Caplinger v. Medtronic, Inc.

784 F.3d 1335, 2015 U.S. App. LEXIS 6630, 2015 WL 1786742
CourtCourt of Appeals for the Tenth Circuit
DecidedApril 21, 2015
Docket13-6061
StatusPublished
Cited by56 cases

This text of 784 F.3d 1335 (Caplinger v. Medtronic, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Tenth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Caplinger v. Medtronic, Inc., 784 F.3d 1335, 2015 U.S. App. LEXIS 6630, 2015 WL 1786742 (10th Cir. 2015).

Opinions

GORSUCH, Circuit Judge.

Some medical devices are so risky they can’t be sold without the federal government’s prior approval. While even relatively simple things like bandages face some degree of federal oversight, manufacturers of pacemakers, heart valves, and the like must prove the “safety and effectiveness” of their devices to the FDA’s satisfaction before offering them for sale. Batteries of tests must be performed and presented and the agency’s premarket approval process can take years. Beyond guarding the gate to the.market square, the FDA also acts as censor for those allowed to enter. A manufacturer must receive the agency’s approval for,any instructional or warning label associated with its device. And once the device and label are approved, the manufacturer usually may not change them without the agency’s consent. See 21 U.S.C. § 360e(d)(1)(A), (d)(6)(A)(i); Riegel v. Medtronic, Inc., 552 U.S. 312, 319, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008).

As with most federal regulatory regimes, Congress had to balance competing goods when it enacted the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetics Act (FDCA). Perhaps most notably, it had to weigh the good of ensuring that proposed medical devices are carefully scrutinized for safety against the good of preserving the freedom of patients and doctors to use potentially life-saving technology as they see fit and without undue delay. One arena in which these objectives clashed during the legislative process involved this question: to what extent (if any) should states be able to layer additional. rules on top of Congress’s? Allowing more regulation of medical devices could yield benefits for patient safety. But it could also mean forcing manufacturers to abide not one but fifty-one sets of requirements, a prospect that could deter or delay access to innovative devices and wind up hurting more patients than it helps.

Exercising its authority under the Supremacy Clause, Congress chose to balance these competing considerations by instructing that:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any [1337]*1337other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a).

The question we face is whether this provision forecloses Patricia Caplinger’s state law tort suit against Medtronic. Medtronic produces Infuse, a device that stimulates bone growth to repair damaged or diseased vertebrae. When it approved the device for sale, the FDA required the company to include a warning label instructing that Infuse should “be implanted via an anterior” surgical approach. The label further cautioned that the device’s “safety and effectiveness ... in surgical techniques other than anterior open or anterior laparoscopic approaches have not been established” and that “[w]hen degenerative disc disease was treated by a posterior lumber [sic] interbody fusion procedure with cylindrical threaded cages, posterior bone formation was observed in some instances.” Medtronic Sofamor Danek, InFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device Important Medical Information (2002).

Despite this warning, Ms. Caplinger alleges, Medtronic and its representatives promoted Infuse for use in a posterior surgical approach — an “off-label” use as it’s known in the industry. Ms. Caplinger alleges that' a Medtronic representative personally recommended using the device in this particular way to her and her doctor. All the while, Ms. Caplinger asserts, the company harbored evidence documenting dangers associated with posterior surgical approaches that it kept hidden. According to Ms. Caplinger, she and her doctor relied on Medtronic’s representations and elected to implant the device using a posterior approach' — only to watch complications emerge that could have been avoided had they known the truth about Infuse. Ms. Caplinger alleges that Medtronic’s conduct exposed the company to liability under a variety of state tort theories. But the district court held all of these state law claims either insufficiently pleaded or preempted, and it’s this decision we’re now asked to revisit.

At first glance the answer to this appeal might appear easy enough. Section 360k(a) preempts “any requirement” imposed by states on manufacturers that differs from or adds to those found in the FDCA. Given this expansive language one might be forgiven for thinking all private state law tort suits are foreclosed. After all, a “requirement” usually means a request, need, want, or demand. See 13 The Oxford English Dictionary 682 (2d ed. 1989). And an adverse tort judgment seems to involve just that: a demand that a defendant appear to answer for its conduct and pay damages for failing some state law duty. Certainly some commentators have argued that the obligation to pay state law judgments amounts to an additional state law requirement warranting preemption under § .360k(a). See, e.g., Mark Herrmann & Geoffrey J. Ritts, Preemption and Medical Devices: A Response to Adler and Mann, 51 Food & Drug L.J. 1, 15-16 (1996).

But the answer to this appeal isn’t so simple. The Supreme Court has issued a number of opinions that embody “divergent views” about the proper role of the. MDA’s preemption provision, a fact that has yielded - considerable “uncertainty” among the lower courts seeking to apply the statute to cases like this one. Max N. Helveston, Preemption Without Borders: The Modem Conflation of Tort and Contract Liabilities, 48 Ga. L.Rev. 1085, 1124 (2014); see also Martin v. Medtronic, Inc., 254 F.3d 573, 578-79 (5th Cir.2001) (observing the difficulty in “extracting the [1338]*1338final meaning” of the Supreme Court’s cases in this area); Schouest v. Medtronic, Inc., 13 F.Supp.3d 692, 700 (S.D.Tex.2014) (“Courts have struggled with applying the Supreme Court’s preemption rulings to cases involving the Infuse device.”); Carrelo v. Advanced Neuromodulation Sys., Inc., 777 F.Supp.2d 303, 310 (D.P.R.2011) (noting “the present struggle ... to determine ' whether state-law claims are preempted by the MDA”).

The Supreme Court’s first significant encounter with the MDA’s preemption provision came in Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). There the Court rejected the notion that state law tort suits are always preempted. It held that tort suits do not impose néw “requirements” on manufacturers and are not preempted so long as the duties they seek to impose “parallel” duties found in the FDCA. Id. at 495, 116 S.Ct. 2240. The fact that a manufacturer is “required” to defend itself against a damages remedy nowhere provided for in federal law is, the Court indicated, neither here nor there.

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Bluebook (online)
784 F.3d 1335, 2015 U.S. App. LEXIS 6630, 2015 WL 1786742, Counsel Stack Legal Research, https://law.counselstack.com/opinion/caplinger-v-medtronic-inc-ca10-2015.