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Engleman v. Ethicon, Inc.

Superior Court of Pennsylvania

September 20, 2019


          Appeal from the Judgment Entered, September 12, 2017, in the Court of Common Pleas of Philadelphia County, Civil Division at No(s): March Term, 2014 - No. 05384.



          KUNSELMAN, J.

         Ethicon, Inc. and Johnson & Johnson ("the manufacturers") designed, produced, marketed, and sold transvaginal-mesh, named "TVT-Secur, " from 2006 through 2012. Unaware of the mesh's health risks, in 2007, Margaret Engleman's physicians implanted the product in her to treat stress urinary incontinence ("SUI"). This surgery occurred in Philadelphia.

         In 2013, Ms. Engleman sued the manufacturers in the Court of Common Pleas of Philadelphia. She claims their vaginal mesh permanently damaged her internal organs, continues to cause her pain and suffering, and will negatively impact her standard of life indefinitely. Because Ms. Engleman and the manufacturers are New Jersey residents, the parties agreed New Jersey's substantive law governs this case.

         The manufacturers argued at trial that the statute of limitations time-barred Ms. Engleman's lawsuit. The jury disagreed, found them liable, and awarded her $20, 000, 000 in damages. Both sides appealed.

         The manufacturers continue to argue Ms. Engleman's case is time-barred. Additionally, they argue the punitive damages must be reduced. We agree that, under New Jersey's punitive-damages cap, this Court must reduce the punitive damages to $12, 500, 000 – i.e., to five times the compensatory damages of $2, 500, 000. This lowers the jury's total verdict to $15, 000, 000. In all other respect, we affirm the judgment below.

         Factual Background

         Ms. Engleman filed this lawsuit against the manufacturers on October 8, 2014. Among many defenses raised at trial, the manufacturers asserted the two-year statute of limitations for personal-injury causes of action.

         The facts set forth in the trial court's 1925(a) Opinion are as follows:

Beginning in 2003, Dr. Gregory Bolton, a Philadelphia gynecologist, began treating [Ms. Engleman] for mild stress urinary incontinence ("SUI"). In June 2007, Dr. Bolton recommended surgery.
On June 14, 2007, Dr. Bolton performed surgery to correct [Ms. Engleman's] incontinence and implanted [the manufacturers'] Tension Free Vaginal Tape Secur ("TVT-Secur"). A month after surgery, [Ms. Engleman] experienced pain in her vagina and a return of urinary incontinence. In September 2007, Dr. Bolton surgically removed [part of the] TVT-Secur mesh which was exposed in [Ms. Engleman's] vagina.
[Ms. Engleman's] vaginal pain continued and her incontinence increased. Dr. Bolton referred [Ms. Engleman] to Dr. Joseph Montella, a urogynecologist at Thomas Jefferson University Hospital in Philadelphia. In February 2008, Dr. Montella performed a third surgery and removed all but approximately three centimeters of the TVT-Secur. In 2012 and 2013, [Ms. Engleman] pelvic pain returned. [Ms. Engleman's] new gynecologist, Dr. Geoffrey Bowers, identified additional TVT-Secur erosion in [Ms. Engleman's] vaginal wall. In December 2013, Dr. Montella performed yet another procedure to remove the remaining mesh. [Ms. Engleman] continued to experience dyspareunia, vaginal spasms, and sexual dysfunction following the surgery.
[Ms. Engleman] continued to treat with Dr. Bowers for chronic vaginal pain, urgency, and frequent urination. Physical therapy, oral medications, creams and vaginal suppositories failed to alleviate [Ms. Engleman's] symptoms. [Ms. Engleman] testified that her pain has changed her life "drastically."

Trial Court Opinion, 1/23/18, at 2-3.

