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Four Products Liability $4M Verdicts; Transvaginal Mesh


Severe stress urinary incontinence occurs when physical movement or activity — such as coughing, sneezing, running, or heavy lifting — puts pressure (stress) on a person’s bladder causing the unintentional loss of urine. If noninvasive treatments are not effective, there are various surgical options to treat severe stress urinary incontinence. One option is to use polypropylene mesh to support the junction between the bladder and the urethra and create some degree of urethral compression. One way to implant this mesh is through an abdominal incision. In around 2003, surgeons began using devices to implant the mesh transvaginally, i.e., through the vagina.

 

One company manufactured and sold polypropylene transvaginal mesh devices designed to be permanently implanted as a treatment for severe stress urinary incontinence. The transvaginal mesh device was approved through the 510(k) process, meaning that the FDA found it to be “substantially equivalent” to a product already legally marketed, so clinical trials of this device were not required. Prior to marketing, the FDA also approved the transvaginal mesh device’s directions for use, which included information for physicians on potential complications including pain, dyspareunia (pain with intercourse), and urinary retention.

 

The transvaginal mesh device was made of a particular type of polypropylene. While polypropylene mesh has long been used in implantable medical devices, the manufacturer of this particular type of polypropylene included a warning on its Material Safety Data Sheet (MSDS) stating that it should not be used in medical applications involving permanent implantation in the human body.

 

Four women suffered from severe stress urinary incontinence. Each woman underwent a surgical implantation of the transvaginal mesh device. After the implantation, each woman experienced severe complications from the transvaginal mesh device.

 

Each of the four women filed a separate products liability action against the manufacturer of the transvaginal mesh device seeking compensatory and punitive damages based on theories of negligence and strict liability for both design defects and failure to warn.

 

Following the Multidistrict Litigation (MDL) procedure implemented to handle the more than 25,000 total cases involving transvaginal mesh devices, the United States District Court for the Southern District of West Virginia consolidated the four women’s actions. The district court noted that all four actions were brought by women who were implanted with the same transvaginal mesh device and alleged severe resulting complications, all four women received implants in West Virginia and asserted the same design-defect and failure-to-warn claims under West Virginia law, all four women shared expert witnesses and evidence, and the manufacturer asserted in all cases that the device was not defective and the device’s directions for use provided sufficient warnings.

 

During the course of the proceedings, the district court took a number of steps to address the risk that consolidation might deny the manufacturer a fair trial. At the outset of trial, the district court instructed the jury that the trial concerned four separate claims and informed the jury that they must treat each as if each was tried by itself. During the trial, the manufacturer had the opportunity to address each woman’s claims independently, and in fact pursued a comparative negligence defense against one woman that it did not pursue against the other women. Following trial and prior to jury deliberations, the district court emphasized that the jurors were not to even consider that more than one claim was brought in weighing the evidence and that they must consider each case separately. To promote an independent review of each case, the district court used special interrogatories on separate verdict forms for each woman.

 

Prior to trial, the women filed a motion in limine to exclude evidence of the FDA’s 510(k) approval of the transvaginal mesh device. According to the manufacturer, the transvaginal mesh device’s approval by the FDA was relevant to show both that the product was reasonably safe for its intended use and that the manufacturer acted reasonably in deciding to market the transvaginal mesh device. The district court excluded the manufacturer’s proffered evidence regarding the FDA’s 510(k) approval process. The district court concluded that the 510(k) evidence was at best of questionable relevance, and that, even if marginally relevant, it was inadmissible because of its potential to confuse the issues and mislead the jury.

 

The manufacturer filed a motion in limine to exclude evidence of the polypropylene manufacturer’s warning on the Material Safety Data Sheet (MSDS). The manufacturer argued that the MSDS warning was inadmissible hearsay. The district court allowed the evidence holding that it was not inadmissible hearsay because the MSDS warning was offered not to establish that it was accurate, but instead to demonstrate that the transvaginal mesh device manufacturer had notice of the polypropylene manufacturer’s concerns about the safety of its product for permanent implantation and to address the transvaginal mesh device manufacturer’s knowledge of potential safety concerns regarding its final product.

