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.

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