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Eghnayem v. Boston Scientific Corp.

United States Court of Appeals, Eleventh Circuit

October 19, 2017

AMAL EGHNAYEM, MARGARITA M. DOTRES, MANIA NUNEZ, JUANA BETANCOURT, Plaintiffs - Appellees,
v.
BOSTON SCIENTIFIC CORPORATION, Defendant -Appellant. MARGARETTE DUBOIS-JEAN, Plaintiff, 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.

          Dismissed 02/23/2017

         Appeal from the United States District Court for the Southern District of Florida D.C. Docket Nos. 1:14-cv-24061-JRG, 1:14-cv-24064-JRG, 1:14-cv-24065-JRG, 1:14-cv-24066-JRG

          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 Multi district 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 arguments, based largely on the same reasoning it had provided in the initial consolidation and exclusion orders.

         BSC now appeals the denial of these post-trial motions.

         II.

         We review a district court's decision whether to consolidate multiple actions only for a "clear abuse of discretion." Hendrix v. Raybestos-Manhattan, Inc., 776 F.2d 1492, 1495 (11th Cir. 1985). We also review the evidentiary rulings of a trial court "only for a clear abuse of discretion." United States v. Brannan, 562 F.3d 1300, 1306 (11th Cir. 2009). "[W]e must affirm unless we find that the district court has made a clear error of judgment, or has applied the wrong legal standard." Id. (quoting United States v. Frazier, 387 F.3d 1244, 1259 (11th Cir. 2004) (en banc)). Finally, we review the district court's ruling on a motion for judgment as a matter of law de novo, considering the evidence and the reasonable inferences drawn from it in the light most favorable to the nonmoving party. Middlebrooks v. Hillcrest Foods, Inc., 256 F.3d 1241, 1246 (11th Cir. 2001). Thus, we've explained, "[j]udgment as a matter of law is appropriate only if the evidence is so overwhelmingly in favor of the moving party that a reasonable jury could not arrive at a contrary verdict." Id.

         III.

         BSC first contends that the district court abused its discretion by consolidating the plaintiffs' suits, because individual issues predominated and the consolidation yielded unacceptable prejudice. BSC also argues that the district court abused its discretion by excluding evidence relating to the Pinnacle's clearance through the FDA's 510(k) regulatory process, because this evidence was relevant to the Pinnacle's safety. Neither claim succeeds.

         A.

         The district court acted well within its discretion in consolidating each of these four lawsuits. Under Federal Rule of Civil Procedure 42(a), a district court may consolidate multiple actions that "involve a common question of law or fact." A district court's decision whether to consolidate is "purely discretionary." Hendrix, 776 F.2d at 1495. In exercising its considerable discretion, the trial court is obliged to consider:

Whether the specific risks of prejudice and possible confusion are overborne by the risk of inconsistent adjudications of common factual and legal issues, 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.

Id. (quotation omitted and alterations adopted). Moreover, "[t]he court must also bear in mind the extent to which the risks of prejudice and confusion that might attend a consolidated trial can be alleviated by utilizing cautionary instructions to the jury during the trial and controlling the manner in which the plaintiffs' claims (including the defenses thereto) are submitted to the jury for deliberation." Id. "A joint trial is appropriate where there is clearly substantial overlap in the issues, facts, evidence, and witnesses required for claims against multiple defendants." Allstate Ins. Co. v. Vizcay, 826 F.3d 1326, 1333 (11th Cir. 2016) (quotation omitted and alteration adopted). But "[w]here prejudice to rights of the parties obviously results from the order of consolidation, the action of the trial judge has been held reversible error." Dupont v. S. Pac. Co., 366 F.2d 193, 196 (5th Cir. 1966).[2] "District court judges in this circuit have been urged to make good use of ...


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