197 F. Supp. 3d 1026
N.D. Ill.2016Background
- Plaintiffs Terence and Sherry Laverty sued Smith & Nephew alleging that a Class III hip resurfacing device (Birmingham Hip Resurfacing, BHR) implanted in 2011 failed and caused injury, and that the manufacturer failed to report and warn about adverse events.
- Smith & Nephew obtained FDA premarket approval for the BHR in 2006, subject to post‑approval study and reporting conditions; plaintiffs allege the company delayed or inadequately reported hundreds of adverse events to the FDA.
- Plaintiffs assert Illinois tort claims: negligence and strict products liability (failure‑to‑warn and manufacturing defect theories) and loss of consortium; defendant moved for partial judgment on the pleadings under Rule 12(c) arguing preemption.
- Smith & Nephew argued the Lavertys’ failure‑to‑warn claims are (1) expressly preempted by 21 U.S.C. § 360k(a) because they would impose requirements different from federal PMA conditions, and (2) impliedly preempted under Buckman as an attempt to privately enforce the FDCA.
- The Lavertys countered that their claims parallel federal obligations (alleging breaches of FDA post‑approval reporting/warning duties) and therefore are not preempted; they rely on Illinois common‑law failure‑to‑warn duties that can be violated by noncompliance with federal post‑approval duties.
- The district court denied Smith & Nephew’s Rule 12(c) motion, holding that the complaint survives both express and implied preemption challenges because plaintiffs pled state tort claims that can be parallel to, and based on violations of, federal requirements without impermissibly seeking to enforce the FDCA.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether §360k(a) expressly preempts Lavertys’ failure‑to‑warn claims | Lavertys: claims parallel FDA post‑approval obligations; seek to enforce state duties that align with federal requirements | Smith & Nephew: state law would impose obligations different from or additional to PMA requirements, so express preemption applies | Court: Not expressly preempted — plaintiffs allege violations of federal post‑approval duties and seek parallel state remedies, so §360k(a) does not bar the claims |
| Whether Lavertys’ claims are impliedly preempted under Buckman (i.e., whether they impermissibly attempt to enforce the FDCA) | Lavertys: claims are traditional state tort failure‑to‑warn/strict liability claims based on failure to disclose adverse events; not fraud‑on‑FDA claims | Smith & Nephew: plaintiffs are effectively suing to enforce FDCA post‑approval requirements, which Buckman precludes | Court: Not impliedly preempted — claims are state law duties (duty to warn/disclose) that may be shown by violating federal reporting duties and are not the fraud‑on‑FDA claims Buckman barred |
| Whether public records showing FDA found post‑approval study "adequate" preclude plaintiffs’ allegations | Lavertys: adequacy on paper does not establish that required adverse‑event analysis and disclosures occurred; plaintiffs allege delayed/inadequate reporting | Smith & Nephew: archived FDA notes show compliance and timeliness, undermining plaintiffs’ claims | Court: Archival records do not resolve the pleaded factual dispute at the Rule 12(c) stage; plaintiffs plausibly alleged inadequate reporting and follow‑up |
| Whether prior district decisions (e.g., Mink) mandate preemption here | Lavertys: distinguish cases that found preemption and rely on Seventh Circuit precedent allowing parallel state claims | Smith & Nephew: points to Mink and other rulings that rejected similar claims | Court: Disagrees with Mink; follows Seventh Circuit authority (Bausch, McMullen distinctions) and finds plaintiffs’ pleading can survive preemption challenge |
Key Cases Cited
- McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir.) (analyzed when state failure‑to‑warn claims are preempted by PMA conditions)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (federal PMA process can preempt state design/manufacturing claims that would impose different requirements)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir.) (state common‑law claims may proceed where plaintiff can show harm from violation of federal law; §360k is limited)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (state fraud‑on‑FDA claims conflict with FDCA enforcement and are impliedly preempted)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir.) (discusses breadth of preemption and when post‑approval‑based claims may be preempted)
- In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir.) (explains narrow gap for non‑preempted claims against PMA‑approved devices)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir.) (found failure‑to‑warn claim based on post‑approval disclosure obligations not preempted)