WHITE v. Medtronic Sofamor Danek, Inc., Defendant. (2020)

ORDER

Plaintiff Michael White, pro se, appeals the district court's orders denying his motion to remand and dismissing his products liability claims against Defendants Medtronic, Inc., Medtronic Sofamor Danek USA, Inc., and Medtronic Sofamor Danek, Inc. (collectively, “Medtronic”). White also moves to invite the participation of amicus curiae. This case has been referred to a panel of the Court that, upon examination, unanimously agrees that oral argument is not needed. See Fed. R. App. P. 34(a). For the reasons set forth below, we affirm the orders of the district court and deny the motion inviting the participation of amicus curiae as moot.

I. Background

White's case arises out of a national wave of litigation against Medtronic for allegedly promoting an improper use of its Infuse Bone Graft/LT-CAGE Lumbar Tapered Fusion (“Infuse”) device. Infuse is a bio-engineered device that contains two primary components: a “bone morphogenetic protein” that acts as a substitute for grafting bone and an “LT-Cage,” which essentially houses the morphogenetic protein and resulting bone. Thorn v. Medtronic, Inc., 624 F. App'x 433, 434 (6th Cir. 2015). The purpose of the Infuse device is to graft bone without the pain and risk of harvesting an individual's living bone. Id. It does this by allowing the Infuse protein to graft bone while the LT-Cage grows with the bone as if it were actual tissue. Id. Infuse is classified as a Class III medical device by the Federal Drug Administration (“FDA”), meaning that it went through the rigorous Premarket Approval (“PMA”) process and received approval from the FDA before entering the market. In 2002, the FDA approved Infuse for anterior-approach lumbar surgery only and only when the bone graft protein and LT-Cage are used together as a system. Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F. Supp. 3d 619, 621 (W.D. Mich. 2015).

According to White, in 2009, his now-deceased wife, Darla White (“Darla”), underwent a spinal disc surgery at the University of Michigan Medical System in Ann Arbor, in which the surgeons implanted the Infuse device in an “off-label” manner. (Compl., R. 1-1, Pg. ID 37–38.) Darla's surgeons implanted the device via a posterior, rather than an anterior, approach, meaning that they implanted the device through her back. (Id. at Pg. ID 39.) And the surgeons did not use the LT-Cage. (Id.) Construing White's complaint in his favor, he alleges that this off-label use of the Infuse device caused his wife “serious,” “permanent,” and “catastrophic” injuries because it caused “ectopic/exuberant bone growth” that itself caused nerve compression and other injuries. (Id. at Pg. ID 60.) According to White, Medtronic knew about the dangers associated with this off-label use, but illegally promoted it and knowingly circulated materially false information about its safety. (Id. at Pg. ID 55–58.)

After Darla's death, White brought this action in state court on behalf of himself and Darla's estate alleging several causes of action, including negligence and negligence per se, failure to warn, breach of warranty, violations of Michigan's consumer protection laws, design defects, manufacturing defects, and fraud. Medtronic removed the case to federal court on the basis of diversity jurisdiction under 28 U.S.C. § 1332 or, in the alternative, pursuant to federal question jurisdiction under 28 U.S.C. § 1331 based on its assertion that White's state law claims were completely preempted by the Medical Device Amendments (“MDA”), 21 U.S.C. §§ 360c et seq., to the Federal Food, Drug, and Cosmetics Act (“FDCA”), 21 U.S.C. §§ 301 et seq. White filed a motion to remand the case to state court, arguing that Defendant Medtronic Sofamor Danek, Inc. (“MSDI”) did not join in the removal. The district court denied White's motion to remand because it found that MSDI had not properly been served at the time that Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. filed their notice of removal. Thus in federal court, Medtronic moved to dismiss the action arguing that each of White's state law claims was preempted by the MDA. The district court adopted the magistrate judge's report and recommendation and granted Medtronic's motion to dismiss because it found that White's claims were preempted by the MDA.

This timely appeal followed.

II. White's Motion to Remand

We review de novo a district court's denial of a motion to remand. Music v. Arrowood Indem. Co., 632 F.3d 284, 286 (6th Cir. 2011).

