4th Circuit Court of Appeals: MDL “bellwether” trial was fair

A medical-implant manufacturer, the defendant at a consolidated trial arising from a much larger multidistrict litigation, did not demonstrate either that consolidation was unfair or that the trial court otherwise committed reversible error, the court of appeals held.

Appellant Boston Scientific Corp. manufactured a transvaginal mesh device called the Obtryx Transobturator Mid-Urethral Sling System, a permanent implant designed to treat urinary incontinence. The Food and Drug Administration approved the Obtryx under its 510(k) process for products that are “substantially equivalent” to a device already legally on the market, removing the need for clinical trials prior to marketing.

The Obtryx is made of Marlex polypropylene, whose manufacturer includes a caution on its Material Safety Data Sheet stating that it should not be used in medical applications involving permanent implantation in the human body. When implanted transvaginally, it can elicit scar tissue that causes the mesh to shrink.

This case involves a consolidated trial of four cases that are each part of a multidistrict litigation encompassing over 25,000 cases. The four Plaintiffs in this consolidated action are women who received Obtryx implants and allegedly experienced severe complications as a result. Prior to trial, the district court decided to admit evidence of the Marlex polyprophylene Data Sheet and to exclude evidence concerning the FDA’s 510(k) approval process.

Following an 11-day trial, the jury returned verdicts awarding past-compensatory damages of $250,000 and $1 million to each Plaintiff. The jury also awarded future-compensatory damages of between $3 to 4 million to each Plaintiff.

Consolidation

The district court in this case appropriately considered the necessary factors in ultimately ordering consolidation of the four separate actions, pursuant to Federal Rule of Civil Procedure 42(a). It first identified the many common questions of law and fact across the actions: The four Plaintiffs were each diagnosed with stress urinary incontinence before receiving the Obtryx implants. Each Plaintiff alleged similar complications from the Obtryx that required subsequent medical treatment. Each Plaintiff received her Obtryx implant in West Virginia and asserted the same design-defect and failure-to-warn claims under West Virginia law.

Because of these many similarities, the Plaintiffs also shared expert witnesses and relied on much of the same evidence from Boston Scientific documents. Boston Scientific asserted the same defenses in each case. These many similarities certainly provided the common questions of law or fact required by Rule 42(a) and also make clear that separate trials would have been largely repetitive.

Alert to the risk that consolidation could deny Boston Scientific a fair trial, the district court endeavored to limit any potential jury confusion or prejudice resulting from the consolidation. At the outset of trial, the district court instructed the jury that they must treat each claim as if each had been tried by itself. The district court emphasized that the jurors, in weighing the evidence, were not to even consider that more than one claim was brought. To promote independent review of each case, the district court made use of special interrogatories on separate verdict forms for each Plaintiff.

Although Boston Scientific complains of evidence regarding events that took place after some Plaintiffs had received their implants, it is not clear that this evidence is irrelevant to any of the Plaintiffs. For example, email chains among Boston Scientific employees in May 2009 may shed light on what the company knew in April 2009, when one of the Plaintiffs received her implant. Similarly, studies published after the women received their implants, and evidence of how Boston Scientific reacted to those studies, may be relevant both to the actual safety of the product and to BSC’s general policies regarding how to handle evidence of safety risks. This court certainly cannot say that allowing this evidence in the consolidated trial prejudiced Boston Scientific to the extent of being an abuse of discretion.

Boston Scientific also asks this court to infer jury confusion based on the similarities of the damages awarded to each Plaintiff. But the four Plaintiffs did not receive identical damages awards. That the awards were of the same order of magnitude appears to reflect the very similarities between the cases that justified consolidation in the first place.

The multidistrict litigation procedure out of which these cases originated reflects the need to promote efficiency without sacrificing fairness in the resolution of large-scale disputes. The specific MDL of which these cases were a part illustrates the effectiveness of streamlining the judicial process when federal courts are faced with a large number of closely related complaints. The district court judge supervising this MDL saw the utility of bellwether trials to promote settlement and, thus, consolidated a small number of cases for trial in West Virginia. Thousands of cases have since settled out of the MDL.

While unfounded products-liability suits may run the risk of discouraging product innovation in areas important to public health, Boston Scientific fails to make the case that consolidation in and of itself heightens that danger. Consolidation does not alter the basic standard of care required of manufacturers, and its benefits run to both plaintiffs and defendants.

The results here were not purchased at the cost of fairness to any party. The district court bent over backwards to ensure that distinct questions of fact and law could be appropriately developed at trial and distinguished by the jury. It would be inconceivable to hold that the trial court abused its discretion in these circumstances.

Evidence

The district court’s decision to exclude 510(k) evidence is governed by Cisson v. C.R. Bard Inc., 810 F.3d 913 (4th Cir. 2016), and Huskey v. Ethicon Inc., 848 F.3d 151 (4th Cir. 2017), both products-liability cases involving transvaginal mesh devices. In Cisson, this court held that while 510(k) clearance might say something about the safety of the cleared product, it does not say much that is specific. Similarly, in Huskey, the court held that focusing on the specifics of each product’s regulatory compliance processes would only amplify the risk of jury confusion and wasted time.

In the face of this binding precedent, the district court was clearly within its discretion to exclude evidence of the Obtryx’s 510(k) approval.

Additionally, Cisson supports the district court’s decision to admit the Marlex polypropylene Data Sheet, over Boston Scientific’s objection that it was inadmissible hearsay. The Data Sheet was offered not to establish that the cautionary language was accurate, but instead to demonstrate that Boston Scientific had notice of the manufacturer’s concerns about the safety of its product for permanently implantation. One need not assume that the caution is true to find it relevant to Boston Scientific’s state of mind.

In Cisson, the manufacturer’s caution was introduced to suggest that the defendant company should have further investigated the safety of its medical device, rather than marketing the product immediately. By analogy, a cloud may not bring rain, but it may certainly suggest the possibility of rain and the need to check the forecast.

This court approved that rationale for use of the Data Sheet evidence in Cisson, and does so here as well. It is true that, for the failure-to-warn claim to succeed, the Plaintiffs needed to establish that there were risks from the Obtryx and that those risks injured them. But in this case, they did not rely on the Data Sheet evidence to establish those facts. Rather, the Data Sheet evidence evinced not that its warning was correct as to the Obtryx, but rather that Boston Scientific reasonably could have provided the relevant information to physicians, even while explaining why it nonetheless believed the Obtryx to be safe. It is not unreasonable to expect manufacturers of medical devices to level with the physicians who are responsible for implanting their devices in who knows how many patients.

Punitive damages

Boston Scientific notes that, after the trial in this case, the West Virginia legislature passed a statute establishing that punitive damages may be awarded only if a plaintiff establishes by clear and convincing evidence that she is entitled to such damages. In contrast, in this case the district court instructed the jury that the appropriate standard was preponderance of the evidence. At the time the instruction was given, the preponderance-of-the-evidence standard was a correct statement of the law. Various West Virginia trial courts had applied it, and the state’s Supreme Court of Appeals had affirmed such decisions.

Based on the foregoing, the judgments of the district court are affirmed.

Campbell v. Boston Sci. Corp., Case No. 16-2279, Feb. 6, 2018; 4th Cir. (Wilkinson); SDWV at Charleston (Goodwin). Daniel Brandon Rogers for Appellant; Anthony J. Majestro for Appellees. VLW No. 018-2-020, 21 pp.