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.
784 F.3d 1335
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.
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
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.
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
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
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
Since Lohr, the Supreme Court has twice revisited and cut back the scope of its initial decision. The first blow fell in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). There the Court addressed
The Court retreated further from Lohr in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). As Riegel saw it, the clause in
How are we supposed to apply all these competing instructions? It‘s “no easy task.” Martin, 254 F.3d at 579. Even the usually straightforward job of laying out the rules governing our review is a real “struggle[]” in this area. Schouest, 13 F.Supp.3d at 700. One can‘t help but wonder if perhaps some of those rules warrant revisiting and reconciliation. But if we understand our directions, it seems we aren‘t supposed to ask whether Ms. Caplinger wishes to use state tort law to impose on Medtronic a safety requirement that is “different from, or in addition to” a federal requirement so much as whether she seeks to vindicate a state duty that is “narrower” or “broader” than a federal duty. To the extent the state law duty is narrower than or equal to the federal duty it survives, through what seems a sort of Venn diagram approach to preemption. Still, even if the state claim fails that test because it would impose a “broader” duty than can be found in federal law, it appears we may not find the claim preempted just because it conflicts with “any” federal requirement. Instead, we may find the state law claim preempted only if there exists a device-specific federal requirement, though this test admittedly finds no analogue when it comes to the state requirement clause interpreted in Riegel. Finally, should the state claim survive this far, we must ask whether it exists “solely by virtue” of the federal statutory scheme (unacceptable) or “predates” the scheme (acceptable). It‘s no wonder that the difficulty of crafting a complaint sufficient to satisfy all these demands has been compared to the task of navigating between Scylla and Charybdis. Jean Macchiaroli Eggen, Navigating Between Scylla and Charybdis: Preemption of Medical Device “Parallel Claims,” 9 J. Health & Biomedical L. 159, 161 (2013). Certainly the task we face in trying to apply the Court‘s directions faithfully feels something like that.
*
How do Ms. Caplinger‘s pleadings measure up to the Court‘s announced preemption principles? Her complaint raises claims for strict products liability (alleging defective design and inadequate warning), breach of warranty, negligent misrepresentation, and negligence.1 There‘s no dispute in our case that device-specific federal requirements apply to Infuse: the device endured the premarket approval process. So the MDA will preempt all of Ms. Caplinger‘s claims unless federal requirements impose duties that are at least as broad as those she seeks to vindicate through state law. See Riegel, 552 U.S. at 322-24, 128 S.Ct. 999.
It‘s here the problems begin. When it comes to her design defect and
Even with respect to her remaining labeling attack that falls within the arguable (Venn diagram) scope of the regulations she‘s cited, another problem quickly emerges. Infuse is a prescription device. As federal regulations explain, that usually means it isn‘t possible to prepare adequate directions for its safe use by laymen.
In these circumstances, we cannot see how the district court can be faulted for dismissing her claims. A district court may grant judgment as a matter of law under
That‘s not to say another plaintiff won‘t ever be able to succeed where Ms. Caplinger has failed. For example, we don‘t question the possibility that buried somewhere in the heap of federal law parallel provisions exist to save claims like Ms. Caplinger‘s. After all, the FDA‘s medical device regulations alone cover 592 pages of eight-point type and the Supreme Court has suggested that in searching for a parallel federal duty a plaintiff may scour them all as well as the statute itself. See Lohr, 518 U.S. at 495, 116 S.Ct. 2240. And lurking in there somewhere might be some answer to the apparent conundrum of how a plaintiff might use state law to require more label warnings that federal law seems to prohibit. But despite the challenge of Medtronic‘s motion to dismiss, Ms. Caplinger has never—in all her voluminous briefs in the district court or this one—identified any legally viable federal requirement that might parallel and thus permit her claims. Neither are the courts under an obligation to perform that work for her, searching out theories and authorities she has not presented for herself. Indeed, we are especially hesitant to try that here, where Ms. Caplinger has been ably represented by counsel and the effort to supplement their efforts would require us to venture into a field in which so many others who‘ve come before have struggled to find their way and there exists so much risk of going astray. See, e.g., Aquila, Inc. v. C.W. Mining, 545 F.3d 1258, 1268 (10th Cir.2008).3
