McCormick v. Medtronic, Inc.

ARTHUR, J. This case principally concerns the extent to which federal law expressly or impliedly preempts state common-law and statutory claims for personal injuries that resulted from the so-called “off-label” promotion of a medical device. Relying on one of the first of what are now numerous federal district court decisions concerning the specific device at issue in this case, the Circuit Court for Montgomery County ruled that federal law preempted all of the plaintiffs’ claims, except those for fraud. The court then ruled that the plaintiffs had failed to plead fraud with particularity. Consequently, the court dismissed the claims against the manufacturer with prejudice.

We shall hold that federal law does not expressly or impliedly preempt the plaintiffs’ claims concerning misrepresentations or express warranties that the manufacturer may have made in voluntary communications with the public or with members of the medical profession. We shall also hold that the plaintiffs failed to plead common-law fraud with particularity, but that the circuit court, on remand, should allow them an opportunity to replead. We shall affirm the circuit court in all other respects. Questions Presented Appellants present two questions for our review, which we have rephrased as follows: I. Did the trial court err in holding that all of the appellants’ causes of action (except those for fraud) are expressly and impliedly preempted by federal law?

II

Did the trial court err in holding that appellants had failed to plead fraud with particularity? ⁴⁹⁷ As stated above, we shall affirm in part and reverse in part on the preemption issues. On the issue of pleading fraud with particularity, we shall affirm, but shall direct the circuit court to afford leave to amend on remand. Factual and Procedural History A. Introduction This is one of numerous cases nationwide concerning the Infuse Bone Graft device, a medical device that is manufactured and marketed by defendant Medtronic, Inc. In 2007, plaintiff Steven McCormick underwent spinal-fusion surgery, in which his surgeon, defendant Michael K. Rosner, M.D., implanted the Infuse device in an “off-label” manner — i.e., in a manner other than the one “for which it has been approved by the FDA.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 , 121 S.Ct. 1012 , 148 L.Ed.2d 854 (2001). Mr. McCormick claims to have suffered serious complications, including excessive bone growth, which allegedly necessitated a second surgery and has left him disabled.

He attributes his condition to what he characterizes as Medtronic’s “illegal” promotion of off-label uses of the device, including alleged misrepresentations concerning the risks of the off-label uses. B. The Infuse Device As approved by the FDA in 2002, the Infuse device consists of three components: a genetically-engineered version of a naturally-occurring protein that stimulates bone growth; a collagen sponge; and a cage or hollow cylinder that holds the vertebrae in place and directs the development of bone growth. In surgery employing the device, the genetically-engineered protein is applied to the sponge, which acts as a carrier and scaffold for the protein. The surgeon implants the protein-infused sponge and the cage into the spine, where the protein evidently spurs the bone growth necessary to achieve the fusion.

The device thus appears to have been intended to ⁴⁹⁸ replace or supplant the conventional method of performing spinal-fusion surgery, which involves harvesting bone (either from the patient’s hip or from a cadaver) and implanting the harvested bone in the patient’s spine. C. FDA Approval The McCormicks allege that the majority of spinal-fusion procedures, including those that are used to treat nerve compression, are performed by means of a “posterior approach” through the back. The McCormicks further allege that even before the FDA approved the Infuse device in 2002, Medtronic knew, from clinical trials, that when the surgeons employed a posterior approach, the use of the genetically-engineered protein led to undesired or “heterotopic” bone growth. According to the McCormicks, an FDA advisory panel admonished Medtronic to guard against the use of the device in procedures other than an “anterior approach,” by which the surgeon approaches the spine from the front of the body, through an incision in the abdomen.

One panel member allegedly observed that because the cage is difficult to implant in a posterior approach, the use of the cage would prevent most surgeons from employing the posterior approach. When the FDA approved the Infuse device, it required the labeling to warn that the device may be used only via the anterior approach. In addition, the approved labeling warns that the product “must not be used” without the cage. D. Off-Label Marketing The McCormicks’ complaint is replete with allegations that, after obtaining FDA approval of the Infuse device, Medtronic engaged in an extensive and (they allege) illegal effort to promote the off-label use of the device, apparently by means of a posterior approach without the required cage.

