Products Liability Law Daily Patient granted new trial in mesh injury case against Ethicon
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Friday, April 17, 2020

Patient granted new trial in mesh injury case against Ethicon

By Susan Engstrom

Jury’s finding that the device did not cause injury was against the weight of the evidence.

A state trial court did not abuse its discretion in ordering a new trial for a patient who alleged that she was injured as a result of a defectively designed implantable pelvic-mesh device manufactured by Ethicon, Inc. and Johnson & Johnson, the Superior Court of Pennsylvania held. The jury had found in favor of the manufacturers even though their own causation expert had acknowledged during trial that from 2011 to 2012, the erosion of the mesh (as found by the jury to be a defect) had caused the patient to suffer from injuries such as pelvic pain and mesh exposure. Thus, the jury’s finding that the device did not cause the patient’s injuries was against the weight of the evidence, warranting a new trial on damages. The new trial also must re-litigate the issue of the manufacturers’ liability for design defect, the court determined (Adkins v. Johnson & Johnson, April 15, 2020, Elliott, F.).

A woman from Ohio was implanted with a pelvic-mesh device known as TVT SECUR for treatment of female stress urinary incontinence. Alleging that she sustained injuries as a result of the implantation, the patient filed a product liability suit against the manufacturers of the device, Ethicon and Johnson & Johnson (collectively, Ethicon), asserting causes of action for defective design and inadequate warnings.

Prior proceedings. The case was tried before a jury, which returned a verdict in favor of Ethicon. Although the jurors found that the mesh device at issue was defective in design and that Ethicon failed to adequately warn surgeons of the device’s risk of harm, they also found that neither the design defect nor the inadequate warnings proximately caused the patient’s injuries. The trial court subsequently granted the patient’s post-trial motion and ordered the case to proceed on a damages hearing on design defect only. The trial court later determined that the new trial should not be limited to the issue of compensatory and punitive damages; it also should include re-litigation on the issue of Ethicon’s liability for design defect.

Nature of post-trial motion. On appeal, Ethicon argued that even though the patient characterized her post-trial motion as a weight-of-the-evidence challenge, its true nature was that of an inconsistent-verdict claim, and that because the patient failed to object to the trial court’s jury instructions, the verdict sheets, and/or the verdict itself, she waived her inconsistent-verdict challenge on appeal. The superior court disagreed.

In her post-trial motion, the patient had asserted that because the jury found that the device was defectively designed and because the medical testimony was undisputed that she sustained some injury because of the device, the jury’s finding of no causation was against the weight of the evidence. The superior court explained that because this challenge could not be corrected in pre-trial proceedings or during trial and ripened only after the verdict was announced, it was a challenge to the weight of the evidence, and the patient raised it properly for the first time in her post-trial motion.

Causation. Ethicon’s second argument on appeal was that the jury’s finding of no causation was not against the weight of the evidence despite its finding that the device was defective. The superior court rejected this contention as well.

Under Ohio product liability law, which governed the parties’ rights and duties in this case, the plaintiff bears the burden of proving that: (1) there was, in fact, a defect in the product manufactured and sold by the defendant that existed at the time the product left the defendant’s control; and (2) the defect directly and proximately caused the plaintiff’s injuries or loss. In the instant case, to demonstrate a design defect, the patient had proceeded under the risk/benefit theory, under which a product is defective in design if, at the time it left the manufacturer’s control, the foreseeable risks associated with its design exceeded the benefits associated with that design.

Ethicon pointed out that its causation expert testified that factors other than the at-issue device—such as smoking or failing to properly use medication—could have caused or contributed to the patient’s pain, vaginal bleeding, and the erosion of the device, such that the verdict was not against the weight of the evidence. However, Ethicon’s causation expert agreed on cross-examination that from 2011 to 2012, the erosion of the mesh (as found to be a defect by the jury) caused the patient to suffer vaginal bleeding, pelvic and vaginal pain, palpable mesh, pain with sex, and mesh exposure in her vagina. Moreover, there was no dispute that because the device caused those injuries, the patient had to have it surgically removed.

In the court’s view, because the evidence did not conflict with respect to the injuries the device caused in 2011 to 2012, as well as the necessity for surgical removal, the jury’s finding that the device did not cause any injury to the patient was against the weight of the evidence. As such, the trial court did not abuse its discretion in granting a new trial as to damages. Moreover, the superior court agreed with the lower court that the new trial also must include re-litigation on the issue of Ethicon’s liability for design defect. As stated by the trial court, because Ethicon’s defense claims were colorable and made in good faith, the issue of liability was not free from doubt and must be tried again.

The case is No. 2700 EDA 2017.

Attorneys: Kenneth Alonzo Murphy (Faegre Drinker Biddle & Reath LLP) for Kimberly L. Adkins. Lee Barry Balefsky (Kline & Specter, P.C.) for Johnson & Johnson, Ethicon, Inc. d/b/a Ethicon, Gynecare, Secant Medical, Inc., Secant Medical, LLC and Prodesco, Inc.

Companies: Johnson & Johnson; Ethicon, Inc. d/b/a Ethicon; Gynecare; Secant Medical, Inc.; Secant Medical, LLC; Prodesco, Inc.

MainStory: TopStory MedicalDevicesNews DesignManufacturingNews CausationNews ExpertEvidenceNews DamagesNews PennsylvaniaNews OhioNews

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