In its non-precedential decision filed on May 11, 2016, the Superior Court of Pennsylvania (“Superior Court”) affirmed a $3 million Pennsylvania jury verdict in favor of the parents of a child born with a cleft lip and palate that the plaintiffs alleged were due to defendant Janssen Pharmaceuticals, Inc.’s (“Janssen”) negligent failure to warn the woman’s prescribing health care providers of the risks of birth defects associated with the use of the migraine medication Topamax during pregnancy.
The child’s mother had experienced severe migraine headaches since she was 10. Beginning in 2006, she was prescribed Topamax for migraine treatment. On December 26, 2007, she found out that she was pregnant (she and her husband had been trying to conceive a child). One of her treating physicians prescribed Topamax for the duration of her pregnancy and none of her physicians warned her that taking Topamax during pregnancy would put her baby at risk for developing cleft lip and palate.
The child was born on August 17, 2008 with a severe bilateral cleft lip and palate. She has undergone multiple surgeries affecting her jaw, nose, and lips. The child has experienced hearing loss and speech problems, and she has been bullied because of her speech and appearance.
The Pennsylvania drug claim jury had awarded $1.5 million to the minor child for her non-economic damages and $1.5 million to the child’s parents to pay for anticipated healthcare expenses for their child, following a fifteen-day trial that ended on March 7, 2014. Post-trial motions filed by the parties were denied by the trial judge and Janssen thereafter filed its notice of appeal.
The Superior Court held that the evidence presented at trial indicated that Janssen knew of a causal relationship between Topamax and specific defects, including cleft palate, but failed to disseminate the information so that the woman’s physicians would be adequately warned (the Superior Court rejected Janssen’s federal law preemption arguments).
The Superior Court also rejected Janssen’s argument that the mother was at least partially at fault for her child’s birth defects because she decided to continue to take Topamax during her pregnancy. The Superior Court stated that Janssen’s focus on the mother’s actions as a patient was misplaced because the plaintiffs’ cause of action involved the learned intermediary doctrine under which the pharmaceutical company’s duty to warn flows exclusively to the prescribing physician.
The Superior Court affirmed the jury’s award of future medical expenses in the amount of $1.5 million, which was more than three times the amount that was testified to by the plaintiffs’ damages expert. The Superior Court stated that the plaintiffs’ damages expert’s testimony was an estimate and did not represent an “outside limit.” Furthermore, the jury heard testimony regarding the severity of the child’s oral clefts that were resistant to repair, resulting in fistulas that have required repeated procedures. The Superior Court noted that the life care plan had not specifically addressed the complication-prone medical history of the child, and that the jury’s verdict “is by no means shocking.”
Source Anderson v. Janssen Pharmaceuticals, Inc., No. 2330 EDA 2014.
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