A civil case brought in state court may be removed to federal court if the action could have been brought in federal court originally. 28 U.S.C. § 1441(a). In order for removal to be proper under § 1441(a), “all defendants who have been properly joined and served must join in or consent to the removal of the action.” 28 U.S.C. § 1446(b)(2)(A); see also Harper v. AutoAlliance Int'l, Inc., 392 F.3d 195, 201 (6th Cir. 2004). However, consent of all defendants is not required when the non-consenting defendant “has not been served with service of process at the time the removal petition is filed,” or “is merely a nominal or formal party.” Beasley v. Wells Fargo Bank, N.A., 744 F. App'x 906, 914 (6th Cir. 2018) (quoting Klein v. Manor Healthcare Corp., Nos. 92-4328/4347, 1994 WL 91786, at *3 n.8 (6th Cir. Mar. 22, 1994)).

Although White argues that the district court erred in denying his motion to remand because MSDI did not consent to removal, MSDI had not been served properly at the time the other Defendants moved for removal. As relevant here, Michigan law provides that service on a corporation can be effectuated by “serving a summons and a copy of the complaint on an officer or the resident agent” or by “sending a summons and a copy of the complaint by registered mail to the corporation or an appropriate corporation officer and to the Michigan Bureau of Commercial Services, Corporation Division.” Mich. Ct. R. 2.105(D)(1) and (4). White failed to comply with Rule 2.105(D)(1) or (4) because he did not mail the summons and complaint to the corporation itself, the resident agent, or an appropriate officer of MSDI. In fact, the summons and complaint were received by a mailroom clerk employed by Xerox Corporation and were not served on an agent or officer of MSDI. Moreover, to the extent that White argues that he effected service pursuant to Michigan Court Rule 2.105(H)(1), this issue is not properly before the court because issues raised for the first time in objections to a magistrate judge's report and recommendation are deemed forfeited. See Murr v. United States, 200 F.3d 895, 902 n.1 (6th Cir. 2000). In any event, White did not comply with Rule 2.105(H)(1) because he did not serve process by “serving a summons and a copy of the complaint on an agent authorized by written appointment or by law to receive service of process.” Mich. Ct. R. 2.105(H)(1). Accordingly, because MSDI was not properly served, the district court did not err in determining that MSDI did not need to consent to removal.

Therefore, we affirm the district court's order denying White's motion to remand.

III. Federal Preemption

White also appeals the district court's dismissal of his state law claims on the basis of federal preemption. We review de novo a district court's dismissal of a complaint under Federal Rule of Civil Procedure 12(b)(6). Winget v. JP Morgan Chase Bank, N.A., 537 F.3d 565, 572 (6th Cir. 2008).

The district court, adopting the magistrate judge's report and recommendation, found that White's claims were expressly preempted by 21 U.S.C. § 360k and impliedly preempted by § 337(a). Section 360k of the MDA provides:

Except as provided in subsection (b), no 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.

Id. at § 360k(a).

The Supreme Court has interpreted this preemption provision in two cases. First, in Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), the Court held that a plaintiff's common law tort claims were not preempted by the MDA where the device at issue had not undergone PMA review but instead had been approved pursuant to the “substantially equivalent” exception found in § 501(k). Id. at 480, 501–02, 116 S.Ct. 2240; see also Kemp v. Medtronic, Inc., 231 F.3d 216, 223–24 (6th Cir. 2000) (explaining Lohr's holding). The Court held that a common law claim does not impose a new “requirement” regarding a device, such that the claim would be preempted under § 360k, if the state and federal duties are “parallel.” Id. at 495, 116 S.Ct. 2240; see also id. (“Nothing in § 360k denies Florida the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.”).

