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From Products Liability Law Daily, March 3, 2015

Rulings for pelvic mesh manufacturer on patient’s design, warning defect claims upheld in bellwether case

By Susan Lasser, J.D.

Judgment for the manufacturer of a pelvic mesh device in a patient’s action alleging design defect and failure-to-warn claims was proper, the U.S. Court of Appeals for the Fourth Circuit ruled, upholding a federal district court in West Virginia. In an unpublished opinion, the appellate court found that the patient failed to provide expert testimony in support of the causation element of her design defect claim. The court also determined that the patient did not provide evidence that but for an inadequate warning concerning the device, her doctor would not have prescribed or implanted it (Lewis v. Johnson & Johnson, March 2, 2015, per curiam).

Background. In 2009, Carolyn Lewis was diagnosed with stress urinary incontinence (SUI) by her urogynecologist, Muriel Boreham. After a series of tests and upon Dr. Boreham’s recommendation, Lewis was implanted with a tension-free vaginal tape (TVT) mesh device to correct the SUI. The TVT was manufactured by Ethicon, Inc., a subsidiary of Johnson & Johnson. At a follow-up visit, Dr. Boreham told Lewis that she “was healing” and implied that Lewis could resume sexual activity with her husband. Lewis, however, found that she suffered from pain during sexual activity, and she also developed intermittent pelvic pain during daily activities. Approximately three years later, Lewis filed suit in a Texas federal district court seeking compensatory and punitive damages. Her case was transferred to the Southern District of West Virginia as part of one of the multidistrict litigations relating to pelvic repair system devices. Prior to trial, in May 2013, Lewis saw urologist Dr. Philippe Zimmern to discuss her symptoms, and he informed her about the option of “explant” surgery to remove parts of the TVT. She elected to have the procedure, and following the surgery, her pain decreased noticeably. In December 2013, Ethicon moved for summary judgment, which the district court granted as to Lewis’s failure-to-warn claim. Lewis presented testimony from current and former Ethicon employees and from five experts at trial on her remaining claims. At the conclusion of Lewis’s case, the court requested briefing on the possibility of a directed verdict. The court directed a verdict following the briefing and arguments for the manufacturer. Lewis appealed.

Failure to warn. The court upheld the district court’s grant of summary judgment to Ethicon on the patient’s failure-to-warn claim, agreeing with the trial court that the patient failed to provide sufficient evidence to create a dispute of material fact as to whether a different warning would have changed Dr. Boreham’s decision to prescribe the TVT. Texas law requires that a plaintiff must show both that the warning was inadequate and that the inadequate warning “was a producing cause of the plaintiff’s condition or injury.” To establish a “producing cause,” a plaintiff must show that a warning’s alleged inadequacies “would have changed [the] prescribing physician[’s] decision to prescribe” the device. Further, under Texas law, a device manufacturer’s duty to warn of risks extends only to the physician prescribing the device—the learned intermediary—and not to the “end user” of the device. As such, if a plaintiff does not offer evidence that a different warning would have changed her physician’s decision to prescribe a device, the inadequate warning cannot have caused the plaintiff’s injury.

The court of appeals determined that Lewis failed to present evidence that her doctor relied on the warning in Ethicon’s patient brochure in deciding to prescribe the TVT. Dr. Boreham testified that she did not recall whether she had a TVT patient brochure at the time of the patient’s surgery, and none of the patient’s other testimony established that Dr. Boreham considered the patient brochure warning or relied on it in deciding to prescribe the TVT for Lewis. Also, the doctor testified that she did not rely on the TVT’s instructions for use in deciding to prescribe the device. The appellate court, therefore, concluded that the evidence did not establish that “but for the inadequate warning,” Dr. Boreham “would not have used or prescribed” the TVT. According to the court, when a physician relies on her own experience and examination of a patient in deciding to prescribe a device, as was the case for Lewis, and not on the device’s warning, the warning is not the cause of the patient’s injury.

Expert testimony. The patient also challenged the trial court’s exclusion of parts of Dr. Uwe Klinge’s expert opinion testimony. The patient argued that the court erroneously prevented Dr. Klinge, a former hernia specialist, from connecting his observations about the condition of her mesh implant with her pain. The appellate court found that the lower court did not abuse its discretion in its evidentiary rulings. Before trial, Ethicon moved to exclude portions of Dr. Klinge’s expert report related to the TVT mesh on the grounds that the doctor, who was not a pathologist, was unqualified to offer expert testimony on that issue and that his testimony was unreliable. The district court agreed, finding that Dr. Klinge’s testimony was unreliable, noting that his report did not explain how he had selected the TVT samples on which his opinions were based and did not indicate that his analysis “controlled for error or bias.” Ethicon raised the issues again at trial and throughout direct examination of Dr. Klinge, whom the court allowed to testify as to the general characteristics of mesh samples explanted from Lewis. The trial court concluded that Dr. Klinge was not qualified to offer testimony regarding specific causation. In her appeal, Lewis challenged three trial court rulings: (1) the ruling preventing Dr. Klinge from opining on whether “entrapped nerves in this slide … would indicate chronic pain for Ms. Lewis”; (2) the striking of Dr. Klinge’s answer to the question of whether the patient’s slides “would relate to any complications of pain in Ms. Lewis”; and (3) the striking of Dr. Klinge’s opinion that loose particles from the TVT “can very good explain the manifestation of pain” in Ms. Lewis.

