Caplinger v. Medtronic, Inc.
2015 U.S. App. LEXIS 6630
| 10th Cir. | 2015Background
- Patricia Caplinger sued Medtronic after complications from off‑label posterior use of Infuse, a PMA‑approved bone‑growth device; she alleges Medtronic promoted off‑label use and concealed risks.
- The FDA approved Infuse with labeling warning against posterior lumbar interbody use and required anterior approach warnings as part of Premarket Approval (PMA).
- District court dismissed Caplinger’s claims (strict liability design, inadequate warning, breach of warranty, negligence, negligent misrepresentation, fraud) as either inadequately pleaded or preempted.
- Medtronic moved to dismiss based on express preemption under 21 U.S.C. § 360k(a) and related doctrines; it argued no parallel federal requirement permits the state claims.
- The Tenth Circuit majority affirmed dismissal, concluding most claims are preempted because (1) Infuse underwent PMA (device‑specific federal requirements apply), (2) Caplinger failed to identify parallel federal duties for many claims, and (3) federal law generally bars manufacturers from changing PMA‑approved labeling, undermining alleged state duties to warn.
- Judge Lucero concurred in part and dissented in part, arguing some claims (failure to warn, negligence, negligent misrepresentation) plausibly parallel federal misbranding/adulteration prohibitions and should survive dismissal at this early stage.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state tort claims are expressly preempted by 21 U.S.C. § 360k(a) for a PMA device | Caplinger: her state claims parallel federal duties (or concern off‑label use which should not be preempted) | Medtronic: PMA means device‑specific federal requirements preempt any state safety requirement different from or additional to federal law | Held: Majority — preempted; plaintiff failed to identify parallel federal requirements for many claims and PMA status bars state‑imposed duties that would differ/add to federal scheme. |
| Whether off‑label use claims escape preemption | Caplinger: off‑label use lies outside FDA’s PMA focus so state claims about off‑label use should not be preempted | Medtronic: § 360k(a) makes no on/off‑label distinction; allowing off‑label exceptions would disrupt federal scheme | Held: Majority — off‑label distinction not textually or precedentially supported; off‑label‑based state claims can be preempted. |
| Whether plaintiff’s failure‑to‑warn and related claims can survive as "parallel" to federal labeling/misbranding rules | Caplinger/Lucero: alleged off‑label promotion and misbranding/adulteration can make labeling inadequate and create parallel state duties (and plausible negligence claims) | Medtronic: applicable federal regs (e.g., prescription‑device labeling rules, PMA label exclusivity) foreclose imposing different/additional labeling duties | Held: Majority — plaintiff failed to show viable parallel duties; Lucero would remand because parallelism is plausible and dismissal premature. |
| Whether Buckman implied‑preemption (exclusive federal enforcement of MDA) bars claims premised solely on FDCA violations | Caplinger: many claims rest on traditional state tort duties that predate FDCA and are not "solely by virtue" of federal law | Medtronic: some claims effectively enforce federal regulatory standards and thus implicate Buckman | Held: Majority — Buckman limits only those claims that exist solely by virtue of FDCA violations; court found plaintiff’s claims either non‑parallel or inadequately pleaded, so Buckman did not change outcome; concurrence emphasized Buckman does not bar traditional state tort claims grounded in misbranding/adulteration. |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (held some state common‑law claims survive § 360k(a) when they "parallel" federal requirements and addressed scope of device‑specific preemption)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (held federal enforcement scheme evinces "clear evidence" Congress intended exclusive federal enforcement for certain FDCA matters; claims that exist solely by virtue of FDCA violations are preempted)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (held § 360k(a) preempts state requirements that are different from or in addition to federal requirements for PMA devices)
- Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (explained that state requirements need not use identical language to federal law to avoid preemption)
- Wolicki‑Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (affirmed dismissal where plaintiff failed to identify parallel federal duty)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (reversed dismissal where plaintiff lacked access to relevant PMA materials, creating factual dispute about applicable federal requirements)
- In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (discussed limits of the parallel‑requirements exception and affirmed dismissal where parallel duty not established)