Caplinger v. Medtronic, Inc.

• Decision Date: 21 April 2015
• Docket Number: No. 13–6061.,13–6061.
• Citation: 784 F.3d 1335
• Parties: Patricia CAPLINGER, Plaintiff–Appellant, v. MEDTRONIC, INC., a Minnesota corporation; Medtronic Sofamor Danek USA, Inc., a Tennessee corporation, Defendants–Appellees. The Product Liability Advisory Council, Inc., Amicus Curiae.
• Court: U.S. Court of Appeals — Tenth Circuit

784 F.3d 1335

Patricia CAPLINGER, Plaintiff–Appellant

v. MEDTRONIC, INC., a Minnesota corporation; Medtronic Sofamor Danek USA, Inc., a Tennessee corporation, Defendants–Appellees.The Product Liability Advisory Council, Inc., Amicus Curiae.

No. 13–6061.

United States Court of Appeals, Tenth Circuit.

April 21, 2015.

Allison M. Zieve of Public Citizen Litigation Group, Washington, D.C. (Scott L. Nelson of Public Citizen Litigation Group, Washington, D.C., and James W. Dobbs of Rhodes Dobbs & Stewart, PLLC, Edmond, OK, with her on the briefs), for Plaintiff–Appellant.

Andrew E. Tauber of Mayer Brown LLP, Washington, D.C. (Daniel L. Ring of Mayer Brown LLP, Washington, D.C. and Scott M. Noveck, formerly of Mayer Brown LLP, Washington, D.C., and Michael K. Brown, James C. Martin, and Lisa M. Baird of Reed Smith LLP, Los Angeles, CA, with him on the brief), for Defendants–Appellees.

Alan Untereiner and Donald Burke of Robbins, Russell, Englert, Orseck, Untereiner & Sauber LLP, Washington, D.C., and Hugh F. Young, Jr., of the Product Liability Advisory Council, Inc., Reston, VA, on the brief for amicus curiae Product Liability Advisory Council, Inc., in support of Defendants–Appellees.

Before LUCERO, HARTZ, and GORSUCH, Circuit Judges.

Opinion

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 other 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 Modern 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 final 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 new “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.

But the Court's answer only invited the next question: when exactly does a state law duty “parallel” a federal law duty enough to evade preemption? That term doesn't appear in the statute, so its meaning was left entirely to judicial exposition. And in Lohr itself five justices took the view that state and federal law duties “parallel” each other not only when they are identical, but also when state law imposes duties on the defendant that are “narrower, not broader” than those found in the FDCA. Id. So, for example, a state claim requiring a plaintiff to prove that a manufacturer negligently breached a duty of care might survive preemption if a federal regulation would impose strict liability in the same situation.

Now, you might ask, why isn't a narrower state law requirement at least “different from” a broader federal requirement—and thus preempted by § 360k(a)'s express terms? The Lohr majority acknowledged that a state duty imposing a “narrower requirement” is indeed “ ‘different from’ the federal rules in a literal sense.” Id. And when it comes to interpreting the text of a statute, that's often the sense that matters most. See, e.g., Hartford Underwriters Ins. Co. v. Union Planters Bank, N.A., 530 U.S. 1, 6, 120 S.Ct. 1942, 147 L.Ed.2d 1 (2000) (noting that “when the statute's language is plain, the sole function of the courts—at least where the disposition required by the text is not absurd—is to enforce it according to its terms” (internal quotation marks omitted)). But all the same the Lohr majority adopted a test that leaves it to lower courts to try to resolve whether a state duty is “literally different” but “narrower” (and thus permissible) or “too different” and “broader” (and thus impermissible). Lower courts have struggled ever since when it comes to trying to decide...