The McCormicks specifically allege that Medtronic promoted the off-label use of the Infuse device by giving financial incentives to physicians, by providing physicians with information from consultants and “key opinion leaders” whom Medtronic had targeted and paid, and by placing Medtronic sales representa ⁴⁹⁹ tives in operating rooms when surgeons were performing surgeries in which they employed the off-label, posterior approach. 1 The McCormicks allege that, as a result of Medtronic’s off-label promotion of the Infuse device, sales of the device exceeded $900 million in 2010, of which more than 85 percent resulted from off-label procedures. E. The Spine Journal The McCormicks’ complaint prominently mentions the July 2011 edition of a medical periodical, The Spine Journal, which, they say, devoted an entire issue to articles concerning the Infuse device. The complaint alleges that the journal articles discussed Medtronic’s failure to accurately report the adverse side-effects that occurred in the clinical trials of the device; Medtronic’s failure to disclose that many of the authors who studied and promoted the device had conflicts of interest because of their significant financial ties to Medtronic (having received a median range of payments of between $12 million and $16 million per study); and Medtronic’s downplaying of the risks associated with the device (including the stimulation of excessive bone growth) while overemphasizing its advantages over conventional procedures (such as bone grafts). F. The Disclosure of Increased Risks of Cancer The McCormicks also allege that a November 2011 study showed that a high-dosage use of the Infuse device, which, they say, occurs in some off-label procedures, can result in a nearly four-fold increased risk of cancer.

They go on to allege ⁵⁰⁰ that, according to the study’s lead researcher, the genetically-engineered protein in the Infuse device is a cancer-promoting substance. The McCormicks claim that Medtronic knew of the alleged risks of cancer, but failed to inform the public or the medical community of them. G. Mr. McCormick’s Unsuccessful Surgery On July 27, 2007, well before the allegations about the Infuse device became public, Mr. McCormick himself underwent spinal-fusion surgery to relieve his complaints of persistent back pain. His surgeon, Dr. Rosner, took a posterior approach (rather than the approved anterior approach), and he used a Medtronic cage that the FDA had not approved for use with an Infuse bone graft.

Additionally, the McCormicks appear to allege that the surgeon used an inappropriate amount of the genetically-engineered protein component of the device. According to the McCormicks’ complaint, at least one Medtronic sales representative — defendant Vincent Profitt— was present in the operating room during Mr. McCormick’s surgery. The McCormicks allege that the surgery did not succeed in relieving Mr. McCormick’s complaints. As a consequence, the McCormicks allege, Mr. McCormick was unable to continue to work and was forced to go on permanent disability in October 2008.

They claim that in the spring of 2010 Mr. McCormick’s physicians discovered that he suffered from neural foraminal stenosis, or narrowing of the cervical disc space, at the site where the Infuse device had been implanted. Eventually, in September 2010, Mr. McCormick underwent revision surgery to remove the “bony overgrowth” and inflammation that had allegedly resulted from the earlier surgery in 2007. The McCormicks allege that in the revision surgery Mr. McCormick’s surgeon was forced to chisel away the excess bone-growth that, they say, the Infuse product had caused. According to the McCormicks, Mr. McCormick learned in August 2011 that he had two nodules in his lungs that he must monitor to ensure that they do not become cancerous.

The ⁵⁰¹ McCormicks contend that Mr. McCormick’s exposure to the Infuse product significantly increases the risk that the nodules will become cancerous. H. The Complaint On the basis of these essential allegations, Mr. McCormick asserted a series of claims against Medtronic, a Medtronic subsidiary, the Medtronic sales representative who was in the operating room during his surgery (collectively, “Medtronic”), and Dr. Rosner. 2 As against Medtronic, Mr. McCormick asserted claims for negligence (Count II), strict products liability (Count III), breach of warranty (Count IV), fraud (Count V), negligence per se (Count VI), and violations of the Consumer Protection Act (Count VII). As against the surgeon, Dr. Rosner, McCormick asserted a claim for failure to obtain informed consent (Count VIII). Finally, Mr. McCormick and his wife asserted a joint claim for loss of consortium (Count IX). 3 I. The Proceedings in the Circuit Court Medtronic moved to dismiss the McCormicks’ complaint on several grounds, including federal preemption and the failure to allege fraud with particularity.

