D. N. UWY-CV14-6025333-S
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`ROBIN SHERWOOD, ET AL
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`V.
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`STAMFORD HOSPITAL
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`SUPERIOR COURT/CLD
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`J.D. OF WATERBURY
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`AT WATERBURY
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`JANUARY 10, 2017
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`THIRD SUPPLEMENTAL OBJECTION TO STAMFORD HOSPITAL’S
`MOTION FOR SUMMARY JUDGMENT
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`The Plaintiffs hereby provide additional authority in opposition to the Defendant
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`Stamford Hospital’s Motion for Summary Judgment dated September 30, 2016. Defendant
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`claims that Ms. Sherwood knew or should have known that the mesh implanted into her was
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`defective as a result of Ms. Sherwood’s suspicions or awareness that she was having problems
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`related to the mesh. Just last week that same argument was rejected in another pelvic mesh case
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`in Pennsylvania. In Carlino et al v. Ethicon, Inc., et al, In the Court of Common Pleas, First
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`Judicial District of Pennsylvania, Civil Trial Division, Case No. 1306-03470, Powell, Jr., J.,
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`January 3, 2017, attached, the court applied Pennsylvania law in concluding that the statute of
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`limitations was tolled “until such time that the plaintiff knew or should have known both that she
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`was injured and that her injuries were caused by the tortious conduct of another.” (Emphasis
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`added). Id. at 21.
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`“In Pennsylvania, the discovery rule is a judicially created exception that tolls the
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`applicable statute of limitations when an injury or its cause was not known or reasonably
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`knowable. It is for the jury to decide the knowability of the harm or its cause.” (Internal citations
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`omitted). Id. at 23. Connecticut employs an identical discovery rule in tolling the statute of
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`limitations. “Actionable harm occurs when the plaintiff discovers or should discover, through the
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`exercise of reasonable care, that he or she has been injured and that the defendant's conduct
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`caused such injury. Id.; see Lambert v. Stovell, 205 Conn. 1, 6, 529 A.2d 710 (1987).”
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`(Emphasis added). Champagne v. Raybestos-Manhattan, Inc., 212 Conn. 509, 521, 562 A.2d
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`1100, 1107 (1989).
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`In tolling the statute of limitations the Carlino court recognized that Ms. Carlino
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`underwent mesh revision surgery in 2007 and 2010. Despite Ms. Carlino’s awareness of
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`problems related to the mesh the court concluded that the statute of limitations did not begin to
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`run until 2013 when Ms. Carlino became aware that there was a defect in the mesh and that the
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`defect could be the reason for her issues.
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`Therefore, the Defendant’s motion should be denied.
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`THE PLAINTIFFS,
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`BY:__Jacqueline E. Fusco
` Brenden P. Leydon
` Jacqueline E. Fusco
` Tooher Wocl & Leydon LLC
` 80 Fourth Street
` Stamford, CT 06905
` (203) 324-6164
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` Juris No. 106151
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`CERTIFICATION
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`This is to certify that a copy of the foregoing was Emailed this date, to all counsel of
`record.
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`Eric J. Stockman, Esq.
`estockman@npmlaw.com
`Simon I. Allentuch, Esq.
`sallentuch@npmlaw.com
`Neubert Pepe & Monteith, PC
`195 Church Street
`13th Floor
`New Haven, CT 06510
`Counsel for Defendant Stamford Health
`System Inc. d/b/a Stamford Hospital
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`/s/ Jacqueline E. Fusco
` Jacqueline E. Fusco
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`IN THE COURT OF COMMON PLEAS
`FIRST JUDICIAL DISTRICT OF PENNSYLVANIA
`CIVIL TRIAL DIVISION
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`SHARON CARLINO AND CHARLES
`CARLINO,
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`Plaintiffs,
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`v.
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`ETHICON, INC., et al.,
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`Defendants
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`POWELL, JR. KENNETH J., J.
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`I.