Not only do we acknowledge others might succeed where Ms. Caplinger has failed. We also acknowledge that there‘s always the possibility an antecedent dispute of material fact will preclude a court from being able to render judgment as a matter of law on an affirmative defense like preemption. In Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir.2010), for example, the court found that the plaintiff lacked access to the certain confidential premarket approval documents for the device in question. Id. at 561. According to the court, the plaintiff didn‘t and couldn‘t know at the time of the motion to dismiss what federal requirements applied to the device in question. And without knowing, as a factual matter, what federal requirements did and didn‘t apply to the device
But, once again, Ms. Caplinger has never suggested anything like that here. She‘s never argued that she lacks access to any relevant documents for the Infuse device and she has never identified any other missing material fact essential to analyzing the preemption question. She has not so much as cited Bausch to suggest the preemption question presented in our case raises anything less than a purely legal question. In these circumstances we can again hardly fault the district court for granting judgment as a matter of law when no one has suggested a material dispute of fact exists that might require otherwise.4
*
Still, that doesn‘t come close to ending our encounter with this case. So far we‘ve hewed to the path the Supreme Court mapped out in Lohr, Riegel, and Buckman, asking whether Ms. Caplinger‘s state law claims seek to impose duties that parallel federal duties but do not depend solely on federal law. Recognizing the weakness of her position under the tests announced by the Supreme Court, she now seeks to suggest they don‘t much matter. Even if no parallel federal requirements exist for her state tort claims, Ms. Caplinger argues that‘s immaterial and her tort claims should survive preemption anyway. As she sees it, the fact that her suit concerns an off-label use is enough all by itself to insulate all her claims from preemption. Her reasoning goes something like this: When weighing whether a medical device is sufficiently safe to enter the market, the FDA usually examines the use the manufacturer intends the device to be put—its “on-label” use. See
Neither was Congress oblivious to the potential pitfalls (and promises) of off-label uses when it wrote such a broad preemption provision. Congress spoke directly to off-label uses in
At this point in the proceedings and recognizing the absence of any textual authority for limiting
This theory faces a similar textual dead-end. Section 360k(a) doesn‘t preempt only those state safety requirements addressing the “same subject” as federal requirements. Instead and again, the statute re-
Not only does the statute lack Ms. Caplinger‘s latest precondition to preemption, it once again contains evidence suggesting that Congress knew how to prescribe ones exactly like it when it wished. Section 360k(a) preempts any state requirement that (1) adds to or differs from federal requirements and (2) relates either to (a) a device‘s “safety or effectiveness” or (b) “any other matter included in a [federal] requirement applicable to the device.” The category we‘ve labeled (b) is noteworthy because there a federal requirement concerning the “same subject” as a state requirement may be a necessary precondition to preemption. Meanwhile, none of this is true of the first category—what we‘ve labeled (a). That category specifies its preemptive reach plainly and broadly: any state requirement that adds to federal requirements and that relates to the safety or effectiveness of the device is preempted. No other qualification exists. It seems pretty clear, then, that Congress knew not only how to impose a “same subject” precondition to preemption but actually chose to do so in an adjacent clause. In this light, its decision not to include a “same subject” precondition in the clause under review seems all the more deliberate and difficult for a court to disregard. See Roberts, 132 S.Ct. at 1357 n. 5.
Beyond these textual impediments, Ms. Caplinger‘s theories face precedential problems. Like Ms. Caplinger, the plaintiff in Riegel argued that a medical device was poorly designed for the particular off-label use his doctor made of it. The plaintiff in Riegel claimed, too, that the manufacturer failed to provide sufficient warnings about off-label uses. Even so, the Court didn‘t hesitate to find all of his claims preempted. Once a device endures the premarket approval process, Riegel held, any state safety requirement differing from or adding to the body of federal regulations is preempted, even if that requirement comes in the guise of a general tort suit addressing only safety issues relating to off-label uses. See 552 U.S. at 322-24, 128 S.Ct. 999. Indeed, the Court told us unequivocally that “[s]tate tort law that requires a manufacturer‘s [device] to be safer ... than the model the FDA has approved disrupts the federal scheme.” Id. at 325, 128 S.Ct. 999. And the Court proceeded to dismiss the plaintiff‘s design defect and failure to warn claims addressing off-label uses. We fail to see how we might faithfully reach a different view here.