Dr. Rosner also moved to dismiss the complaint, arguing that the McCormicks had failed to comply with their obligation to submit their claim to the Health Care Alternative Dispute Resolution Office before filing suit. See Md.Code (1974, 2013 Repl.Vol.) § 3-2A-04(a)(1)© of the Courts and Judicial Proceedings Article. ⁵⁰² Meanwhile, Mr. McCormick voluntarily dismissed the claim that alleged negligence per se. After a hearing, the circuit court dismissed the claims against Medtronic, relying exclusively on Caplinger v. Med-tronic, Inc., 921 F.Supp.2d 1206 (W.D.Ok.2013), one of the first reported cases to consider the extent to which federal law preempts state-law claims concerning the Infuse device. Rather than dismiss the claims against Dr. Rosner, however, the court stayed the proceedings to permit the McCormicks to file the claim in the Health Care Alternative Dispute Resolution Office.

In response, the McCormicks initially asked the court to allow them to appeal the order as to Dr. Rosner under the collateral order doctrine, “a very narrow exception to the final judgment rule.” See, e.g., Nnoli v. Nnoli, 389 Md. 315, 329 , 884 A.2d 1215 (2005). After the court complied with their request, however, the McCormicks dismissed the claims against Dr. Rosner, without prejudice. Then they took this appeal. Discussion I. Before we discuss the substantive issues in this case, we first must address whether there was a final judgment from which the McCormicks were entitled to appeal.

Although the circuit court granted Medtronic’s motion to dismiss, the court did not adjudicate all of the claims against Medtronic’s co-defendant, Dr. Rosner. Because the court, therefore, had “adjudicate[d] the rights and liabilities of fewer than all the parties to the action,” its ruling was “not a final judgment.” Md. Rule 2-602(a)(1). Generally, therefore, the McCormicks would have no right to appeal unless they could establish that the ruling fell within one of the exceptions to the final judgment rule. See generally Waterkeeper Alliance, Inc. v. Maryland Dep’t of Agriculture, 439 Md. 262, 286-89 , 96 A.3d 105 (2014); Falik v. Hornage, 413 Md. 163, 175-76 , 991 ⁵⁰³ A.2d 1234 (2010); St. Joseph Med.

Ctr., Inc. v. Cardiac Surgery Assocs., 392 Md. 75, 84 , 896 A.2d 304 (2006). The collateral order doctrine, which the McCormicks briefly invoked, would not assist them. Even if the doctrine somehow applied, 4 the court had permitted an appeal only as to Dr. Rosner, not as to Medtronic — the party that the McCormicks most wanted to pursue. The McCormicks did not solve the problem of Dr. Rosner’s continued presence by dismissing all claims against him without prejudice: in Miller and Smith at Quercus LLC v. Casey PMN, LLC, 412 Md. 230, 248-53 , 987 A.2d 1 (2010), the Court of Appeals held that parties cannot transform an otherwise interlocutory ruling into an appealable final judgment through the voluntary dismissal, without prejudice, of the unadjudicat-ed aspects of a case.

Thus, in light of Miller and Smith, we directed the parties, on our motion, to address whether and how we could exercise appellate jurisdiction. Having reviewed the parties’ submissions, we are convinced that we have the power to decide the appeal under Md. Rule 8-602(e)(l). That rule provides as follows: (e) Entry of judgment not directed under Rule 2-602. (1) If the appellate court determines that the order from which the appeal is taken was not a final judgment when the notice of appeal was filed but that the lower court had discretion to direct the entry of a final judgment pursuant to Rule 2-602(b), the appellate court may, as it finds appropriate, (A) dismiss the appeal, (B) remand the case for the lower court to decide whether to direct the entry of a final judgment, (C) enter a final judgment on its own ⁵⁰⁴ initiative or (D) if a final judgment was entered by the lower court after the notice of appeal was filed, treat the notice of appeal as if filed on the same day as, but after, the entry of the judgment.

