Wake Forest Law Review

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By Elissa Hachmeister

Today, March 2, 2015, in the civil case Lewis v. Johnson & Johnson, the Fourth Circuit affirmed in an unpublished opinion the District Court for the Southern District of West Virginia’s decisions granting summary judgment for the defendant on Lewis’ failure-to-warn claim and directing a verdict for the defendant on Lewis’ design defect claim.

Lewis’ Products Liability Suit

Carolyn Lewis, a Texas resident, alleged injuries resulting from tension-free vaginal tape (TVT) manufactured by a subsidiary of Johnson & Johnson. The defendant moved for summary judgment, and the district court granted summary judgment as to Lewis’ failure-to-warn claim. At trial, Lewis presented testimony from five expert witnesses as well as current and former employees of the TVT manufacturer. Nonetheless, the district court directed a verdict for the defendant on the remaining design defect claim at the conclusion of Lewis’ case.

Summary Judgment on Failure-to-Warn Claim

A district court’s grant of summary judgment is reviewed de novo. The grant will be affirmed if there is no genuine dispute as to a material fact and the moving party is entitled to judgment as a matter of law. The evidence is viewed in the light most favorable to the non-moving party.

Under Texas law, the applicable law in this diversity case, a failure-to-warn claim requires proof of two elements: (1) that the product warning was inadequate, and (2) that the inadequate warning “was a producing cause of the plaintiff’s condition or injury.” Porterfield v. Ethicon, Inc., 183 F.3d 464, 468 (5th Cir. 1999).

In order to establish the “producing cause” element, the plaintiff must show that a different warning would have changed her physician’s decision to prescribe the device. (A device manufacturer’s duty to warn of risks extends only to physicians prescribing the device and does not reach patients who ultimately receive the device.) Absent such proof, the inadequate warning cannot be said to have caused the patient’s injuries.

Prescribing Doctor’s Failure to Rely on Inadequate Warning Defeats Causation

The doctor who recommended and implanted Lewis’ TVT did not rely on the warning or instructions for use in making her decision to prescribe the device. The doctor could not recall whether or not she even possessed the patient brochure containing the warning at the time of Lewis’ surgery. She had last read the TVT’s instructions for use during her surgery fellowship in 2002, seven years before prescribing the device to Lewis. When asked whether she had relied on these documents in prescribing the TVT, the doctor admitted she did not. Instead, she relied on her own experience and her examination of the patient. Because the doctor did not rely on the allegedly inadequate warning in prescribing the device, the warning cannot be the cause of  Lewis’ injuries. The Fourth Circuit affirmed the district court’s grant of summary judgment, agreeing that Lewis did not offer sufficient evidence to create a dispute as to material fact regarding whether a different warning would have changed her doctor’s decision to prescribe the TVT.

Judgment as a Matter of Law on the Design Defect Claim

The grant of a motion for a directed verdict is reviewed de novo. A directed verdict is appropriate where, without weighing the evidence or considering the credibility of the witnesses, there is just one verdict that reasonable jurors could reach. Plaintiff can avoid a directed verdict by presenting sufficient evidence to establish a prima facie case.

Under Texas law, a design defect claim requires the plaintiff to show “that (1) the product was defectively designed so as to render it unreasonably dangerous; (2) a safer alternative design existed; and (3) the defect was a producing cause of the injury for which the plaintiff seeks recovery.” Timpte Indus., Inc. v. Gish, 286 S.W.3d 306, 311 (Tex. 2009). The district court directed a verdict for the defendant based on the final element.

Expert Testimony Needed to Prove Causation in Cases Involving Complex Medical Issues

Expert testimony is necessary to establish causation when an issue involves matters beyond a lay juror’s general experience and common understanding. Cases involving medical diagnoses and complex medical devices will normally require expert testimony. Indeed, the Fourth Circuit characterizes the issues in this case as “complex and technical medical issues beyond common knowledge and experience,” and therefore agrees with the district court’s assessment that Texas law required Lewis to present expert testimony on the causation element.

Experts Failed to Establish Causal Connection Between TVT Defect and Lewis’ Injuries

Although Lewis presented five expert witnesses, the Fourth Circuit concluded that no testimony was sufficient to show causation. One expert testified that the TVT caused Lewis’s pain, but did not testify that a particular defect caused her pain. Another expert did point to a specific property of the TVT, explaining how it might cause pain, but the testimony established only that the device could cause injuries, not that it did in this specific case. (The expert had not examined or treated Lewis.) A third expert’s testimony failed for the same reason: identifying a characteristic of the TVT and connecting it to chronic pain generally does not suffice to establish a causal link between a defect in Lewis’ TVT and Lewis’ pain. And a fourth expert testified to degradation of the TVT in Lewis, but failed to connect it to her pain.

Finally, the fifth expert did offer the right opinion—but the district court excluded it because the expert was unqualified. Rulings on the admissibility of expert testimony are reviewed under a deferential abuse of discretion standard, and the Fourth Circuit concluded that the district court did not abuse its discretion in excluding the opinion. Absent expert testimony that a defect in the TVT caused Lewis’ injuries, the district court properly directed a verdict for the defendant.

Court of Appeals for the Fourth Circuit Affirmed