Grubbs v. Medtronic, Inc.
| Decision Date | 22 July 2019 |
| Docket Number | Civil Action Number 2:18-cv-01468-AKK |
| Parties | JONATHAN DAVID GRUBBS, Plaintiff, v. MEDTRONIC, INC., et al., Defendants. |
| Court | U.S. District Court — Northern District of Alabama |
Jonathan David Grubbs brings this products liability action based on alleged defects in a pain pump manufactured by the Medtronic Defendants. According to Grubbs, the pain pump malfunctioned several months after his physician implanted it in Grubbs' body, necessitating a subsequent surgery to replace the pump with one made by another manufacturer. Medtronic moves to dismiss all but one of Grubbs' claims, arguing that the failure-to-warn (Count II) and implied warranty (Count IV) claims are preempted, the warranty claims (Counts III and IV) fail under Alabama law, and the negligent misrepresentation claim (Count V) is insufficiently pleaded. Docs. 6 and 7. Because the failure-to-warn claim is preempted by federal law and Grubbs did not plead the negligent misrepresentation fraud claim with the requisite particularity, the motion to dismiss is due to be granted as to these two claims.
Under Federal Rule of Civil Procedure 8(a)(2), a pleading must contain "a short and plain statement of the claim showing that the pleader is entitled to relief." "[T]he pleading standard Rule 8 announces does not require 'detailed factual allegations,' but it demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). Mere "'labels and conclusions'" or "'a formulaic recitation of the elements of a cause of action'" are insufficient. Id. at 678 (quoting Twombly, 550 U.S. at 555). "Nor does a complaint suffice if it tenders 'naked assertion[s]' devoid of 'further factual enhancement.'" Id. (quoting Twombly, 550 U.S. at 557).
Federal Rule of Civil Procedure 12(b)(6) permits dismissal when a complaint fails to state a claim upon which relief can be granted. When evaluating a motion brought under Rule 12(b)(6), the court accepts "the allegations in the complaint as true and construe[s] them in the light most favorable to the plaintiff." Hunt v. Aimco Props., L.P., 814 F.3d 1213, 1221 (11th Cir. 2016). However, "[t]o survive a motion to dismiss, a complaint must . . . 'state a claim to relief that is plausible on its face.'" Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 570). A complaint states a facially plausible claim for relief "when the plaintiff pleads factual content that allows the court to draw the reasonable inference that thedefendant is liable for the misconduct alleged." Id. In other words, the complaint must establish "more than a sheer possibility that a defendant has acted unlawfully." Id.; see also Twombly, 550 U.S. at 555 ().
Grubbs suffers from chronic back pain, which his physician, Dr. Thomas Kraus, treated by implanting in Grubbs' abdomen a SynchroMed® II Programmable Implantable Infusion Pump System with sutureless catheter (the "Device") manufactured by Medtronic. Doc. 1 at 2, 4, 7. The Device delivered a programmed amount of pain medication into Grubbs' spine. Id. at 4. The first Device performed as designed. Id. at 4-5. The claims in this lawsuit are related to the second Device Dr. Kraus implanted after the first Device reached the end of its seven-year battery life. Id. This second SynchroMed® II Device controlled Grubbs' pain for several months, and then began to stall and fail to deliver the appropriate amount of medication. Id. at 5. This resulted in increased pain and medication withdrawal, which led to additional surgery during which Dr. Kraus replaced the Device with a different type of pain pump. Id.
