Wake Forest Law Review

By: Katherine Wenner & Holly Ingram

On February 6, 2018, the United States Court of Appeals for the Fourth Circuit published an opinion for Campbell v. Boston Scientific Corporation. The case affirmed a major products liability decision involving four plaintiffs, where each plaintiff received awards for over $4 million.

I. Facts and Procedural History

The case involved four plaintiffs who were each involved in a multidistrict litigation, which encompassed over 25,000 cases total. Defendant Boston Scientific Corporation (“BSC”) manufactured a transvaginal mesh prescription medical device, called Obtryx Transobturator Mid-Urethral Sling System (“Obtryx”) which was approved by the Food and Drug Administration (“FDA”) under its 510(k) approval process. That process approves products which are “substantially equivalent” to a device already approved on the market and does not require clinical trials. The problem with the device, according to the plaintiffs’ experts, was that it could degrade when implanted and cause the growth of scar tissue. Over the course of a few years, each of the plaintiffs experienced device dysfunction and brought separate lawsuits against BSC. Their claims were filed against BSC directly into a pre-existing Judicial Panel on Multidistrict Litigation, which is pending in the Southern District of West Virginia. The district court consolidated several cases before case-specific discovery began. BSC moved to conduct separate trials for the cases at issue today, but the motion was denied.

There were also two evidentiary motions that occurred prior to trial. In one motion, BSC moved to exclude evidence of the Marlex polypropylene’s MSDS, but this was denied. Additionally, plaintiffs moved to exclude evidence regarding the FDA’s 510(k) process and approval. This motion the district court granted.

Following an eleven-day trial, the jury returned verdicts in favor of plaintiffs, awarding $250,000 for past-compensatory damages, $1,000,000 for punitive damages, and future-compensatory damages ranging from $3–4.5 million dollars to each plaintiff.

BSC appealed the judgments on the grounds that the district court abused its discretion by (1) consolidating the four cases for trial; (2) permitting the MSDS evidence; and (3) excluding the 510(k) evidence. It also challenged the verdicts for lacking sufficient evidence and challenged the punitive damages awards, asserting there was an erroneous jury instruction.

II. The District Court did not abuse its discretion in consolidating the four cases, excluding the 510(k) evidence, or permitting the MSDS evidence.

The Fourth Circuit concluded that consolidating the independent cases did not render the decision unfair because the court first identified many common questions of law and fact across the trials. Additionally, the plaintiffs shared expert witnesses and presented much of the same evidence. Thus, the trials would have been largely repetitive and caused undue burdens, delays, and expenses. Moreover, the district court adequately endeavored throughout the trial to limit any potential jury confusion or prejudice. BSC lacked evidence to claim that the district court’s safeguards were inadequate. Further, although the four awards were similar, the damages were not identical. This evidenced that the merely similar values were because of the acute similarities between the injuries—which further justifies the consolidation. The Fourth Circuit ultimately notified that this illustrates the effectiveness of streamlining the judicial process, especially in cases such as this Multidistrict Litigation, which has over 25,000 cases involved.

Turning to the evidentiary dispute, the Fourth Circuit concluded that exclusion of the 510(k) evidence was not an abuse of discretion. BSC attempted to use this to argue that its conduct was reasonable. Yet, the court noted that although the 510(k) clearance may have said something about the safety of the product, it did not say anything very specific. Further, it would likely have only amplified the risk of confusion and wasted time. Thus, exclusion was not an abuse of discretion.

Next the Fourth Circuit concluded that including the MSDS was not inadmissible hearsay, as BSC so argued, because it was not admitted for the truth of the matter asserted. While it may have suggested that the company should have further investigated the safety of their product, it did not evince that the warning was actually correct. Thus, including the evidence was appropriate, and the district court did not abuse its discretion.

III. BSC was not entitled to judgment as a matter of law and the district court used the proper standard to instruct the jury on punitive damages.

