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Hammons v. Ethicon, Inc.

Superior Court of Pennsylvania

June 19, 2018


          Appeal from the Judgment Entered April 14, 2016 In the Court of Common Pleas of Philadelphia County Civil Division at No: 3913 MAY TERM 2013

          BEFORE: OTT, STABILE, JJ. and STEVENS, [*] P.J.E.


          STABILE, J.

         In this product liability action, Appellants, Ethicon, Inc. and Johnson & Johnson, Ethicon's parent company (collectively "Ethicon") and Appellee, Patricia Hammons ("Hammons"), appeal and cross-appeal, respectively, from a judgment of $12, 850, 945.18 entered in favor of Hammons in the Philadelphia Court of Common Pleas. Hammons alleged that she suffered injuries caused by Ethicon's negligent design of, and failure to provide adequate warnings about, the Prolift Kit, a medical product used to treat prolapsed pelvic organs. Appellants challenge the trial court's denial of (1) their preliminary objections alleging lack of specific personal jurisdiction, (2) their post-trial motions seeking judgment n.o.v. on the basis of the statute of limitations and Appellee's failure to present sufficient evidence, (3) their post-trial motions seeking a new trial based on the trial court's evidentiary and instructional errors, (4) their post-trial motions seeking remittitur on the compensatory damage verdict and vacatur or remittitur of the punitive damage verdict. In her cross-appeal, Hammons argues that the trial court erred by awarding delay damages only on the compensatory damage verdict instead of the entire verdict. We affirm in all respects.


         Johnson & Johnson has its worldwide headquarters in New Jersey. Ethicon is a wholly owned subsidiary of Johnson & Johnson with a principal place of business in New Jersey. As discussed in greater detail below, Ethicon worked closely with other entities and individuals in Pennsylvania to design, test and manufacture the Prolift Kit ("Prolift").

         Our review of the record reveals the following. Pelvic organ prolapse is a pelvic floor disorder that affects the muscles and tissues that hold the pelvic organs, including the bladder, uterus, vagina, small bowel, and rectum, in place. Due to childbirth, advancing age, or other causes, these muscles and tissues can weaken, and one or more pelvic organs "prolapse, " or descend into or outside of the vaginal canal or anus. Pelvic organ prolapse is accompanied by a number of other symptoms, including a bulge or feeling of fullness in the pelvic area, back problems, pain during sexual intercourse, urinary problems such as leaking of urine or a chronic urge to urinate, or constipation.

         In the early 2000s, a group of surgeons in France developed Prolift in an attempt to improve treatment of pelvic repairs. In 2005, Ethicon brought Prolift to market. Prolift includes a precut piece of surgical mesh and single-use implanting tools called trocars. The mesh is woven from non-absorbable polypropylene sutures and is pre-cut into distinct shapes for anterior, posterior or total pelvic repairs. During implantation, the mesh is inserted into the patient's body through the vagina, pulled through the vaginal wall, placed to support prolapsed pelvic organs and anchored with mesh "arms" through a woman's bones and muscles via trocars. Prolift surgery is a quality-of-life decision.

         In 2009, Hammons, a post-menopausal woman who lives with her boyfriend in Washington, Indiana, was diagnosed with prolapse of her uterus and bladder. Her physician, Michael Baker, D.O., recommended surgical repair of her bladder prolapse and removal of her uterus and ovaries. On May 5, 2009, Hammons signed a consent form authorizing a total vaginal hysterectomy and "anterior repair with mesh." Defense Trial Exhibit ("DTX")-36. The form stated that Dr. Baker advised Hammons why the procedure was necessary, "the risks thereof, [and] its advantages and possible complications . . . ." Id. On the same date, Dr. Baker performed the surgery and implanted the Prolift device in Hammons' body to support her organs. Dr. Baker wrote in his report of the operation, "I discussed the . . . risk of injury to bowel, bladder or ureter as well as . . . having pain with intercourse or other types of pain following surgery. [Hammons] agreed to these risks and wishes to proceed with surgery despite these risks." DTX-37 at 208-09. Hammons testified, however, that Dr. Baker did not tell her prior to surgery that pain during sexual intercourse was one of the risks of surgery. Notes of Testimony ("N.T."), 12/11/15 (PM), at 32.

         On July 20, 2009, Hammons returned to Dr. Baker with complaints of pinching and sharp pain that caused her to stop engaging in intimate relations. Dr. Baker noted sexual dysfunction but did not offer a causal explanation. During the next visit, Dr. Baker diagnosed Hammons with rectal prolapse, or rectocele. She sought referral to a different gynecologist, Dr. Lackey.

