289 F. Supp. 3d 877
N.D. Ill.2018Background
- Plaintiffs Catherine and Travis Gravitt sued Mentor Worldwide after Catherine received Mentor MemoryGel silicone breast implants; the products are FDA Class III devices requiring PMA and post-approval studies.
- The FDA issued a November 17, 2006 PMA letter imposing six post-approval study requirements (core study with 10-year follow-up, a 41,900-patient large study, device-failure study, focus groups, physician survey, adjunct survey).
- Plaintiffs allege numerous deficiencies in Mentor's post-PMA studies (low follow-up rates, truncated reporting, fewer-than-required enrollees, incomplete reporting of reasons for re-operation) and manufacturing/process compliance failures cited by FDA inspections.
- Catherine experienced implant rupture, systemic symptoms, lymph node contamination, and later explantation; Plaintiffs allege Mentor concealed higher rupture/gel-bleed risks and failed to warn patients and physicians.
- Mentor moved to dismiss under Rule 12(b)(6), arguing federal preemption (express under 21 U.S.C. §360k(a) and implied under Buckman), and that Travis’s loss-of-consortium claim depends on Catherine’s claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law tort claims are expressly preempted by 21 U.S.C. §360k(a) | Gravitts allege Mentor violated PMA-related obligations and failed to warn; so their claims parallel federal requirements and are allowed. | Mentor says Plaintiffs fail to allege noncompliance with PMA specifications and thus state claims are preempted. | Court: Mixed. Claims tied to plausible violations of PMA/regulatory duties (e.g., failure to complete core 10-year reporting, under-enrollment, failure to report known rupture/bleed risk, manufacturing noncompliance citations) survive express-preemption challenge; purely procedural study shortcomings that do not violate federal requirements do not. |
| Whether Plaintiffs’ claims are impliedly preempted under Buckman as "fraud-on-the-FDA" policing | Gravitts frame claims as traditional state torts (failure-to-warn/negligence) based on Mentor concealing higher rupture/bleed rates. | Mentor contends these allegations are really attempts to police FDA reporting and are preempted by Buckman. | Court: Buckman preempts claims that exist solely by virtue of federal reporting requirements (e.g., failing to meet study enrollment/follow-up/reporting terms and facility compliance allegations) because they are not tied to traditional state duties; but claims alleging concealment/underreporting of rupture risk (failure-to-warn) are not impliedly preempted. |
| Adequacy of pleading given evidentiary asymmetry in Class III device cases | Gravitts argue limited detail is expected because manufacturers hold relevant information confidentially; discovery is needed. | Mentor argues Plaintiffs’ underreporting/defect allegations are insufficiently pleaded. | Court: Pleading suffices; Seventh Circuit precedent recognizes information asymmetry, so allegations that Mentor underreported rupture rates are adequate to survive Rule 12(b)(6). |
| Viability of derivative loss-of-consortium claim | Travis contends loss of consortium derives from Catherine’s viable tort claims. | Mentor argues derivative claim fails if Catherine’s claims fail. | Court: Because Catherine’s failure-to-warn/concealment claim survives, Travis’s derivative consortium claim also survives. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (§360k(a) can preempt state requirements that are different from or in addition to federal PMA conditions)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (state-law claims that effectively police fraud on a federal agency are impliedly preempted)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (state common-law remedies may proceed when duties parallel federal requirements)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (distinguishes Buckman and allows state tort claims tied to manufacturing defects or failure-to-warn where they parallel federal duties)