         The case proceeded to a jury trial in April 2017. The jurors found the manufacturers' vaginal mesh defective under New Jersey's Product-Liability Act[1] and awarded Ms. Engleman compensatory and punitive damages. The trial court denied all post-trial motions, including the manufacturers' request for a new trial. The manufacturers timely appealed. [2]

         They bring eleven appellate issues before this Court, which we have reordered for ease of disposition as follows:

1. Did the trial court err in not awarding defendants judgment as a matter of law under the two-year statute of limitations?
2. Did the trial court err in excluding evidence of public-health notices issued in 2008 and 2011 that linked Ms. Engleman's symptoms with the type of mesh device she was implanted with?
3. Did the trial court commit reversible error by barring all evidence from the federal Food and Drug Administration (FDA) regarding TVT-Secur, an FDA-regulated medical device?
4. Did the trial court commit reversible error by admitting evidence regarding Australian complaints about TVT-Secur that Ethicon received months after Ms. Engleman's implantation surgery?
5. Did the trial court err when it refused to remit the compensatory-damages award?
6. Should the punitive-damages award be eliminated, because New Jersey law prohibits any award?
7. Should the punitive-damages award be eliminated or reduced, because the award violates New Jersey law and is constitutionally excessive?
8. Did the trial court err in instructing the jury to consider whether fraudulent concealment tolled the statute?
9. Did the trial court commit legal error in not awarding defendants judgment as a matter of law on the design-defect claim, when Ms. Engleman failed to present legally sufficient evidence of a safer, effective, feasible, and available alternative design to TVT-Secur?
10. Did the trial court commit legal error in excluding evidence demonstrating that Ms. Engleman's theoretical "alternative" was neither available in 2007 nor safer than TVT-Secur?
11. Did the trial court commit legal error in refusing to instruct the jury that Ms. Engleman was required to prove a safer, effective, feasible, and available alternative design?

See Manufacturers' Brief at 3-4.

         Manufacturers' Request for Judgment N.O.V. under Pennsylvania's and New Jersey's Statute of Limitations

         As their first appellate issue, the manufacturers assert that the trial court erred by not granting them judgment notwithstanding the verdict ("n.o.v.") on their statute-of-limitations defense. They argue Ms. Engleman brought this case well after the two-year statute of limitations had expired, under both New Jersey and Pennsylvania law. Thus, they believe they are entitled to a judgment as a matter of law, regardless of which state's statute applies.

         The trial court ruled that Pennsylvania's statute of limitations applied and instructed the jury accordingly. The jury found that Ms. Engleman had timely filed her lawsuit, and the trial court denied the manufacturers' post-trial motion for judgment n.o.v. on this issue. As we will explain below, Pennsylvania's statute of limitations and corresponding discovery rule apply.

         When reviewing a trial court's ruling on a post-trial motion for judgment n.o.v., our scope of review:

is plenary, as with any review of questions of law. Our standard of review when examining the lower court's refusal to grant a judgment n.o.v. is whether, when reading the record in the light most favorable to the verdict winner and granting that party every favorable inference therefrom, there was sufficient, competent evidence to sustain the verdict. Although we accord deference to a trial court with regard to its factual findings, our review of its legal conclusions is de novo.

Bailets v. Pennsylvania Tpk. Comm'n, 181 A.3d 324, 332 (Pa. 2018). To the extent that the manufacturers challenge the trial court's interpretations of various statutes, they "present this Court with questions of law for which our standard of review is de novo, and our scope of review is plenary." Id.

         To support their assertion for judgment n.o.v., the manufacturers begin by claiming that we should apply New Jersey's statute of limitations, because they think that Ms. Engleman's claim accrued there. See Manufacturers' Brief at 21 n. 2. Under New Jersey law, the trial court, and not the jury, decides whether the discovery rule tolls a plaintiffs' claims. Compare Burd v. New Jersey Telephone Co., 386 A.2d 1310, 1312 (N.J. 1978) (accepting, for New Jersey statute-of-limitations purposes, "findings of fact made by the trial judge") with Nicolaou v. Martin, 195 A.3d 880, 894-895 (Pa. 2018) (reinforcing Pennsylvania's long history of submitting all statute-of-limitations factual disputes to a jury).