(Emphasis added.) In other words, if this Court confronts an improper, interlocutory appeal in a case where the circuit court could have certified its ruling as final and appealable under Rule 2-602(b), then Rule 8-602(e) authorizes this Court, among other things, to “enter a final judgment on its own initiative.” The question thus becomes whether the circuit court could have certified its ruling as final and appealable under Rule 2-602(b). Rule 2-602(b) provides as follows: (b) When allowed. If the court expressly determines in a written order that there is no just reason for delay, it may direct in the order the entry of a final judgment: (1) as to one or more but fewer than all of the claims or parties; or (2) pursuant to Rule 2 — 501(f)(3), for some but less than all of the amount requested in a claim seeking money relief only. (Emphasis added.) In dismissing the claims against Medtronic but not against Dr. Rosner, the circuit court disposed of all claims against one or more, but fewer than all, of the parties.

If, therefore, the circuit court had expressly determined in a written order that there was no just reason to delay the entry of final judgment as to Medtronic, it would have had some discretion to certify an immediate appeal of that ruling under Rule 2-602(b). See, e.g., Tharp v. Disabled American Veterans Dep’t of Maryland, Inc., 121 Md.App. 548, 562-64 , 710 A.2d 378 (1998); Allstate Ins. Co. v. Angeletti, 71 Md.App. 210, 215-17 , 524 A.2d 798 (1987); Canterbury Riding Condo. v. Chesapeake Investors, Inc., 66 Md.App. 635, 646 , 505 A.2d 858 (1986); see also USA Cartage Leasing, LLC v. Baer, 202 Md.App. 138, 169-70 , 32 A.3d 88 (2011), aff'd, 429 Md. 199 , 55 A.3d 510 (2012). ⁵⁰⁵ While the circuit court’s exercise of discretion under Rule 2-602(b) would have been subject to appellate scrutiny to ensure that it did not conflict with Maryland’s strong policy against piecemeal appeals (see, e.g., Tharp, 121 Md.App. at 562-64 , 710 A.2d 378 ), the Court of Appeals recently approved the exercise of discretion in a similar case, where the circuit court had disposed of all claims against the central defendant, leaving only the claims against a minor defendant who may have been insolvent. Barclay v. Briscoe, 427 Md. 270 , 278 n. 6, 47 A.3d 560 (2012).

In reaching that decision, the Court of Appeals specifically noted the “financial hardship” that the injured plaintiffs would face were they forced to incur the time and expense of litigating the case to a conclusion before they could appeal. Id.; compare Waterkeeper Alliance, 439 Md. at 289 , 96 A.3d 105 (declining to exercise authority under Rule 8-602(e) because there was a significant reason to delay the entry of judgment). Under Barclay , the circuit court could properly have exercised its discretion to certify its ruling as to Medtronic as an appealable final judgment under Rule 2-602(b). Not only is this case almost entirely about Medtronic, but the McCor-micks have told us that Dr. Rosner has no liability insurance and that they now regard the Medtronic defendants as the only culpable parties.

In fact, after we directed the parties to address the issue of appellate jurisdiction, the McCormicks corroborated their assertions by dismissing their claims against Dr. Rosner with prejudice. An appellate court “should be reluctant” to enter judgment on its own initiative under Rule 8-602(e) when no party asked the circuit court to exercise its authority under Rule 2-602(b). Smith v. Lead Indus. Ass’n, Inc., 386 Md. 12, 26 , 871 A.2d 545 (2005).

In fact, the appellate court may not exercise that authority at all if the circuit court was asked to certify the judgment under Rule 2-602(b), but exercised its discretion not to do so. Addison v. Lochearn Nursing Home, LLC, 411 Md. 251, 263 , 983 A.2d 138 (2009); Brown & Williamson Tobacco Corp. v. Gress, 378 Md. 667, 682 , 838 A.2d 362 (2003). ⁵⁰⁶ In this case, however, it seems clear that the circuit court would have exercised its authority under Rule 2 — 602(b) had the McCormicks asked it to employ that specific tool. After dismissing the claims against the Medtronic defendants, the court and counsel engaged in a discussion about facilitating an appeal. As a result of that discussion, the court signed the order that made its ruling as to Dr. Rosner immediately appealable under the collateral order doctrine.