Our conclusion finds support in circuit precedent too. Several circuits have already recognized that once a device survives premarket approval it‘s immune from state tort suits that seek to impose different or additional safety-related duties like those alleged here. See, e.g., Stengel v. Medtronic, Inc., 704 F.3d 1224, 1233 (9th Cir.2013) (en banc); Walker v. Medtronic, Inc., 670 F.3d 569, 577 (4th Cir.2012); Hughes v. Bos. Scientific Corp., 631 F.3d 762, 768 (5th Cir.2011); Wolicki-Gables, 634 F.3d at 1301; Howard v. Sulzer Orthopedics, Inc., 382 Fed.Appx. 436, 439-40 (6th Cir.2010); Bausch, 630 F.3d at 552-53; Sprint Fidelis, 623 F.3d at 1205; see also Helveston, supra, at 1111 (explaining that “the MDA grants manufacturers of
Instead, she notes that the FDA recently submitted a legal brief in another case that arguably endorses her view that
Aside from statutory terms, structure, and precedent there remains the question of statutory purpose. The business of hazarding a guess about the intent of a legislative body composed of more than 500 individuals, each with his or her own interests and ends, always bears its risks. But as explored by the parties and amicus, the legislative history suggests that to the extent Congress considered any of the questions here it opted for the broadest available preemption provision in circulation during the drafting process. Compare H.R. 11124, 94th Cong. § 2 (as reported by H. Comm. on Interstate & Foreign Commerce, Feb. 29, 1976), with S. 510, 94th Cong. § 704 (as passed by Senate, April 17, 1975).
It‘s easy to imagine, too, why Congress adopted a preemption provision that doesn‘t distinguish between on- and off-label uses. Any additional state duties on top of those imposed by federal law, even if nominally limited to off-label uses, might check innovation, postpone access to life-saving devices, and impose barriers to entry without sufficient offsetting safety gains. For example, a state‘s judgment that a device is unsafe for a particular off-label use could require design changes that adversely affect the device‘s safety for on-label uses. Requiring manufacturers to comply with fifty states’ warning requirements concerning off-label uses, on top of existing federal on-label warning requirements, might introduce sufficient uncertainty and cost that manufacturers would delay or abandon at least some number of life-saving innovations. See, e.g., Sharkey, supra, at 361; Samuel Issacharoff & Catherine M. Sharkey, Backdoor Federalization, 53 UCLA L.Rev. 1353, 1385-86 (2006); Catherine M. Sharkey, Products Liability Preemption: An Institutional Approach, 76 Geo. Wash. L.Rev. 449, 483 (2008). Regulating any aspect of a device also raises the possibility of “spillover effects” from rules that “benefit in-state residents” at the expense of out-of-staters. Issacharoff & Sharkey, supra, at 1386-87. In short, we can see a number of ways in
Not everyone may agree with how Congress balanced the competing interests it faced in this sensitive and difficult area. We can surely imagine a different statute embodying a different judgment. But strike a balance Congress had to and did, and it is not for this court to revise it by beating a new path around preemption nowhere authorized in the text of the statute and nowhere recognized in any of the Supreme Court‘s many forays into this field.
Affirmed.
LUCERO, Circuit Judge, concurring in part and dissenting in part.
According to the majority, Patricia Caplinger cannot recover for harms, long cognizable under state law, that flow directly from Medtronic‘s alleged violations of federal laws forbidding the introduction of misbranded or adulterated medical devices into the market. This result is compelled neither by binding precedent nor by the plain text and clear purpose of the Federal Food, Drug, and Cosmetic Act as amended by the Medical Devices Amendments of 1976 (“MDA“), which were enacted to promote the safety of medical devices through honest labeling and promotion.1
Federalism concerns caution against rushing to preempt state law. See The Federalist No. 33, at 206-08 (Alexander Hamilton) (J. Cooke ed.1961). Those concerns are heightened when, as here, the district court misapprehended the scope of relevant law. Although I agree with most of the majority‘s preemption analysis, I write separately to express these concerns, discuss how the district court misapprehended law, and explain why some of Caplinger‘s claims are at least plausibly parallel and should survive a motion to dismiss at this early stage of the litigation.
