Metropolitan News-Enterprise


Monday, June 17, 2013


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C.A. Rejects Preemption Defense to Suit Over Drug Labeling




Federal law does not bar a products liability suit in which the plaintiff claims that a generic drug manufacturer’s failure to update a warning label caused the plaintiff to needlessly suffer a harmful side effect, the Fourth District Court of Appeal has ruled.

Div. Three Thursday denied a writ petition by companies that make and market alendronate sodium, a generic version of the osteoporosis drug Fosamax.  Merck, whose patent on Fosamax expired in 2008, and the generic manufacturers are defendants in a number of lawsuits over alleged side effects, including femur fractures.

The defendants have argued that failure-to-warn claims regarding the drugs are preempted by PLIVA, Inc. v. Mensing (2011) 131 S.Ct. 2567. The Supreme Court held in that case that the state may not impose a duty on generic manufacturers to provide stronger warnings than those which appear on the brand-name label.

The high court reasoned that it would be impossible for a manufacturer to comply with such a duty while simultaneously complying with federal law, which requires that the generic and brand-name labels match.

Coordinated Suits

A number of suits, filed around the state against Merck and generic manufacturers Teva Pharmaceuticals USA, Inc., Barr Pharmaceuticals LLC, Barr Laboratories, Inc., Mylan Pharmaceuticals, Inc., Caraco Pharmaceutical Laboratories, Ltd., Sun Pharmaceutical Industries, Inc., and NorthStar Rx LLC have been coordinated before Orange Superior Court Judge Steven L. Perk since April 2011.

The defendants in the coordinated cases agreed that a complaint filed in January of last year by Olga Pikerie could serve as a test case on the preemption issue with respect to the non-Merck defendants. Pikerie alleges that she used Fosamax and/or generic equivalents between 2006 and 2011, and that she broke her femur because the defendants failed to warn that the drug could cause such fractures due to suppression of bone turnover.

The complaint alleges that Merck updated the Fosamax label in March 2010 and January 2011 to reflect concerns over femoral fractures. The non-Merck defendants, she alleged, failed to update their labels to communicate the updated information, and also failed to warn physicians, continued to market the drug despite the concerns, and failed to request the FDA to order a change to the Fosamax label that would have allowed the non-Merck defendants to match the updated information. 

Case Distinguished

Perk overruled the demurrer but certified that appellate review of the issue might expedite the litigation, and the Court of Appeal agreed.

Justice Richard Fybel, writing for the court Thursday, said the issue was different than the one decided by the Supreme Court. The non-Merck defendants, he reasoned, could have updated their labels to match Merck’s without violating federal law.

The justice acknowledged an inconsistency in Pikerie’s pleading, in that she was simultaneously claiming that that the updates to the Fosamax label were inadequate and that the non-Merck defendants had a duty to match the updated Fosamax label. But such inconsistent pleading is permitted by California law, Fybel said, and Pikerie’s ability to prove the allegations cannot be tested on demurrer.

Same Analysis

The jurist went on to say that the same preemption analysis applies to Pikerie’s claim that the defendants should have warned doctors about the problems with the drug. He acknowledged that the Fifth U.S. Circuit Court of Appeals had reached the opposite result in a recent case, but said that ruling “is supported by neither the language nor the rationale of Mensing.

The defendants’ attorneys on appeal were Jon B. Eisenberg of Horvitz & Levy, Steven A. Ellis of Goodwin Procter, and Michael D. Shumsky for Teva and Barr; Shook, Michelle M. Fujimoto and Eva M. Weiler of Hardy & Bacon for Mylan; Mark W. Yocca and Jared Glicksman of The Yocca Law Firm for Caraco and Sun, and Pamela M. Ferguson of Lewis Brisbois Bisgaard & Smith for NorthStar.

Pikerie was represented by Mark P. Robinson Jr., Robert M. Partain, and Karen B. Menzies of Robinson Calcagnie Robinson Shapiro Davis, and by Steven J. Skikos and Mark G. Crawford of Skikos, Crawford, Skikos & Joseph.

The case is Teva Pharmaceuticals, Inc. v. Superior Court (Pikerie), 13 S.O.S. 3053.


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