Although that order had no effect on the McCormicks’ ability to appeal the decision in favor of Medtronic, it strongly suggests that the court intended to permit an immediate appeal, but used the wrong rule. In these specific circumstances, it would make little sense not to permit the appeal to proceed. If we were to dismiss the appeal because of a “technical” problem (Smith, 386 Md. at 26 , 871 A.2d 545 ) resulting from the decision to stay rather than dismiss the claims against Dr. Rosner, we would only prolong the litigation and increase the financial hardship that the plaintiffs face. Thus, because the circuit court could have certified its ruling as final under Rule 2-602(b), we have the power, under Rule 8 — 602(e)(1)(C), to enter a final judgment on our own initiative, which we hereby do. 5 II.

The McCormicks’ claims arise against the backdrop of a highly-detailed scheme of federal regulation. To evaluate the extent to which federal law preempts the McCormicks’ claims, we must examine that scheme at some length. A. The FDCA and the MDA In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act (the “FDCA”), 21 U.S.C. § 301 et seq., which ⁵⁰⁷ generally required the Food and Drug Administration (the “FDA”) to approve the introduction of new drugs onto the market. Until the 1970s, however, “the introduction of new medical devices was left largely for the States to supervise as. they saw fit.” Riegel v. Medtronic, Inc., 552 U.S. 312, 315 , 128 S.Ct. 999 , 169 L.Ed.2d 892 (2008) (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-76 , 116 S.Ct. 2240 , 135 L.Ed.2d 700 (1996)).

In the 1970s, in the aftermath of the failure of some complex devices, particularly the Daikon Shield, 6 several states adopted regulatory measures, including measures requiring premarket approval of new devices. Id. In an effort to standardize the regulatory environment, Congress responded by passing the Medical Device Amendments of 1976 (the “MDA”), 21 U.S.C. § 360c et seq., which “swept back some state obligations and imposed a regime of detailed federal oversight.” Riegel, 552 U.S. at 316 , 128 S.Ct. 999 . The MDA contains an express preemption provision, which provides, in pertinent part, as follows: [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). 7 The MDA established three levels of oversight of medical devices: Class I, Class II, and Class III.

Class I, which ⁵⁰⁸ includes devices such as elastic bandages and examination gloves, is subject to the lowest level of oversight, consisting of “general controls,” such as labeling requirements. Riegel, 552 U.S. at 316, 128 S.Ct. 999 (citing 21 U.S.C. § 360c(a)(1)(A)). “Class II, which includes such devices as powered wheelchairs and surgical drapes, ... is subject to ‘special controls’ such as performance standards and postmarket surveillance measures.” Id. at 316-17, 128 S.Ct. 999 (citing 21 U.S.C. § 360c(a)(1)(B)). Lastly, Class III devices, “which include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators,” receive “the most federal oversight.” Id. at 317, 128 S.Ct. 999 . A device is classified as Class III if “it cannot be established that a less stringent classification would provide reasonable assurance of safety and effectiveness, and the device is ‘purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,’ or ‘presents a potential unreasonable risk of illness or injury.’ ” Id. at 317 , 128 S.Ct. 999 (quoting 21 U.S.C. § 360c(a)(1)(C)(ii)).

Medtronic’s Infuse device is a Class III medical device under the MDA. Unless the FDA deems a new Class III device to be “substantially equivalent” to a device that was on the market in 1976, the device must go through a “rigorous regime of premarket approval.” Riegel, 552 U.S. at 317 , 128 S.Ct. 999 . To begin that process, the manufacturer must submit what is typically a multi-volume application, which includes: full reports of all studies and investigations of the device’s safety and effectiveness that have been published or should reasonably be known to the applicant; a “full statement” of the device’s “components, ingredients, and properties and of the principle or principles of operation”; “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, pack ⁵⁰⁹ ing and installation of, such device”; samples or device components required by the FDA; and a specimen of the proposed labeling. Id. at 318 , 128 S.Ct. 999 (quoting 21 U.S.C. § 360e(c)(l)). “Before deciding whether to approve the application, the agency may refer it to a panel of outside experts, ... and may request additional data from the manufacturer.” Id.