I
Caplinger alleges that Medtronic promoted and marketed uses of its Infuse product to Caplinger and her physicians that were not approved by the Food and Drug Administration (“FDA“). This “off-label” promotion allegedly induced Caplinger and her physicians to implant Infuse in Caplinger‘s spine using a technique that had never been evaluated by the FDA.2 A Medtronic representative, acting in the course of her employment, actively provided information regarding Infuse as it applied to Caplinger‘s particular surgery and was present during her surgery. Ca-
II
After a device has been submitted for Premarket Approval (“PMA“), the FDA carefully studies its safety “under the conditions of use prescribed, recommended, or suggested in the proposed labeling” by the manufacturer.
The FDA guards against this danger by forbidding manufacturers from introducing “misbranded” or “adulterated” devices into the marketplace.
This objective intent may, for example, be shown by labeling claims, advertising
matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.
If a manufacturer wishes to sell a device for an intended use not analyzed in the PMA process, it must generally “submit a PMA supplement for review and approval by FDA.”
These prohibitions against misbranding or adulteration do not limit the ability of doctors to exercise professional judgment in their use of approved devices. As the majority notes, a medical practitioner does not violate federal law by using a medical device off-label. See
Unlike the patient protection achieved by practitioner liability for off-label use, the result of allowing injured individuals to pursue state tort remedies against medical device manufacturers who legally sold and marketed FDA-approved devices would be an undue burden on those manufacturers. To avoid federal liability, each modification made to a device in order to forestall such a state tort claim would need to comply with the exacting PMA process. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 344-45, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (explaining that “the PMA process is ordinarily quite time consuming because the FDA‘s review requires an ‘average of 1,200 hours [for] each submission‘” (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996))). Congress’ solution to this problem was enacting
In contrast, when a plaintiff alleges harms predicated on a manufacturer‘s violation of both FDA regulations and “parallel” state law duties, the enforcement of state tort law complements the federal scheme. See Riegel, 552 U.S. at 330, 128 S.Ct. 999; see also Lohr, 518 U.S. at 513, 116 S.Ct. 2240 (O‘Connor, J., concurring in part and dissenting in part) (“[T]he threat of a damages remedy will give manufacturers an additional cause to comply.... Section 360k does not preclude States from imposing different or additional remedies, but only different or additional requirements.“). This is a form of “cooperative
Thus,
To hold otherwise would “have the perverse effect of granting complete immunity” from state law torts stemming from misbranding and adulteration practices forbidden by federal law and regulation “to an entire industry that, in the judgment of Congress, needed more stringent regulation in order to provide for the safety and effectiveness of medical devices intended for human use.” Lohr, 518 U.S. at 487, 116 S.Ct. 2240 (quotation omitted). Moreover, allowing medical device companies to escape state tort liability in such a situation would improperly shift the risk of liability from device companies that intentionally mislead physicians to the physicians who rely upon that misleading advice when deciding to utilize a device off-label. Congress sensibly refused to establish such a dystopic regime.
