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From Health Law Daily, August 11, 2015

Depakote® labeling claims preempted, others proceed

By Mary Damitio, J.D.

An individual who brought suit against Abbott Laboratories, Inc. alleging that her ingestion of its antiepileptic drug, Depakote®, during pregnancy caused her daughter to suffer physical and cognitive impairments presented sufficient evidence to allow some of her claims to survive summary judgment, a district court ruled. While her claim that Abbott failed to provide warnings as to risks for developmental delays associated with the use of the product was preempted by federal law, sufficient questions of fact remained as to many of her other claims to preclude summary judgment (Rheinfrank v. Abbott Laboratories, Inc., August 10, 2015, Dlott, S.).

Background. Pamela Rheinfrank suffered from epilepsy since childhood. In 1988, she was prescribed Depakote and Phenobarbital to treat her seizures. She took both drugs during four pregnancies. While pregnant with her fifth child, she took Depakote, and her child was born with congenital malformations, facial dysmorphisms, a cognitive impairment, a developmental delay, and Fetal Valproate Syndrome (FVS), which is a rare congenital disorder caused by fetal exposure to valproic acid that can be associated with distinct facial features and a wide variety of birth defects.

Depakote. The FDA approved Depakote to treat seizures in March 1983. The drug became a Pregnancy Category D drug in 1988 and in 2003, a Black Box warning was added to the label that included a statement relating to “Teratogenicity,” and warned that the use of the drug could cause neural tube defects. It also contained language relating to “Usage and Pregnancy,” that listed warnings about birth defects.

Lawsuit. Rheinfrank brought suit against Abbott Laboratories, Inc., Abbvie, Inc., and Abbott Laboratories (collectively Abbott) in 2013, alleging that the drug caused her daughter’s injuries, and brought claims based on strict liability under the theories of design defect, inadequate warning, and state statutory and common law claims. Rheinfrank and Abbott filed cross motions for summary judgment.

Preemption. Rheinfrank’s claim based on Abbott’s failure to warn of the risk of developmental delay was preempted by federal law. A failure to warn claim is preempted by federal law where the manufacturer proves through “clear evidence” that it was impossible to comply with state and federal law because the FDA would not have approved a change to the drug label. Abbott presented evidence that it made requests to add a developmental delay warning to the drug’s labeling in 2005 and 2007, both of which were rejected by the FDA in 2006 and in 2008. Therefore, the evidence demonstrated that the FDA would not have approved a developmental delay warning prior to the Rheinfrank’s daughter’s injuries.

Remaining warning claims. Summary judgment was denied for both parties on the remaining failure to warn claims because there remained outstanding questions of fact. The court rejected Abbott’s arguments that its Depakote labeling was adequate as a matter of law because the court was not persuaded that listing the drug as a Pregnancy Class D drug and including a Black Box warning was adequate because Rheinfrank presented expert testimony to point out a number of alleged inadequacies about the warning. The court also found that a question of fact existed as to whether it was adequate for Abbott to offer a comparative warning.

Common knowledge. The court also refused to grant summary judgment based on Abbott’s common knowledge defense because Rheinfrank demonstrated that there existed a genuine issue of material fact as to whether, at the time of Rheinfrank's pregnancy in 2003, it was common knowledge in the industry that the teratogenicity of Depakote increased at higher doses and that the risk of malformations increased when the drug was prescribed as polytherapy.

Learned intermediary. The court rejected Rheinfrank’s motions for summary judgment based on the learned intermediary defense because a question of fact remained as to whether the information communicated to Rheinfrank’s physician was sufficient.

Causation. Summary judgment in favor of Abbott relating to causation was also inappropriate because a genuine issue of material fact existed relating to whether an adequate warning would have change Rheinfrank’s physician’s treatment.

Design defect. The court granted Abbott’s motion for summary judgment on Rheinfrank’s claim based on design defect because there was no evidence to support Rheinfrank’s claims that there were alternative drugs that could have controlled her seizures as well as the Depakote/Phenobarbital combination. As a result, Rheinfrank was unable to meet her burden to demonstrate that an alternative design existed that would have prevented the harm to her daughter.

Punitive damages. Rheinfrank was able to pursue punitive damages based on her common law negligence claims but is precluded from seeking them under statutory products liability claims because the FDA has not found that fraud or misrepresentations occurred.

Remaining claims. Rheinfrank failed to present sufficient evidence that she or her physician relied upon Abbott’s misrepresentations and/or omissions, and therefore, summary judgment in favor of Abbott was appropriate. However, Abbott failed to meet its burden demonstrating that it was entitled to summary judgment based on the claims for breach of express warranty, nonconformance with representations, breach of implied warranty of merchantability, breach of implied warranty of fitness, and loss of consortium.

The case is No. 1:13-cv-144.

Attorneys: Barry David Jacobson Levy (O'Connor Acciani & Levy) for Pamela Rheinfrank. Kathleen F. Sullivan Hardway (Venable LLP) for Abbott Laboratories Inc., Abbvie Inc., Abbott Laboratories.

Companies: Abbott Laboratories, Inc.; Abbvie, Inc.; Abbott Laboratories

MainStory: TopStory PLDrugNews LabelingNews FDCActNews PreemptionNews PrescriptionDrugNews SafetyNews OhioNews

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