         In November 2009, Dr. Lackey diagnosed Hammons with pelvic pressure and incontinence, rectocele, a tear in the vaginal septum and dyspareunia (pain during sexual intercourse). In December 2009, Dr. Lackey surgically repaired the rectocele by using Hammons' own tissue to provide support for her rectum. In January 2010, Dr. Lackey told Hammons that she could resume sexual intercourse. It appears that Hammons did not visit Dr. Lackey again until January 2012.

         On August 16, 2011, Hammons signed a form authorizing the release of her "implant related medical records" for use in "plaintiff litigation for product liability." DTX-42; N.T., 12/11/15 (PM), at 63.

         In January 2012, Hammons returned to Dr. Lackey complaining of pain during intercourse. Dr. Lackey did not identify Prolift as the cause of Hammons' discomfort. On August 14, 2012, Hammons returned to Dr. Lackey complaining of incontinence and recurrent prolapse. Dr. Lackey referred Hammons to urogynecologist Michael Heit in Louisville, Kentucky.

         On August 30, 2012, Dr. Heit diagnosed Hammons with symptoms caused by implantation of Prolift mesh and recommended additional surgeries for excision of the mesh and repair of the entire pelvic floor. In November 2012, Dr. Heit surgically excised mesh from Hammons' anterior vaginal wall, repaired two cystotomies (holes in her bladder), placed a ureteral stent and repaired her recurring rectocele. In January 2013, Dr. Heit removed the ureteral stent, noting new penetration of mesh into the left lateral bladder wall. Dr. Heit surgically removed additional mesh from her bladder. In all, Dr. Heit performed three surgeries.

         Hammons continues to suffer from incontinence and pain during intercourse. Because of pain, and because her vagina is shortened and rigid with scar tissue, she has abstained from sex, causing humiliation and impairing her relationship with her boyfriend.

         On May 31, 2013, Hammons filed a civil complaint against Ethicon in the Philadelphia Court of Common Pleas ("trial court") alleging negligence, strict liability and other torts at May Term, 2013, No. 3913 ("Individual Docket"). In March 2014, the trial court transferred Hammons' case to a Mass. Tort Program action, In Re Pelvic Mesh Litigation, which encompassed all pelvic mesh cases pending in Philadelphia.

         On March 31, 2014, the trial court issued a case management order dividing the Pelvic Mesh Litigation matter into proceedings on a Master Docket and proceedings on each plaintiff's Individual Docket.[1] On the Master Docket, all pelvic mesh plaintiffs collectively were to file a "long form" complaint alleging facts and causes of action that applied globally to all pelvic mesh cases, and each defendant was to file (1) preliminary objections that raised global objections to all pelvic mesh cases or (2) an answer to the long form complaint. Within 25 days after the answer to the long form complaint, each plaintiff was to file a "short form" complaint on her Individual Docket identifying the counts of the long form complaint that she incorporated by reference and asserting any new facts or causes of action not in the long form complaint. Each defendant could then file preliminary objections on the Individual Docket raising objections that applied specifically to the short form complaint. If the defendant did not file preliminary objections, an entry of appearance by counsel for the defendant would constitute a denial of allegations in the short form complaint and an assertion of all applicable new matter and defenses.

         On May 14, 2014, the plaintiffs filed an eighteen-count long form complaint on the Master Docket against Ethicon and other defendants, including Secant Medical, Inc. and Secant Medical LLC ("Secant"), a manufacturer of surgical mesh located in Perkasie, Pennsylvania. Among the counts in the long form complaint were strict liability actions for design defect, manufacturing defect and failure to warn. The long form complaint also asserted that personal jurisdiction existed over Ethicon in Pennsylvania.

         On May 21, 2014, the plaintiffs served Ethicon with the long form complaint. On June 10, 2014, Ethicon filed preliminary objections to the long form complaint arguing that eleven of the eighteen counts failed to state a cause of action and objecting to the lack of specificity of certain averments. Ethicon did not file any objection to personal jurisdiction. Secant also filed preliminary objections seeking dismissal of the claims under the Biomedical Access Assurance Act, 21 U.S.C. § 1601 et seq. On August 22, 2014, the trial court sustained Secant's preliminary objections and dismissed all claims against Secant with prejudice. On September 2, 2014, the trial court overruled Ethicon's preliminary objections. On September 23, 2014, Ethicon filed an answer to the long form complaint with new matter.

         On October 7, 2014, Hammons filed a short form complaint on her Individual Docket. On October 28, 2014, Ethicon filed preliminary objections to the short form complaint asserting lack of personal jurisdiction. On November 6, 2014, the trial court entered an order on the Master Docket directing the parties to take discovery on the jurisdictional issue. On March 30, 2015, the trial court overruled Ethicon's motion on the Master Docket to dismiss for lack of personal jurisdiction and Ethicon's preliminary objections on Hammons' Individual Docket asserting lack of personal jurisdiction. The trial court did not provide any explanation for its ruling.