III
I suspect that the majority would not disagree with the above preemption analysis. Our disagreement in this case stems primarily from our varying characterization of Caplinger‘s complaint and her appellate briefing. In my view, the majority holds Caplinger‘s complaint and appellate briefing to an excessively stringent standard that places the onus on her to affirmatively demonstrate that state law claims are parallel to federal requirements. The majority does this by minimizing the scope of her state tort claims and their relationship with the relevant federal laws. I admit that Caplinger‘s briefing on the topic, especially before the district court, was not a model of clarity, but the presence of parallel state claims in Caplinger‘s complaint is certainly more apparent than in the operative complaint in Lohr, where the Supreme Court allowed a suit to proceed on remand. See 518 U.S. at 495, 116 S.Ct. 2240 (allowing the Lohrs’ suit against Medtronic to proceed despite the fact that “the precise contours of their theory of recovery have not yet been defined” because “it is clear that the Lohrs’ allegations may include claims that Medtronic has, to the extent that they exist, violated FDA regulations“). Moreover, because the district court based its dismissal on a mistaken understanding of the MDA and relevant FDA regulations, and failed to compare the elements of state tort law with the federal requirements, Caplinger
A
As the majority explains, federal law “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations.” Riegel, 552 U.S. at 330, 128 S.Ct. 999. Such a claim seeks a “parallel” remedy and is not expressly preempted by
Crucially, federal law and state law remedies need not be identical in order to be parallel and thus avoid express preemption. See Lohr, 518 U.S. at 495, 116 S.Ct. 2240; see also Bates, 544 U.S. 431, 454, 125 S.Ct. 1788 (2005) (holding that “to survive pre-emption, the state-law requirement need not be phrased in the identical language as its corresponding [statutory] requirement; it would be surprising if a common-law requirement used the same phraseology as [the statute]“). As the Court explained in Lohr, “additional elements of the state-law cause of action” requiring plaintiffs to show that “violations were the result of negligent conduct, or that they created an unreasonable hazard for users of the product ... would make the state requirements narrower, not broader, than the federal requirement.” 518 U.S. at 494, 116 S.Ct. 2240. For example, in the context of misbranded or adulterated medical devices, a state may permissibly determine that it only wishes to provide private remedies to individuals who can demonstrate that they relied upon false statements or omissions about the safety of the misbranded products, or that the misbranding or adulteration created an unreasonable hazard for its citizens.
B
The majority does not reach the question of implied preemption, because it holds that all of Caplinger‘s claims were either insufficiently pled or expressly preempted. The district court did reach the question, incorrectly holding that several of Caplinger‘s claims relating to Medtronic‘s “off-label marketing” would be impliedly preempted. Some otherwise parallel state claims are impliedly
The contours of implied preemption are eloquently explained by the Sixth Circuit in Loreto v. Procter & Gamble Co., 515 Fed.Appx. 576 (6th Cir.2013) (unpublished). Loreto held that Buckman preempted a claim alleging that Procter & Gamble failed to tell consumers that its products were “illegal” when that claim‘s theory of liability depended “entirely upon an FDCA [Federal Food, Drug, and Cosmetic Act] violation—i.e., the only reason Procter & Gamble‘s products were allegedly ‘illegal’ was because they failed to comply with FDCA labeling requirements.” 515 Fed.Appx. at 579. But the court allowed a claim to proceed alleging that Procter & Gamble made false or misleading statements regarding the same product, because the false-or-misleading “theory relies solely on traditional state tort law predating the FDCA, and would exist in the absence of the Act.” Id. at 580; see also Hughes, 631 F.3d at 775 (holding that state tort law failure-to-warn claim was not impliedly preempted); Bausch, 630 F.3d at 557 (holding that tort law claims based on manufacturing defects were not impliedly preempted).
As discussed below, it is clear that at least some of Caplinger‘s claims are not dependent entirely upon a violation of federal law. Instead, they are grounded in traditional state-law duties that predate the MDA and would be cognizable even if the MDA did not exist. These claims are not impliedly preempted.
