Brooks v. Mentor Worldwide
985 F.3d 1272
10th Cir.2021Background:
- Mentor Worldwide’s MemoryGel silicone breast implants underwent FDA premarket approval (PMA) after a multi‑year application; FDA conditioned approval on post‑approval studies and reporting.
- Mentor allegedly failed to conduct and report required post‑approval studies properly (low follow‑up, inconsistent reporting, failure to update labels); earlier whistleblower allegations and an FDA consent decree addressed manufacturing deficiencies.
- Plaintiffs Amber Brooks and Jamie Gale received MemoryGel implants, developed symptoms, had implants removed (some leaked), and sued in D. Kan. alleging failure to warn and manufacturing‑defect claims under negligence, negligence per se, and strict liability.
- The district court dismissed the Complaint with prejudice for failure to state a claim, concluding federal law (the FDCA/MDA) preempted Plaintiffs’ claims and, alternatively, the pleadings were insufficient; it denied leave to amend.
- On appeal the Tenth Circuit reviewed preemption de novo and denial of leave to amend for abuse of discretion and affirmed the dismissal.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether negligence per se claims based on MDA/FDCA violations survive | Negligence per se viable because Mentor violated FDA requirements and that creates a state‑law standard | FDCA/MDA violations cannot be enforced by private suit; such claims are impliedly preempted under Buckman | Dismissed: negligence per se preempted (no private cause of action under FDCA/MDA) |
| Whether failure‑to‑warn claims (patients, physicians, FDA) are preempted | Plaintiffs: Mentor failed to warn patients/physicians and failed to report to FDA, which injured Plaintiffs | Mentor: PMA and labeling/reporting scheme are federal; state duties that would add or differ are expressly or impliedly preempted | Dismissed: failure‑to‑warn claims preempted (no federal requirement to warn patients directly; labeling changes require FDA approval; reporting enforcement is federal) |
| Whether Plaintiffs pleaded a plausible manufacturing‑defect claim under Iqbal/Twombly | Plaintiffs: allegations of widespread regulatory noncompliance and generic manufacturing failures suffice to infer defect | Mentor: allegations are conclusory, lack specific facts connecting conduct to Plaintiffs’ implants or a particular manufacturing defect | Dismissed: manufacturing‑defect claims not plausibly pleaded (conclusory assertions insufficient) |
| Whether denial of leave to amend was an abuse of discretion | Plaintiffs: requested leave to amend (one‑sentence) and argue procedure is burdensome; should be allowed to cure defects | Mentor/District Ct: Plaintiffs failed to timely amend as of right, did not file a formal motion or comply with local rule, and gave no proposed amendment or grounds | Affirmed: no abuse of discretion—bare, late request not a proper motion and plaintiffs chose not to use available amendment procedures |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (establishes express‑preemption test for PMA‑approved devices)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (FDCA enforcement is exclusively federal; implied preemption of private suits predicated solely on FDCA violations)
- Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015) (applies Riegel/Buckman; plaintiff must show a parallel state law duty to avoid preemption)
- In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (describes the narrow gap for state tort claims post‑PMA)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading standard: conclusory allegations insufficient to state a plausible claim)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) (Iqbal/Twombly pleading framework for plausibility)