         On August 31, 2015, Ethicon moved for summary judgment on the Individual Docket. Among other arguments, Ethicon claimed that it was entitled to summary judgment on Hammons' manufacturing defect claim because there was no evidence that the Prolift device used in her surgery deviated from its intended design. On November 24, 2015, the trial court granted summary judgment to Ethicon on the manufacturing defect claim and other claims. The court left intact Hammons' design defect and failure-to-warn claims.

         Hammons' expert witnesses, gynecologist Daniel Elliott, M.D., and urogynecologist Anne Weber, M.D., testified that Prolift was defectively designed. Dr. Elliott testified that Prolift's mesh contains too much suture for implantation through the wall of the vagina. Prolift also requires implantation of approximately 260 yards of a plastic material foreign to the patient's body. Dr. Elliott testified that the mesh is over-engineered and too heavy and dense, and the pores of the mesh are too small for the product to perform properly and as intended. Another expert, Uwe Klinge, M.D., opined that Prolift mesh's one millimeter pores were inadequate. He testified Ethicon should have used a mesh with pores larger than three millimeters. Plaintiff's Exhibit ("P-") 3401 at 10-15; P-3402 at 12-17; P-3408 at 4-10.

         Dr. Elliott also testified that the process of implantation recommended by Ethicon actually causes Prolift's mesh pores to collapse. For instance, he explained, pores collapse because the vagina is a dynamic organ that moves, shifts, and changes shape with normal movement. Pores also collapse because implantation requires a physician to pull on the mesh to guide it through the vagina, the vaginal wall, and pelvic muscles to anchor it into place. Lastly, pores collapse when physicians cause tension in the mesh when they pull it under the bladder. Ethicon knew the vagina and pelvic organs create an environment different from any other (such as the abdominal cavity for which the mesh was created) but failed to modify the Prolift mesh and surgical techniques to account for the differences. P-3402 at 27-37; P-3407 at 1-7; P-3408, at 10-17; P-3415 at 6-7.

         Dr. Elliott testified that implantation of materials foreign to the body naturally causes chronic foreign body reaction and inflammatory response, and Prolift causes severe inflammatory reaction proportional to the large amount of plastic used. Severe inflammation causes scar tissue formation. Prolift mesh's small pores and pore collapse impede normal tissue growth through the pores. The mesh bands and rolls to exacerbate the inflammatory and scar formation cycle. The process results in platting or bridging, that is, scar tissue becomes rigid, contracts and bunches. As the mesh contracts, it erodes layers of tissue in the vagina and then in neighboring organs. It can become exposed in the vagina and damage the bladder, intestines and other organs, which then might experience dysfunction. Further, mesh that contracts causes tissue irritation and pulls painfully on the patient's muscles, causing chronic muscle pain and pelvic floor muscle spasms. Dr. Elliott testified that the inflammatory response is chronic and triggers a progressive cycle of mesh contraction and erosion that causes pain response and organ dysfunction. He added that pain management techniques are generally unsuccessful, and that Prolift's design precludes successful and complete excision without risk of "severe damage" to the pelvic structures. P-3401 at 2-13; P-3402, at 12-37.

         Dr. Elliott and Dr. Weber added that Prolift has limited effectiveness in repairing prolapse. Dr. Elliott testified that Ethicon's pre-launch clinical study data indicated more than a twenty percent rate of prolapse recurrence at both six and twelve months following Prolift implantation. Even by Ethicon's predefined criteria, Prolift failed performance expectations because prolapse recurs frequently and shortly after implantation. Dr. Weber testified that she independently analyzed raw clinical data and concluded Ethicon underreported the true rate of recurrence by ten percent. Dr. Weber also noted the existence of clinical experience and studies known to Ethicon that demonstrated nearly twenty percent of women suffered mesh shrinkage with pain during intercourse, and another approximately twenty percent suffered mesh erosions within a year of implantation. N.T., 12/8/15 (A.M.), at 23-64; P-3401 at 6; P-3402, at 21-24; P-3404 at 18; P-3415 at 7.