Moving on to BSC’s contention that it was entitled to judgment as a matter of law, BSC argued that the plaintiffs did not have sufficient evidence for their claims. However, the Fourth Circuit noted that jury verdicts are only set aside in unusual circumstances, which were not present in this case. The plaintiffs identified several aspects of the Obtryx’s design that contributed to its danger and presented evidence of safer alternative designs that existed. BSC claimed that the jury should have been instructed that a safer alternative was an element of the plaintiffs’ claim, but the Fourth Circuit noted that this argument was made for the first time on appeal and was therefore inappropriate.

Under the failure to warn claims, BSC argued that the plaintiffs’ testimony was also inadequate. However, because the plaintiffs did provide testimony, then it was sufficient. The court agreed that expert testimony may have been helpful, but it was not required.

Finally BSC challenged that the district court’s jury instruction standards for punitive damages. However, the court concluded that the district court’s instruction was a correct statement of West Virginia law at the time. Since the time of trial, the West Virginia legislature has changed its statute regarding the award of punitive damages, but the new statute was not in effect at the time of the trial. Therefore, the punitive damages award was also affirmed.

IV. Conclusion

Because the district court did not abuse its discretion or use any improper legal standards, the judgments of the district court were affirmed.

By Mickey Herman

On Thursday, January 17, 2017, the Fourth Circuit issued a published opinion in the civil case Huskey v. Ethicon, Inc. The defendant-appellants, Ethicon, Inc. and Johnson & Johnson (collectively “Ethicon”), appealed the district court’s denial of their post-trial renewed motion for judgment as a matter of law (“JMOL”) or, alternatively, for a new trial. After reviewing the evidence presented to the jury in this products liability action, the Fourth Circuit affirmed the district court’s denial of both motions.

Facts & Procedural History

In 2008, Mrs. Jo Huskey began suffering from Stress Urinary Incontinence. By 2011, her condition had deteriorated such that she underwent surgery to implant a Tension-Free Vaginal Tape-Obturator (“TVT-O”) to alleviate her symptoms. Following the surgery, Mrs. Huskey began experiencing pelvic pain, which her doctor determined was caused by erosion in the TVT-O’s heavy-weight polypropylene mesh. After several non-invasive attempts to relieve her pain failed, Mrs. Huskey again underwent surgery to cover the eroded mesh. Unfortunately, Mrs. Huskey’s pain persisted and she was referred to a specialist who performed a third surgery in an effort to remove the mesh entirely. That procedure too was unsuccessful, as a portion of the mesh was unrecoverable. As a result, Mrs. Huskey suffers from severe pain when engaging in physical activity and sexual intercourse. That pain will last of the rest of her life and she will require medication for pain management.

In 2012, Mrs. Huskey and her husband, Allen, filed suit in the Southern District of West Virginia as part of In Re Ethicon Inc., Pelvic Repair Sys. Prods. Liab. Litig., MDL 2327. Following the district court’s grant of partial summary judgment in favor of Ethicon, the trial proceeded on five claims: strict liability and negligent design defect, strict liability and negligent failure to warn, and Mr. Huskey’s loss of consortium. Mrs. Huskey sought both actual and punitive damages for her claims.

Following the Huskey’s case, Ethicon moved for JMOL pursuant to Fed. R. Civ. P. 50(a). The district court granted the motion as to punitive damages; it otherwise deferred ruling on the motion. After Ethicon renewed the motion following its case, the district court again deferred and submitted the case to the jury. After the jury returned a unanimous general verdict for the Huskeys on all five claims, Ethicon renewed its motion for JMOL pursuant to Fed. R. Civ. P. 50(b) and, alternatively, requested a new trial under Fed. R. Civ. P. 59(a)(1)(A). The district court denied both motions. Ethicon appealed.

Denial of JMOL Motion

Ethicon first argued that the district court improperly denied its motion for JMOL. Noting that it reviews such denials de novo, the Fourth Circuit stressed that JMOL is appropriate only if “a reasonable jury would not have a legally sufficient evidentiary basis to find for the party on that issue.” Fed. R. Civ. P. 50(a). Because the jury returned a general verdict, the Fourth Circuit emphasized that reversal was only appropriate if the Huskeys failed to prove both their design defect and failure to warn claims.