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`Procedural History
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`June Term 2013
`No. 03470
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`1129 EDA 2016
`1294 EDA 2016
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`r··-·
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`OPINION
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`January 3, 2017
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`On June 26, 2013, the Plaintiffs, Sharon and Charles Carlino, commenced this action by
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`filing a complaint against Ethicon, Inc. ("Ethicon"), as well as numerous other defendants. On
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`October 7, 2014, in response to a case management order, the Plaintiffs filed a short-form
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`complaint clarifying that their action was against Ethicon, Johnson and Johnson ("J&J"), Secant
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`Medical, Inc., Secant Medical, LLC (collectively, hereinafter "Secant"), and Prodesco, Inc.
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`("Prodesco"). The complaint arises from the implantation of Tension-free Vaginal Tape, or TVT,
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`a transvaginal mesh product, which was surgically implanted in Ms. Carlino on August 18, 2005.
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`The complaint brought numerous claims based in New Jersey product liability law.
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`Ultimately, the jury found that Ms. Carlino's TVT has a design defect that was a cause of her
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`injuries, and further found that Ethicon failed adequately to warn of TVT' s medical risks, and
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`that the failure to warn was also a cause of Ms. Carlino's injuries. On February 10, 2016, after a
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`fourteen-day trial, the jury awarded $3.25 million in compensatory damages to Ms. Carlino,
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`Carlino Etal Vs Ethicon Women'S Health And U-OPFLD
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`13060347000639
`COPIES SENT PURSUANT TO Pa.R.C.P. 236(b) 01/04/2017
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`IIIII 11111111111111
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`$250,000 to Mr. Carlino for loss of consortium, and punitive damages of $10 million. The total
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`verdict was thus $13.5 million for the plaintiffs.
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`On February 22,2016, Ethicon and J&J filed a post-sentence motion, which this Court
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`denied on March 23,2016. On March 15,2016, this Court granted in part and denied in part the
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`Plaintiffs' motion for delay damages, molding the gross verdict of $13,500,000 to add delay
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`damages in the amount of$239,119.48, for a total judgment of$13,738,119.48. On April1,
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`2016, the parties stipulated to entry of judgment in that amount and this Court approved the
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`parties' stipulation, which further stated that Plaintiffs will not seek to execute on the judgment
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`during the pendency of the appeal. On that same date, the Defendants filed a notice of appeal to
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`the Superior Court. On April 12, 2016, the Plaintiffs filed a cross-appeal. Both parties filed
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`timely statements pursuant to Pa.R.A.P. 1925(b ).
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`II.
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`Facts
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`Ms. Carlino, a fifty-eight year old services coordinator for Monmouth University's
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`Registrar's Office, was suffering from back pain caused by uterine fibroids and stress urinary
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`incontinence ("SUI"), and her gynecologist referred her to Dr. Andrew Blechman for surgery.
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`Dr. Blechman suggested that she receive a laparoscopic hysterectomy and bilateral salpingo(cid:173)
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`oophorectomy with bladder sling procedure to alleviate her pain and SUI. On August 18, 2005,
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`Dr. Blechman implanted the Plaintiffs' TVT during the bladder sling procedure. Her
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`hysterectomy was effective in alleviating her back pain, and initially it seemed that the TVT
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`implantation was also successful. N.T. January 27,2016, a.m., pp. 57-100.
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`However, in 2007, she noticed a sharp foreign body penetrating her right vaginal wall
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`from within her body. She returned to Dr. Blechman, who removed that portion of the TVT and
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`repaired her vaginal wall. In 2010, she again felt a sharp foreign body penetrating her vaginal
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`wall from inside her body. She returned to Dr. Blechman, who told her he was hesitant to
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`perform a third procedure and referred her to a colleague, Dr. Conner. Dr. Conner removed the
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`right side of the TVT. Ms. Carlino's incontinence returned, but she elected to endure it rather
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`than risk another TVT implantation. !d. at 100-104.
