By Jeffrey H. Brochin, J.D.
A Pennsylvania trial court properly asserted personal jurisdiction over Ethicon, Inc., a manufacturer of pelvic mesh implants, in a products liability action, and did not commit error in denying the company’s motion for judgment notwithstanding the verdict, an appellate panel in that state ruled. In addition, the trial court did not err in its jury instructions regarding safer alternative designs, nor did it abuse its discretion in denying Ethicon’s post-trial motion for remittitur of a $5.5-million compensatory damages verdict or a $7-million punitive damages verdict rendered against the company, the panel found (Hammons v. Ethicon, Inc., June 19, 2018, Stabile, V.).
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 the patient’s vaginal wall, and two holes in her bladder were repaired. In January 2013, however, 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, but the patient continued 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 [see Products Liability Law Daily’s December 23, 2015 analysis]. Ethicon sought a judgment notwithstanding the verdict, which the trial court denied, and the company appealed the trial court’s decision.
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 the Prolift implant. Ethicon argued that a reasonable person in her position would have realized the possibility that Prolift was to blame, given her prolonged/persistent post-surgical pain and incontinence. However, the trial court found that as of January 28, 2010, two experienced gynecologists had failed to diagnose Prolift as the cause of her injuries and, as such, the jury could conclude that it was reasonable for her not to have drawn any connection between the mesh and her condition. The appeals court affirmed the trial court’s ruling that Ethicon was not entitled to judgment notwithstanding the verdict based on the statute of limitations because less than two years had elapsed between the August 16, 2011 date when she authorized release of her implant medical records and the date she filed her lawsuit, i.e., 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 appellate panel disagreed with both arguments, noting that the Indiana Products Liability Act (IPLA) does not require proof of a safer alternative design and that, 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 panel 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 lower court improperly admitted the testimony of an Ethicon corporate designer that the company had destroyed over 20,000 documents possessed by high-ranking employees relating to the development of Prolift. However, the appellate panel held that the trial court acted within its discretion by permitting the patient to present testimony regarding the document destruction.
Damages. The panel 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 Nos. 1522 EDA 2016 and 1526 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
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