In the 11 months since the U.S. Supreme Court limited consumers' ability to sue generic drug companies for personal injuries in Pliva v. Mensing, the acid reflux drug Reglan has been front and center as lower courts interpret the decision. As you may recall, Reglan, or metoclopramide, was the drug at issue in the high court. The ruling held that because generics are required to carry the same warning labels as the brand-name version of the drugs, generic manufacturers cannot be liable for failing to warn of side effects.

In the wake of Mensing, state courts in Pennsylvania, California, and New Jersey have been considering what to do with thousands of suits by metoclopramide users who claim they weren't warned about the long-term risks of developing a neurological disorder. (The cases were mostly filed in state courts after the Judicial Panel on Multidistrict Litigation denied a bid to consolidate the metoclopramide litigation at a federal level.) What's notable is that judges in those states have taken markedly different approaches to their metoclopramide dockets: In Philadelphia and San Francisco, judges have allowed thousands of personal-injury suits against the generics to move forward despite Mensing. But on Friday Superior Court Judge Carol Higbee in Atlantic City, New Jersey, ruled that generics are largely off the hook in her court.

Higbee found that, as a matter of law, the suits are barred under the Supreme Court's decision and the doctrine of federal preemption. "At this point, precedent constrains this court's decision," the judge wrote. "Until the FDA modifies its regulations, or Congress takes action to amend the status, there is no authority to allow claims for 'failure to warn' to proceed against generic drug manufacturers that have mimicked the brand-name labeling."

It's not clear how many of the nearly 980 metoclopramide-related suits in New Jersey state courts will be affected by Higbee's ruling. The decision leaves room for plaintiffs to continue asserting claims against any generic manufacturer that failed to update labels to match those produced by brand manufacturers. That could include claims against Pliva, which Teva acquired in 2008. "We know that after 2003, Pliva never copied the (brand) drug companies' labels," said Bill Curtis of the Curtis Law Group, who argued for the plaintiffs in Philadelphia and San Francisco.

Higbee's ruling is nonetheless a "great defense win," said Frederick Fern of Harris Beach, liaison counsel for the generics in New Jersey and counsel to Actavis Group, one of the defendants. It stands in contrast to the results in Philadelphia and San Francisco. In those cities, plaintiffs salvaged claims against generic makers by arguing that even if the generics couldn't change the FDA-mandated labels, they could have taken other steps to warn consumers, such as sending letters to doctors about the drugs' risks or pulling metoclopramide products from the shelves.

In Philadelphia, which had 2,000 pending metoclopramide cases at the time on the docket, Judge Sandra Mazer Moss of the Court of Common Pleas said in an opinion in November 2011 that the generic defendants had not met their "heavy burden" of showing the plaintiffs couldn't succeed. Last month San Francisco Superior Court Jude Richard Kramer agreed, ruling from the bench that he would not dismiss California state-court claims.

"Mensing does not hold that any claim relating to labeling is precluded by federal law," Kramer said, according to a transcript. "It only states that a state cannot require a drug manufacturer to label its product, where to do so would violate federal law. So I don't find that any of the causes of action are preempted by Mensing."

Jay Lefkowitz of Kirkland & Ellis, who has argued the Mensing issue for the generics at the Supreme Court and in the three state courts, declined comment, as did a spokeswoman for Teva. Ralph Pittle of Medical Legal Consultants, who argued for the plaintiffs in New Jersey, did not respond to requests for comment.

(Reporting by Nate Raymond)

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