         Dr. Elliott and Dr. Weber concluded that Prolift is unsafe. Dr. Elliott further testified that Ethicon's product warnings were inadequate, because they failed to convey all of the risks of the product, including severe and permanent pain during sexual intercourse.[2] Dr. Baker, the surgeon who implanted the Prolift device, testified that he would not have recommended the product had Ethicon adequately warned him of its risks. Moreover, Ethicon knew about the risks of the product before placing it on the market. Prolift's inventors, Professor Jacquetin and Dr. Cosson, insisted both before and after Prolift's launch on replacement of the Prolene/Gynemesh mesh with a safer mesh alternative called Ultrapro. Dr. Weber agreed that Ultrapro mesh reduced the risk because it contained less mesh, had larger pores and was softer in place. Ultrapro's characteristics were thought to reduce inflammation and scar plating. N.T., 12/7/15 (A.M.), at 57-95; N.T., 12/7/15 (P.M.), at 237-48; P-3401 at 2-3, 9-12; P-3402, at 5-7, 33-35; P-3404, at 9; P-3407 at 8-12; P-3415, at 7-8; P-3417 at 1-4.

         The parties agreed that Indiana law defines the elements of Hammons' product liability claims, while New Jersey law provides the standards for determining punitive damages.[3] [4] At the end of a three-week trial, the trial court denied Ethicon's motion for directed verdict. On December 21, 2015, the jury returned a verdict that Ethicon was liable for causing Hammons' injuries and awarded compensatory damages of $5.5 million. After additional evidence, argument, and instructions, on December 22, 2015, the jury assessed an additional $7 million in punitive damages. Both sides filed post-trial motions. The trial court denied Ethicon's post-trial motions and granted delay damages upon only the compensatory award rather than the entire verdict. On May 12, 2016, Hammons filed a praecipe to enter judgment in the amount of $12, 850, 945.18 on the Individual Docket. Both sides filed timely notices of appeal and timely Pa.R.A.P. 1925(b) statements of errors complained of on appeal.


         In its appeal at 1526 EDA 2016, Ethicon raises ten issues that we have re-ordered for the sake of convenience:

1. Did the trial court commit legal error by exercising personal jurisdiction over [Ethicon], even though [Ethicon is not] incorporated in [and does not] maintain [its] principal place[] of business in Pennsylvania, and even though [Hammons'] claims do not arise from or relate to any of [Ethicon]'s contacts with Pennsylvania?
2. Did the trial court commit legal error when it denied [Ethicon]'s directed-verdict and JNOV motions, where [Hammons'] claims were barred by the statute of limitations and [Hammons] did not present legally sufficient evidence that Indiana's discovery rule extended the limitations period?
3. Did the trial court commit legal error when it denied [Ethicon]'s directed-verdict and JNOV motions, where [Hammons] failed to present legally sufficient evidence that an inadequacy in Prolift's warnings caused her alleged injuries?
4. Did the trial court commit legal error when it denied [Ethicon]'s directed-verdict and JNOV motions, where [Hammons] failed to present legally sufficient evidence that a safer alternative design to the Prolift medical device was available at the time of her May 2009 implantation?
5. Did the trial court commit reversible error by refusing to instruct the jury that, to prevail on the design-defect claim, [Hammons] was required to show a safer alternative design to Prolift?
6. Did the trial court commit legal error when it denied [Ethicon]'s directed-verdict and JNOV motions, where [Hammons] failed to present legally sufficient evidence that a defect in Prolift, as opposed to potential alternatives, caused her alleged injuries?
7. Did the trial court commit reversible error by admitting evidence and allowing argument that [Ethicon] supposedly spoliated evidence, when there was no showing or finding that spoliation occurred or that [Hammons] was prejudiced?
8. Did the trial court commit reversible error by instructing the jury that [Ethicon]'s awareness of any potential misuse of Prolift by surgeons made them responsible for all misuses of Prolift, whether or not they were foreseeable?
9. Did the trial court err when it refused to remit the compensatory damages award?
10. Did the trial court err when it denied [Ethicon]'s directed-verdict and JNOV motions as to punitive damages?

Ethicon's Brief at 3-5.

         Hammons raises the following issue in her appeal at 1522 EDA 2016: "Did the trial court improperly mold the jury's verdict to add delay damages calculated only on the compensatory portion of the verdict?" Hammons' Brief at 4.


         Ethicon first asserts that the trial court erroneously denied its preliminary objections to Hammons' Short Form Complaint, in which Ethicon argued that personal jurisdiction does not exist over Ethicon in Pennsylvania.[5]In support of this argument, Ethicon relies on the United States Supreme Court's recent decision in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco County ("Bristol-Myers"), - U.S. -, 137 S.Ct. 1773 (2017), which held that California courts lacked specific jurisdiction to entertain product liability claims by nonresidents against a nonresident drug manufacturer, where the nonresidents were not prescribed the drug in California and did not purchase, ingest or suffer injury from the drug there. Hammons responds that Ethicon waived this issue by failing to raise it in preliminary objections to the Long Form Complaint on the Master Docket. In any event, Hammons continues, Bristol-Myers actually supports the conclusion that "the trial court properly exercised specific jurisdiction over Ethicon, given Ethicon's activities in Pennsylvania relating to this case." Hammons' Supplemental Brief at 1.