 

The case proceeded to a jury trial. During the trial, the women proffered evidence that identified several aspects of the transvaginal mesh device’s design that allegedly contributed to its dangers. These included the difficulty of removing the transvaginal mesh device after implantation, the use of the particular type of polypropylene, and the use of polypropylene generally. The women pointed out that the transvaginal mesh device, unlike other slings, was made from this particular type of polypropylene, and that this particular type of polypropylene had an MSDS warning against permanent implantation.

 

The women presented evidence of safer alternatives. For example, one expert discussed a comparative study of the transvaginal mesh device and another device manufactured and distributed by the same manufacturer that found no difference in cure rates between the two devices, but more groin pain among women who received the transvaginal mesh device implanted in the women.

 

The women provided expert testimony on the risks posed by the transvaginal mesh device, but they did not provide expert testimony on the adequacy of the transvaginal mesh device’s directions for use. Evidence regarding the adequacy of the transvaginal mesh device’s directions for use was largely introduced through the testimony of physicians, some of whom testified that there were significant risks not included in the transvaginal mesh device’s directions for use.

 

The district court instructed the jury to apply a preponderance-of-the-evidence standard to evaluate the women’s punitive damages claims.

 

The jury returned verdicts for the women, awarding past-compensatory damages and punitive damages totaling over $4 million to each.

 

The Fourth Circuit United States Court of Appeals affirmed. The court held that (1) the district court did not abuse its discretion in consolidating the four actions, (2) the probative value of evidence that the FDA approved the transvaginal mesh device on the grounds that it was substantially equivalent to a device already legally on the market was outweighed by the danger of confusing the issues and misleading the jury, (3) evidence that the polypropylene manufacturer warned against using its material for permanent implantation in the human body was not hearsay, (4) the jury’s verdict finding the transvaginal mesh device to be defective was supported by sufficient evidence, (5) the jury’s verdict finding that the manufacturer failed to adequately warn of the risks of the transvaginal mesh device was supported by sufficient evidence, and (6) the district court did not err in instructing the jury on the standard for punitive damages.

 

The district court did not abuse its discretion in consolidating the four actions. The district court appropriately considered a number of factors in ordering consolidation. First, as required by Rule 42(a), the district court identified the many common questions of law and fact across the trials. The many factual similarities also made clear that separate trials would have been largely repetitive, and consequently would have increased burdens, delays, and expense. Alert to the risk that consolidation might deny a party a fair trial, the district court endeavored throughout the trial to limit any potential jury confusion or prejudice resulting from the consolidation. The court held that the admission of evidence in the consolidated trial that was admissible as to only some of the women did not prejudice the manufacturer to the extent that consolidation itself was an abuse of discretion. The court also found that the manufacturer lacked evidence that the district court’s safeguards were inadequate or that consolidation in fact resulted in any prejudice or jury confusion. The court concluded that the district court was well within its discretion in consolidating these four cases for trial.

 

The probative value of evidence that the FDA approved the transvaginal mesh device on the grounds that it was substantially equivalent to a device already legally on the market was outweighed by the danger of confusing the issues and misleading the jury. The 510(k) approval was only marginally relevant as to the issues of defect and failure to warn. The probative value of regulatory compliance evidence must depend on the extent to which the regulatory framework safeguards consumer safety. The 510(k) process, although certainly not a rubber stamp program for device approval, does operate to exempt devices from rigorous safety review procedures. The court concluded that, while 510(k) clearance might say something about the safety of the cleared product, it does not say very much that is specific. Admitting the evidence on these grounds would invite a battle of the experts regarding the exact meaning of 510(k) approval in these circumstances. Focusing on the details of each product’s regulatory compliance process would only amplify the risk of confusion and wasted time. The district court acted within its discretion in excluding evidence of the FDA’s 510(k) approval of the transvaginal mesh device.

