The United States Supreme Court has declined to review a California appellate court’s decision allowing a state law failure-to-warn claim to proceed against several generic drug manufacturers, including Teva Pharmaceuticals USA, Inc, Barr Pharmaceuticals LLC, and Caraco Pharmaceutical Laboratories, Ltd.
The action was brought by Plaintiff Olga Pikerie for injuries she sustained as a result of ingesting sodium alendronate manufactured by Teva, Barr, and Caraco. Sodium alendronate belongs to a family of drugs known as bisphosphonates, and is primarily prescribed for treatment of osteoporosis in postmenopausal women. The brand-name version of the drug is called Fosamax, which is manufactured by Merck.
Ms. Pickerie filed her action in Orange County Superior Court, and it was coordinated with other individual actions for discovery and pre-trial purposes. Her Complaint contained traditional state law tort claims, including claims for negligence and strict liability failure-to-warn. The failure-to-warn claims focused on the generic manufacturers’ failure to warn about the risk of femur fracture and the warning signs of fractures.
The generic manufacturers sought dismissal of Ms. Pikerie’s case on the theory that all her claims were preempted under the Supreme Court’s decision in PLIVA v. Mensing. In Mensing, the Court barred Plaintiffs from pursuing traditional state law claims (specifically, failure-to-warn and design defect claims) against generic drug manufacturers by holding that federal law preempts state law claims targeting generic drug warnings and designs.
The trial court refused to dismiss Ms. Pikerie’s claims, and the generic manufacturers filed a petition for writ of mandate to the state appellate court. The appellate court denied the petition, holding that Ms. Pikerie’s claims were not preempted because federal regulations did not make it impossible, prior to Ms. Pikerie’s injury, for the generic manufacturers to include in their generic drug labels a warning about femur fracture and warning signs of fracture, because such warning had already been included in the brand-name label. The addition of a warning, therefore, was not barred by the requirement that generic drug labeling generally be the same as the labeling of the brand-name counterpart.
The court further held that in these circumstances, unlike in Mensing, federal regulations allowed the generic manufacturers to send a “Dear Doctor” letter or other communication to Ms. Pikerie’s doctors informing them about risks contained in the FDA-approved label.
The appellate court also rejected the generic manufacturers’ argument that Ms. Pikerie’s claims are preempted by Buckman Co. v. Plaintiffs’ Legal Comm., finding that her claims “are not based on a fraud-on-the-FDA theory, but on state law tort principles of a drug manufacturer’s duty to the consumers of its product.”
The generic manufacturers sought review in the Supreme Court of California and the United States Supreme Court and were denied. The issue may now be decided by the FDA, which plans to issue a new rule later this year that would permit generic drug makers to update labeling independently in response to new risk information. The FDA proposed the rule in response to the 2011 Supreme Court ruling, although a final version has been delayed amid protests from generic drug manufacturers. If you have any questions about this litigation, contact Beau Darley, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Beau.Darley@beasleyallen.com.
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