Campbell v. Bos. Scientific Corp.

Decision Date06 February 2018
Docket NumberNo. 16-2279,16-2279
Citation882 F.3d 70
Parties Carol Sue CAMPBELL; Chris Rene Wilson, Plaintiffs–Appellees, and Jeanie Blankenship; Karen Marie Canterbury; Donna Kay Billings; Beverly Sexton; Virgil Sexton; Tammy Hendricks; Stanley Hendricks; Dreama Moore; Jacquelyn Tyree; Robert Tyree; Sharon Pugh; Thomas Wiley Pugh; Neasha R. Workman, Plaintiffs, v. BOSTON SCIENTIFIC CORPORATION, Defendant–Appellant, Federation of Defense & Corporate Counsel ; Product Liability Advisory Council, Incorporated, Amici Supporting Appellant.
CourtU.S. Court of Appeals — Fourth Circuit

ARGUED: Daniel Brandon Rogers, SHOOK HARDY & BACON L.L.P., Miami, Florida, for Appellant. Anthony J. Majestro, POWELL & MAJESTRO, PLLC, Charleston, West Virginia, for Appellees. ON BRIEF: Robert T. Adams, SHOOK, HARDY & BACON L.L.P., Kansas City, Missouri, for Appellant. Scott A. Love, CLARK, LOVE & HUTSON, GP, Houston, Texas, for Appellees. Jeffery A. Kruse, BAKER STERCHI COWDEN & RICE LLC, Kansas City, Missouri; Robert E. Scott, Jr., Marisa A. Trasatti, SEMMES, BOWEN & SEMMES, Baltimore, Maryland, for Amicus Supporting Appellant Federation of Defense & Corporate Counsel. Terri S. Reiskin, Eric C. Tew, DYKEMA GOSSETT PLLC, Washington, D.C.; Hugh F. Young, Jr., PRODUCT LIABILITY ADVISORY COUNCIL, INC., Reston, Virginia, for Amicus Supporting Appellant Product Liability Advisory Council, Inc.

Before WILKINSON and DIAZ, Circuit Judges, and SHEDD, Senior Circuit Judge.

Affirmed by published opinion. Judge Wilkinson wrote the opinion, in which Judge Diaz and Senior Judge Shedd joined.

WILKINSON, Circuit Judge

This case involves a consolidated trial of four products liability cases that are each part of a multidistrict litigation encompassing over twenty-five thousand total cases. The jury returned verdicts for the plaintiffs, awarding over $4 million to each. Defendant Boston Scientific Corporation asserts that the consolidation itself rendered the trial unfair, disputes two evidentiary rulings, claims there was insufficient evidence to support the verdicts, and challenges one of the district court's jury instructions. We reject each of these arguments, and affirm the judgments.


Boston Scientific Corporation (BSC) manufactured a transvaginal mesh prescription medical device called the Obtryx Transobturator Mid-Urethral Sling System. The Obtryx was designed to be permanently implanted as a treatment for severe stress urinary incontinence. The Food and Drug Administration approved the Obtryx in 2004 under the 510(k) process for medical device approval. Approval through the 510(k) process indicates that the FDA found the Obtryx to be "substantially equivalent" to a device already legally on the market, and thus did not require clinical trials of the Obtryx before it was marketed. Prior to marketing, the FDA also approved the Obtryx's directions for use, which included information for physicians on potential complications including pain, dyspareunia (pain with intercourse), and urinary retention.

The Obtryx is made of Marlex polypropylene. While polypropylene mesh has long been used in implantable medical devices, Marlex polypropylene's manufacturer included a caution on its Material Safety Data Sheet (MSDS) stating that it should not be used "in medical applications involving permanent implantation in the human body." J.A. 4355. The plaintiffs' experts testified at trial that Marlex can degrade when implanted transvaginally, and that it can elicit scar tissue that causes the mesh to shrink.

The plaintiffs whose cases were consolidated for trial below are four women who received Obtryx implants to treat their severe stress urinary incontinence and who allege that they experienced severe complications from the implants. The first plaintiff received her Obtryx implant in 2011. When she later complained of dyspareunia, she was diagnosed with an erosion of the Obtryx, and received follow-up surgery to excise portions of the mesh. The second plaintiff had her Obtryx implanted in 2009, and had the Obtryx sling released in 2012 after complaining of voiding dysfunction. The third plaintiff had the Obtryx implanted in 2010. She received a sling-release procedure in 2013 after she was diagnosed with narrowing of the urethra. The final plaintiff received her Obtryx implant in 2010, and subsequently complained of chronic pelvic pain and dyspareunia.