         We conclude that Ethicon did not waive this issue, because the case management order for pelvic mesh cases did not require Ethicon to contest personal jurisdiction in preliminary objections to the Long Form Complaint.

         To begin with, the case management order was a valid exercise of the court's authority. In 1992, the Philadelphia Court of Common Pleas initiated the Mass. Tort Program to deal efficiently with large numbers of complex but similar tort cases by coordinating and streamlining pleadings, discovery, pretrial motions, and trial. The legal foundation for the Program is Pa.R.Civ.P. 213, which authorizes courts to consolidate related cases and issue case management orders for their efficient disposition. See Pa.R.Civ.P. 213(a) ("In actions pending in a county which involve a common question of law or fact . . . the court on its own motion . . . may order the actions consolidated[] and may make orders that avoid unnecessary cost or delay"). The case management order in this case—which appears to be a standard order in all Philadelphia mass tort cases—fits well within the boundaries of Rule 213(a) by delineating applicable procedures in pelvic mesh cases.

         The case management order restricts preliminary objections to the Long Form Complaint to issues that apply to all pelvic mesh cases. The question whether the trial court had personal jurisdiction over Ethicon did not apply to all pelvic mesh cases. While a question of personal jurisdiction over Ethicon exists with regard to out-of-state plaintiffs such as Hammons, it appears fairly certain personal jurisdiction would exist over Ethicon in actions brought by plaintiffs who underwent Prolift surgery in Pennsylvania due to the "affiliation between the forum and the underlying activity." Bristol-Myers, 137 S.Ct. at 1781 ("In order for a court to exercise specific jurisdiction over a claim, there must be an affiliation between the forum and the underlying controversy, principally, [an] activity or an occurrence that takes place in the forum State . . . When there is no such connection, specific jurisdiction is lacking regardless of the extent of a defendant's unconnected activities in the State"). Thus, Ethicon was not required to raise objections to personal jurisdiction in preliminary objections to the Long Form Complaint on the Master Docket. Indeed, as Ethicon observes, it was impossible for Ethicon to challenge personal jurisdiction in preliminary objections to the Long Form Complaint, because this complaint "lacked any of the plaintiff-specific allegations required to assert such objections—for example, the state where the plaintiff resides, the state where she had the device implanted, and the state where the injury occurred . . . When [Hammons] filed her short-form complaint that added those allegations . . . [Ethicon] promptly and timely filed their preliminary objetions to personal jurisdiction." Ethicon's Reply Brief, at 3.

         On the merits, however, we conclude that personal jurisdiction exists over Ethicon in this case. The trial court applies the following standards to preliminary objections asserting lack of personal jurisdiction:

When preliminary objections, if sustained, would result in the dismissal of an action, such objections should be sustained only in cases which are clear and free from doubt. Moreover, when deciding a motion to dismiss for lack of personal jurisdiction the court must consider the evidence in the light most favorable to the non-moving party. A defendant making a challenge to the court's personal jurisdiction has, as the moving party, the burden of supporting its objection to jurisdiction.

De Lage Landen Services, Inc. v. Urban Partnership, LLC, 906 A.2d 586, 589 (Pa. Super. 2006) (citation omitted). "Our standard of review of an order of the trial court overruling . . . preliminary objections is to determine whether the trial court committed an error of law. [Furthermore], the appellate court must apply the same standard as the trial court." Id.

         The Due Process Clause of the Fourteenth Amendment to the United States Constitution limits the authority of a state to exercise in personam jurisdiction over non-resident defendants. Burger King Corp. v. Rudzewicz, 471 U.S. 462, 471-72 (1985). The extent to which the Due Process Clause proscribes jurisdiction depends on the nature and quality of the defendant's contacts with the forum state. Id. at 474-76; Kubik v. Letteri, 614 A.2d 1110, 1114 (Pa. 1992). Where a defendant "has established no meaningful contacts, ties or relations" with the forum, the Due Process Clause prohibits the exercise of personal jurisdiction. Burger King, 471 U.S. at 472. However, where a defendant has "purposefully directed" his activities at the residents of the forum, he is presumed to have "fair warning" that he may be called to suit there. Id.