The Supreme Court further clarified Lohr's holding in 2008. In Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), the Court considered preemption under § 360k for a device that had undergone the PMA review process. In Riegel, the plaintiff sued Medtronic, the manufacturer of the balloon catheter used in his angioplasty. Id. at 320, 128 S.Ct. 999. The Supreme Court held that all of the plaintiff's state law claims were preempted by § 360k because it found that the state laws imposed safety requirements that were more stringent than the federal requirements. Id. at 325, 128 S.Ct. 999. It found that “[s]tate tort law that requires a manufacturer's catheters to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect,” id., and rejected the dissent's attempt to “narrow the pre-emptive scope of the term ‘requirement’ ” in § 360k, id. at 326, 128 S.Ct. 999. The Court established the following two-part test for determining if a state law claim is expressly preempted by the MDA: “(1) determine whether the federal government has established requirements applicable to the medical device; and (2) if so, determine whether the state law claims are based upon requirements with respect to the device that are different from, or in addition to, the federal ones, and that relate to safety and effectiveness.” White v. Medtronic, Inc., No. 18-11590, 2019 WL 1339613, at *3 (E.D. Mich. Feb. 20, 2019) (citing Riegel, 552 U.S. at 321–22, 128 S.Ct. 999), report and recommendation adopted, No. 18-11590, 2019 WL 1330923 (E.D. Mich. Mar. 25, 2019).

Since Riegel, courts have struggled to determine which claims fit into the “narrow exception” to MDA preemption left open by Riegel and Lohr. Weber v. Allergan, Inc., 940 F.3d 1106, 1114 (9th Cir. 2019); see also Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1337 (10th Cir. 2015) (finding that the Supreme Court's “divergent views” on MDA preemption has yielded “considerable uncertainty” among the lower courts). Further complicating the issue is that the Supreme Court has also recognized that the MDA may impliedly preempt state law claims. In Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), the Court found that some of the state law fraud claims that survived express preemption under Lohr (because they imposed only parallel duties) were impliedly preempted by the MDA because they existed “solely by virtue” of an FDCA violation. Id. at 352–53, 121 S.Ct. 1012. The Court stated that “although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.” Id. at 353, 121 S.Ct. 1012.

Construing his pleadings in his favor, White brings challenges under both parts of the Riegel test. First, he argues that there should be no question of preemption here because the device implanted in his wife was not the Infuse device approved by the FDA—which includes both the Bone Graft component and the LT-Cage—but instead the Bone Graft only. Accordingly, he argues that § 360k is “completely inapplicable” because the Bone Graft without the LT-Cage constituted a “non-medical device” that was not approved by the FDA. (Appellant's Br. at 3.) While a relatively novel argument, we are not convinced that the use of the Bone Graft without the LT-Cage precludes federal preemption. As the magistrate judge correctly noted, device-specific federal requirements clearly apply to Infuse, a Class III device, because it received approval through the PMA process. White, 2019 WL 1339613, at *3; see also Caplinger, 784 F.3d at 1340 (“There's no dispute ․ that device-specific federal requirements apply to Infuse: the device endured the premarket approval process.”). To the extent that White argues that the federal requirements, and thus the issue of preemption, only attach to the dual system itself, including the Bone Graft and LT-Cage, we note that the Third Circuit recently rejected a similar argument in Shuker v. Smith & Nephew, PLC, 885 F.3d 760 (3d Cir. 2018). In Shuker, the Third Circuit found that the “device” at issue under the first part of the Riegel test includes even the components of a hybrid system. Id. at 772. Thus, § 360k is implicated even where a physician uses only a component or part of a Class III hybrid device in an off-label manner. Id. at 774; see also id. at 773 (“Put differently, the regulatory landscape contemplates that devices may be broken down into component parts and individual components used separately by third parties. Even then, however, premarket approval requirements ‘apply equally’ to the components, as manufacturers ‘generally may not deviate from the requirements imposed through premarket approval regardless of how [a component] is used.’ ” (alteration in original) (citation omitted)).

