Angeles v. Medtronic, Inc.
| Citation | 863 N.W.2d 404 |
| Decision Date | 20 April 2015 |
| Docket Number | Nos. A14–1149,A14–1153,A14–1152,A14–1150,A14–1154.,A14–1151,s. A14–1149 |
| Parties | Paul V. ANGELES, et al., Appellants, Charlene Mead, et al., Appellants, Charles Starovasnik, Jr., Appellant, Trudy Marse, et al., Appellants, Rebecca Manuel, et al., Appellants, Claude Davenport, et al., Appellants, v. MEDTRONIC, INC., et al., Respondents. |
| Court | Court of Appeals of Minnesota |
Stuart L. Goldenberg, Marlene J. Goldenberg, Goldenberglaw, PLLC, Minneapolis, MN; and Louis M. Bograd, (pro hac vice), Center for Constitutional Litigation, P.C., Washington, D.C.; and Wilbur W. Fluegel, Fluegel Law Office, Minneapolis, MN, for appellants.
Michael T. Nilan, Andrew J. Sveen, Nilan Johnson Lewis, P.A., Minneapolis, MN; and Andrew E. Tauber (pro hac vice), Mayer Brown LLP, Washington, D.C., for respondents.
Considered and decided by PETERSON, Presiding Judge; WORKE, Judge; and CONNOLLY, Judge.
In these consolidated appeals, appellants challenge the dismissal of their claims arising out of respondents' advertising and promotion of a medical device that was used and allegedly caused injury to appellants during spinal surgeries. Appellants argue that the district court erred by (1) dismissing as expressly or impliedly preempted by the federal Food, Drug, and Cosmetic Act (FDCA) their claims for negligence, breach of warranty, unjust enrichment, and violation of state consumer-protection statutes; and (2) dismissing their fraud claims for failure to plead with particularity pursuant to Minn. R. Civ. P. 9.02. We affirm in part, reverse in part, and remand.
Respondent Medtronic, Inc., et al. (Medtronic) manufactures and markets the Infuse Bone Graft
/LT–CAGE Lumbar Tapered Fusion Device (the Infuse Device), a Class III medical device. The Infuse Device is generally used for patients seeking a vertebral fusion and is composed of three components: (1) a tapered metallic spinal fusion cage (LT–Cage), (2) a recombinant human bone morphogenetic protein (the Infuse Protein), and (3) a carrier/scaffold for the Infuse Protein and resulting bone. Class III medical devices pose the highest level of risk and receive the highest level of regulatory scrutiny before marketing. See 21 U.S.C. §§ 360c, 360e (2014). A manufacturer of a Class III device must submit to the Food and Drug Administration (FDA) a premarket approval application before distributing and marketing the device, which must specify the intended use of the product. Id. § 360e(c)(2)(A)(iv).
On July 2, 2002, the FDA granted initial premarket approval of the Infuse Device pursuant to the Medical Device Amendment of 1976 (the MDA), finding that it was safe and effective for its intended use. The FDA specified that the premarket approval was limited to the use of the three components together and to uses in surgeries featuring an anterior approach. The FDA label also states: “The safety and effectiveness of the Infuse Bone Graft
component with other spinal implants, implanted at locations other than the lower lumbar spine, or used in surgical techniques other than anterior open or anterior laparoscopic approaches have not been established.”
Appellants in this case are patients who underwent surgeries involving allegedly unapproved, off-label uses of the Infuse Device. Each appellant alleges that he or she was injured after the Infuse Protein was used without the other components of the Infuse Device. Each appellant brought suit against Medtronic for his or her injuries in Hennepin County District Court, where the cases were companioned. Appellants alleged the following 11 causes of action against Medtronic: (1) negligence, (2) strict liability, (3) breach of express and implied warranty, (4) actual fraud, (5) constructive fraud, (6) violation of the Minnesota False Statements in Advertising Act, (7) violation of the Minnesota Deceptive Trade Practices Act, (8) unjust enrichment, (9) violation of Minnesota's consumer protection statutes, (10) negligence per se, and (11) loss of consortium. Generally, appellants allege that Medtronic compensated doctors who agreed to promote off-label uses of the Infuse Device, and that consequently, the off-label use is now the primary use.
