.

But in the deal Schiller approved on Monday, consumers get no cash. The plaintiffs' lawyers get $3.2 million in fees and $1.3 million in expenses -- a discount, according to the five plaintiffs' firms, who say their hourly fees totaled $6.5 million. Teva and Impax did agree to some concessions, such as removing references to Wellbutrin XL from Budeprion's label and implementing monitoring procedures for consumer complaints. But that's it.

The terms drew some objections, including one from the office of Texas Attorney General Greg Abbott, which argued in a letter that Impax and Teva had already made many of the changes the settlement demanded and that the accord should be rejected unless some money was put on the table for consumers. But Schiller said that, in light of Mensing, the settlement was reasonable.

"Absent the settlement agreement, (Impax and Teva) would face no compulsion to keep these changes in place," Schiller wrote. "Thus, the settlement agreement undeniably works a change in the relationship between the parties, and the relief afforded the class is not illusory."

Co-lead plaintiffs' counsel Richard Golomb of Golomb & Honik did not respond to a request for comment. But he told The Legal Intelligencer that he was "pleased with the injunctive relief we were able to provide to the class in the form of label changes and quality control and thank Judge Schiller who was very involved every step of the way."

Impax, represented by Asim Bhansali of Keker & Van Nest, declined to discuss the effects of the injunction on the company. "The court blessed the settlement, exactly as agreed to by the parties," Mark Donohue, an Impax spokesman, said in a statement. Teva counsel Jay Lefkowitz of Kirkland & Ellis, who won the Mensing case at the Supreme Court, declined to comment.

(Reporting by Nate Raymond)

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