(citing 21 C.F.R. § 814.44 (a); 21 U.S.C. § 360e(c)(1)(G)). “The FDA spends an average of 1,200 hours reviewing each application.” Id. (citing Lohr, 518 U.S. at 477 , 116 S.Ct. 2240 ). The FDA “grants premarket approval only if it finds there is a ‘reasonable assurance’ of the device’s ‘safety and effectiveness.’ ” Riegel, 552 U.S. at 318 , 128 S.Ct. 999 (quoting 21 U.S.C. § 360e(d)). In making that finding, the FDA must “ ‘weig[h] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.’ ” Id.

(quoting 21 U.S.C. § 360c(a)(2)(C)). The agency “may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.” Id. “The premarket approval process includes review of the device’s proposed labeling.” Id. “The FDA evaluates safety and effectiveness under the conditions of use set forth on the label ... and must determine that the proposed labeling is neither false nor misleading.” Id. (citing 21 U.S.C. § 360c(a)(2)(B); 21 U.S.C. § 360e(d)(1)(A)). Premarket approval “incorporates an FDA finding that a device is safe and effective under the conditions of use included on the label and that the label is not false or misleading.” Cornett v. Johnson & Johnson, 211 N.J. 362, 381 , 48 A.3d 1041 (2012) (citing 21 U.S.C. § 360e(d)(1)(A), (d)(2)).

After the FDA has granted premarket approval, the MDA imposes further restrictions. For instance, without FDA permission, the manufacturer may not make any “changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Riegel, 552 U.S. at 319 , 128 S.Ct. 999 (citing 21 U.S.C. ⁵¹⁰ § 360e(d)(6)(A)(i)). Furthermore, if the manufacturer wishes to make such a change, “it must submit, and the FDA must approve, an application for supplemental premarket approval,” which is “evaluated under largely the same criteria as an initial application.” Id. (citing 21 U.S.C. § 360e(d)(6); 21 C.F.R. § 814.39 (c)).

B. Express Preemption Under the MDA As stated above, the MDA expressly preempts certain state-law “requirement[s]” “with respect to” federally-regulated medical devices — specifically, requirements that “relate[] to the safety or effectiveness of the device” and are “different from, or in addition to, any requirement applicable” under the MDA itself. 21 U.S.C. § 360k(a). In Riegel, 552 U.S. at 323-24 , 128 S.Ct. 999 , the Supreme Court held that common-law causes of action for negligence and strict liability impose “requirements,” within the meaning of the MDA’s express preemption provision in § 360k(a). 8 In addition, the Court held that the state-law duties underlying negligence, strict liability, and implied-warranty claims impose requirements “with respect to” devices, within the meaning of § 360k(a). Id. at 327-30, 128 S.Ct. 999 . Thus, because the Riegel plaintiffs contended that a Class III medical device (a heart catheter) was defective under state law notwithstanding the manufacturer’s full compliance with all of the requirements that the FDA had imposed, the Supreme Court held that the MDA expressly preempted their claims (id. at 323-30, 128 S.Ct. 999 ): the plaintiffs had improperly attempted to impose state-law requirements that were “different from, or in addition to,” the requirements for safety and effectiveness that the FDA itself had imposed.