         Since International Shoe Co. v. Washington, 326 U.S. 310, 317-18 (1945), the Supreme Court has recognized two types of personal jurisdiction: general and specific. Id., 326 U.S. at 317-18. The court has general jurisdiction over a foreign corporation when its affiliations with the state are so "continuous and systematic" as to render them essentially at home in the forum State. Goodyear Dunlop Tires Operations, S. A. v. Brown, 564 U.S. 915, 919 (2011). "A court with general jurisdiction may hear any claim against that defendant, even if all the incidents underlying the claim occurred in a different State." Bristol-Myers, 137 S.Ct. at 1780. Recently, however, the United States Supreme Court held that general jurisdiction will not lie in a state in which neither a parent corporation nor its subsidiary is incorporated or has its principal place of business. Daimler AG v. Bauman, 571 U.S. 117, 134 S.Ct. 746, 762 (2014). The record does not indicate that any entity within Ethicon's corporate hierarchy is incorporated in Pennsylvania or has its principal place of business in Pennsylvania. Therefore, we need not discuss general jurisdiction concepts further.

         If general jurisdiction does not exist over a foreign defendant, it may still be subject to specific jurisdiction in Pennsylvania pursuant to Pennsylvania's long arm statute, 42 Pa.C.S.A. § 5322 ("Bases of personal jurisdiction over persons outside this Commonwealth"). Section 5322(a) contains ten paragraphs that specify particular types of contact with Pennsylvania deemed sufficient to warrant the exercise of specific jurisdiction. In addition, Section 5322(b) operates as a "catchall, " providing that jurisdiction may be exercised over persons who do not fall within the express provisions of Section 5322(a) to the fullest extent permitted by the Due Process Clause of the United States Constitution. Mendel v. Williams, 53 A.3d 810, 821 (Pa. Super. 2012) (citation omitted). Regardless, if a defendant's activities in Pennsylvania only give rise to jurisdiction under section 5322(a) or (b), the plaintiff's cause of action is limited to those activities that formed the basis of jurisdiction. See 42 Pa.C.S.A. § 5322(c) ("when jurisdiction over a person is based solely upon this section, only a cause of action or other matter arising from acts enumerated in subsection (a), or from acts forming the basis of jurisdiction under subsection (b), may be asserted against him").

         Specific jurisdiction enables a court to adjudicate claims arising from activity that occurs within the forum state's borders and is "therefore subject to the State's regulation." Bristol-Myers, 137 S.Ct. at 1780. There are three requirements for the exercise of specific jurisdiction. First, the defendant must have "purposefully availed itself of the privilege of conducting activities within the forum State or have purposefully directed its conduct into the forum State." Id. at 1785. Second, the plaintiff's claim must "arise out of or relate to" the defendant's activities in the forum state. Id. Third, jurisdiction must be fair and reasonable so as not to offend tradition notions of fair play and substantial justice. Id. The fairness factors in the third requirement that a court will consider are "the burden on the defendant, the forum State's interest in adjudicating the dispute, the plaintiff's interest in obtaining convenient and effective relief, the interstate judicial system's interest in obtaining the most efficient resolution of controversies, and the shared interest of the several States in furthering fundamental substantive social policies." Id. at 1786.

         In Bristol-Myers, a group of plaintiffs, consisting mainly of non-California residents, filed a mass tort action in California state court alleging injuries caused by a blood thinner drug called Plavix. Id. at 1778. The Supreme Court held that California did not have personal jurisdiction over the defendant with regard to claims of the non-California residents. Id. at 1783. California did not have general jurisdiction over Bristol-Myers because the pharmaceutical company was incorporated in Delaware and headquartered in New York. Id. at 1783-84. Moreover, California lacked specific jurisdiction because there was no connection to the non-residents' claims. The nonresidents did not allege they purchased, ingested or suffered harm from Plavix in California or received treatment for their injuries in California. Id. at 1778. Nor did they allege that they were prescribed Plavix in California or by California physicians. Id. The mere fact that California residents were prescribed Plavix or ingested it in California, or allegedly sustained the same injuries as the nonresidents, "[did] not allow the State to assert specific jurisdiction over the nonresidents' claims." Id. at 1781.

         Moreover, Bristol-Myers' decision to contract with a California company to distribute the drug nationally did not provide a sufficient basis for personal jurisdiction. Id. at 1783. The Court ruled that a defendant's contract with a distributor in the forum state is not itself enough to establish personal jurisdiction in the State. Id. It noted that there was no allegation that the defendant engaged in relevant acts together with the distributor in California, or that the defendant was derivatively liable for the distributor's conduct. Id.

         In short, what was needed-and what was missing-was suit-related conduct, i.e., a connection between the forum and the specific claims at issue, "principally, an activity or occurrence that takes place in the forum State." Id. at 1781. "[A]ll the conduct giving rise to the nonresidents' claims occurred elsewhere." Id. at 1782.

         The Court rejected the California Supreme Court's "sliding scale" theory establishing personal jurisdiction. Under this approach, "the strength of the requisite connection between the forum and the specific claims at issue is relaxed if the defendant has extensive forum contacts that are unrelated to those claims." Id. What the California court did "resembles a loose and spurious form of general jurisdiction." Id. For specific jurisdiction, a defendant's general connections with the forum state are not enough. Id.