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`For a time, it seemed as if her problems with the TVT had ended. But in late 2011 and
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`early 2012, she began to experience a dramatic intensification of her incontinence, pain and
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`swelling in her vagina, pain during sex, and a sensation of pulling across her leg. At the time of
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`trial, she was experiencing pain most of the time, on the right side at the site of her corrective
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`surgeries and in her left pelvic area. She takes gabapentin, which is used to treat neuropathic pain
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`(among other conditions). The pain she experiences during and after sexual intercourse severely
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`limits her ability to tolerate penetration. Before 2012, she and her husband had intercourse
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`approximately four times a week; by the time of trial, they had intercourse two or three times per
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`month, in a way that is very limited because of her pain. Her injuries have diminished their
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`sexual relationship, and they discuss the issue ofher injuries and their impact in their lives and
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`marriage on a daily basis. Because she has constant pain at the site of her rescission, penetration
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`is difficult for her to endure. She feels guilty that she can no longer engage with her husband the
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`way she was able to in the past due to her injuries. !d. at 105-112; 118-119. Her husband testified
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`that they can no longer be spontaneous with each other sexually, and that they spend a lot of time
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`discussing her pain and its impact on their lives. He said that it has limited many oftheir other
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`joint activities, such as working out together at the gym, and that it has dampened their visions of
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`their joint retirement. N.T. February 2, 2016, p.m., pp. 11-20.
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`The Plaintiffs filed suit against the Defendants on June 26, 2013. N.T. January 27, 2016,
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`a.m., p. 115.
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`Ms. Carlino testified that if she had been warned about the risks of the TVT implantation
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`(including inflammation, erosion of the TVT into the vaginal canal, degrading of the TVT in the
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`body, mechanically-cut TVT giving off fragments, and pain during sex), she would not have
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`consented to the procedure because the risks would have been far too great given the scope of the
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`problem posed by her SUI.Jd at 97-98.
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`Dr. Blechman testified that, had he known of the full panoply of risks that came with
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`TVT implantation, such as chronic foreign body response, degradation of the mesh material, and
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`permanent pain (including pain during intercourse), he would have warned Ms. Carlino of those
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`risks, and would not have recommended the implantation procedure to her, or to any patient. See
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`Deposition of Andrew Blechman, M.D., January 30, 2016, pp. 42-59.
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`Dr. Michael Margolis gave expert testimony as to urogynecology and pelvic
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`reconstruction surgery. He is a surgeon who performs pelvic surgeries, including sling surgeries,
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`though he only implants organic materials rather than TVT. He has performed surgeries in order
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`to remove TVT. SUI is the most common condition he treats, and he explained that condition.
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`He also explained the procedures by which the TVT was implanted and then removed from Ms.
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`Carlino's body. He testified, based on his examination of her, that TVT is the cause of Ms.
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`Carlino's injuries, and that it will continue to cause irreversible injury in perpetuity. January 27,
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`2016 p.m., pp. 83-123; January 28,2016, pp. 18-36.
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`Dr. Margolis also testified that the remaining TVT sling cannot be safely removed from
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`Ms. Carlino's body, and that even if it could be safely removed, she would still have a permanent
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`painful condition. She has, and will continue to have, inflammation and scarring due to the TVT,
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`along the tract of implantation. He also confirmed that the remaining TVT material is palpable,
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`and will very likely erode through her left vaginal wall, as the prior pieces of TVT did on the
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`other side. Her body is responding to the TVT by rejecting it as foreign, which is causing
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`continuous inflammation which will likely eventually result in her body pushing out the TVT.
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`Dr. Margolis testified that the TVT' s heavy weight, small pore size, and cytotoxicity all
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`contribute to its damaging impact in Ms. Carlino's body. Id. at 36-52.
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`When the 2.4 centimeter section of TVT was removed in 201 0, the tissue was sent to a
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`pathologist for examination. The pathology report documented "[ f]ragments of fibroconnective
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`tissue with mild chronic inflammation and foreign body giant cell reaction to foreign material."