The parties agreed to adjudicate Medtronic's arguments for dismissal in all the lawsuits in the lawsuit brought by Stephen and Barbara Lawrence. The district court ruled that the Lawrences' nonfraud claims were expressly or impliedly preempted by the FDCA. See 21 U.S.C. §§ 360k(a), 337(a) (2014). The district court dismissed the Lawrences' fraud claims on the basis of inadequate pleading under Minn. R. Civ. P. 9.02. The Lawrence plaintiffs amended their complaint, survived a subsequent motion to dismiss, and their fraud-based claims are proceeding on the merits.
After the district court issued this ruling, appellants were allowed to amend their fraud pleadings to include allegations that Medtronic misled their respective surgeons into using the Infuse Protein without the other components in their surgeries. The amended complaints alleged that Medtronic promoted the off-label use of the Infuse Protein in the following ways:
M[edtronic] communicated with the medical community about the purported safe and efficacious use of its Infuse® product by playing an active role in authoring and editing medical journal articles published on Infuse®, utilizing Key Opinion Leaders and other paid physicians to actively promote the off-label use of Infuse®, utilizing M[edtronic] sales representatives to actively promote the off-label use of Infuse®, by directly and through its distributors purchasing gifts for physicians, hospitals and clinics, by paying for physician attendance at sponsored medical conferences (both on and off MDT headquarters), and by actively concealing the role played by Defendants in shaping the safety profile of Infuse® through all actions mentioned above.
The district court concluded that these allegations of fraud were insufficiently pleaded under Minn. R. Civ. P. 9.02 and entered final judgments for Medtronic. These appeals followed.
I. Did the district court err by dismissing as expressly or impliedly preempted by the FDCA appellants' claims for negligence, strict liability, breach of warranty, unjust enrichment, and violation of state consumer-protection statutes?
II. Did the district court err by dismissing appellants' fraud claims for failure to plead with particularity pursuant to Minn. R. Civ. P. 9.02 ?
Appellants argue that the district court erred by dismissing their claims for negligence, breach of warranty, unjust enrichment, and violation of state consumer-protection statutes as preempted by the FDCA. We review de novo the district court's grant of a motion to dismiss under Minn. R. Civ. P. 12.02(e). Sipe v. STS Mfg., Inc., 834 N.W.2d 683, 686 (Minn.2013). “[W]e review de novo the question of whether federal law preempts state law.” Angell v. Angell, 791 N.W.2d 530, 534 (Minn.2010).
Congress enacted the MDA “to provide for the safety and effectiveness of medical devices intended for human use.” Medtronic v. Lohr, 518 U.S. 470, 474, 116 S.Ct. 2240, 2245, 135 L.Ed.2d 700 (1996) (quotation omitted). As stated above, a Class III device must undergo premarket approval pursuant to the MDA before it may be introduced into the market. Id. at 477, 116 S.Ct. at 2246–47. The Infuse Device received premarket approval in 2002.
With respect to federally approved medical devices like the Infuse Device, Congress enacted 21 U.S.C. § 360k(a), which contains the following express preemption provision:
21 U.S.C. § 360k(a). In considering whether appellants' claims are expressly preempted “we must determine whether the Federal Government has established requirements applicable to [the specific device at issue].” Riegel v. Medtronic, Inc., 552 U.S. 312, 321, 128 S.Ct. 999, 1006, 169 L.Ed.2d 892 (2008). We then must determine whether the state common-law claim would impose a requirement different from or in addition to the specific federal requirement. Id. at 323, 128 S.Ct. at 1007.
Additionally, the implied-preemption provision in 21 U.S.C. § 337(a) requires “all such proceedings for the enforcement, or to restrain violations, [of the FDCA] shall be by and in the name of the United States.” 21 U.S.C. § 337(a). State law claims that only enforce federal law are impliedly preempted. Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 343, 121 S.Ct. 1012, 1015, 148 L.Ed.2d 854 (2001).
Appellants argue that there are no specific federal requirements applicable to the use of Infuse Protein in these cases, because “[t]he FDA has not established federal requirements for the Infuse Protein alone.” The district court concluded:
Regarding the first step, the Court finds that the FDA has established requirements for the Infuse device through its premarket approval of the device. [Appellants] sought to convince the Court that the FDA's premarket approval applies only to the Infuse device in its on-label usage. [Appellants] argue that because they have alleged usage of some but not all components of the Infuse device in an off-label procedure, the first Riegel step is not satisfied. [Appellants] contend that the individual components of the Infuse device are somehow different from the device including all of those components which received the FDA's premarket approval. The Court disagrees. Section 360k(a) preempts state requirements “with respect to” a particular device that is subject to federal requirements. [Appellants'] claims...
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