IV
According to the district court, Caplinger‘s state law claims were either not genuinely parallel to the federal laws relating to off-label promotion or were impliedly preempted because they were entirely based upon those laws and “even the concept of ‘off-label use’ is a creature of the FDCA, is defined by the FDCA, and is not part of Oklahoma substantive law.” Caplinger v. Medtronic, Inc., 921 F.Supp.2d 1206, 1219-20 (W.D.Okla.2013). This misstates the scope of federal-law violations alleged in Caplinger‘s complaint, artificially narrowing their grounds. Federal regulations prohibit the promotion of off-label uses, which might itself form the basis of an appropriately parallel state law claim. But that act of forbidden promotion does not capture the extent of Medtronic‘s alleged federal violations, or the state tort claims Caplinger specifically raised in her complaint. Instead, Medtronic‘s allegedly illegal promotion of Infuse, including Medtronic‘s advertising and oral and written statements made by its representatives, is properly viewed as evidence that Infuse was misbranded and/or adulterated in violation of the law. See United States v. Caronia, 703 F.3d 149, 154 (2d Cir.2012) (explaining that misbranding may be proven by, “among other evidence, oral or written statements by [persons legally responsible for the labeling of drugs] or their representatives and the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised” (quotation
Applying this analysis, I would hold that Caplinger‘s claims based on failure to warn and negligence have been sufficiently pled to avoid preemption at this stage of the litigation. For each of these claims, Caplinger alleges that exactly the same conduct that violated federal device requirements also violated state law.
Although Caplinger‘s claims could end up being preempted as the case proceeds, the burden of establishing preemption at this stage falls upon Medtronic, and in my view it has not met that burden.
A
As a preliminary matter, I agree with the majority that Caplinger‘s complaint currently fails to state her fraud claims with the particularity required by
[F]ederal law already prohibits false or misleading off-label promotion. Therefore, to the extent that Plaintiff seeks to impose liability on Defendants for voluntarily making misleading warranties outside the label, Plaintiff is not imposing any requirement different from or additional to what federal law already requires. In other words, to avoid state law liability on this claim, Defendants need only to refrain from making misleading warranties, which adds no burden beyond what federal law already imposes. Nor is the express warranty claim impliedly preempted under Buckman, as a claim for express breach of warranty finds its origin in traditional state law that predates the FDCA.
Id. at 1180–81. This conclusion is consistent with the developing consensus regarding the scope of preemption in this context. See Beavers-Gabriel v. Medtronic, Inc., 15 F.Supp.3d 1021 (D.Haw.2014) (holding that express warranty claim survives preemption); Schouest v. Medtronic, Inc., 13 F.Supp.3d. 692, 707 (S.D.Tex.2014) (same); Arvizu v. Medtronic Inc., 41 F.Supp.3d 783, 793 (D.Ariz.2014) (explaining that “[s]everal courts have found that claims for breach of express warranty are neither expressly nor impliedly preempted in the context of off-label promotion“); see also Scovil v. Medtronic Inc., No. 2:14-CV-00213-APG, 2015 WL 880614, at *12 (D.Nev. Mar. 2, 2015) (unpublished) (similar); Wright v. Medtronic, Inc., No. 1:13- CV-716, 2015 WL 328596, at *15 (W.D.Mich. Jan. 23, 2015) (unpublished) (similar); Arthur v. Medtronic, Inc., No. 4:14-CV-52 (CEJ), 2014 WL 3894365, at *8 (E.D.Mo. Aug. 11, 2014) (unpublished) (similar).
The district court denied Caplinger‘s motion to reconsider or, in the alternative, for leave to amend because it concluded many of her claims were necessarily preempted. Remand for the district court to apply a proper understanding of preemption would allow Caplinger to amend her complaint and possibly state viable fraud and warranty claims. See
B
In contrast, I would hold that Caplinger‘s failure-to-warn and negligence claims are not clearly preempted at this stage of the litigation and are also plausibly stated. Caplinger contends that Medtronic had a state law duty to warn both the plaintiff and her physician about the dangers associated with off-label use of Infuse. The district court concluded that this claim was expressly or impliedly preempted. To the extent that her claim is predicated on a general failure to warn about off-label uses or asserts a state-imposed duty to include different or additional labeling, I agree with the majority and the district court that it is preempted by
However, in my judgment, Caplinger may be advancing a more specific failure-to-warn claim that survives preemption. A medical device must contain directions that are adequate for its intended use. See
Caplinger also alleged that even as it promoted Infuse in violation of those requirements, Medtronic failed to include adequate warnings and directions for the misbranded product that it was promoting. Other courts have imagined just this scenario as the type of “narrow failure-to-warn claim that would escape preemption.” Riley v. Cordis Corp., 625 F.Supp.2d 769, 783 (D.Minn.2009).