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`Fibroconnective tissue is scar tissue. Giant cells are indicative of a continuous, aggressive
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`immune reaction to the foreign material. ld. at 60-62, PlaintiffExh. 44. The pathology report
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`indicated that Ms. Carlino's body is continuing to attack the remaining TVT, sending potent
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`immune cells and attempting to wall the TVT off behind scar tissue. In response, the TVT
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`contracts, potentially creating or contributing to the pulling sensation of pain that Ms. Carlino
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`experiences. Id. at 62-65.
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`The "Instructions For Use," or IFU, in use at the time the TVT was implanted listed
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`transitory local irritation and transitory foreign body response among its potential adverse
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`reactions. Ms. Carlino's experiences were not described in the listing of adverse reactions, but
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`Dr. Margolis testified that they should have been, because doctors and patients should be able to
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`rely on notifications of adverse reactions to understand the potential risks of procedures before
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`they agree to them, and because these adverse reactions were known to Ethicon at the time of
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`Ms. Carlino's surgery in 2005. ld. at 78-84.
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`Dr. Margolis' examination of Ms. Carlino confirmed that the remaining sling material has
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`"shrunk up and rolled" on the left side, and she has palpable scar tissue on the right side, where
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`the sling used to be. He identified her options for treatment as a very invasive surgical procedure
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`aimed at removing all remaining material (though he cautioned that such a surgery would not be
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`successful in removing all material), or treatment that would destroy the nerves of the vagina.
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`Pain medication is a third option. Id. at 85-88. Dr. Margolis concluded to a reasonable degree of
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`medical certainty that Ms. Carlino's symptoms are caused by the TVT implantation and
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`subsequent inflammation and surgeries caused by the implant's failure. Id. at 94-98.
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`Piet Hinoul, M.D., Ethicon worldwide medical director and designated medical affairs
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`corporate representative, acknowledged that the TVT product has a number of serious
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`complications, including erosion, pain, scarring, mesh contracture, pain during intercourse, and
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`the potential necessity of subsequent surgeries to remove mesh that was malfunctioning or
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`causing harm. See Deposition ofPiet Hinoul, M.D., June 27, 2013, at pp. 548-550. He also
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`confirmed that these risks were known to Ethicon at the time they launched the TVT product.
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`See id. at pp. 551-55. Ethicon Medical Director Dr. Martin Weisberg gave similar testimony,
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`confirming that the risk of lifelong pain and additional surgeries was known to Ethicon, but was
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`not included in the IFU. See Deposition of Martin Weisberg, M.D., August 9, 2013, at pp. 968-
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`69. Former Ethicon Medical Director, Dr. David Robinson, testified that that there is lifelong risk
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`of erosion as long as the foreign body remains in place, but that Ethicon did not warn of the
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`lifelong risk of erosion, the possibility of multiple surgeries, or permanent painful sexual
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`intercourse in the IFU or patient brochure. See Deposition of David Robinson, M.D., September
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`11, 2013, at pp. 1139-1140.
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`III.
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`Issues
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`Plaintiff raises the following issue:
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`1. On March 15, 2016, the trial court granted in part and denied in part Plaintiffs Motion for
`delay damages. This motion sought delay damages on the entirety of the jury's verdict(cid:173)
`both the compensatory award and the punitive damages award. The trial court molded the
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`jury's gross verdict of$13,500,000.00 to add delay damages of$238,119.48 for a total
`judgment of $13,738,119.48. In doing so, the trial court calculated delay damages only on
`the compensatory damages portion of the jury's verdict. The trial court denied Plaintiffs
`request that delay damages be calculated based on the punitive damages award as well. Did
`the trial court misinterpret Pa.R.C.P. 238 and err by refusing to calculate delay damages
`based on the entire verdict, including the punitive award?
