A woman suffered from pelvic organ prolapse (POP), which occurs when pelvic floor muscles become weak or dysfunctional and cease supporting the organs in the pelvic area, causing connective tissue attachments to stretch or break and organs to become displaced. If noninvasive treatments are not effective, there are various surgical options for POP. One option is to use polypropylene mesh to support the vagina.
In 2002, the designers, manufacturers, and marketers of a polypropylene mesh previously approved for hernia repairs, received 510(k) clearance from the FDA to use the polypropylene mesh in the pelvic floor. One way to implant this mesh is through an abdominal incision. Beginning around 2003, surgeons began using kits to implant the mesh transvaginally, i.e., through the vagina. This approach consisted of a pre-cut mesh implant and the instruments needed to perform a vaginal repair, which incorporated a large central implant with six straps or “arms”—four straps secured the anterior portion of the implant between the bladder and the vagina and two secured the posterior portion between the rectum and the vagina. These straps extended into the hip, thigh, groin and buttocks, and were designed to become fully integrated into the body. The transvaginal mesh kit inserted a larger volume of mesh into the pelvic space that the product that received 510(k) clearance from the FDA. As early as July of 2003, surgeons identified problems with the mesh material including erosion (exposure through the vaginal wall or into organs), contraction (formation of scar tissue around the mesh, which pushes it together), and recurrence (the return of prolapse). None of the materials issued with the kits mentioned the risks of repeated erosions, dyspareunia, the inability to remove mesh, pudendal neuralgia (an abnormality in the nerve fibers), or chronic pain.
The woman underwent POP repair surgery using the tranvaginal mesh kit. The surgery involved the placement of an anterior vaginal mesh under the bladder, resuspension of the vaginal apex, and placement of a posterior vaginal mesh.
At her six-week follow up appointment, the woman complained of pelvic pain. Her doctor found no signs of mesh erosion or extrusion. At her two-month follow up appointment the woman complained of persistent pelvic pain. During the physical examination, the woman reported pain where the superficial arm of the mesh would have penetrated through the obturator membrane. The doctor treated the area with a local anesthetic and a steroid. Eight days later the woman returned reporting the pain was worse after increasing activity and at the end of the day. Two days later the doctor performed exploratory surgery during which he discovered some irritation inside the bladder, which was consistent with interstitial cystitis.
Four months after the POP repair surgery, the doctor performed another surgery. The surgery identified a small extrusion of mesh at the posterior vaginal apex (the top of the vagina); some bunched mesh in the area where plaintiff felt discomfort was removed. The mesh had contracted into a ball rather than lying flat. The location of the mesh contraction was where plaintiff had complained of pain, but he did not remove the mesh wings.
Six months after the POP repair surgery, the doctor performed another surgery. He removed the anterior portion of mesh in the vaginal area.
Ten months after the POP repair surgery, another doctor removed a mass consisting of a residual piece of mesh embedded in scar tissue.
Fifteen months after the POP repair surgery, a third doctor performed exploratory surgery on the woman and found mesh wrapped around and embedded in the left ureter and additional mesh embedded in the left vaginal wall. Two weeks later, he removed the exposed mesh. Afterwards, he told the woman that removal of additional mesh might not alleviate the pain but might instead make it worse. She, however, returned to the third doctor, at which time he removed more mesh.
Altogether, the woman underwent 22 surgical procedures after the POP repair surgery, nine of which found mesh. The mesh had migrated. The woman suffered chronic pelvic pain, dyspareunia, bladder infections, urinary retention, pudendal neuralgia, depression, and anxiety.
The woman and her husband sued the designers, manufacturers, and marketers of the transvaginal surgical mesh. The complaint alleged that as a result of the implantation of the transvaginal surgical mesh the woman sustained multiple complications and required intensive medical treatment and numerous operations. The suit was assigned, along with all future pelvic mesh state court litigation, to the Superior Court of New Jersey, Law Division, Atlantic County, for centralized management.
At the outset of the trial, the parties stipulated that South Dakota law would apply to the substantive issues, but New Jersey law and rules would govern procedural issues and the punitive damages claim.
