By George Basharis, J.D.
A jury award of over $13.5 million against Johnson & Johnson to the recipient of Ethicon’s transvaginal tape was affirmed by the Superior Court of Pennsylvania.
The Superior Court of Pennsylvania affirmed a jury’s award of $3.5 million in compensatory damages and $10 million in punitive damages against transvaginal mesh device maker Johnson & Johnson and its subsidiary Ethicon for faulty design. The evidence supported claims by an implant patient that the Ethicon TVT® device used to treat stress urinary incontinence eroded inside of her, causing her organ damage and permanent pain (Carlino v. Ethicon, Inc., April 11, 2019, Stabile, V).
Injury and lawsuit. Ethicon’s TVT device was implanted in the patient in August 2005 to correct incontinence. Her doctor advised her that complications of the surgery included bleeding, infection, and possible organ damage, although there was conflicting testimony as to whether the patient was advised that the TVT itself could cause post-operative complications. After experiencing pain, the patient had corrective surgery in November 2007 to revise and remove part of the Ethicon device. Another corrective surgery was performed in December 2010. Her pain returned again in late 2012, and in 2013, the patient filed a product liability lawsuit against Johnson & Johnson and Ethicon, Inc. The lawsuit alleged that the patient suffered injuries from a design defect in the TVT and that Ethicon failed to adequately warn of the TVT’s medical risks.
Following trial, the jury determined that Ethicon’s TVT was defective because it posed a high risk of catastrophic injury to patients and that Ethicon sold the device without adequate warnings. The jury awarded the patient compensatory damages for past and future pain. It also awarded punitive damages after finding that the TVT had a high probability of failure and risk of injury of which Ethicon was aware but nonetheless continued to market the device.
Statute of limitations. Ethicon argued that the patient’s product liability lawsuit was barred by the applicable two-year statute of limitations. The trial court properly rejected the argument because it wasn’t until 2014 and 2015 that the patient’s doctor determined that the patient’s pain and discomfort were chronic conditions and not temporary. Although there was evidence that the patient’s doctors may have identified the TVT as the source of the patient’s pain in 2007 and 2010, other medical records suggested that the patient was told that the source of her pain was the corrective surgeries. This fact-sensitive question was decided in the patient’s favor.
FDA evidence. The trial court excluded evidence of the FDA’s section 501(k) clearance of the TVT device in 2008 and an FDA publication in 2013 relating to the safety of the device. Turning first to the section 501(k) clearance, the panel determined that the trial court did not err by excluding this evidence because a section 501(k) clearance does not constitute the FDA’s approval of a medical device. It is not a substitute for premarket approval. The clearance process allows a device to remain on the market only until the FDA completes a premarket approval for it.
Ethicon argued that the trial court also erred by not permitting it to offer as evidence an FDA publication regarding the safety of TVTs. However, the trial court correctly determined that the publication was irrelevant. It stated that TVT devices are safe for 70 to 80 percent of patients "within one year" of incontinence surgery. The patient’s problems began almost two years after her initial implant surgery, and the essence of her case was that the TVT was defective because of long-term erosion. Further, Ethicon’s counsel violated the trial court’s order precluding the FDA evidence when, referring to the publication, counsel asked the patient’s doctor whether he would have recommended the implant had he known of the FDA’s position regarding the short-term safety of TVT devices. An appropriate sanction for the violation was to preclude Ethicon from introducing its entire cross-examination and re-cross-examination of the doctor.
Design defect. Ethicon argued that the patient’s design defect claim required evidence of a safer alternative. Not only did the patient introduce evidence that a reasonably feasible alternative to the TVT design was available, the jury was correctly instructed that the patient was required to prove the existence in August 2005 of a reasonably feasible alternate design unless the risk involved in the TVT’s use outweighed its utility even though there was no reasonably feasible alternative design.
Damages. The trial court did not abuse its discretion by upholding the jury’s award of compensatory and punitive damages. The jury’s verdict was based on evidence of chronic and irreversible pain, emotional harm, and injury to her marriage. Further, expert testimony and the testimony of Ethicon’s medical director established that the TVT has a high rate of failure, and the rate of long-term success as a treatment of incontinence is only 66 to 68 percent. However, Ethicon officially reported that the TVT had a success rate of over 90 percent. It also did not warn about the TVT’s risk for causing severe and permanent injury. Under the circumstances, the evidence supported the jury’s award of punitive damages.
The cases are Nos. 1129-EDA-2016 and 1294-EDA-2016.
Attorneys: Shanin Specter (Kline & Specter, PC) for Sharon Carlino and Charles Carlino. Dorothy Alicia Hickok (Drinker Biddle & Reath, LLP) and Nils Burton Snell (Butler Snow LLP) for Ethicon, Inc. and Johnson & Johnson.
Companies: Ethicon, Inc.; Johnson & Johnson
MainStory: TopStory FDCActNews MDeviceNews PLDeviceNews SafetyNews
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