Wake Forest Law Review

Businessman with files

By Taylor Anderson

On January 14, 2016, the Fourth Circuit issued its published opinion regarding the civil case Cisson v. C.R. Bard, Inc. The appellant, transvaginal mesh proprietor C.R. Bard, Incorporated (“Bard”), raised four issues on appeal. In addition, the appellee, Donna Cisson (“Cisson”) cross-appealed the district court’s finding regarding punitive damages. The Fourth Circuit affirmed the district court’s judgment as to all issues raised on appeal.

Cisson Alleged Design Defect

On May 6, 2009, Cisson was implanted with the Avaulta Plus, a transvaginal mesh medical device developed and marketed by Bard. This device addressed pelvic organ prolapse and stress urinary incontinence. Three months after implantation, Cisson’s doctor diagnosed her with “an adhesion band” of scar tissue that was causing Cisson pain. Dr. Raybon resected the mesh, which involved cutting out a thick band of scar tissue and mesh encased in the tissue. A few months later, Cisson went to a different doctor who explanted the Avaulta Plus from Cisson’s body, although complete removal of the mesh was not possible.

Complaining that the surgical mesh marketed by Bard caused ongoing “loss of sexual feeling” and “severe pain with intercourse and otherwise,” Cisson filed a lawsuit against Bard in March 2011. Cisson’s claims for design defect, failure to warn, and loss of consortium proceeded to trial.

Cisson presented evidence that the Avaulta Plus caused her injuries. Furthermore, Cisson also presented evidence that painted a picture of Bard as ignoring the warning signs that its product could cause injuries. One piece of such evidence was a material data safety sheet (“MSDS”) received from the corporation that manufactured the polypropylene pallets used to extrude the Avaulta Plus mesh. The MSDS contained an explicit warning that polypropylene should not be used in short- or long-term human implantations.

Ultimately, the jury credited Cisson’s evidence, awarding damages for the design defect and failure to warn claims. The jury awarded Cisson $250,000 in compensatory damages and awarded an additional $1.75 million in punitive damages. The punitive damages award was split pursuant to a Georgia statute, with seventy-five percent going to the State of Georgia and twenty-five percent going to Cisson. The jury returned a verdict for Bard on the consortium claim. Bard timely appealed.

Bard Believed Compliance Evidence Should Have Been Admissible

Bard’s first issue on appeal was that the district court abused its discretion by granting Cisson’s motion in limine asking the court to exclude all evidence that Bard had complied with the Food & Drug Administration’s (“FDA”) 510(k) process. The district court excluded the evidence under Federal Rule of Evidence 402 for lack of relevance and under Rule 403 for being substantially more prejudicial than probative.

After noting that district courts have “broad discretion” in deciding whether “the probative value of evidence is substantially outweighed by the danger of unfair prejudice, misleading the jury, or confusion of the issues” under Rule 403, the Fourth Circuit affirmed the district court’s ruling. The Fourth Circuit focused mainly on the fact that Bard’s compliance with the FDA’s 501(k) process did not prove that the product was safe. This alone presented substantial dangers of misleading the jury and confusing the issues. The district court excluded this compliance evidence so that the jury would not confuse Bard’s compliance with the safety of Bard’s product, and the Fourth Circuit affirmed this decision.

The Fourth Circuit did not reach the district court’s ruling that that 501(k) evidence could be excluded as irrelevant under Rule 402 because the evidence was properly excluded under Rule 403.

Bard’s Hearsay Objections Were Meritless

Bard’s second issue on appeal was that the district court erred when it overruled Bard’s hearsay objections to the admission of the MSDS pertaining to polypropylene, a material used in the construction of the Avaulta Plus implanted in Cisson’s body. The MSDS at issue contained a warning and disclaimer stating that the polypropylene should not be used “in medical applications involving permanent implantation in the human body.” The district court admitted the MSDS for the limited purpose of showing that the statement was made and that Bard was aware of it. The district court also ruled that the MSDS was admissible for substantive purposes under the hearsay exceptions contained in Federal Rules of Evidence 803(17), 803(18), and 807.