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`Defendant raises the following issues:
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`1. The Court erred in permitting Plaintiffs to litigate their claims because the Court lacks
`personal jurisdiction over Defendants. Plaintiffs reside in New Jersey, yet the Court allowed
`them to litigate claims in Pennsylvania under New Jersey law against New Jersey
`defendants about conduct that occurred entirely in New Jersey. As a result, both specific
`jurisdiction and general jurisdiction were lacking under 42 Pa.C.S. § 5322 and the federal
`Constitution. See Defs.' Ethicon, Inc. and Johnson & Johnson's Mot. for Post-Trial Relief
`Pursuant to Pa.R.C.P. No. 227.1 ("Post-Trial Mot.") at 1-2.
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`2. The Court erred in denying Defendants' motions for directed verdict and post-trial relief,
`includingjnov, and Defendants' oral motion for mistrial and other curative measures, on the
`basis of preemption because Plaintiffs' claims are preempted insofar as they are based on (a)
`a state-law duty to sell an alternative design that required, but had not received, FDA's
`permission by the time of Ms. Carlino's TVT surgery; (b) a challenge to the information on
`which the FDA based its decision to permit the marketing of the product and the scope and
`content of the product's warnings; or (c) Plaintiffs' suggestion that Defendants had a duty
`not to sell TVT or to stop selling TVT altogether. See Post-Trial Mot. 17-18, 26-27, 84-86
`(citing, e.g., Wyeth v. Levine, 555 U.S. 555 (2009), PLIVA, Inc. v. Mensing, 131 S. Ct. 2567
`(2011), Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013), Buckman Co. v. Plaintiffs'
`Legal Comm., 531 U.S. 341 (2001)).
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`3. Plaintiffs did not bring suit within two years of the accrual of their claims. Accordingly,
`under either New Jersey or Pennsylvania law, these claims were barred, and the Court erred
`in permitting them to go forward and in denying Defendants' motions for directed verdict
`and jnov, in permitting improper argument on the issue, and in failing to properly charge the
`jury on the issue. See Post-Trial Mot. 7-16. In particular:
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`A. The Court erred in denying Defendants' motions for directed verdict andjnov
`because Plaintiffs' claims are time-barred. First, given Pennsylvania's borrowing
`statute, New Jersey law governs the issue, and it should have been resolved as a
`matter oflaw in Defendants' favor. By applying Pennsylvania law on this issue and
`allowing the jury to decide it, the Court improperly gave Plaintiffs greater rights than
`those available in the state where the cause of action arose. Under New Jersey law,
`Plaintiffs' claims were time-barred because they failed to present evidence sufficient
`to carry their burden of proving that the discovery rule rendered their claims timely.
`Second, even under Pennsylvania law, Plaintiffs' claims were time-barred because
`they failed to present evidence sufficient to carry their burden of proving that the
`discovery rule rendered their claims timely. In particular, Ms. Carlino was prescribed
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`TVT in August 2005, but Plaintiffs did not file suit until June 2013, even though she
`underwent revision surgeries in 2007 and 2010 to remove portions of the TVT that
`had become exposed in her vagina and, she says, caused her sharp vaginal pain.
`Given Plaintiffs' and their counsel's judicial admissions, Ms. Carlino could not rely
`on the discovery rule. It is no excuse to say that she did not know the full extent of
`her injuries or what about the mesh caused them; she was obligated to exercise
`reasonable diligence to determine any details she was lacking, yet Plaintiffs failed to
`present sufficient evidence that she did so. See Post-Trial Mot. 7-16.
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`B. In giving the case to the jury, the Court erred in not enforcing--despite Defendants'
`objections-its own ruling on nonsuit that Plaintiffs could not avoid the statute of
`limitations by claiming that they were not seeking damages from the 2007 and 201 0
`manifestations of the claimed injury. By allowing Plaintiffs to argue precisely that in
`closing, Defendants were prejudiced and a new trial is necessary. See Post-Trial Mot.