         The connection between Ethicon and Pennsylvania is considerably stronger than the connection between Bristol-Myers and California. Ethicon supervised the design and manufacturing process of pelvic mesh in Pennsylvania in collaboration with Secant Medical, Inc., a Bucks County company. Ethicon also worked closely with an Allentown, Pennsylvania physician, Vincent Lucente, M.D., in developing Prolift. Both of these factors support the exercise of specific jurisdiction over Ethicon in Pennsylvania.

         To elaborate, Hammons claims that she suffered bodily injuries due to the properties of the mesh that Ethicon used in its transvaginal mesh product, Prolift. She contends that Ethicon defectively designed and manufactured the mesh with polypropylene material that was toxic, dense and inelastic. Because of its defective design, she asserts, the mesh caused scar plating, erosion of mesh into her pelvic organs, and extensive personal injuries. The record illustrates that Ethicon worked together with Secant in Pennsylvania to design, test and manufacture the Prolift mesh.

         Three high-level officials of Secant provided affidavits (R.R. 266b-278b) that Ethicon provided all material specifications for the weaving of mesh at Secant's Pennsylvania plant, including specifications concerning the mesh's elasticity, mass, and density, the specifications at the center of Hammons' claims. Ethicon delivered polypropylene filament to Secant in Pennsylvania. Id. Secant knitted the filament into large rolls of mesh in, and tested samples for, compliance with Ethicon's specifications. Id. Ethicon received the rolls of mesh from Pennsylvania and processed them further. Id. Emails between Ethicon and Secant officials demonstrate that Ethicon repeatedly communicated its requirements for mesh design and development, manufacturing, quality control, testing, and certification to Secant—all issues central to this litigation. The emails also show that Ethicon employees visited Secant's plant in Pennsylvania on multiple occasions to observe the mesh production process. This evidence establishes an affiliation between Pennsylvania and Hammons' cause of action against Ethicon for defective design of the Prolift device. Bristol-Myers, 137 S.Ct. at 1781.

         Trial evidence[6] also shows that Ethicon relied heavily on an Allentown, Pennsylvania gynecologist, Vincent Lucente, M.D., for the development, study, and marketing of Prolift. N.T., 12/8/15 (AM), at 19-60. Ethicon retained Dr. Lucente as its investigator for three important clinical studies that Ethicon funded concerning the outcomes and safety of Prolift mesh: the Gynemesh PS study of Prolift's mesh materials, the U.S. TVM study of the Prolift prototype, and the Lucente IIS study. Hammons' Trial Exhibits 750, 2299, 3404, 3410, 3416. Dr. Lucente's role was so important to Ethicon's development of Prolift that Ethicon employees traveled to Pennsylvania in February 2006 to meet with Dr. Lucente for guidance concerning the marketing and development strategy for Prolift. Id. Dr. Lucente advised it would be a "disaster" for a woman to need revision surgery with Prolift. Hammons' Trial Exhibit 3404. At Ethicon's behest, Dr. Lucente interceded on Ethicon's behalf to persuade the American College of Obstetricians and Gynecologists to remove a designation of these mesh procedures as "experimental." Hammons' Trial Exhibits 2299, 3416. Ethicon paid Dr. Lucente over $1.7 million for his services in Pennsylvania, services that were relevant to Hammons' claims. Hammons' Trial Exhibit 3404. This evidence too provides an affiliation between Pennsylvania and Hammons' design defect claim, thus permitting exercise of specific jurisdiction over Ethicon in Pennsylvania. Bristol-Myers, 137 S.Ct. at 1781; see also Cortina, 2017 WL 2793808 at *3 (two pharmaceutical companies were subject to specific jurisdiction in California based on clinical trials conducted in California that were relevant to plaintiff's claims and part of "causal chain" that led to plaintiff's injury); Symbolstix, LLC v. Smarty Ears, LLC, 152 F.Supp.3d 1027, 1036 (N.D. Ohio 2015) (in copyright infringement action in Ohio, specific jurisdiction existed over Texas company that sold educational mobile device applications, where company's contacts with speech pathologists in Ohio were central to its product development and marketing strategies).

         For these reasons, the trial court correctly denied Ethicon's motion to dismiss this action for lack of personal jurisdiction.[7]


         Ethicon argues that the trial court erred in denying its post-trial motions seeking judgment n.o.v. on the ground that Hammons' action is time-barred under Indiana's two-year statute of limitations. Hammons counters that following her May 2009 surgery, Dr. Baker and Dr. Lackey failed to discover over the next several years that Prolift caused her injuries, and since these experienced physicians could not detect the problem, neither could she. She asserts that she only became aware that Prolift caused her injuries when Dr. Heit diagnosed the problem on August 30, 2012, less than two years before May 31, 2013, the date she filed suit.

