SCOTUS Wants SG’s to Take On Generic-Drug Maker Liability

The Supreme Cpurt of the United States, or SCOTUS, shows interest in whether a generic-drug manufacturer could be held liable for pharmaceutical injuries.

The Supreme Cpurt of the United States, or SCOTUS, shows interest in whether a generic-drug maker could be held liable for pharmaceutical injuries.

The U.S. Supreme Court on Monday asked the solicitor general to weigh in on Teva Pharmaceutical USA Inc.’s challenge to a California appeals court finding that the generic-drug maker can be held liable for injuries because it did not immediately update its warning label to match the brand-name equivalent version.

In June 2013 the California appeals panel gave the go ahead to Olga Pikerie’s suit alleging Teva and others failed to warn of potential safety issues with a generic form of the osteoporosis drug Fosamax, finding her claims were not preempted by the high court’s Mensing decision.

Pikerie alleges that taking the drug caused her to break her thigh bone and that the generics makers failed to update their label to explain the risks associated with the medication.

Teva, Barr Laboratories Inc. and Caraco Pharmaceutical Laboratories Ltd. said in a February petition for writ of certiorari that the Supreme Court’s 2001 decision in Buckman Co. v. Plaintiffs’ Legal Committee held that federal law bars private parties from pursuing state law tort claims that are predicated on alleged violations of the federal Food, Drug and Cosmetic Act.

They also cited the high court’s preemption rulings in Pliva Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett as reasons to overturn the appeals panel’s decision.

“The California Court of Appeal’s decision in this case frames the nationwide split of authority over Buckman’s scope in its sharpest possible relief: The appellate court expressly departed from both federal and other state appellate decisions which have held that federal law preempts the very same novel tort theory that the appellate court’s decision allows plaintiffs to pursue in California,” the companies said in their petition.

The appeals court’s ruling allows Pikerie’s complaint — which served as a test case to resolve federal preemption issues in a group of coordinated actions against the makers of branded and off-brand versions of the osteoporosis drug — to move forward and upholds a lower court’s decision to overrule a demurrer filed by the generic-drug makers.

But in a response to the company’s petition, Pikerie said the Supreme Court doesn’t have jurisdiction over the California appellate court’s interlocutory order.

“But even beyond the jurisdictional flaw, the decision… does not warrant review because the Food and Drug Administration has proposed a regulatory revision that, if finalized, will undercut the premise for petitioners’ preemption argument, and because the case does not implicate a conflict among the circuits warranting review,” Pikerie said.

Her brief also said the companies have greatly exaggerated the impact of the California panel’s decision, which she said applies only to claims for injuries caused by a generic drug that occurred after a change to the brand-name labeling.

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