`9-10, 13-14, 84-85. In addition, the Court erroneously permitted Plaintiffs to
`encourage the jury to nullify or disregard the statute of limitations by neither ( 1)
`instructing the jury that it must consider the earliest injury that Ms. Carlino could
`reasonably have discovered, without regard to whether Plaintiffs were seeking
`damages for that injury nor (2) correcting Plaintiffs' mischaracterization of the statute
`of limitations during closing. Defendants were prejudiced by the Court's rulings and a
`new trial is necessary. See Post-Trial Mot. 84-85, 91-92
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`A. The Court erred by giving an inadequate and inaccurate instruction on Plaintiffs'
`burden to prove an alternative design that is safer, available, practical, and feasible
`and would have prevented or lessened their alleged injuries. Specifically, the Court
`erred by refusing to give Defendants' proposed instruction No. 31 and instead
`instructing the jury that Plaintiffs were required to prove a safer alternative design
`"unless the risk involved in the TVT's use outweigh its utility even though there is no
`reasonably feasible ... alternative design." These errors prejudiced Defendants and
`require a new trial. See Post-Trial Mot. 89-91.
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`B. The Court erred in denying Defendants' motions for directed verdict and jnov
`because Plaintiffs failed to present evidence sufficient to carry their burden of proving
`the existence of an alternative design to TVT that was safer, available, practical, and
`feasible and that would have prevented or lessened their alleged injuries. See Post(cid:173)
`Trial Mot. 19-27
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`A. The Court erred in providing proximate causation instructions and a verdict form that
`(1) failed to convey New Jersey law on the learned intermediary doctrine because
`they improperly asked the jury what the patient would have done if the warnings had
`been provided rather than limiting the alleged failure to warn to the prescribing
`physician and (2) did not instruct the jury that it could not find proximate causation
`when Dr. Blechman already knew the risks of the mesh at the time he prescribed it
`and testified that he did. Defendants were prejudiced by the Court's rulings and a new
`trial is necessary. See Post-Trial Mot. 31-34, 86-88, 93-96.
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`4.
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`5.
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`B. The Court erred in finding that Plaintiffs had presented legally sufficient evidence
`that an inadequacy in Ethicon's warnings caused their alleged injuries. Under New
`Jersey law, there is no duty to warn of the frequency, severity, or incidence of
`complications, but the Court permitted Plaintiffs to argue that that information was
`necessary to an adequate label. For this reason, the Court also erred in permitting
`Plaintiff to argue that Defendants were liable for failing to include that information in
`TVT's warnings. In addition, New Jersey law requires that Plaintiffs prove that the
`prescribing physician would have changed his prescribing decision if the product had
`had an adequate warning. Plaintiffs did not show that Dr. Blechman was unaware of
`the complications Ms. Carlino complained of. Because Plaintiffs failed to present
`sufficient evidence that an inadequacy in Ethicon's warnings caused their alleged
`injuries, the Court erred in denying Defendants' motions for directed verdict and
`post-trial relief, includingjnov, on this issue. See Post-Trial Mot. 31-38,74-76.
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`C. The Court erred in permitting the jury to be misled about whether Dr. Blechman's
`decision to prescribe in general would have changed had he known of Ms. Carlino's
`complications. This error, described further at~ 6, infra, arose because the Court
`admitted testimony from Dr. Blechman without permitting other testimony in which
`he clarified that the admitted testimony was based on his misunderstanding of the
`question. This and the other stricken portions of the testimony from Dr. Blechman
`would have negated the notion that an inadequacy in Ethicon's warnings caused Dr.
`Blechman to use TVT. See Post-Trial Mot. 36-38.
