Jones v. Medtronic, Inc.
| Decision Date | 26 March 2018 |
| Docket Number | A17-1124 |
| Parties | Patricia A. Jones, as Trustee for the Next of Kin of Kaitlyn M. Jones (deceased) and Personal Representative to be appointed for the Estate of Kaitlyn M. Jones (minor), Appellant, v. Medtronic, Inc., et al., Respondents. |
| Court | Minnesota Court of Appeals |
This opinion will be unpublished and may not be cited except as provided by Minn. Stat. § 480A.08, subd. 3 (2016).
Affirmed in part, reversed in part, and remanded
Hennepin County District Court
Gale D. Pearson, Stephen J. Randall, Pearson, Randall & Schumacher, P.A., Minneapolis, Minnesota; and
Robert S. Peck (pro hac vice), Center for Constitutional Litigation, P.C., New York, New York (for appellant);
Andrew E. Tauber (pro hac vice), Mayer Brown, L.L.P., Washington, D.C.; and
Michael C. McCarthy, Nicole E. Narotzky, Keiko L. Sugisaka, Erica A. Holzer, Maslon L.L.P., Minneapolis, Minnesota (for respondents)
Considered and decided by Cleary, Chief Judge; Larkin, Judge; and Florey, Judge.
UNPUBLISHED OPINION
Appellant is a mother whose daughter died due to an allegedly defective medical device manufactured by respondents. Appellant filed suit against respondents alleging several claims, including manufacturing defect, failure to warn, negligence, negligence per se, breach of express and implied warranties, negligent misrepresentation, and violations of various Minnesota and Florida consumer-protection statutes. The district court dismissed all claims as being either expressly or impliedly preempted by federal law. We affirm in part, reverse in part, and remand.
Appellant Patricia A. Jones (Jones) is a Florida resident and the mother of Kaitlyn M. Jones (Kaitlyn). When she was young, Kaitlyn was diagnosed with cerebral palsy with spastic quadriplegia, which caused her muscle spasms. To help manage the spasticity, Kaitlyn had a device called the SynchroMed II Infusion Pump and System (SynchroMed II) implanted in her body in March 2011. This device delivers a programmed amount of medication into the patient's spine and was implanted in Kaitlyn to reduce or eliminate the need for oral medications to control her muscle spasms. Respondents (collectively referred to as Medtronic) designed and manufactured the SynchroMed II.
On July 31, 2014, Kaitlyn was taken to a hospital emergency room for extreme discomfort and pain. Doctors adjusted the medication dosage in her SynchroMed II, which seemed to help, and she was discharged and sent home. But the next morning, Jones and her husband discovered that Kaitlyn had died during the night. An autopsy showed thatthe levels of medication in Kaitlyn's system were lower than expected. The medical examiner determined that Kaitlyn died from bowel ischemia, which was related to her withdrawal from the medication she should have received from the SynchroMed II. An analysis of the pump showed that there was a blockage in the device that likely caused it to deliver less than the required dosage of medication into Kaitlyn's body.
Jones, as trustee for the next of kin of Kaitlyn, filed a complaint alleging 12 claims against Medtronic, including: (1) manufacturing defect; (2) failure to warn; (3) negligence; (4) negligence per se; (5) breach of express warranty; (6) breach of implied warranty; (7) negligent misrepresentation; (8) violations of Florida law concerning deceptive, unconscionable, and unfair trade practices; (9) violations of Florida regulations concerning deceptive and unfair trade practices; (10) violations of Minnesota law prohibiting unlawful trade practices; (11) violations of Minnesota law prohibiting consumer fraud; and (12) violations of the Minnesota law regarding false advertising.
Medtronic filed a motion to dismiss Jones's complaint, which the district court granted. In its order for dismissal, the district court determined that all of Jones's claims were either expressly or impliedly preempted by federal law, or were not sufficiently pleaded to show an adequate causal connection between Medtronic's behavior and Kaitlyn's death. Additionally, the district court determined that Jones was precluded from bringing her claims under Minnesota's consumer-protection statutes because these statutes do not create a private right of action and Jones failed to meet the requirements to sustain claims under the private attorney general statute. Finally, the district court determined thatJones's fraud claims did not meet the heightened pleading requirements in Minn. R. Civ. P. 9.02. Jones appealed.
