In its opinion filed on April 11, 2019, the Superior Court of Pennsylvania (“Pennsylvania Appellate Court”) affirmed a Pennsylvania jury’s verdict in the amount of $13,500,000.00 against Ethicon, Inc. and Ethicon’s parent company, Johnson & Johnson (collectively “Ethicon”), including affirming the jury’s determination that Ethicon was liable for punitive damages due to its willful and wanton disregard of the plaintiff’s rights for the injuries she suffered from Ethicon’s defective design of, and failure to provide adequate warnings about, its TVT device (“TVT”).
TVT is a medical product used to treat stress urinary incontinence (“SUI”). SUI is a chronic condition that causes urine to leak involuntarily during everyday activities such as laughing, coughing, sneezing, and exercise. The TVT is designed to cure or reduce SUI by supporting the mid-urethra with a tape-like sling of polypropylene surgical mesh. The mesh is knitted from filaments of Ethicon’s Prolene polypropylene, a material long used to make surgical sutures, that is cut into strips to comply with the TVT’s specific shape and design.
The mesh tape works like a hammock, supporting the urethra to stop urinary leakage. To place the tape, the surgeon makes a small incision in the vagina and then passes the tape through the incision using two trocars (hollow surgical needles) to position the tape. Once placed, only the tape remains in the body. The tape is not tied to the pelvic structure but instead is held in place by natural ingrowth of surrounding tissue into the mesh.
In 2005, the plaintiff experienced back pain caused by uterine fibroids and SUI. On August 18, 2005, the plaintiff had a laparoscopic hysterectomy and bladder sling procedure to alleviate her pain. The TVT was implanted during the bladder sling procedure. The hysterectomy was effective in alleviating the plaintiff’s back pain, and initially it seemed that the TVT implantation was successful.
In 2007, the plaintiff felt something sharp in her vagina and her surgeon advised her that part of her TVT was exposed and recommended surgery to revise the mesh and treat her pain. The plaitiff underwent corrective surgery on November 26, 2007. In 2010, the plaintiff again suffered sharp pain in her vagina. On December 17, 2010, corrective surgery was performed to remove part of the TVT. In March 2011, the plaintiff declined her doctor’s recommendation to implant a second mesh sling because she had so much trouble with the first one.
The plaintiff’s pain returned in late 2012. In April 2013, she saw a television advertisement describing her symptoms and relating them to mesh products. On June 26, 2013, the plaintiff filed suit against Ethicon alleging that (1) she suffered injuries from a design defect in the TVT and (2) Ethicon failed to adequately warn of the TVT’s medical risks.
In 2014 and 2015, the plaintiff’s doctor examined her and determined that her pain and discomfort were chronic conditions, not temporary byproducts of healing or surgery. The plaintiff’s expert examined the plaintiff in 2016 and found that the mesh remaining on the plaintiff’s left side was roped, contracted, banded, and could be felt through the vaginal wall, confirmimg that the remaining sling material shrunk up and rolled on the left side, and the right side had palpable scar tissue, where the sling used to be.
The plaintiff’s expert opined that the plaintiff’s treatment options were (1) a very invasive surgical procedure aimed at removing as much remaining material as possible though he cautioned that such a surgery would not be successful in removing all material, (2) treatment that would destroy the nerves of the vagina, or (3) pain medication. The plaintiff’s expert concluded to a reasonable degree of medical certainty that the plaintiff’s symptoms were caused by the TVT.
On February 10, 2016, the Pennsylvania jury returned a verdict for the plaintiffs (including the plaintiff’s husband) on their design defect and failure to warn claims, awarding $3,500,000.00 in compensatory damages (including $250,000.00 for the husband’s loss of consortium) and $10,000,000.00 in punitive damages. The trial court ultimately entered judgment for the plaintiffs in the amount of $13,738,119.48, including $238,119.48 in delay damages.
Pennsylvania Appellate Court Opinion
The Pennsylvania Appellate Court stated that the evidence at trial demonstrated that Ethicon knew that the TVT poses a high risk of injury but nevertheless continued to market the product, ignored calls for improvement, and failed to warn physicians of its known and serious risks.
The Pennsylvania Appellate Court stated that under New Jersey law (the law that applied to the case), a plaintiff in a design defect action generally must provide evidence of a safe and reasonable feasible alternative design. The determination whether a product has been defectively designed ordinarily involves a “risk-utility analysis,” under which a manufacturer is held liable only “if the danger posed by the product outweighs the benefits of the way the product was designed and marketed.”
