Health Law Daily Pennsylvania law prevails over Delaware in pelvic mesh lawsuit, keeps contested issues alive
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Friday, September 11, 2020

Pennsylvania law prevails over Delaware in pelvic mesh lawsuit, keeps contested issues alive

By Leah S. Poniatowski, J.D.

Strict liability failure to warn and design defect, in addition to negligent failure to warn and gross negligence claims, to go trial.

Certain products liability-based claims filed by a patient allegedly injured from two implanted pelvic mesh devices manufactured by Johnson & Johnson survived the manufacturer’s motion for summary judgment, largely because Pennsylvania, and not Delaware, law applied to the case, a federal district court in Pennsylvania ruled (Bernard v. Johnson & Johnson, September 9, 2020, Younge, J.).

Background. An 83-year-old Pennsylvania resident had two mesh products implanted to treat pelvic organ prolapse in 2006 and 2007, respectively. She had Johnson & Johnson’s Prolift System implanted to rest her bladder prolapse, and the tension-free Vaginal Tape (TVT) imparted to treat urinary incontinence. She had problems at the surgical site and serval years later, in 2012, underwent revision surgery. Her surgeon observed that the anterior mesh had rolled up and eroded, and the posterior vaginal mesh also has rolled up but did not erode.

She filed a personal injury lawsuit against the manufacturer, which was directly filed into the multi-district litigation (MDL) managed by a federal district court in West Virginia. Once the discovery and pretrial proceedings were completed in the MDL, her lawsuit was transferred to the federal district court in Pennsylvania. That court was directed to "immediately set [this case] for trial without reopening discovery." The manufacturer filed for summary judgment, and the patient opposed the motion. The patient sought to proceed to trial on several theories. She conceded several issues, but contested the following: negligent failure to warn, strict liability failure to warn, strict liability design defect, and gross negligence.

Validity of claims. The manufacturer argued that Delaware law should apply to the case, which would bar the strict liability claims as they are not recognized under Delaware law. In the absence of a Pennsylvania Supreme Court decision on point, the court predicted that the state high court would permit strict liability claims against a medical device manufacturer.

Choice of law. The court stated that Pennsylvania choice-of-law principles applied because the case had been properly transferred to a Pennsylvania court for trial. Pennsylvania uses a "flexible rule" for choice-of-law analysis, which combines the "significant contacts" analysis under the applicable Restatements of Conflicts of Law and a "governmental interest analysis." Thus, the court looks to whether: (1) there is an actual conflict between the states’ laws; (2) in the event there is a conflict, if it is a "true conflict" based on governmental interests, and (3), if it is a "true conflict," which state has more significant contacts and a greater interest in its law being applied.

The court determined that an actual conflict of law existed between Pennsylvania and Delaware law on the viability of strict product liability claims. With respect to the governmental interest of both states, in the application of its own law, the court concluded that Delaware has no actual interest in the outcome of this case. The lex loci delicti conflicts analysis, which Pennsylvania abandoned, was not applicable because despite Delaware being where the surgeries occurred, the cause of action was not medical malpractice. The manufacturer is headquartered in New Jersey and sold the devices through ought the United States. The manufacturer provided instructional seminars in Pennsylvania, which the patient’s doctor attended. Finally, Pennsylvania has the most significant interest in this lawsuit because the patient is a Pennsylvania resident, the progressive nature of her alleged injury occurred in Pennsylvania, and her doctor received training in Pennsylvania. Therefore, Pennsylvania law applied.

Failure to warn. Under Pennsylvania law, the patient needed to establish that the manufacturer issued a proper warning to the doctor, the warning would have altered the doctor’s behavior or treatment and the injury would have been avoided in order for her negligent failure to warn claim to survive summary judgment. The patient offered the testimony of two experts, who opined that the labeling and instructions for use were not adequate because the risk of the pelvic mesh was not disclosed. When read in conjunction with the patient’s treating surgeon, the court held that the surgeon’s judgment would have been affected in using the product. Therefore, summary judgment on negligent failure to warn was denied.

With respect to strict liability failure to warn, the patient needed to establish that the product was in a defective condition, the defect was a proximate cause of the patient’s injuries, and the defect existed at the time it left the manufacturer’s control. Further, a product is "defective" if it is distributed without sufficient warnings to put the ultimate user on notice of the dangers inherent in the product. The expert testimonies proffered by the patient outlined the deficiencies of the manufacturer’s warnings, therefore summary judgment on the strict liability failure to warn claim was denied.

Design defect. In order for the patient’s strict liability design defect claim to survive summary judgment, she needed to show that the product was in a defective condition, the defect was the proximate cause of her injuries and that the defect existed while in the manufacturer’s control. Further, the patient needed to show that the device was in a defective condition by establishing that the danger was unknowable and unacceptable to an average consumer or that a reasonable person would determine that the risk of the product would outweigh the burden or costs of precautions. The court was satisfied that the expert testimony as to the design failures of the devices, which connected the patient’s injuries to these defects. Therefore, the strict liability design defect claim was not dismissed. Additionally, because the court determined that the case should proceed to trial, it declined to dismiss the gross negligence claim as well.

The case is No. 19-cv-5184-JMY.

Attorneys: Lee B. Balefsky (Kline & Specter, PC) for Elva Bernard. Christy D. Jones (Butler Snow LLP) and David B. Thomas (Thomas Combs & Spann PLLC) for Ethicon Inc. and Johnson & Johnson.

Companies: Ethicon Inc.; Johnson & Johnson

MainStory: TopStory CaseDecisions CMSNews MDeviceNews PLDeviceNews SafetyNews PennsylvaniaNews

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