The manufacturers contend that:
Plaintiff's claims accrued in New Jersey, where she resides and experienced complications. Thus, Pennsylvania's borrowing statute compels the Court to apply New Jersey limitations law if it first bars Plaintiff's claims. 42 Pa.C.S.A. § 5521(b).

Manufacturers' Brief at 21 n. 2.

         We disagree. Pennsylvania's Uniform Statute of Limitations on Foreign Claims Act only applies to claims "accruing outside this Commonwealth . . . ." 42 Pa.C.S.A. § 5521. Thus, we must establish when and where Ms. Engleman first suffered harm from the manufacturers' product.

         The manufacturers suggest that their mesh only harmed Ms. Engleman after she returned home from Pennsylvania to New Jersey. In support of their contention, the manufacturers cite to Gwaltney v. Stone, 564 A.2d 498 (Pa. Super. 1989). That case cuts against them.

         Gwaltney involved a car accident in Tennessee, but the plaintiffs filed suit in Pennsylvania. This Court held that Tennessee's one-year statute of limitations applied, because "a claim accrues when and where the injury is sustained." Id. at 501 (emphasis in original). Because the wreck happened in Tennessee, the Gwaltneys sustained their injuries in Tennessee.

         Here, Ms. Engleman's doctors implanted the manufacturers' defective vaginal mesh in Philadelphia. See Complaint at 6. Additionally, the manufacturers failed to warn Ms. Engleman and her doctors that their product could harm her in the manufacturer's product literature in Pennsylvania. When Ms. Engleman's surgeons implanted the vaginal mesh inside her body, the manufacturers' tort of product liability was completed and accrued. Thus, as in Gwaltney, we conclude that Ms. Engleman's cause of action accrued in the state where the wrongful conduct occurred – i.e., in Pennsylvania.

         The manufacturers' suggestion that Ms. Engleman's tort accrued in New Jersey, because that is where she first felt pain from their vaginal mesh, has no basis in the law. Were we to accept their theory that the situs of pain dictates where and when a cause of action accrues, then a person in a Tennessee car accident, who did not feel its effects until returning to Pennsylvania, would be able to circumvent Gwaltney simply because his injury did not manifest itself immediately. But the event that caused the underlying harm – i.e., the tort – would have still occurred in Tennessee. The same is true of Ms. Engleman. The harmful event occurred in Pennsylvania, even though the resultant pain manifested after she returned to New Jersey.

         Thus, the Uniform Statute of Limitations on Foreign Claims Act does not apply in the instant case, because Ms. Engleman's cause of action did not accrue in a foreign jurisdiction. It accrued here. As a matter of law, the trial court properly applied Pennsylvania's statute of limitations to Ms. Engleman's lawsuit.

         Under Pennsylvania's two-year statute of limitations for personal injuries and corresponding discovery rule, whether a plaintiff exercised reasonable diligence in investigating the cause of her injuries generally raises a question of fact for the jury. See 42 Pa.C.S.A. § 5524; see also Nicolaou, supra. As the trial court explained:

In Pennsylvania, the discovery rule is a judicially created exception that tolls the applicable statute of limitations when an injury or its cause was not known or reasonably knowable. Fine v. Checcio, D.D.S., 870 A.2d 850 (Pa. 2005). The discovery rule is invoked in cases "involving latent injury, and/or instances in which the causal connection between an injury and another's conduct is not apparent." Wilson v. El-Daief, 964 A.2d 354, 361-62 (Pa. 2009). "Application of the discovery rule involves a factual determination as to whether a party was able, in the exercise of reasonable diligence, to know of his injury and its cause. Therefore, application of the rule ordinarily must be decided by a jury." Mariner Chestnut

Partners v. Lenfest, 152 A.2d 265, 279 (Pa. Super. 2016) . . .