At trial, an email from a doctor describing a patient who suffered a “permanently destroyed vagina” as a result of surgery using the transvaginal mesh system was admitted into evidence. The designated representative of the designers, manufacturers, and marketers on medical affairs identified the email as an adverse event report. The email, written after the woman had undergone the POP repair, stated that the doctor was taking to the operating room a patient who had an anterior and posterior transvaginal mesh system implanted by another physician. The doctor wrote that the patient had mesh extruding “literally everywhere,” that she would “likely lose any coital function” and that she had “a large stone in the bladder from a bladder perforation with the anterior arm.” The doctor also wrote that he would no longer perform these procedures and that he “bet” a majority of surgeons using the transvaginal mesh system were not qualified to do so, adding: “This patient will have a permanently destroyed vagina, and I am only hoping to get her out of this without more morbidity.” In ruling the email was admissible, the trial judge found that the medical affairs representative said the designers, manufacturers, and marketers monitored their products by: reaching out to customers for feedback; encouraging company dialogue with surgeons who used the transvaginal mesh system; providing the adverse event reports to the FDA; and retaining these reports as part of their records.
During cross-examination, the couple’s counsel asked a medical expert for the defense about a telephone call he made to her office to talk about one of her patients. Defense counsel objected. At side bar, the couple’s counsel argued he tried to contact the defense expert three times, that she would not return his calls, and that these actions showed bias against the plaintiffs. The judge overruled the objection, finding a jury could consider the witness possessed a general antagonism towards plaintiffs’ lawyer as a basis of bias and as relevant to her credibility. Consequently, the couple’s counsel asked the defense expert, in the presence of the jury, if she recalled being contacted by an attorney regarding one of her patients with a transvaginal mesh kit implant who had filed a lawsuit. The defense expert replied: “That’s correct. I did. It was from you.” She also acknowledged receiving a call and two letters, and not answering them. The defense expert explained she could not speak to the attorney without HIPAA authorization and that the patient would not speak with her.
After a trial, the jury found in favor of the designers, manufacturers, and marketers on the claims of defective design and fraudulent misrepresentation to the implanting surgeon. However, the jury found in favor of the couple on their claims of failure to provide adequate warnings to the implanting surgeon, fraudulent misrepresentation to the woman, and loss of consortium. The jury awarded the couple $3.35 million in compensatory damages and $7.76 million in punitive damages.
The Superior Court of New Jersey, Appellate Division, affirmed. The court held that the trial court did not err in determining that the learned intermediary doctrine did not apply to the deceit claim, the trial court did not err in applying the learned intermediary doctrine to the failure to warn claim, the causation evidence was sufficient to support a failure to warn claim, the trial court did not abuse its discretion in admitting evidence about subsequent changes to the transvaginal mesh system’s instructions for use (IFU) regarding warnings, the trial court did not abuse its discretion in admitting evidence about the so-called “destroyed vagina” email, the trial court did not abuse its discretion in allowing the cross-examination of a defense expert about her failure to respond to inquiries for information about a former patient, and the trial court did not err in permitting the punitive damage award to stand.
The trial court did not err in determining that the learned intermediary doctrine did not apply to the deceit claim. The learned intermediary doctrine imposes a duty on a manufacturer to warn physicians of the risks involved with its product, thereby placing the physician in the role of intermediary between manufacturer and patient. The court found the record contained sufficient evidence from which the jury could have found the designers, manufacturers, and marketers willfully deceived the woman by providing intentionally misleading information in the patient brochure and by suppressing facts they were bound to disclose, that they made the misrepresentations to induce the woman to use the transvaginal mesh system, that the woman relied on the information in the brochure, and that she suffered damages as a result of their deception. The court held that the learned intermediary doctrine cannot serve to negate the deceit claim. The jury determined that the designers, manufacturers, and marketers failed to give adequate notice to the woman’s doctor. The court reasoned that when there is a failure to adequately warn the physician, the learned intermediary doctrine as a defense simply drops away.
The trial court did not err in applying the learned intermediary doctrine to the failure to warn claim. The trial court instructed the jury that the couple was required to prove an adequate warning would have caused the woman’s doctor to recommend against the transvaginal mesh system or the woman to decline its use. The court found the record contained sufficient evidence from which the jury could have found that adequate warnings would have caused her doctor to alter his recommendation to use the transvaginal mesh system and the woman to choose another treatment option. The court reasoned that the jury was presented with sufficient evidence by which it could reasonably conclude that the lack of adequate warnings was a proximate cause of the woman’s injuries.