Congress enacted the Medical Device Amendments ("MDA") of 1976, 21 U.S.C. § 360k et seq., to the Food, Drug, and Cosmetic Act to give the Food & Drug Administration "regulatory authority over medical devices for human use." Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1325 (11th Cir. 2017) (citation omitted). "Under that authority, the FDA classifies medical devices into three categories, depending on the level of risk presented." Id. (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 316-17 (2008)). Class III devices, such as the SynchroMed® II Device, present the highest category of risk and must "undergo the FDA's 'premarket approval' process." Id. (citing 21 C.F.R. § 814.1).1
"Premarket approval is a 'rigorous' process," Riegel, 552 U.S. at 317-18 (citations omitted), requiring medical device manufacturers "to demonstrate a 'reasonable assurance' that the device is both 'safe and effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof,'" Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341, 344 (2001) (citing 21 U.S.C. §§360e(d)(2)(A)-(B)). During the process, the FDA reviews, among many other things, the manufacturer's proposed labeling for the device, and "must determine that the proposed labeling is neither false nor misleading . . . ." Riegel,552 U.S. at 318 (citing §§ 360c(a)(2)(B) and 360e(d)(1)(A)). The FDA "grants premarket approval only if it finds there is a 'reasonable assurance' of the device's 'safety and effectiveness.'" Id. (citing § 360e(d)). After a device is approved, "the MDA forbids the manufacturer to make, without FDA permission, changes in design specification, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness." Id. at 319 (citing § 360e(d)(6)(A)(i)). In addition, after premarket approval, the MDA imposes a continuing duty on manufacturers to report certain information to the FDA, "including new studies about the device and any adverse events." Mink, 860 F.3d at 1325 (citing § 360i). See also Riegel, 552 U.S. at 319 (citing 21 C.F.R. § 803.50(a)).
The FDA granted premarket approval for the original Class III SynchroMed® II Device in 1988. Docs. 1 at 7; 7-1 at 2.2 Since then, the FDA has approved multiple supplemental applications for modifications. See docs. 1 at 7; 7-1. The specific type of Device implanted in Grubbs received premarket approval in 2003. See docs. 1 at 4; 7-2. Based on this premarket approval, Medtronic argues in part that certain claims pleaded by Grubbs are preempted. The courtturns now to the motion to dismiss, and the parties' respective contentions as to each claim at issue.
Medtronic argues that Grubbs' failure to warn claim is preempted by the MDA. Section 360(k)(a) of the MDA expressly preempts "any claim based on a state law requirement 'which is different from, or in addition to, any requirement' under the MDA that 'relates to the safety or effectiveness of the device' or any other MDA requirement." Mink, 860 F.3d at 1317 (quoting 21 U.S.C. § 360k(a)). In other words, "duties imposed by state law are preempted only to the narrow extent that they add different or extra requirements to the safety and effectiveness of the medical device beyond those required by the federal scheme." Id. at 1326. However, "'[p]arallel' state duties survive so long as they claim a violation of state tort law that aligns with a federal requirement." Id. (citing Riegel, 552 U.S. at 330).
To determine if a claim is expressly preempted, a court must determine (1) whether the Federal Government has established requirements applicable to the device; and (2) if the plaintiff's state law claims are based upon any state law duties or requirements "that are different from, or in addition to, the federal [requirements], and that relate to the safety and effectiveness" of the device. Id. (quoting Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11thCir. 2011)). The first prong is not in contention, and Grubbs concedes that devices that are subject to premarket approval, such as the SynchroMed® II Device, satisfy this inquiry. See Thomas v. Alcon Labs., 116 F. Supp. 3d 1361, 1367 (N.D. Ga. 2013) (citations omitted). See also Riegel, 552 U.S. at 322-23. For the second prong, generally, if the state law claim merely parallels federal requirements, without imposing addition or different duties related to the device, then express preemption will not apply. Riegel, 552 U.S. at 330.
Even when express preemption does not apply, certain state law claims related to medical devices may be impliedly preempted by the MDA. Section 337(a) provides, for example, that "all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States." 21 U.S.C. § 337(a). Thus, section 337(a) impliedly preempts state tort claims that seek to enforce a duty owed by a manufacturer to the FDA. Mink, 860 F.3d at 1327 (citing Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 353 (2001)). But, "traditional state-law tort claims survive implied preemption so long as [the plaintiff does not] seek to privately enforce a duty owed to the FDA." Id. Stated differently, sections 360(k)(a) and 337(a) work together to create a "'narrow gap' for pleadings," and "[t]o make it through, a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violated that federal requirement (avoidingimplied preemption)." Mink, 860 F.3d at 1237 (citing In re Medtronic, Inc., 623 F.3d 1200, 1204 (8th Cir. 2010)). In other words, Grubbs "may proceed on [his] [failure to warn] claim so long as []he claims the 'breach of a well-recognized duty owed to [him] under state law' and so 'long as []he can show that []he was harmed by a violation of applicable federal law.'" Id. (quoting Bausch v. Stryker Corp., 630 F.3d 546, 558 (7th Cir. 2010)).
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