Next, White challenges preemption under the second part of the Riegel test. He argues that his state law claims are not expressly preempted because they are based on duties that “parallel” federal law rather than imposing requirements that are “ ‘different from, or in addition to,’ the federal ones.” Riegel, 552 U.S. at 322, 128 S.Ct. 999 (quoting § 360k(a)). The Tenth Circuit recently rejected this argument in Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015). In Caplinger, the Tenth Circuit considered whether the plaintiff's state law claims against Medtronic premised on her physicians' off-label use of the Infuse device by implanting the device using the posterior rather than anterior approach, like those here, were preempted by the MDA. Id. at 1337. The Tenth Circuit found that the plaintiff's design defect and breach of warranty claims were expressly preempted because the plaintiff did not identify “a single parallel federal statute or regulation.” Id. at 1340–41. The same is true here regarding White's design defect and breach of warranty claims. Next, the Tenth Circuit found that the plaintiff's other claims, including her failure to warn and negligence claims, implicated parallel federal duties imposed by federal statute and regulations. Id. at 1341 (citing 21 U.S.C. § 352 and 21 C.F.R. § 801.5). But it found that “as a matter of law [the plaintiff's] state law claims substantially exceed the potential scope of any federal regulation she's identified” because the plaintiff's claims challenged more than the device's labeling. Id. Again, the same is true here. White does not challenge Infuse's labeling or the actual manufacture of the Infuse device but instead seeks relief pursuant to state law claims challenging Medtronic's alleged promotion of the off-label use of the device. But White does not sufficiently allege that federal law imposed a parallel duty on a device's manufacturer to prevent such off-label use by third parties. Therefore, White's state law claims impose requirements “ ‘different from, or in addition to,’ the federal ones.” Riegel, 552 U.S. at 322, 128 S.Ct. 999; see also Kemp, 231 F.3d at 218 (prior to Riegel, finding the plaintiff's state law claims of negligence per se, fraud on the FDA, and failure to warn preempted by the MDA).

In response, White directs this Court's attention to decisions of the Seventh and Ninth Circuits in which those courts held that certain state law claims were not preempted by the MDA. In Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), the Seventh Circuit held that the plaintiff's state law claims based on defective manufacturing of the Trident hip system were not expressly preempted by § 360k nor impliedly preempted because the plaintiff adequately alleged that the manufacturer failed to comply with Quality System Regulations established by the FDA, which include the Current Good Manufacturing Practices, and thus the device was “adulterated.” Id. at 553–54. In Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), the Ninth Circuit, sitting en banc, held that the plaintiff's state law failure to warn claim based on Medtronic's failure to warn the FDA about known risks associated with one of its medical devices was not expressly or impliedly preempted by the MDA. Id. at 1234. In Stengel, the plaintiff alleged that at the time the FDA approved the at-issue pain pump and catheter, Medtronic “was not aware of certain risks associated with the device” but became aware before the pump and catheter were implanted into the plaintiff. Id. at 1227. Medtronic eventually recalled the device, but prior to the recall, it did not warn the FDA about the defects with the device. Id. In a well-reasoned concurrence, Judge Watford explained that the plaintiff's failure to warn claim was not preempted because the plaintiff did not predicate the claim “on a duty to warn doctors directly.” Id. at 1234 (Watford, J., concurring). Rather, the plaintiff premised his claim on Medtronic's failure to report risks associated with the device “to the FDA” and, therefore, the claim survived preemption. Id. (emphasis preserved).

In contrast, White does not allege defects with regard to the Infuse device itself when that device is used in an appropriate manner. Instead, as the magistrate judge correctly found, the gravamen of White's claims “center[s] on the off-label use of the Infuse device, and his allegations that Defendants failed to provide him or his wife's physicians proper information as to the risks and dangers of off-label use.” White, 2019 WL 1339613, at *5. However, the regulatory scheme established by the FDCA expressly contemplated the off-label use of medical devices when it passed the MDA. See 21 U.S.C. § 396; see also Caplinger, 1335 at 1344. And the Supreme Court has expressly recognized that “ ‘off-label’ usage of medical devices ․ is an accepted and necessary corollary of the FDA's mission to regulate in this area without directly interfering with the practice of medicine.” Buckman Co., 531 U.S. at 350, 121 S.Ct. 1012. Thus, White's state law claims, premised on the off-label use of the Infuse Bone Graft, seek to impose requirements that are “ ‘different from, or in addition to,’ the federal ones.” Riegel, 552 U.S. at 322, 128 S.Ct. 999 (quoting § 360k(a)). Accordingly, the district court did not err in determining that White's claims are preempted by the MDA.

For these reasons, we AFFIRM the orders and judgment of the district court and DENY the motion inviting the participation of amicus curiae as moot.