The causation evidence was sufficient to support a failure to warn claim. The woman’s doctor testified he read and relied on the warnings in the instructions for use (IFU), assumed the IFU provided a comprehensive list of the risks and potential complications, and trusted the designers, manufacturers, and marketers to provide “truthful and complete” information. There was also ample evidence that the designers, manufacturers, and marketers were aware of additional risks at the time of the transvaginal mesh system’s launch. There was sufficient evidence for the jury to find that if the designers, manufacturers, and marketers had placed adequate warnings in the IFU, the warnings would have altered the doctor’s conduct and prevented the woman’s injuries.
The trial court did not abuse its discretion in admitting evidence about subsequent changes to the transvaginal mesh system’s IFU regarding warnings. The trial court ruled that admission of the FDA clearance of the transvaginal mesh system after the woman’s POP repair surgery was conditioned upon admission of the revised warnings. The court was satisfied that the information provided to the trial court supported her determination that the warnings were mandated and the revised-warnings evidence admissible if evidence of FDA clearance was elicited. As represented by the designers, manufacturers, and marketers, the FDA granted 510(k) clearance to the transvaginal mesh system in May 2008, with a revised IFU that included additional warnings and omitted several statements contained in the original IFU.
The trial court did not abuse its discretion in admitting evidence about the “destroyed vagina” email. The “destroyed vagina” email fell under the business records exception to the hearsay rule, however its relevance was of limited value because the email post-dated the woman’s surgery and it was highly prejudicial. Nonetheless, the jury’s consideration of the email was not clearly capable of generating an unjust result. The designers, manufacturers, and marketers had an ample opportunity to cross-examine the emails recipient to emphasize the fact that the email post-dated the woman’s implant surgery. Moreover, any prejudice was not significant because the medical affairs representative’s testimony fully demonstrated the designers, manufacturers, and marketers knew about all potential complications from the transvaginal mesh system surgery from the beginning. Because the designers, manufacturers, and marketers were aware of all known adverse reactions “from day one,” the fact that the email in question post-dated the woman’s surgery was of limited significance. The court reasoned that even if the email was more prejudicial than probative and should, therefore, have been excluded, it had a limited impact when considering the great amount of other similar evidence presented to the jury.
The trial court did not abuse its discretion in allowing the cross-examination of a defense expert about her failure to respond to inquiries for information about a former patient. The trial court should not have permitted the couple’s counsel to question the defense expert about their failed communications about another patient. However, it was not a valid ground for granting a new trial. The line of questioning was short relative to the length of the trial, the circumstances were not repeated in closing arguments, and the defense expert offered a correct explanation an implied a question about the bona fides of the attorney attempting to communicate with her.
The trial court did not err in permitting the punitive damage award to stand. The evidence more than adequately supported the jury’s award of punitive damages. The designers, manufacturers, and marketers knew of additional risks omitted from the instructions for use (IFU) and patient brochure. Experts confirmed the IFU did not include all known complications. Surgeons also advised the designers, manufacturers, and marketers about complications arising from the mesh implant, including a patient’s inability to void after surgery and dyspareunia with pain at the six-arm insertion point. There also was evidence of clinical studies and reports which raised warnings about the transvaginal mesh system. The jury was entitled to find from this and other evidence that the designers, manufacturers, and marketers provided warnings so deliberately misleading as to warrant the imposition of punitive damages. The evidence suggested patients would rely on the brochure and assume the designers, manufacturers, and marketers would tell them the truth about the benefits and risks of the transvaginal mesh system, and that the brochure, which referred to the transvaginal mesh system as a minimally invasive surgical technique that offered long-term results, played a role in the physician-patient discussion. The brochure’s omissions and misrepresentations were relevant to the jury’s consideration and support of its award of punitive damages.
The Superior Court of New Jersey, Appellate Division, affirmed the trial court’s entry of a judgment on a jury verdict awarding the couple $11.11 million.
See: Gross v. Gynecare, 2016 WL 1192556 (N.J.Super.A.D., March 29, 2016) (not designated for publication).
See the Medical Law Perspectives December 8, 2014, Blog: First Appellate Decision on Merits Affirms Verdict for Plaintiffs’ Transvaginal Mesh Case