Eghnayem v. Bos. Scientific Corp.

• Decision Date: 19 October 2017
• Docket Number: No. 16-11818.,16-11818.
• Citation: 873 F.3d 1304
• Parties: Amal EGHNAYEM, Margarita M. Dotres, Mania Nunez, Juana Betancourt, Plaintiffs-Appellees, Margarette Dubois-Jean, Plaintiff, v. BOSTON SCIENTIFIC CORPORATION, Defendant - Appellant. Margarita M. Dotres, Plaintiff, v. Boston Scientific Corporation, Defendant. Mania Nunez, Plaintiff-Appellee, v. Boston Scientific Corporation, Defendant-Appellant. Juana Betancourt, Plaintiff-Appellee, v. Boston Scientific Corporation, Defendant-Appellant.
• Court: U.S. Court of Appeals — Eleventh Circuit

873 F.3d 1304

Amal EGHNAYEM, Margarita M. Dotres, Mania Nunez, Juana Betancourt, Plaintiffs-Appellees,

Margarette Dubois-Jean, Plaintiff,

v.BOSTON SCIENTIFIC CORPORATION, Defendant - Appellant.

Margarita M. Dotres, Plaintiff,

v.Boston Scientific Corporation, Defendant.

Mania Nunez, Plaintiff-Appellee,

v.Boston Scientific Corporation, Defendant-Appellant.

Juana Betancourt, Plaintiff-Appellee,

v.Boston Scientific Corporation, Defendant-Appellant.

No. 16-11818.

United States Court of Appeals, Eleventh Circuit.

October 19, 2017

Jane Kreusler-Walsh, Stephanie L. Serafin, Rebecca Mercier Vargas, Kreusler-Walsh Compiani & Vargas, PA, West Palm Beach, FL, Bryan Fredrick Aylstock, Douglass A. Kreis, Aylstock Witkin Kreis & Overholtz, PLLC, Pensacola, FL, Clayton Clark, Shelley Hutson, William Michael Moreland, Clark Love & Hutson, Erin Copeland, Fibich Leebron Copeland Briggs Josephson, Jim M. Perdue, Jr., Perdue & Kidd, Houston, TX, Joseph Anthony Osborne, Ami Rebecca Romanelli, Osborne Law Office, Boca Raton, FL, Josh B. Wages, Blasingame Burch Garrard & Ashley, PC, Athens, GA, Roy D. Wasson, Wasson & Associates, Chartered, Miami, FL, for Amal Eghnayem.

Jane Kreusler-Walsh, Stephanie L. Serafin, Rebecca Mercier Vargas, Kreusler-Walsh Compiani & Vargas, PA, West Palm Beach, FL, Clayton Clark, Shelley Hutson, William Michael Moreland, Clark Love & Hutson, Erin Copeland, Fibich Leebron Copeland Briggs Josephson, Scott A. Love, Fleming Nolen & Jez, LLP, Jim M. Perdue, Jr., Perdue & Kidd, Houston, TX, Joseph Anthony Osborne, Osborne Law Office, Boca Raton, FL, Josh B. Wages, Blasingame Burch Garrard & Ashley, PC, Athens, GA, Roy D. Wasson, Wasson & Associates, Chartered, Miami, FL, for Mania Nunez and Juana Betancourt.

Daniel B. Rogers, Hildy M. Sastre, I, Shook Hardy & Bacon, LLP, Miami, FL, Eric Anielak, Matthew D. Keenan, Williams F. Northrip, Shook Hardy & Bacon, LLP, Kansas City, MO, James Hood, Mary Agnes Hood Craig, Hood Law Firm, LLC, Charleston, SC, for Defendant-Appellant.

Patricia Genevieve Duret, Wooden & McLaughlin, LLP, Indianapolis, IN, for Cook Incorporated, Cook Medical, LLC, and Cook Biotech Incorporated.

Before HULL, MARCUS, and ROGERS,^* Circuit Judges.

MARCUS, Circuit Judge:

In this products liability suit, Boston Scientific Corporation (BSC) appeals from various orders and a final judgment in favor of the plaintiff, Amal Eghnayem. Eghnayem alleged substantial injuries caused by the Pinnacle Pelvic Floor Repair

Kit, a transvaginal mesh prescription medical device manufactured and sold by BSC. She initially filed suit in the Southern District of West Virginia as part of a transvaginal mesh Multidistrict Litigation; her suit was consolidated with three other similar suits and transferred to the Southern District of Florida for trial. The consolidated plaintiffs all brought the same four claims under Florida law, arguing that BSC was both negligent and strictly liable for the Pinnacle's defective design, and both negligent and strictly liable for failing to warn them of the resultant danger from the Pinnacle. After eight days of trial, the jury found for each of the plaintiffs on all four claims, awarding more than six million dollars to each plaintiff. BSC now appeals from the judgment entered for Eghnayem.¹

BSC argues that the district court abused its discretion in two distinct ways: by consolidating the four plaintiffs' suits and trying them together, and by excluding all evidence relating to the Food and Drug Administration's clearance of the Pinnacle for sale through its 510(k) "substantial equivalence" process. BSC also says that the district court erred in denying it judgment as a matter of law because Eghnayem failed to present sufficient evidence to prove her design defect claim; she failed to present sufficient evidence that the Pinnacle's warnings were not per se adequate, and that the alleged failure to warn was the proximate cause of her injuries; and finally, the relevant statute of limitations barred all of her claims as a matter of law.

