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From Health Law Daily, June 20, 2018

No error in denying manufacturer’s motions to disregard jury verdict, damages amounts

By Jeffrey H. Brochin, J.D.

A Pennsylvania Court of Common Pleas properly asserted personal jurisdiction over Ethicon, Inc. (Ethicon) in a products liability action, and did not commit error in denying Ethicon’s motions for judgment notwithstanding the verdict, nor in their instructions to the jury regarding safer alternative designs and spoliation of records, the Superior Court of Pennsylvania has ruled. Also, the court did not abuse its discretion in denying Ethicon’s post-trial motion for remittitur of the compensatory damage verdict of $5.5 million or of the punitive damage verdict of $7 million. (Hammons v. Ethicon, Inc., June 19, 2018, Stabile, J.).

Prolift® Kit. In May, 2009, an Indiana patient suffering from prolapse of her uterus and bladder was implanted with Ethicon’s Prolift Kit (Prolift) a surgical mesh intended to improve treatment of pelvic repairs. She subsequently experienced pain during intercourse and she returned to her surgeon in July 2009 with that complaint. On a subsequent visit, the doctor diagnosed rectal prolapse and referred her to a different doctor who diagnosed incontinence, a vaginal tear and other conditions. The rectal prolapse was surgically repaired, but the patient continued to experience incontinence and recurrent prolapse as well as pain during intercourse. In August 2012 a doctor in Kentucky determined that her symptoms were caused by implantation of Prolift mesh and recommended additional surgeries for excision of the mesh and repair of the entire pelvic floor.

The mesh was surgically excised from her vaginal wall, two holes in her bladder were repaired and other procedures performed, but in January 2013, the doctor noted a new penetration of mesh into the left lateral bladder wall and he surgically removed additional mesh from her bladder. In all, he performed three surgeries, and the patient continues to suffer from incontinence and pain during intercourse. She filed suit against Ethicon in May 2013 in the Philadelphia Court of Common Pleas, and a jury awarded her a verdict of over $12 million. Ethicon sought a judgment notwithstanding the verdict which the trial court denied, and this appeal ensued.

Statute of limitations. The parties disputed whether the patient knew, or should have known through the exercise of reasonable diligence, that her symptoms were a result of implant of Prolift. Ethicon argued that a reasonable person in her position would have realized the possibility that Prolift was to blame, given her prolonged and persistent post-surgical pain and incontinence. However, the court found that as of January 28, 2010, two experienced gynecologists had failed to diagnose Prolift as the cause of her injuries, and therefore the jury could conclude that it was reasonable for her not to have drawn any connection. The appellate court affirmed the trial court ruling that Ethicon was not entitled to judgment notwithstanding the verdict based on the statute of limitations because less than two years elapsed between the August 16, 2011 date when she authorized release of her implant medical records and the date she filed her lawsuit, May 31, 2013.

Safer design alternative. Ethicon also asserted that the design defect claim should fail as a matter of law because the patient failed to prove the existence of a feasible safer alternative design, and that the trial court erred by failing to instruct the jury that the patient was required to prove that a safer alternative design was available. The court disagreed with both arguments, noting that the Indiana Products Liability Act (IPLA) does not require proof of a safer alternative design, and even if it did, the patient provided evidence that a safer alternative design existed: In January 2005, before Prolift’s product launch an Ethicon engineer suggested the possibility of using a different mesh for pelvic floor repair. The appellate court affirmed that Ethicon’s request for judgment notwithstanding the verdict failed, as did its claim that the trial court erred by declining to give a safer alternative design instruction to the jury.

Spoliation of records. Ethicon also sought a new trial on the ground that the trial court improperly admitted the testimony of an Ethicon corporate designer that Ethicon destroyed over 20,000 documents possessed by high-ranking Ethicon employees relating to the development of Prolift. However, the court held that the trial court acted within its discretion by permitting the patient to present testimony as to the document destruction.

The court also denied Ethicon’s motions for remittitur of compensatory damages and punitive damages, citing the persistent pain and inability to have sex suffered by the patient, the effect on her relationship with her boyfriend, the effect on her self-image, the embarrassment and humiliation she has suffered, her multiple surgeries, and other factors.

The case is No. 1522 EDA 2016.

Attorneys: Shanin Specter (Kline & Specter, PC) for Patricia L. Hammons. Kenneth Alonzo Murphy (Drinker Biddle & Reath, LLP) and Julie Callsen (Tucker Ellis LLP) for Ethicon, Inc. and Johnson & Johnson.

Companies: Ethicon, Inc.; Johnson & Johnson

MainStory: TopStory MDeviceNews PLDeviceNews SafetyNews

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