         As an appellate court, we must decide issues such as this by construing the evidence in the light most favorable to the verdict winner, Hammons. Construed in this light, the evidence establishes that August 16, 2011 was the earliest date on which Hammons had notice that Prolift caused her injuries.[8]Since this was less than two years before Hammons filed suit, Ethicon's statute of limitation argument fails.

         There are two bases on which the court can grant judgment n.o.v.:

[O]ne, the movant is entitled to judgment as a matter of law and/or two, the evidence is such that no two reasonable minds could disagree that the outcome should have been rendered in favor of the movant. With the first, the court reviews the record and concludes that even with all factual inferences decided adverse to the movant[, ] the law nonetheless requires a verdict in his favor, whereas the second, the court reviews the evidentiary record and concludes that the evidence was such that a verdict for the movant was beyond peradventure.

Menkowitz v. Peerless Publications, Inc., 176 A.3d 968, 976-77 (Pa. Super. 2017) (en banc) (citation omitted). In an appeal from the trial court's decision to deny judgment n.o.v.,

we must consider the evidence, together with all favorable inferences drawn therefrom, in a light most favorable to the verdict winner. Our standard of review when considering motions for a directed verdict and judgment notwithstanding the verdict are identical. We will reverse a trial court's grant or denial of a judgment notwithstanding the verdict only when we find an abuse of discretion or an error of law that controlled the outcome of the case. Further, the standard of review for an appellate court is the same as that for a trial court.

Id. at 977 (citation omitted).

         The Indiana Products Liability Act ("IPLA") imposes liability upon a seller for physical harm caused by a "product in a defective condition unreasonably dangerous to any user or consumer" when:

(1) the user or consumer is in the class of persons that the seller should reasonably foresee as being subject to the harm caused by the defective condition;
(2) the seller is engaged in the business of selling the product; and
(3) the product is expected to and does reach the user or consumer without substantial alteration in the condition in which the product is sold by the person sought to be held liable under this article.

Ind. Code § 34-20-2-1. In an action for design defect, "the party making the claim must establish that the manufacturer or seller failed to exercise reasonable care under the circumstances in designing the product." Ind. Code § 34-20-2-2. For purposes of a design defect claim,

[a] product is in a defective condition under [IPLA] if, at the time it is conveyed by the seller to another party, it is in a condition:
(1) not contemplated by reasonable persons among those considered expected users or consumers of the product; and
(2) that will be unreasonably dangerous to the expected user or consumer when used in reasonably expectable ways of handling or consumption.

Ind. Code § 34-20-4-1.

         In an action for failure to provide adequate warnings, a product is defective if the seller fails to: "(1) properly package or label the product to give reasonable warnings of danger about the product; or (2) give reasonably complete instructions on proper use of the product; when the seller, by exercising reasonable diligence, could have made such warnings or instructions available to the user or consumer." Ind. Code § 34-20-4-2. The plaintiff must show the manufacturer "failed to exercise reasonable care under the circumstances . . . in providing the warnings or instructions." Ind. Code § 34-20-2-2.

         The IPLA provides that the defendant may raise defenses to product liability claims. Ind. Code §§ 34-20-6-1 and 34-20-6-2. The burden of proving any defense is upon the defendant. Ind. Code § 34-20-6-2.

         Indiana Code § 34-20-3-1 provides that "any product liability action in which the theory of liability is negligence or strict liability in tort . . . must be commenced within two (2) years after the cause of action accrues . . ." Although the statute does not define "accrues, " Indiana courts have adopted a "discovery rule" under which "the two-year statute of limitations begins to run from the date the plaintiff knew or should have discovered that she suffered an injury or impingement, and that it was caused by the product or act of another." Degussa Corp. v. Mullens, 744 N.E.2d 407, 410 (Ind. 2001). "[C]ase law regarding medical malpractice claims is instructive" in Indiana product liability cases, "because medical and diagnostic issues are common between the two actions, the statute of limitations for both claims is two years, and discovery is sometimes at issue in determining whether the respective statutes of limitation have been triggered." Id.

         In Degussa, the leading Indiana case on this subject, the plaintiff suspected that workplace chemicals caused her persistent cough. On March 17, 1992, her primary care physician diagnosed her with bronchitis and told her that the cough might have several causes, including the workplace. On March 26, 1992, a specialist, Dr. Reihman, told the plaintiff that it was possible that work-related chemical exposure only was triggering an injury caused by something else. In June 1992, after performing tests, Dr. Reihman observed, "The etiology of [the plaintiff's] chronic airflow obstruction and its relationship to her work environment remains unclear." At ...

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