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Gurley v. Janssen Pharms., Inc.

Superior Court of Pennsylvania

March 16, 2015


Argued October 29, 2014

Page 284

Appeal from the Judgment of the Court of Common Pleas, Philadelphia County, Civil Division, No.: May Term 2011 No. 02251. Before OVERTON, J.

Alfred W. Putnam, Jr., Philadelphia, for appellant.

Howard J. Bashman, Willow Grove, for appellees.



Page 285


Appellant, Janssen Pharmaceuticals, Inc.,[1] appeals from the judgment entered in favor of Appellees, Haley Powell, Brayden Gurley, and Michael Gurley, following a jury trial. We affirm.

We take the relevant facts and procedural history of this case from the trial court's April 25, 2014 opinion and our independent review of the record. In April 2005, at age eighteen, while living in Iva, South Carolina, Appellee Haley Powell (Haley) experienced an epileptic episode that caused her to lose consciousness.[2] In May 2005, Powell's neurologist, Dr. Bret Warner, diagnosed her as having juvenile myoclonic seizures. Dr. Warner initially prescribed Keppra and Lexapro, and Haley discontinued Lexapro within a few weeks. On March 27, 2006, Dr. Warner prescribed Topamax[3] for Haley to control her headaches and seizures, and she continued using Keppra as the main agent in treating her seizure disorder. Haley continued taking Topamax through December 1, 2007.[4] Neither Dr. Warner nor Haley

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were aware that use of the drug during pregnancy could possibly cause birth defects such as cleft lip, cleft palate, or oral palate. At the time Dr. Warner prescribed Topamax to Haley, the Food and Drug Administration (FDA) categorized it as a Pregnancy Category C drug.[5]

On November 19, 2007, Haley learned that she was pregnant with her son, Brayden Gurley (Brayden). She and her husband, Michael Gurley, had conceived Brayden in late October 2007. On November 21, 2007, Haley informed Dr. Warner that she was pregnant and he advised her to taper off Topamax. Haley reduced her intake and completely stopped taking the drug by December 1, 2007. When Haley was twenty-seven weeks pregnant, she learned through an ultrasound that her son had a cleft lip on the right side of his mouth.[6] On July 7, 2008, Brayden Gurley was born with a right side unilateral cleft lip and gum line defects. Brayden had surgery to correct the cleft lip on October 1, 2008. He still has a red scar running from under his nose to his lip as a result of the surgery. Brayden's tooth never grew in correctly in the area where there is a notch in his gum, which makes it appear as though he is missing a tooth. Brayden has difficulties with speech and becomes extremely frustrated when people cannot understand him. He treats with a speech therapist twice a week and regularly visits a plastic surgeon as part of a cleft lip and palate team. Treatments that Brayden will need in the future may include graft surgery to repair the notch in his gums, evaluations to test his hearing, psychological evaluations, dental care related to dental abnormalities, and rhinoplasty for his nasal deformity.

On May 19, 2011, Haley Powell, individually and as guardian of Brayden Gurley, along with Michael Gurley, filed a negligence complaint against Appellant based on a products liability theory. Appellees alleged, inter alia, that Appellant failed to warn Haley and her physician about the

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risk of birth defects associated with Topamax use during pregnancy, including the risk of cleft lip, and that this failure to warn resulted in Brayden's birth defect.[7] On April 1, 2013, Appellant filed a motion for summary judgment, which the trial court granted in part and denied in part.[8] On June 10, 2013, Appellant filed a motion in limine, requesting that the trial court preclude Appellees from offering evidence or argument that Appellant could have unilaterally changed Topamax's Pregnancy Category from C to D, without FDA approval. On September 26, 2013, the court entered an order granting Appellant's motion in limine.[9]

Appellees' failure to warn claim proceeded to a jury trial on October 29, 2013. On November 19, 2013, the jury returned a verdict in favor of Appellees. It awarded Appellees a total sum of $10,955,000.00; $10,620,000.00 for non-economic loss, and $335,000.00 for future health care costs. On November 22, 2013, Appellees filed a post-trial motion seeking the addition of delay damages to the verdict. Appellant filed a posttrial motion on November 29, 2013, requesting the trial court to grant judgment notwithstanding the verdict (JNOV) or a new trial. On December 3, 2013, the court denied Appellant's post-trial motion. On December 5, 2013, the court granted Appellees' request for delay damages and ordered $700,294.62 added to the verdict, resulting in a total judgment against Appellant in the amount of $11,655,294.62. This timely appeal followed.[10]

Appellant raises three issues for our review:

1. Does federal law preempt a state-law negligent failure-to-warn claim where (a) [Appellant] could not have changed the pregnancy category without the Food and Drug Administration's prior permission and assistance; and/or (b) there was clear evidence that the Food and Drug Administration would not have approved the proposed additional warning that [Appellees] advocate?
2. Did the trial court err in permitting the negligent failure-to-warn claim to go to the jury when [Appellees] could not prove causation (a) because the Topamax Haley ingested was prescribed to a different patient in a higher dosage by a doctor who had never treated Haley; and/or (b) because [Appellees] failed to meet their burden of proving that their proposed changes to Topamax's warnings would have caused either doctor not to prescribe Topamax?

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3. Did the trial court err in affirming the non-economic damage award of $10,620,000?

( Appellant's Brief, at 5).[11]

An appellate court will reverse a trial court's grant or denial of a JNOV only when the appellate court finds an abuse of discretion or an error of law. Our scope of review with respect to whether judgment n.o.v. is appropriate is plenary, as with any review of questions of law.
In reviewing a motion for judgment n.o.v., the evidence must be considered in the light most favorable to the verdict winner, and he must be given the benefit of every reasonable inference of fact arising therefrom, and any conflict in the evidence must be resolved in his favor. Moreover, a judgment n.o.v. should only be entered in a clear case and any doubts must be resolved in favor of the verdict winner. Further, a judge's appraisement of evidence is not to be based on how he would have voted had he been a member of the jury, but on the facts as they come through the sieve of the jury's deliberations.
There are two bases upon which a judgment n.o.v. can be entered: one, the movant is entitled to judgment as a matter of law, . . . and/or two, the evidence was such that no two reasonable minds could disagree that the outcome should have been rendered in favor of the movant[.] With the first a court reviews the record and concludes that even with all factual inferences decided adverse to the movant the law nonetheless requires a verdict in his favor, whereas with the second the court reviews the evidentiary record and concludes that the evidence was such that a verdict for the movant was beyond peradventure.
Questions of credibility and conflicts in the evidence are for the [fact-finder] to resolve and the reviewing court should not reweigh the evidence. If there is any basis upon which the jury could have properly made its award, the ...

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