The Pennsylvania Appellate Court stated that the plaintiffs had introduced evidence that reasonably feasible alternatives to the TVT design were available in 2005: Ethicon could have used either (1) macroporous Ultrapro or Vypro as the mesh in the TVT; (2) a different polymer; or (3) the different technique of lasercutting mesh. Therefore, the plaintiffs’ lawyer “fairly argued this evidence to the jury in closing argument” and “Ethicon’s objection to the jury instruction on design defect is devoid of merit.”
The Pennsylvania Appellate Court further held that the “evidence demonstrates [the plaintiff] suffered considerable physical disfigurement, pain, suffering, embarrassment, and loss of life’s pleasures, and she will continue to suffer these injuries for the remainder of her life. The court acted within its discretion under these circumstances by determining that the verdict did not shock its conscience.”
Punitive Damages Award
The Pennsylvania Appellate Court stated that New Jersey law allows punitive damages if the plaintiff demonstrates that the defendant acted with “wanton and willful disregard” of her rights and that these acts caused her injuries. N.J. Stat. § 2A:15–5.12(a). Wanton and willful disregard is “a deliberate act or omission with knowledge of a high degree of probability of harm to another and reckless indifference to the consequences of such act or omission.” N.J. Stat. § 2A:15–5.10. The standard of proof is “clear and convincing evidence.” N.J. Stat. § 2A:15–5.12(a).
The Pennsylvania Appellate Court stated that the jury may consider all evidence relevant to the defendant’s misconduct and the plaintiff’s injuries, such as: (1) the likelihood, at the relevant time, that serious harm would arise from the defendant’s conduct; (2) the defendant’s awareness of reckless disregard of the likelihood that the serious harm at issue would arise from the defendant’s conduct; (3) the conduct of the defendant upon learning that its initial conduct would likely cause harm; and (4) the duration of the conduct or any concealment of it by the defendant.
The Pennsylvania Appellate Court stated that when a plaintiff asserts that a failure to warn caused her injuries, punitive damages are appropriate where the manufacturer knew of the dangers created by its product and failed to warn users of serious health hazards. The Pennsylvania Appellate Court stated that witnesses testified during the trial that using mesh in transvaginal implantation created a high risk of injury. One piece of mesh is constructed from 80 feet of suture material knitted together so that it is heavy and thick. At the same time, the mesh has pores that are too small to allow the body to heal properly around and through mesh. The TVT mesh frays and sheds plastic particles because Ethicon used a machine to cut the mesh into the TVT’s precise shape. The implantation procedure and subsequent normal activities put tension on the mesh and collapsed its pore structure. Transvaginal implantation increases the rates of TVT degradation and of infection relative to other locations in the body, in light of the higher amount of bacteria and the oxidation processes that occur in the vagina. Ethicon’s Medical Director testified during the trial that Ethicon knew about these risks at the time it launched the TVT.
The Pennsylvania Appellate Court further stated that the TVT has a high rate of failure. Ethicon’s medical director admitted that the rate of the TVT’s long-term success as a treatment for incontinence was around 66% to 68%; however, Ethicon officially reported the success rate as over 90%. Furthermore, Ethicon’s Instructions For Use (“IFU”) in use at the time of the plaintiff’s initial surgery in 2005 provided no warning about the risks of foreign body reaction, fibriotic bridging, mesh shrinkage, vaginal scarring, vaginal perforation, nerve damage, chronic pain, dyspareunia, or complications requiring mesh removal.
Trial testimony also showed that Ethicon knew about alternatives to the TVT that were both available and safer for implantation in humans, and Ethicon’s failure to utilize available alternative designs rendered the TVT unreasonably unsafe.
The Pennsylvania Appellate Court held that “the evidence demonstrates that Ethicon knowingly understated the risks of the TVT in all six versions of the IFU published between 2000 and 2015. The IFU’s adverse reactions section did not change during that time, and it failed to acknowledge new information Ethicon was obtaining from treaters and its own researchers on adverse effects associated with the TVT. In addition, Ethicon consistently and misleadingly informed physicians that the TVT produced few adverse results and was intentionally evasive about common complications.”
The Pennsylvania Appellate Court held: “Taken as a whole, and viewed in the light most favorable to the verdict winner, this evidence permitted the jury to find Ethicon acted with wanton and willful disregard of [the plaintiff’s] rights and that this conduct caused her injuries. The evidence showed that Ethicon knew that the TVT could cause permanent vaginal and muscular pain and sexual dysfunction, because of its mesh weight, pore size, pore collapse, and particle loss. Despite this knowledge, Ethicon promoted the TVT for patients who sought to fix SUI, knowingly understated the risks of the TVT in its IFU, and consistently misled physicians that the TVT produced few adverse results.”
Source Carlino v. Ethicon, Inc., 2019 PA Super 114.
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