The Fourth Circuit turned first to the Huskey’s design defect claims. Pursuant to Illinois law (under which the Huskeys, Illinois residents, brought their claims), “[t]o prevail [on those] claims, the Huskeys had to demonstrate: 1) that a certain condition of the TVT-O resulted from Ethicon’s design, 2) that this condition made the product unreasonably dangerous, 3) that the dangerous condition existed when Mrs. Huskey’s TVT-O left Ethicon’s control, and 4) that the dangerous condition in the TVT-O proximately caused harm to Mrs. Huskey.” Ethicon argued that the Huskeys not only “failed to prove a specific flaw in the TVT-O’s design” but that Restatement (Second) of Torts § 402(a) comment k shielded the company from liability.

Addressing Ethicon’s first argument, the Fourth Circuit determined that the testimony of four of the Huskey’s expert witnesses—each of whom asserted that the design of the mesh was to blame—constituted sufficient evidence from which a reasonable jury could find that Ethicon’s mesh caused Mrs. Huskey’s injuries and subsequent pain.

Considering Ethicon’s second argument, the Fourth Circuit analyzed the text of comment k, which “recommends that [unavoidably unsafe products], ‘with the qualification that they are properly prepared and marketed, and proper warning is given,’ not trigger strict liability.” Restatement (Second) of Torts § 402(a). Because whether a product is unavoidably unsafe is a question of fact, the Fourth Circuit made clear that “[i]f a reasonable jury could find that the TVT-O did not meet comment k’s parameters, Ethicon’s reliance on comment k fails.” Relying again on the Huskey’s experts’ testimony that the mesh’s design was, in fact, defective, the Fourth Circuit concluded that a reasonable jury could so find and, thus, Ethicon’s comment k argument fails.

Because it could affirm the district court’s denial of Ethicon’s JMOL on these grounds alone, the Fourth Circuit did not address the failure to warn claims.

Denial of New Trial Motion

The Fourth Circuit next turned to Ethicon’s assertion that the district court erred by denying its motion for a new trial. Pursuant to Fed. R. Civ. P. 59(a)(1)(A), a new trial is warranted where “the verdict is contrary to the clear weight of the evidence, rests upon false evidence, or will cause a miscarriage of justice.” The denial of such motions is reviewed for abuse of discretion.

Ethicon first argued that it was entitled to a new trial because the district court, by failing to clarify comment k’s policy rationale, improperly instructed the jury on comment k. Only where a jury instruction “fails to inform the jury of the controlling legal principle,” such that the challenging party suffers prejudice, is a new trial warranted. After comparing the language of comment k to the instruction given, the Fourth Circuit determined that, although the instruction failed to explain that comment k shifts the burden of proof to the defendant, that deficiency did not prejudice Ethicon. Furthermore, it concluded that because comment k requires a “case by case” analysis, its underlying policy was irrelevant and could be omitted without prejudice to Ethicon.

Ethicon next argued that it was entitled to a new trial because the district court improperly excluded four pieces of evidence concerning the FDA’s approval of the mesh used in the TVT-O. Evidentiary exclusions are reviewed for an abuse of discretion and a new trial is appropriate only where there exists “a high probability that the error . . . affect[ed] the judgment.” Reviewing each piece of evidence in turn, the Fourth Circuit concluded that they were properly excluded under Fed. R. Evid. 403 because their probative value was outweighed both by a risk of confusion and wasted time, as well as because of their needlessly cumulative nature.

Thus, because the Fourth Circuit determined that the district court did not abuse its discretion with respect to the contested jury instructions and exclusion of evidence, it held that Ethicon was not entitled to a new trial.

Conclusion

Determining that sufficient evidence supported the jury’s verdict in favor of the Huskeys, the Fourth Circuit affirmed the district court’s denial of Ethicon’s motion for JMOL. Furthermore, because it concluded that district court did not abuse its discretion in instructing the jury and excluding evidence, the Fourth Circuit affirmed the district court’s denial of Ethicon’s alternative motion for a new trial.