After thorough review, and having had the benefit of oral argument, we can discern no error in the district court's rulings, and accordingly we affirm the judgment of the district court.

I.

The Pinnacle is a medical device used to remedy pelvic organ prolapse in a female patient. Essentially, this device is a mesh sheet that is implanted transvaginally and works by physically preventing pelvic organs (the bladder, uterus, or rectum) from falling through the vagina. The mesh is made from polypropylene, a type of plastic. In 2007, the FDA cleared BSC to sell the Pinnacle pursuant to its 510(k) process, which entailed finding that the Pinnacle was "substantially equivalent" to another device already available on the market.

The plaintiff, Amal Eghnayem, had a Pinnacle surgically implanted on February 28, 2008, to treat her pelvic organ prolapse. In the months following her surgery, she began to experience bleeding and pain during intercourse, incontinence, and pelvic pain and pressure. She visited a doctor for these problems in October 2008, who performed a pelvic exam

and told Eghnayem that she had exposed mesh in her vagina. The doctor performed in-office surgery to trim the exposed mesh in an attempt to alleviate Eghnayem's symptoms. Unfortunately, this treatment did not resolve her problems, and in May 2012, she visited another doctor and complained of similar symptoms. This doctor examined Eghnayem, found another mesh exposure, and performed a second mesh-removal surgery in August 2012. Since then, Eghnayem's pain has largely subsided, but she has lost vaginal sensitivity.

Eghnayem and three other plaintiffs filed separate lawsuits against BSC in MDL 2326—In re: Boston Scientific Corporation Pelvic Repair System Products Liability Litigation—in the United States District Court for the Southern District of West Virginia. They each sought compensatory and punitive damages based on claims for negligent design defect, negligent failure to warn, strict-liability design defect, and strict-liability failure to warn. The district court sua sponte consolidated the suits for all purposes, including trial. The court observed that, although "there will be separate evidence relating to failure to warn and individual damages," "the similarities in these cases, particularly as to the claim of design defect," outweighed the differences and warranted consolidation.

BSC moved the district court to sever the suits after discovery, arguing that the similarities in the plaintiffs' suits did not predominate and that consolidation would lead to jury confusion and prejudice. It pointed out that each plaintiff had different complaints, different medical histories, and different treating doctors; was prescribed the Pinnacle at different times for different conditions; and claimed to suffer different injuries, after different lengths of exposure, resulting in different treatment courses. But the district court was "unpersuaded that the barriers suggested by defendants in a consolidated trial [were] insurmountable or [would] result in [ ] prejudice" and so denied BSC's motion.

The consolidated case was transferred to the United States District Court for the Southern District of Florida. Prior to trial, the district court excluded all evidence relating to the Food and Drug Administration's ("FDA") regulatory scheme and clearance of the Pinnacle for sale pursuant to the 510(k) "substantial equivalence" process. The court excluded the evidence under both Federal Rule of Evidence 402, which provides that "[i]rrelevant evidence is not admissible," and Federal Rule of Evidence 403, which provides that relevant evidence may be excluded "if its probative value is substantially outweighed by a danger of ... unfair prejudice, confusing the issues, misleading the jury, undue delay, [or] wasting time."

Trial began in the Southern District of Florida on November 3, 2014, and continued over eight days. The plaintiffs offered twenty-five witnesses, including themselves and their implanting physicians. The witnesses, mostly doctors, testified regarding the plaintiffs' medical conditions, implantation processes, and injuries; BSC's structure and policies; the Pinnacle's development process; and the Pinnacle's and polypropylene mesh's chemical characteristics, design features, uses, and potential dangers. BSC contested all four of the plaintiffs' claims on the merits and also asserted Florida's four-year statute of limitations for products liability claims as an affirmative defense against Eghnayem's claims in particular. At the conclusion of the plaintiffs' case, and again after the conclusion of their own case, BSC moved for judgment as a matter of law on all claims; the district court deferred ruling. The jury returned a verdict in favor of each of the plaintiffs on all claims except for punitive damages, and rejected BSC's statute of limitations defense, awarding $6,722,222 in damages to Eghnayem, $6,533,333 to Nuñez, $6,766,666 to Dotres, and $6,722,222 to Betancourt.

BSC renewed its motion for judgment as a matter of law on all of the plaintiffs' claims. BSC argued, among other things, that Eghnayem failed to present sufficient evidence on her design defect claim; that the Pinnacle's warnings were adequate as a matter of law, and that regardless Eghnayem failed to show that the alleged failure to warn was the proximate cause of her injuries; and, finally, that the evidence indisputably showed that Eghnayem's claims had accrued more than four years before she filed suit. The district court rejected all of these arguments, concluding that Eghnayem had provided sufficient evidence to support her claims and thus they were all properly reserved for the jury.

BSC also moved in the alternative for a new trial on the grounds that it was substantially prejudiced by the wrongful exclusion of the 510(k) evidence, and that consolidation confused the jury and also prejudiced BSC. Again, the district court rejected these...