The Fourth Circuit reversed the district court’s rulings as to the hearsay exceptions; however, the Fourth Circuit affirmed the decision to admit the MSDS as non-hearsay. First, the Fourth Circuit held that the MSDS did not fall within Rule 803(17)’s “Market Reports and Similar Commercial Publications” hearsay exception because the MSDS did not contain factual information as required by this exception. Instead, the MSDS operated as a warning and disclaimer of liability for the self-interested issuing party. For this reason, Rule 803(17) did not apply. Second, the Fourth Circuit held that the MSDS did not fall within Rule 803(18)’s “Statements in Learned Treatises, Periodicals, or Pamphlets” hearsay exception because the MSDS was not “relied on by [an] expert on direct examination,” nor was it “called to the attention of an expert witness on cross-examination” as required by Rule 803(18). For this reason, the MSDS did not fall under Rule 803(18)’s exception. Lastly, the Fourth Circuit held that the MSDS did not fall within Rule 807’s “Residual Exception” because there was other evidence available to address polypropylene’s viability as a material for surgical implants, such as studies, reports, empirical evidence, and tissue sample slides. Because the MSDS evidence did not fall within the hearsay exceptions enumerated in Rule 803(17), 803(18), or 807, the MSDS evidence was not admissible as substantive evidence. For this reason, the Fourth Circuit reversed the district court’s rulings as to these hearsay exceptions.

Although the Fourth Circuit reversed the district court’s rulings as to the hearsay exceptions, it affirmed the district court’s decision to admit the MSDS evidence as non-hearsay. The Fourth Circuit agreed with the district court that Cisson used the MSDS to show that Bard had received warning that its product might be unsafe. Bard did not dispute this non-hearsay purpose on appeal, but argued instead that Cisson used the MSDS for its truth during the trial, which is not allowed because the MSDS did not fall within one of the hearsay exceptions. The Fourth Circuit disagreed with Bard and held that “even if Cisson did at any time use the MSDS for its truth, she did so in a way that did not prejudice the defendant.” Because Cisson’s use of the MSDS did not prejudice Bard, the alleged error was harmless. The Fourth Circuit affirmed the district court’s admission of the MSDS evidence.

Bard Argued the Jury Instruction as to Causation

Bard’s third issue on appeal was that the district court erred in its instruction to the jury on causation, as well as in its subsequent ruling upholding the jury’s causation finding pursuant to its denial of Bard’s renewed motion for judgment as a matter of law. Bard charged that it was prejudiced because the court’s causation instruction did not reflect Georgia law.

Bard’s position was that Georgia law required injury causation be proved by “expert testimony stated to a reasonable degree of medical probability or certainty.” The Fourth Circuit disagreed and noted that “Bard’s characterization of Georgia law incorrectly states the standard of proof applicable here, inserting the standard for medical malpractice cases into this products liability case.” Additionally, Bard did not point to a single Georgia case stating that the standard in the pattern instruction was incorrect. For these reasons, the Fourth Circuit held that the district court did not err in giving the Georgia pattern jury instruction.

Additionally, the Fourth Circuit held that Cisson presented ample expert and non-expert testimony for a jury to find that the design defect caused her injuries; therefore, the district court correctly upheld the jury’s causation finding and correctly denied Bard’s renewed motion for judgment as a matter of law.

The Punitive Damages Award Was Not Unconstitutional

Bard’s final issue on appeal was the jury’s award of $1.75 million in punitive damages. Bard pointed to the Due Process Clause of the Fourteenth Amendment which prohibits the imposition of grossly excessive or arbitrary punishments on a tortfeasor. Bard cited the Supreme Court of the United State’s decision in State Farm Mutual Automobile Insurance v. Campbell, where the Court stated “an award of more than four times the amount of compensatory damages might be close to the line of constitutional impropriety.” The punitive damage award in this case was seven times the $250,000 compensatory damages award.

The Fourth Circuit held that Bard, relying on the above statement from Campbell, apparently failed to realize that the Court went on to say “these ratios are not binding” and concluded that “[s]ingle-digit multipliers are more likely to comport with due process . . . than awards with ratios in the range of 500 to 1.” Also, the Fourth Circuit pointed to the district court’s finding that the punitive damages against Bard arose from its misconduct that resulted in Cisson’s injuries and grounded its refusal to overturn the award in reprehensibility of Bard’s conduct. Therefore, the Fourth Circuit held that the seven-to-one ration was not constitutionally excessive and affirmed the district court’s decision.

Cisson’s Cross-Appeal Was Unsuccessful

The final issue before the Fourth Circuit was Cisson’s cross-appeal that challenged the district court’s ruling that a Georgia split-recovery statute garnishing seventy-five percent of the punitive damages award arising from a product liability judgment does not violate the Takings Clause of the Fifth Amendment of the United States Constitution.

The Fourth Circuit noted that to succeed on this issue, Cisson must first show that she has “a constitutionally protected property interest” in the punitive damages award at issue; however, Cisson made no such claim. Additionally, Cisson does not explain how Georgia exceeded its authority by defining the contours of the right it allegedly created. For these reasons, the Fourth Circuit affirmed the judgment of the district court as to this issue.

Judgment Affirmed

For the aforementioned reasons, the Fourth Circuit affirmed all of the issues raised on appeal.

okeefe

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