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`6. The Court erred in striking Defendants' cross-examination of Dr. Blechman from his mid(cid:173)
`trial deposition as a sanction, for two reasons. First, the Court erred in holding that
`Defendants violated the Court's ruling on a motion in limine regarding FDA evidence
`(which by its terms governed only the admissibility of evidence at trial) at all, because the
`deposition was taken subject to the Pennsylvania Rules of Civil Procedure governing
`discovery, including, inter alia, Pa.R.C.P. No. 4017.1(h) (providing for the transcribing of
`the portions of video depositions admitted and those excluded on objection) and the
`Pennsylvania Rules of Evidence, and the case law construing them. All parties and the Court
`understood that only portions of the deposition would be designated for trial and that the
`Court would review objections before testimony was admitted. Second, the Court further
`erred in imposing an excessive and prejudicial sanction for what (a) did not violate the terms
`of the Pennsylvania Rules of Civil Procedure or the Court's ruling on the motion in limine;
`and (b) did not take into account and was contrary to (i) the nature and severity ofthe
`supposed violation; (ii) the willfulness or bad faith of the supposed violation; (iii) prejudice;
`(iv) the ability to cure the prejudice; and (v) the importance of the evidence in light of the
`supposed failure to comply. Defendants were prejudiced by the Court's ruling, see supra at
`~S.C., and the motion for mistrial should have been granted and a new trial is necessary.
`See Post-Trial Mot. 49-54.
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`7. The Court erred in denying Defendants' motions for directed verdict and post-trial relief,
`includingjnov, and thereby permitting punitive damages to be awarded, for three reasons.
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`First, the Court lacked constitutional authority to impose punitive damages because a
`Pennsylvania jury may not award punitive damages for conduct that had no nexus to
`Pennsylvania. Punitive damages here were unconstitutional because it is entirely arbitrary to
`have a Pennsylvania jury determine whether and how to "punish" a New Jersey defendant
`for New Jersey conduct regulated by New Jersey law (to the extent that it was not
`preempted). See Post-Trial Mot. 6, 40-42. Second, the New Jersey Punitive Damages Act
`bars punitive damages when, as here, the FDA has recognized a medical device as safe and
`effective pursuant to the conditions and requirements the FDA imposes. See Post-Trial Mot.
`42-44 (quoting N.J.S.A. § 2A:58C-5). Third, under New Jersey's general punitive damages
`statute, N.J.S.A. § 2A: 15-5.12, the Court erred by permitting punitive damages to be
`awarded, because Plaintiffs failed to present evidence sufficient to prove by clear and
`convincing evidence that the acts or omissions causing the Plaintiffs' alleged harm "were
`actuated by actual malice or accompanied by a wanton and willful disregard of persons who
`foreseeably might be harmed by those acts or omissions." See Post-Trial Mot. 42,44-47. In
`the alternative, the Court should have remitted the punitive damages award. The punitive
`damages award was excessive and inconsistent with other New Jersey awards, and it should
`have been remitted, because the compensatory damages were largely non-economic, thus
`already containing a punitive element, and because the punitive damages award was
`unsupported by the evidence. See Post-Trial Mot. 99-103.
`
`8. The Court erred in failing to remit the compensatory damages award. It was excessive and
`unsupported by the evidence because (a) there was no testimony of past or future medical
`costs, and (b) the award was clearly excessive for the alleged injuries (i.e., intermittent post-
`2012 pain and its consequences), particularly in light of the testimony that Ms. Carlino's
`symptoms could be mitigated, but she refused to do so. See Post-Trial Mot. 96-99.
`
`9. The Court erred in excluding all evidence of and argument regarding FDA's clearance of
`TVT as well as related regulatory processes; FDA's advisory committee process and
`statements regarding mesh midurethral slings; FDA's approval, regulation, and study of
`Prolene suture; and FDA's regulation and study of surgical mesh. This evidence was
`admissible to counter Plaintiffs' assertions that Ethicon's warnings were inadequate and that
`TVT is defectively designed. Exclusion of this evidence also deprived Defendants of
`defenses guaranteed by New Jersey law, because (a) manufacturers who comply with FDA
`requirements, as Ethicon did here, are rebuttably presumed to have adequate labels; and (b)
`punitive damages are not permitted where, as here, a medical device has been approved or is
`generally recognized as safe and effective. Defendants were prejudiced by the exclusion of
`this evidence, and a new trial is necessary. See Post-Trial Mot. 55-65.