The Fourth Circuit found that the district court did not abuse its discretion in making these rulings. Dr. Klinge was a specialist in hernia surgery, not pathology or stress urinary incontinence. He did not receive training or board-certification in pathology. Also, he had never treated Lewis, performed surgery to treat SUI, or collected and studied mesh explants from SUI patients. The court of appeals held that the trial court was within its discretion in concluding that Dr. Klinge’s opinions regarding Lewis’s pain and mesh explant were beyond his area of expertise. Excluding these portions of his testimony, therefore, was not an abuse of discretion.

Design defect. Finally, the court ruled that the trial court did not err in directing a verdict for Ethicon on the patient’s design defect claim based on insufficient evidence supporting the causation element of the claim. A causal connection must be established between the defective condition and the plaintiff’s injuries or damages—i.e., the product defect “must be a substantial factor in bringing about the injury, and a cause without which the injury would not have happened.”

Further, whether expert testimony is necessary to prove a plaintiff’s theory of causation is a question of law, the appellate court said, and noted that Texas law does not always require that an expert conclusively opine that the defect in a product caused a plaintiff’s injury. Rather, in many cases, the court said, a jury can infer causation from circumstantial evidence. However, the Supreme Court of Texas has stated that “[e]xpert testimony [on causation] is required when an issue involves matters beyond jurors’ common understanding.”

In her case, the patient alleged that the TVT’s heavyweight, small-pore mesh caused degradation, scar tissue, and nerve entrapment, and that this in turn caused her pelvic pain and dyspareunia. She also contended that the mechanical cutting of the TVT’s mesh caused loose particles that caused her injuries. The court of appeals determined that the question of whether any of these defects caused the patient’s pain entailed complex and technical medical issues beyond common knowledge and experience. Thus, the appellate court agreed with the district court that Texas law required the patient to present expert testimony establishing a causal link between these alleged defects in the TVT and her injuries.

As such, the Fourth Circuit upheld the lower court’s finding that the patient’s design defect claim failed because she did not present supporting expert testimony. None of the patient’s experts opined that a defect in the TVT caused her injuries. Dr. Zimmern testified that the “presence” of the TVT caused Lewis’s pain, but he did not testify that a defect in the TVT caused her pain. Additionally, he could not identify what TVT characteristic, defective or not, caused the patient’s pain. Also insufficient was the testimony of Dr. Bruce Alan Rosenzweig, who testified that “small particles” from a TVT “can fall off into the vagina,” and that these particles “can migrate and cause pain during intercourse.” He did not testify, however, that this happened in Lewis’s case and admitted that he had never examined or treated Lewis. The appellate court agreed with the trial court that a finding that “a product can cause injuries is insufficient to show that it did cause those injuries in a particular case.”

The Fourth Circuit found that the same insufficiency characterized testimony by Dr. Bernd Klosterhalfen, who opined that he “found in most meshes of patients suffering chronic pain … destructive or damaged nerve structures [or] nerve fibers in the interface of the mesh, just by contact of the mesh to the nerve fiber.” His testimony failed to establish a causal link between a defect in the patient’s TVT and her injuries, the court of appeals concluded. Similarly inadequate was testimony by the patient’s fourth expert, Dr. Howard Jordi, who also did not establish a link between a defect in Lewis’s TVT and her pain. Dr. Jordi testified to a reasonable degree of scientific certainty that the TVT degraded in Lewis’s body and that what remained would continue to degrade. However, he did not testify that this degradation, or any effect of it, caused the patient’s pain.

Lastly, the Fourth Circuit found that Dr. Klinge’s testimony did not satisfy the reasonable medical probability standard that a design defect in the TVT caused the patient’s pain. Although the doctor testified that loose particles from the TVT could “explain the manifestation of pain” in Lewis, the district court did not abuse its discretion in finding him unqualified to share his opinion with the jury.

Therefore, because the patient failed to provide any expert testimony that a design defect in the TVT caused her pelvic pain, the Fourth Circuit held that the district court did not err in directing a verdict for the manufacturer, Ethicon.

The case is No. 14-1244.

Attorneys: Adam Steffen Davis (Wagstaff & Cartmell LLP) for Carolyn Lewis. Stephen Dudley Brody (O'Melveny & Myers, LLP), Philip Combs (Thomas Combs & Spann, PLLC), and Christy Jones (Butler Snow LLP) for Johnson & Johnson and Ethicon, Inc.

Companies: Johnson & Johnson; Ethicon, Inc.

MainStory: TopStory DesignManufacturingNews WarningsNews ExpertEvidenceNews EvidentiaryNews MedicalDevicesNews MarylandNews NorthCarolinaNews SouthCarolinaNews VirginiaNews WestVirginiaNews

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