Hammons v. Ethicon, Inc., 1522 EDA 2016

Decision Date19 June 2018
Docket NumberNo. 1522 EDA 2016,No. 1526 EDA 2016,1522 EDA 2016,1526 EDA 2016
Citation190 A.3d 1248
CourtPennsylvania Superior Court
Parties Patricia L. HAMMONS v. ETHICON, INC., Johnson & Johnson; Gynecare; Secant Medical; Secant Medical, Inc.; Prodesco, Inc.; and Secant Medical, LLC Appeal of Patricia L. Hammons Patricia L. Hammons v. Ethicon, Inc., Johnson & Johnson; Gynecare; Secant Medical; Secant Medical, Inc.; Prodesco, Inc.; and Secant Medical, LLC Appeal of Ethicon, Inc., Johnson & Johnson; Gynecare; Secant Medical; Secant Medical, Inc.; Prodesco, Inc.; and Secant Medical, LLC

Charles L. Becker, Philadelphia, for Hammons.

Dorothy A. Hickok, Philadelphia, for Ethicon, Inc.

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

OPINION BY 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.

FACTUAL AND PROCEDURAL HISTORY

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...

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