 

Evidence that the polypropylene manufacturer warned against using its material for permanent implantation in the human body was not hearsay. Under Federal Rule of Evidence 801, an out-of-court statement can constitute hearsay only if a party offers it in evidence to prove the truth of the matter asserted. The MSDS warning was not admitted in evidence to prove that the MSDS warning was accurate, that this particular type of polypropylene was dangerous when permanently implanted in the human body. The existence of the MSDS warning was offered to show that the transvaginal mesh device manufacturer was on notice of potential safety concerns with its product. The court reasoned that one need not assume that the MSDS warning was true to find it relevant to the transvaginal mesh device manufacturer’s state of mind. The court noted that the women did not rely on the MSDS warning to establish that this particular type of polypropylene was dangerous when permanently implanted in the human body. Instead, the women relied on expert testimony and medical evidence to establish that this particular type of polypropylene was dangerous when permanently implanted in the human body. With regard to the failure to warn claim, the women used the existence of the MSDS warning, and the statements of various doctors that they would have used the transvaginal mesh device differently had they known about the MSDS warning, to establish that the transvaginal mesh device manufacturer reasonably could have provided the relevant information to physicians. The court concluded that because the women offered evidence of the MSDS warning not for its truth, but rather for the simple fact of the MSDS warning’s existence and the transvaginal mesh device manufacturer’s awareness of it, it was not hearsay and the district court acted within its discretion in permitting evidence of the MSDS warning.

 

The jury’s verdict finding the transvaginal mesh device to be defective was supported by sufficient evidence. Under West Virginia law, a design defect case requires the plaintiff to show that the involved product is defective in the sense that it is not reasonably safe for its intended use based on what a reasonably prudent manufacturer’s standards should have been at the time the product was made. The women identified several aspects of the transvaginal mesh device’s design that allegedly contributed to its dangers. The court concluded that, while the manufacturer might dispute that any of these aspects of the transvaginal mesh device’s design are “defects,” the jury was entitled to conclude otherwise based on the evidence presented to it. The court noted that the women were not required to demonstrate that the transvaginal mesh device was different from other polypropylene mesh slings as it is possible for an entire class of products to suffer from the same or similar design defects (in fact, several other transvaginal mesh sling manufacturers are also facing product liability MDLs). Even if the women were required to make this showing, the women pointed out that the transvaginal mesh device, unlike other slings, was made from a particular type of polypropylene, and that this particular type of polypropylene had an MSDS warning against permanent implantation. The jury could have seen this as a difference in design from other polypropylene mesh slings. Additionally, the women presented evidence of safer alternatives.

 

The jury’s verdict finding that the manufacturer failed to adequately warn of the risks of the transvaginal mesh device was supported by sufficient evidence. The women did not provide expert testimony on the adequacy of the transvaginal mesh device’s directions for use. The court held that expert testimony on the adequacy of the transvaginal mesh device’s instructions was not required. The jury heard evidence regarding the risks of the transvaginal mesh device, and also heard evidence concerning of what risks the transvaginal mesh device’s directions for use actually warned. This evidence was largely introduced through the testimony of physicians, some of whom testified that there were significant risks not included in the transvaginal mesh device’s directions for use. The court held that a jury could reasonably conclude based on this evidence that the transvaginal mesh device’s instructions were inadequate.

 

The district court did not err in instructing the jury on the standard for punitive damages. The court held that the district court’s instruction was a correct statement of West Virginia law at the time of the trial. Various trial courts in West Virginia had applied the preponderance-of-the-evidence standard, and the West Virginia Supreme Court of Appeals had affirmed such decisions. After the trial in this case, the West Virginia legislature passed a statute establishing that punitive damages may be awarded only if a plaintiff establishes by clear and convincing evidence that the plaintiff is entitled to such damages. The court reasoned that this statute was not in effect at the time of the trial and, consequently, provided little insight into the law at the relevant time. Because the district court correctly instructed the jury regarding the standard for punitive damages in West Virginia as it existed at the time of the trial, the court affirmed the jury’s punitive damages award.

 

The Fourth Circuit United States Court of Appeals affirmed the district court’s entry of a judgment on a jury verdict in favor of the four women.

 

See: Campbell v. Boston Scientific Corporation, 2018 WL 732371 (C.A.4 (W.Va.), February 6, 2018) (not designated for publication).

 

See the Medical Law Perspectives Blog: First Appellate Decision on Merits Affirms Verdict for Plaintiffs’ Transvaginal Mesh Case

 

 

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