Amal Eghnayem v. Boston Scientific Corporation, 873 F.3d 1304

Background

Plaintiff Amal Eghnayem received a Boston Scientific (BSC) Pinnacle transvaginal mesh implant in 2008 and later experienced mesh exposure, pain, incontinence, and loss of vaginal sensitivity; she had mesh removal surgeries in 2008 and 2012.
Eghnayem and three other plaintiffs filed separate suits in MDL-2326 alleging negligent and strict-liability claims for defective design and failure to warn under Florida law; the district court sua sponte consolidated the four suits for trial.
The district court excluded all evidence concerning FDA 510(k) clearance of the Pinnacle under Rules 402 and 403; trial proceeded in the Southern District of Florida.
After an eight-day consolidated trial, the jury found for each plaintiff on all claims (no punitive damages) and awarded each plaintiff roughly $6.5–6.8 million; the district court denied BSC’s motions for judgment as a matter of law and for a new trial.
On appeal BSC challenged (1) consolidation, (2) exclusion of 510(k) evidence, (3) sufficiency of evidence on design defect and failure-to-warn (including causation), and (4) application of Florida’s four-year statute of limitations as to accrual.
The Eleventh Circuit affirmed, holding the district court did not abuse its discretion on consolidation or evidentiary rulings, and that sufficient evidence supported the jury’s verdicts; accrual/timeliness was a jury question.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Consolidation of four suits for a single trial	Consolidation appropriate because common claims (design defect and failure to warn) and overlapping evidence predominate	Consolidation caused juror confusion & prejudice due to differing facts, doctors, timing, and damages	Affirmed — consolidation within district court discretion; precautions and instructions mitigated prejudice
Exclusion of FDA 510(k) clearance evidence	510(k) status not necessary to plaintiff; safety concerns proven by experts and other evidence	510(k) clearance was relevant to device safety and should rebut defect/safety allegations	Affirmed — 510(k) focuses on equivalence not safety; excluded under Rules 402 and 403 as low probative value and high potential for confusion
Sufficiency of evidence for design defect (risk-utility)	Mesh experts testified polypropylene degrades in vivo and crosshatched design impedes removal; risks outweighed benefits	Design criticisms were matters of degree; testimony favorable to BSC, and surgeon testified polypropylene is safe	Judgment as a matter of law denied — record contained sufficient expert testimony for jury to find design defect under Florida risk-utility test
Failure to warn / causation & statute of limitations accrual	Warnings failed to disclose that mesh removal could be irreversible and require removal of healthy tissue; treating physician testified inadequate warning would have affected his decision; injury discovery date was factual	Warnings were adequate as a matter of law; physician testimony insufficient; plaintiff’s symptoms in 2008 triggered accrual more than four years before suit	Judgment as a matter of law denied — warnings were a jury question (not plainly adequate), causation evidence sufficient, and accrual was not obvious as a matter of law and properly left to the jury

Key Cases Cited

Hendrix v. Raybestos-Manhattan, Inc., 776 F.2d 1492 (11th Cir. 1985) (standard and factors for consolidation under Rule 42(a))
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (distinguishing PMA safety review from 510(k) equivalence process)
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (510(k) focuses on equivalence not safety)
Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (background on FDA regulatory scheme and limits of judicial inquiry)
In re C.R. Bard, Inc., 810 F.3d 913 (4th Cir. 2016) (upholding exclusion of 510(k) evidence as more prejudicial than probative in pelvic mesh MDL)
Force v. Ford Motor Co., 879 So. 2d 103 (Fla. Dist. Ct. App. 2004) (Florida adopts risk-utility test for design defect)
Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d 102 (Fla. 1989) (warnings to learned intermediary can be adequate as a matter of law if clear)
Upjohn Co. v. MacMurdo, 562 So. 2d 680 (Fla. 1990) (expert testimony generally required to show inadequacy of warnings)
Univ. of Miami v. Bogorff, 583 So. 2d 1000 (Fla. 1991) (discovery rule and what constitutes sufficient notice to start statute of limitations)
Babush v. Am. Home Prods. Corp., 589 So. 2d 1379 (Fla. Dist. Ct. App. 1991) (critical elements of notice under discovery rule)