See 21 U.S.C. § 360k(a). ⁵¹¹ In reaching its decision, the Court nonetheless recognized that “|s]tate requirements are pre-empted under the MDA only to the extent that they are ‘different from, or in addition to,’ the requirements imposed by federal law.” Riegel, 552 U.S. at 330 , 128 S.Ct. 999 (quoting 21 U.S.C. § 360k(a)(1)) (emphasis added). “Thus,” the Court continued, the express preemption provision in § 360k(a) “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 (emphasis added). “[T]he state duties in such a case,” the Court explained, would “ ‘parallel,’ rather than add to, federal requirements.” Id. (citing Lohr, 518 U.S. at 495 , 116 S.Ct. 2240 ). 9 Since the Riegel decision in 2008, numerous courts have recognized that the MDA expressly preempts state-law claims only when a manufacturer has complied with federal law, and not when the manufacturer has in some way violated federal law. See, e.g., Hughes v. Boston Scientific Corp., 631 F.3d 762, 769 (5th Cir.2011); Bausch v. Stryker Corp., 630 F.3d 546, 549-50 (7th Cir.2010), cert. denied, — U.S. -, 132 S.Ct. 498 , 181 L.Ed.2d 346 (2011); see also Stengel v. Medtronic Inc., 704 F.3d 1224, 1232-33 (9th Cir.2013) (en banc) (holding that the MDA did not expressly preempt a parallel state-law claim based on violations of FDA regulations regarding reporting of adverse events). As the Seventh Circuit stated: “The idea that Congress would have granted civil immunity to medical device manufacturers for their violations of federal law that hurt patients is, to say the least, counter-intuitive.” Bausch, 630 F.3d at 549 . ⁵¹² C. Implied Preemption Under Buckman Nonetheless, even though a state-law claim may survive express preemption if it is based on a violation of federal law, it may be impliedly preempted if it is based solely on a violation of federal law or if the claim would not exist but for federal law.

Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 352-53 , 121 S.Ct. 1012 , 148 L.Ed.2d 854 (2001). Buckman specifically prohibits an attempt to bring a putative state-law claim alleging that a manufacturer defrauded the FDA in obtaining approval for its device. More generally, Buckman prohibits the private enforcement of the statutes and regulations that the FDA alone is empowered to enforce. In Buckman, 531 U.S. at 343-46 , 121 S.Ct. 1012 , the device-manufacturer allegedly obtained FDA approval by making fraudulent representations to the FDA about the intended use of the device (bone screws).

The manufacturer had unsuccessfully applied for approval for the use of the device in spinal surgery. After the FDA rejected the initial application, the manufacturer revised the application to specify a different use (“long bone surgery”). The FDA approved the revised application for that purpose, but physicians later used the device for the so-called “off-label” purpose of spinal surgery. The plaintiffs, who were injured because of the off-label use of the device in spinal surgery, claimed that they would not have suffered damages but for the alleged misrepresentations to the FDA.

See id. at 346-47 , 121 S.Ct. 1012 . 10 ⁵¹³ The district court dismissed the case, characterizing it as a claim of “fraud-on-the-FDA.” Id. at 347 , 121 S.Ct. 1012 . The Supreme Court affirmed, stating that “state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly preempted by, federal law.” Id. at 348 , 121 S.Ct. 1012 . In reaching its decision, the Court explained that the FDA must achieve a “delicate balance of statutory objectives” (id.), and it expressed its concern that the balance could be “skewed by allowing fraud-on-the-FDA claims under state tort law.” Id. In this regard, the Court specifically observed that under federal law the FDA may respond to fraud by instigating both civil and criminal proceedings.

Id. at 349 , 121 S.Ct. 1012 (citing 21 U.S.C. § 332 ; 21 U.S.C. § 333 (f)(1)(A); 21 U.S.C. § 334 (a)(2)(D); 21 U.S.C. § 333 (a)). Indeed, the FDA alone is authorized to enforce the FDCA or to restrain violations of it. Id. at 349 n. 4, 121 S.Ct. 1012 (citing 21 U.S.C. § 337 (a)). Because Buckman involved the off-label use of an FDA-approved device, the Court took pains to remark that off-label usage “is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.” Id. at 350 , 121 S.Ct. 1012 .

The Court worried that fraud-on-the-FDA claims could deter off-label use even though “the FDCA expressly disclaims any intent to directly regulate the practice of medicine, ... and even though off-label use is generally accepted.” Id. at 350-51 , 121 S.Ct. 1012 (citing 21 U.S.C. § 396 ). Finally, the Court rejected the plaintiffs’ effort to characterize their fraud-on-the-FDA claim as a parallel, state-law claim that would survive express preemption under the MDA. The Court explained that, unlike (for example) a claim concerning the failure to use reasonable care in manufacturing a device, the claims in Buckman “existfed] solely by virtue of the FDCA disclosure requirements.” Id. at 352-53 , 121 S.Ct. 1012 . The plaintiffs, thus, were not “relying on traditional state tort law which had predated the federal enactments in question.” Id. at 353 , 121 S.Ct. 1012 .