Each of these four women filed separate lawsuits against BSC. Prior to their individual cases being filed, the Judicial Panel on Multidistrict Litigation had created MDL 2326, In re: Boston Scientific Corporation Pelvic Repair System Products Liability Litigation , which is pending in the Southern District of West Virginia. The plaintiffs filed their separate cases against BSC directly in this MDL, with each seeking compensatory and punitive damages based on theories of negligence and strict liability for both design defects and failure to warn.

Before case-specific discovery began in any of these cases, the district court consolidated eleven cases for trial under Federal Rule of Civil Procedure 42. Of these eleven, six cases were dismissed and one was removed from the consolidated action prior to trial. At the close of discovery, BSC moved to conduct separate trials for the remaining four cases, arguing that the similarities did not predominate. This motion was denied.

Prior to trial, the court also decided two evidentiary motions relevant to this appeal. BSC moved to exclude evidence of the Marlex polypropylene's MSDS, but the district court denied this motion. However, the district court granted the plaintiffs' motion to exclude evidence concerning the FDA's 510(k) process and approval.

Following an eleven-day trial, the jury returned verdicts awarding past-compensatory damages of $250,000 and punitive damages of $1,000,000 to each plaintiff. Additionally, the jury awarded future-compensatory damages of $3 million to the first plaintiff, $3 million to the second, $3.5 million to the third, and $4 million to the fourth. Since trial, BSC has reached settlements with two of the plaintiffs, while BSC appeals the judgments in favor of the remaining two plaintiffs on the grounds that the district court abused its discretion by consolidating the four cases for trial, by permitting the MSDS evidence, and by excluding the FDA 510(k) evidence. BSC also challenges the verdicts for lacking sufficient evidence. Finally, BSC challenges the punitive damages awards based on what it asserts was an erroneous jury instruction.


BSC's primary contention is that the trial was rendered unfair by the consolidation of four independent cases for trial. We review decisions regarding consolidation for abuse of discretion. Arnold v. Eastern Air Lines, Inc. , 681 F.2d 186, 192 (4th Cir. 1982), rev'd on other grounds , 712 F.2d 899 (4th Cir. 1983) (en banc). No such abuse occurred here.

Consolidation is governed by Federal Rule of Civil Procedure 42(a), which provides that: "If actions before the court involve a common question of law or fact, the court may: (1) join for hearing or trial any or all matters at issue in the actions; (2) consolidate the actions; or (3) issue any other orders to avoid unnecessary cost or delay." As this court has previously explained, proper application of Rule 42(a) requires the district court to determine "whether the specific risks of prejudice and possible confusion" from consolidation "were overborne by the risk of inconsistent adjudications ..., the burden on parties, witnesses, and available judicial resources posed by multiple lawsuits, the length of time required to conclude multiple suits as against a single one, and the relative expense to all concerned of the single-trial, multiple-trial alternatives." Arnold , 681 F.2d at 193.

The district court appropriately considered these factors in ultimately ordering consolidation. It first identified the many common questions of law and fact across the trials: The four plaintiffs were each diagnosed with stress urinary incontinence before being implanted with Obtryx devices made by BSC. Each plaintiff alleged that she had experienced similar complications from the Obtryx that required additional 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 among the cases, the plaintiffs shared expert witnesses and relied on much of the same evidence from BSC documents. BSC asserted in all four cases both that the Obtryx was not defective and that the Obtryx's directions for use provided sufficient warnings. These many similarities certainly provided the "common question[s] of law or fact" required by Rule 42(a). They also make clear that separate trials would have been largely repetitive, and thus would have implicated the burdens, delays, and expense that Arnold noted help justify consolidation.

Of course, regardless of efficiency concerns, consolidation is not appropriate if it would deny a party a fair trial. Alert to this risk, the district court endeavored throughout the trial to limit any potential jury confusion or prejudice resulting from the consolidation. At the outset of trial, the district court instructed the jury that the trial concerned four separate claims and informed them that they must treat each as "as if each have been tried by itself." J.A. 1705–06. During the trial, BSC had the opportunity to address each plaintiff's claims independently, and in fact pursued a comparative negligence defense as to one plaintiff that it did not pursue as to the other plaintiffs. Following trial and prior to jury deliberations, the district court emphasized that the jurors were not to "even consider that more than one claim was brought" in weighing the evidence and that they must consider each case separately. J.A. 1084. To promote independent review of each case, the district court made use of special...

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