The question in this appeal is whether Jones's claims are preempted by federal law, specifically, the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301-399h (Supp. 2016). The district court held that all of Jones's claims were either expressly or impliedly preempted by this federal law. We review de novo a district court's decision to grant a motion to dismiss and whether federal law preempts state law. Angeles v. Medtronic, Inc., 863 N.W.2d 404, 409 (Minn. App. 2015).
Analyzing the preemption issue in this case is impossible without explaining some of the regulatory background. To start, a critical statute is the Medical Device Amendments of 1976 (MDA). Pub. L. No. 94-295, 90 Stat. 539 (1976). In 1976, Congress amended the FDCA by enacting the MDA whose purpose was to "provide for the safety and effectiveness of medical devices intended for human use." Medtronic, Inc. v. Lohr, 518 U.S. 470, 474, 116 S. Ct. 2240, 2245 (1996) (quotation omitted). To help accomplish this purpose, the MDA classifies medical devices into three distinct classes of risk. Id. at 476, 116 S. Ct. at 2246. Class I devices pose the least risk, Class II devices pose a "more harmful" risk, and Class III devices—including the SynchroMed II device—pose "a potential unreasonable risk of illness or injury." Id. at 476-77, 116 S. Ct. at 2246 (quotation omitted).
Before a Class III medical device can enter the market, it must undergo a rigorous evaluation process from the Food and Drug Administration called premarket approval. Id.at 477, 116 S. Ct. at 2246-47. Indeed, all parties agree that the SynchroMed II device at issue in this case underwent this premarket approval process. Once a Class III device emerges from premarket approval, the manufacturer cannot change any part of the device that would affect its safety or efficacy without approval from the Food and Drug Administration. 21 U.S.C. § 360e(d)(5)(A)(i).
Regulating these risky Class III medical devices is an enormously complicated task. To deal with this complexity and to create uniform standards across the country, Congress used its power under the Supremacy Clause to preempt state or local laws that would regulate these Class III devices. See U.S. Const. art. VI, cl. 2. The preemption provision in section 360k(a) of the MDA states:
21 U.S.C. § 360k(a).
Section 360k(a)'s provision is known as an "express preemption" provision, which occurs when a federal statute explicitly states that federal law overrides state law. Brandt v. Marshall Animal Clinic, 540 N.W.2d 870, 878 n.4 (Minn. App. 1995), review denied (Minn. Feb. 9, 1996). The United States Supreme Court discussed section 360k(a) in Riegel v. Medtronic, Inc. where it created a two-step inquiry to determine if a state-law cause of action is expressly preempted by the provision: First, courts "must determinewhether the Federal Government has established requirements applicable" to the device, and second, courts "must then determine whether the [plaintiff's] common-law claims are based upon [state] requirements with respect to the device that are different from, or in addition to the federal ones, and that relate to safety and effectiveness." 552 U.S. 312, 321-22, 128 S. Ct. 999, 1006 (2008) (quotation omitted).
The Supreme Court in Riegel held that devices that pass through premarket approval, like the SynchroMed II, establish "requirements" under the first inquiry of the Riegel test. Id. at 322-23, 128 S. Ct. at 1006-07. Neither Jones nor Medtronic dispute this, and we may consider the first inquiry met for all of Jones's claims.1 This focuses attention on the second inquiry. To satisfy the second inquiry and escape express preemption under the MDA's preemption provision, Jones must show that her state common-law claims "parallel" the requirements under federal law, specifically, the FDCA. Lamere v. St. Jude Med., Inc., 827 N.W.2d 782, 790 (Minn. App. 2013) (quotation omitted) (citing Lohr, 518 U.S. at 496, 116 S. Ct. at 2256). In other words, Jones must show that her state-law claims are not different from—nor do they add to—federal requirements.
But showing a parallel state-law claim and escaping the express preemption provision is not enough—there is another step. The United States Supreme Court held in Buckman Co. v. Plaintiff's Legal Comm. that the FDCA does not provide a private right ofaction. 531 U.S. 341, 352-53, 121 S. Ct. 1012, 1019-20 (2001).2 This means that Jones, as a private litigant, cannot bring a state-law claim solely for a violation of the FDCA because state-law claims are impliedly preempted. Id. Therefore, to avoid implied preemption under Buckman, a plaintiff must rely on traditional state tort law which predates the federal enactments in question. Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009).
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