Accordingly, their claims were impliedly preempted. See id. ⁵¹⁴ D. The Scylla and Charybdis of Express and Implied Preemption In light of Riegel and Buckman , a plaintiff can survive a preemption challenge to a state-law tort claim concerning an allegedly defective medical device only by steering between the Scylla of express preemption under § 360k(a) and the Charybdis of the implied Buckman preemption of claims that exist solely by virtue of the FDCA. It is a challenge to avoid one obstacle without colliding with the other, because the plaintiffs must show that a manufacturer has violated federal law if they are to defeat express preemption, but the plaintiffs must also show that their legal theories predated the federal enactment or would exist independently of federal law if they are to defeat implied preemption. In other words, “the conduct on which the plaintiffs claim is premised must violate the FDCA if the claim is to escape express preemption,” but the conduct must also be “the type of conduct that would traditionally give rise to liability under state law — and that would give rise to liability under state law even if the FDCA had never been enacted.” Riley v. Cordis Corp., 625 F.Supp.2d 769, 777 (D.Minn.2009) (emphasis in original).

To put it another way, “[t]he plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).” Id. (emphasis in original). E. The Legality of Off-Label Promotion A central feature of the McCormicks’ complaint is their repeated allegation that Medtronic has engaged in what they call illegal, off-label promotion of the Infuse device. The legality of off-label promotion is important to this case because the McCormicks can avoid express preemption only if their claims are based on some violation of federal law.

See Riegel, ⁵¹⁵ 552 U.S. at 330 , 128 S.Ct. 999 ; Bausch, 630 F.3d at 549 . 11 To understand the legality of off-label promotion, it is necessary, first, to distinguish between off-label uses by healthcare practitioners and the promotion of off-label uses by manufacturers. Off-label use by members of the medical profession “is permissible under the terms of the MDA.” Cornett, 211 N.J. at 380 , 48 A.3d 1041 ; see Buckman, 531 U.S. at 351 n. 4, 121 S.Ct. 1012 . In fact, Congress has specifically denied the FDA any power “to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” 21 U.S.C. § 396 ; see Buckman, 531 U.S. at 350 , 121 S.Ct. 1012 ; Cornett, 211 N.J. at 382 , 48 A.3d 1041 . Off-label promotion by a manufacturer, however, stands on different footing from off-label use by a healthcare practitioner, because off-label promotion may constitute “misbranding,” a criminal violation of the FDCA.

Although “[f]ederal law does not expressly define, or ban, off-label promotion[,] ... the FDCA prohibits ‘the adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.’ ” Schouest v. Medtronic, Inc., 13 F.Supp.3d 692, 701 (S.D.Tex.2014) (quoting 21 U.S.C. § 331 (b)) (emphasis added). “Class III devices may be misbranded if their ‘labeling is false or misleading in any particular,’ 21 U.S.C. § 352 (a), or if they use ‘false or misleading advertising,’ [21 U.S.C.] § 352(q).” Schouest, 13 F.Supp.3d at 701 . “Devices can also be misbranded if their labeling does not bear ‘adequate directions for use,’ [21 U.S.C.] § 352(f),” which is “defined by the FDA as ‘directions under which the layman can use a device safely and for the purposes for which it is intended.’ ” Schouest, 13 F.Supp.3d at 701 (quoting 21 C.F.R. § 801.5 ). “A device’s intended use is ⁵¹⁶ determined by ‘the objective intent of the persons legally responsible for the labeling of devices’ ” — ie., by the objective intent of the manufacturer. Id. (quoting 21 C.F.R. § 801.4 ). In addition, the intended use “can be demonstrated by ‘oral written statements’ ” by the manufacturer or its representatives.

Id. (quoting 21 C.F.R. § 801.4 ). On the basis of this web of statutes and regulations, the FDA takes the position that off-label promotion can constitute misbranding in violation of the FDCA. See Schouest, 13 F.Supp.3d at 701 . “Based on this view, the FDA has recovered million» of dollars in settlements from drug manufacturers that have engaged in off-label promotion.” Id.

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