`
`10. The Court erred in admitting evidence that did not relate to TVT. First, the Court erred by
`admitting evidence of an October 13, 2002 email from Axel Arnaud to Martin Weisberg
`regarding the Prolene Soft material (Pls.' Trial Ex. 46), which is not used in TVT. That
`material was not at issue in this case, and impugning Defendants with it requires a new trial.
`See Post-Trial Mot. 70-71. Second, the Court erred by admitting evidence of an irrelevant
`material safety data sheet issued by Chevron Phillips (Pls.' Trial Ex. 54) regarding a product
`that Defendants neither manufactured nor used in making TVT and thus was both irrelevant
`and prejudicial, warranting a new trial. See Post-Trial Mot. 71-73.
`
`10
`
`

`

`11. The Court erred by holding that any admission of otherwise admissible evidence that TVT
`remains on the market and is the current gold-standard surgical treatment for stress urinary
`incontinence or present-tense references to TVT would open the door to Plaintiffs
`introducing evidence of changes to TVT's Instructions for Use, which is inadmissible as a
`subsequent remedial measure. These errors prejudiced Defendants by effectively precluding
`the admission of this critical evidence and require a new trial. See Post-Trial Mot. 65-68.
`
`IV.
`
`Discussion
`
`a. This Court's Decision to Calculate Delay Damages Only on the
`Compensatory Damages Portion of the Jury's Award Was Proper.
`
`Plaintiff-Appellant argues that this court erred when it calculated delay damages only on
`
`the compensatory damages portion of the jury's award. Pa. R.C.P No. 238 permits a plaintiff to
`
`recover prejudgment interest on awards in tort cases under Pennsylvania Law. The Rule states in
`
`relevant part:
`
`At the request of the plaintiff in a civil action seeking monetary
`relief for bodily injury, death or property damage, damages for delay
`shall be added to the amount of compensatory damages awarded
`against each defendant or additional defendant found to be liable to
`the plaintiff in the verdict of a jury, in the decision of the court in a
`nonjury trial or in the award of arbitrators." Pa.R.C.P. No. 238(a)(1).
`Damages for delay shall be calculated at the rate equal to the prime
`rate as listed in the first edition of the Wall Street Journal published
`for each calendar year for which the damages are awarded, plus one
`percent, not compounded.
`
`Pa.R.C.P. No. 238(a)(3). Rule 238 has been applied narrowly by Pennsylvania Courts. See
`
`Touloumes v. E.S.C. Inc., 899 A.2d 343,348 (Pa. 2006) (citing Colodonato v Consolidated
`
`Rail Corp., 470 A.2d 475 (Pa. 1983) ("Virtually all cases emphasize the narrow breadth ofthe
`
`Rule"); see also Hodges v. Rodriguez, 645 A.2d 1340, 1349 (Pa. Super. 1994) ("Rule 238 applies
`
`only to certain actions and does not encompass every action."). The Pennsylvania Supreme Court
`
`expressly excluded punitive damages from the calculation of delay damages following an
`
`analysis of the "clear and unambiguous language ofRule 238." Colodonato, 470 A.2d at 478.
`
`11
`
`

`

`The Court determined that "inclusion of punitive damages would be offensive to the fairness that
`
`the rule seeks to ensure" because Rule 238 "serves to compensate the plaintiff for the inability to
`
`utilize funds rightfully due him. !d. Since punitive damages are "intended to punish and not to
`
`compensate, they are irrelevant to the concern underlying Rule 238 that tort victims be fully
`
`compensated for their losses." !d.
`
`The Supreme Court adopted Rule 238 in 1978. In Craig v. Magee Mem'l Rehab. Ctr., 515
`
`A.2d 1350, 1353 (1986), the Supreme Court determined that amendments to Rule 238 were
`
`needed and made recommendations to the Civil Procedural Rules Committee. In 1988, The
`
`Supreme Court adopted the Rules Committee's amendments to Rule 238. Our Supreme Court's
`
`decision in Colodonato v. Consol. Rail Corp., 470 A.2d 475,479 (1983), interpreting the 1978
`
`version of Rule 238, is definitiv