During trial, [Ms. Engleman] introduced sufficient evidence to permit the jury to decide whether her claims were timely filed. [Ms. Engleman] testified that she believed that her body was rejecting the pelvic mesh for an unknown reason and that this was the cause of her symptoms. She further testified that, in December 2013, she saw advertisements on television describing the symptoms she was experiencing, and that the advertisements connected the symptoms to TVT-Secur. For the first time, [Ms. Engleman] testified, she was made aware of the connection. On April 2, 2014, within two years of learning of the potential defect, [Ms. Engleman] filed suit.
It is undisputed that none of Plaintiff's physicians advised [Ms. Engleman] of a possible defect in the TVT-Secur. Dr. Bolton testified that he was unaware of any possible defects. Dr. Montella testified that he did not suspect the TVT-Secur caused [Ms. Engleman's] symptoms.
It was proper as a matter of law for the trial court to apply Pennsylvania law with regard to the statute of limitations and the discovery rule. Under Pennsylvania law, the trier of fact determines whether the statute of limitations is tolled by the discovery rule. Viewed in the light most favorable to the [Ms. Engleman], as the verdict winner, the evidence presented at trial was sufficient to permit the jury to determine that [Ms. Engleman] filed suit within two years of learning the cause of her injuries.

Trial Court Opinion, 9/5/17, at 12-13 (emphasis added; citations to the record omitted). The trial court properly submitted the question of whether the discovery rule tolled the Pennsylvania statute of limitations to the jury.

         Because the jury believed Ms. Engleman's version of events, we must defer to its finding of fact that the discovery rule tolled the statute of limitations on her claims. As such, the manufacturer's claim for judgment n.o.v. warrants no relief. See Nicolaou, 195 A.3d at 894-895 (Pa. 2018) (holding "courts may not view facts in a vacuum when determining whether a plaintiff has exercised the requisite diligence as a matter of law, but must consider what a reasonable person would have known had he or she been confronted with the same circumstances that [plaintiff] faced at the time").

         Admissibility of FDA's Website Notifications on Vaginal Mesh

         For their second claim of error, the manufactures assert the "trial court erred by excluding evidence showing that [Ms. Engleman's] claim was time- barred." Manufacture's Brief at 31. Specifically, the manufactures disagree with the trial court's decision to exclude from evidence public-health notices from the Food and Drug Administration (FDA) website.[3] See id. In support of their theory that the trial court erred, the manufacturers offer a case from the United States Court of Appeals for the Fourth Circuit, Timothy v. Bos. Sci. Corp., 665 F.App'x 295 (4th Cir. 2016).

         The manufacturers challenge both the trial court's finding that the FDA website notices were irrelevant and hearsay. They argue that, under the discovery rule, Ms. Engleman should have "the knowledge that a reasonable investigation would have uncovered . . . ." Manufacturers' Brief at 32. Not only do they view the notices as relevant as to when the statute of limitations began to run, the manufactures say the notices are "dispositive." Id.

         Our standard of review for a challenge to an evidentiary ruling is the deferential abuse-of-discretion standard, and, even if an abuse of discretion occurred, we will not disturb the result below without some harm or prejudice befalling the appellant. As we have said:

Admission of evidence is within the sound discretion of the trial court and we review the trial court's determinations regarding the admissibility of evidence for an abuse of discretion. To constitute reversible error, an evidentiary ruling must not only be erroneous, but also harmful or prejudicial to the complaining party. For evidence to be admissible, it must be competent and relevant. Evidence is competent if it is material to the issue to be determined at trial. Evidence is relevant if it tends to prove or disprove a material fact. Relevant evidence is admissible if its probative value outweighs its prejudicial impact. The trial court's rulings regarding the relevancy of evidence will not be overturned absent an abuse of discretion.

Czimmer v. Janssen Pharm., Inc., 122 A.3d 1043, 1058 (Pa. Super. 2015) (quoting Conroy v. Rosenwald, 940 A.2d 409, 417 (Pa. Super. 2007)).

         An "abuse of discretion" is not merely an error of judgment. Paden v. Baker Concrete Construction, Inc., 658 A.2d 341, 343 (Pa. 1995). It only occurs when a trial court renders a judgment that is manifestly unreasonable, arbitrary, or capricious, or if it fails to apply the law or was motivated by partiality, prejudice, bias, or ill will. Harman v. Borah, 756 A.2d 1116, 1123 (Pa. 2000). If the record ...

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