In Englemen v. Ethicon and Johnson & Johnson (“defendants”), the Pennsylvania Superior Court, affirmed the trial court’s decisions concerning: the application of Pennsylvania’s statute of limitation’s discovery rule; several evidentiary issues, remittitur, and the trial court’s decision to reduce the jury’s $20 million verdict to $15 million.
Ethicon, Inc. and Johnson & Johnson manufactured and sold TVT-Secur, a transvaginal-mesh product to treat stress urinary incontinence. In 2007, unaware of the product’s safety risks, Margaret Engleman’s physicians implanted the mesh to treat stress urinary incontinence. Importantly, the surgery occurred in Philadelphia. Over the course of the next six (6) years,
Ms. Engleman’s vaginal pain continued; her incontinence increased; and, she developed frequent urination and sexual dysfunction. During this period of time, Ms. Englemen underwent four (4) additional procedures, wherein the mesh was partially removed due to damage it was causing to her vaginal wall.
In 2013, Ms. Englemen filed suit against the defendants in Philadelphia, claiming that the dangerous defective mesh permanently damaged her internal organs, continued to cause her pain and suffering, and negatively impacted her quality of life. Parenthetically, because Ms. Englemen and the manufacturers were New Jersey residents, the parties agreed New Jersey’s substantive law governed the case. In 2017, the jury found the defendants liable for $2.5 million in compensatory damages, and $17.5 million in punitive damages. The trial court however, reduced the punitive damage award to $12.5 million. The parties appealed the jury’s decision.
On appeal, the defendants argued that plaintiff’s claims accrued in New Jersey, where she resided and experienced complications; therefore, pursuant to Pennsylvania’s Uniform Statute of Limitations on Foreign Claims Act (PUSLFCA), the plaintiff’s claims were time barred by New Jersey law. The Court disagreed, holding that the PUSLFCA, only applied to causes of action that accrued outside the commonwealth. Here, the Superior Court determined that not only was the mesh implanted in Pennsylvania, the defendants failed to warn Ms. Englemen and her doctors that their product could harm her in the manufacturer’s product literature in Pennsylvania. Therefore, it was appropriate for the trial court to submit questions for the jury to determine if plaintiff’s claim was appropriately filed within Pennsylvania’s statute of limitations.
Second, the defendants argued that the trial court erred by excluding internet based FDA notices in 2011 warning the public of the safety risks associated with their product as irrelevant to the issue of the statute of limitations. The Superior Court determined that Pennsylvania imposes a relatively limited notice requirement upon the plaintiff, and, given this limited notice requirement, Ms. Englemen did not need to scour the Internet in the hopes of possibly uncovering the FDA notices and then use them to determine whether the vaginal mesh was harming her, as a matter of law. Thus, the Court held that these notices were irrelevant to Ms. Englemen’s discovery-rule theory. Moreover, the Court stated that the FDA notices did not warn of a “defect,” so, Ms. Englemen would not have had “notice” of a “defect.”
The defendants argued that the $2.5 million verdict for compensatory damages was “excessive, exorbitant, and beyond what the evidence warrants, or where the verdict resulted from partiality, prejudice, mistake, or corruption.” (quoting Smalls v. Pittsburgh-Corning Corp., 843 A.2d 410, 414 (Pa. Super. 2004)). However, the Court held that the defendants’ claim was not the standard to be applied to the Superior Court’s review. On the contrary, the standard the defendants cited applied to the trial court, which when applying this standard, found no issue concerning the compensatory damage award. Here, the Superior Court did not find that the trial court grossly abused its discretion in upholding the $2.5 million compensatory verdict.
Next, the defendant manufacturers claimed that, under New Jersey law, punitive damages are unviable, because they are barred when a medical device is generally recognized as safe and effective pursuant to conditions established by the federal [FDA] and applicable regulations, including packaging and labelling regulations. However, the Superior Court, citing U.S. Supreme Court precedent, determined that the manufacturers’ statement that the FDA’s 510(k)-clearance process “is a safety and efficacy review” is untenable. The Supreme Court of the United States has said “the 510(k) process is focused on equivalence, not safety.” Riegel v. Medtronic, Inc., 552 U.S. 312, 323 (2008); and therefore, the Court affirmed the award of punitive damages. Finally, the Superior Court agreed with the trial court to reduce the punitive damage verdict of $17.5 million to $12.5 million because of New Jersey’s punitive-damages cap, i.e., five times the compensatory damages applied to the facts of the case.