In Oklahoma, the elements of a product liability failure-to-warn claim are: (1) “the product was the cause of the injury“; (2) “the defect existed in the product, if the action is against the manufacturer, at the time the product left the manufacturer‘s possession and control“; and (3) the defect “made the article unreasonably dangerous.” Kirkland v. Gen. Motors Corp., 521 P.2d 1353, 1363 (Okla.1974). That defect “can stem from either a dangerous design
Comparing the relevant elements of federal and Oklahoma law makes it clear that Oklahoma imposes no requirements that are “different from, or in addition to” federal requirements. Cf. Riegel, 552 U.S. at 330, 128 S.Ct. 999. The district court incorrectly determined that this claim would be preempted because it would “permit a finding that defendants were required to provide warnings above and beyond those on the Infuse Device‘s label and accompanying the device.” Caplinger, 921 F.Supp.2d at 1221. This determination misstates the elements of Oklahoma law. Nothing in Oklahoma failure-to-warn law requires that Medtronic provide additional warnings or labeling in order to escape state tort liability. Once the specific elements of state law are apprehended, it becomes clear that Oklahoma is merely providing a mechanism for recovery if Medtronic violates federal law by introducing Infuse for an adulterated or misbranded use and the warnings accompanying Infuse are inadequate for that adulterated or misbranded use. The state duty, like the federal duty, requires that Medtronic provide adequate directions for use. It does not attach “liability to statements on the label that do not produce liability under [federal law].” See Bates, 544 U.S. at 456, 125 S.Ct. 1788 (Thomas, J., concurring in part and dissenting in part). Permitting recovery would properly hold Medtronic accountable for its alleged violations of state and federal law. To hold otherwise would allow Medtronic to shift liability for its illegal misbranding and adulteration to patients and physicians and provide a strong disincentive for Medtronic to seek supplemental FDA approval when the intended use of a device changes.
Because Caplinger‘s failure-to-warn claim is at least arguably parallel to her claim that Medtronic‘s misbranded device failed to contain adequate directions for its intended use, I would hold that it is not preempted at this juncture. Cf. Alton v. Medtronic, Inc., 970 F.Supp.2d 1069, 1101 (D.Or.2013) (holding that plaintiff‘s similar failure-to-warn claim against Medtronic regarding misbranding of Infuse was not preempted).
Caplinger also alleged claims sounding in negligence and negligent misrepresentation. In response to a certified question from our Circuit, the Oklahoma Supreme Court has explicitly acknowledged “the distinction between attempting to enforce a federal regulation and allowing a parallel claim for negligence per se bottomed on violation of the regulation.” It held that Oklahoma negligence law provides a
V
Although I would hold that several of Caplinger‘s claims are not preempted at this early stage of the litigation, and would remand the remaining claims with instructions to permit amendment, I would also echo the Sixth Circuit in reminding Caplinger that over the course of her lawsuit, the “arguments she makes, the proofs she offers, and the evidence she submits are all subject to limitation by preemption principles.” Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 588 (6th Cir.2013). My disagreement with the majority opinion does not turn on the substance of federal preemption law. Instead, our disagreement turns on our respective characterization of Caplinger‘s pleadings and understanding of the proper burden at this stage of the litigation, as described by the Supreme Court in cases such as Lohr and Bates. I suspect that the majority would say that I am “trying out arguments and searching out legal theories [Caplinger] has not presented for herself” (Majority Op. 1342). However, in light of the important federalism concerns at the heart of this case, the district court‘s misapprehension of relevant federal law, and its failure to examine the specific elements of state tort law at issue, I would remand for the district court to revisit its analysis with a proper understanding of this regulatory regime.
Ultimately, Caplinger‘s allegations need not be conclusive at this stage of the litigation. They need only state a plausible claim for relief. Twombly, 550 U.S. at 556, 127 S.Ct. 1955. Although I disagree with the majority‘s interpretation of Caplinger‘s complaint, the text of the majority‘s opinion properly advises that a future plaintiff alleging similar harms can avoid preemption by carefully explicating the parallels between the alleged federal violations and state tort remedies.