Otis-Wisher v. Fletcher Allen Health Care, Inc.

• Decision Date: 25 June 2013
• Docket Number: No. 1:11–cv–64–jgm.,1:11–cv–64–jgm.
• Citation: 951 F.Supp.2d 592
• Court: U.S. District Court — District of Vermont
• Parties: Koleen OTIS–WISHER, Plaintiff, v. FLETCHER ALLEN HEALTH CARE, INC., Medtronic, Inc. and Medtronic Sofamar Danek USA, Inc., Defendants.

951 F.Supp.2d 592

Koleen OTIS–WISHER, Plaintiff,

v.FLETCHER ALLEN HEALTH CARE, INC., Medtronic, Inc. and Medtronic Sofamar Danek USA, Inc., Defendants.

No. 1:11–cv–64–jgm.

United States District Court,

D. Vermont.

June 25, 2013.

Carey C. Rose, Michael J. Gannon, Affolter Gannon & Rose, Ltd., Essex Junction, VT, for Plaintiff.

David M. Pocius, John T. Sartore, Paul Frank Collins PC, Burlington, VT, for Fletcher Allen Health Care, Inc.

Andrew E. Tauber, Mayer Brown LLP, Washington, DC, Potter Stewart, Jr., Potter Stewart, Jr. Law Offices, P.C., Brattleboro, VT, for Medtronic Inc.

RULING ON MEDTRONIC DEFENDANTS' MOTION TO DISMISS

(Docs. 55, 58)

J. GARVAN MURTHA, District Judge.

I. Introduction

In this diversity action commenced in March 2011, Plaintiff Koleen Otis–Wisher (“Otis–Wisher” or “Plaintiff”) asserts a variety of common-law tort and consumer fraud claims against Defendants Fletcher Allen Health Care, Inc. (“Fletcher Allen”), Medtronic, Inc. and Medtronic Sofamar Danek USA, Inc. (“Medtronic”). (Doc. 35 (“Compl.”).) The claims arise from Otis–Wisher's spinal surgery at Fletcher Allen on March 27, 2008. She initially filed suit against Fletcher Allen alleging only medical malpractice. (Doc. 1.) In an amended complaint dated February 2012, she added claims for lack of informed consent and consumer fraud against Fletcher Allen and brought claims against Medtronic. (Doc. 35.) Specifically, Otis–Wisher brings claims against Medtronic for fraudulent misrepresentation and inducement, constructive fraud, strict products liability failure to warn, manufacturing and design defect, negligence, negligent misrepresentation, and consumer fraud. Medtronic moves to dismiss for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6). (Doc. 55) Fletcher Allen also moves to dismiss the lack of informed consent and consumer fraud claims as time-barred. (Doc. 58.) Otis–Wisher opposes the motions. (Docs. 63, 71.) Having considered the parties' pre-hearing memoranda, arguments made at the June 4, 2013 hearing, and post-hearing memoranda (Docs. 85, 87–88), for the following reasons, Medtronic's motion is granted and Fletcher Allen's motion is granted in part and denied in part.

II. Background

For purposes of ruling on this motion to dismiss, the Court accepts as true all well-pleaded allegations in the amended complaint, as summarized below.

In April 2007, Plaintiff Koleen Otis–Wisher was involved in a car accident, sustaining various injuries, including a C2 fracture. On March 27, 2008, after unsuccessful conservative treatment, she underwent a posterior C1–2 fusion at Fletcher Allen Hospital. The surgery included the use of the Medtronic product Infuse to augment fusion. Plaintiff alleges the use of Infuse posteriorly was an “off-label” use which was not approved by the FDA, she was not adequately informed of the risks or potential side effects of Infuse, and was not informed her doctor had a financial and development relationship with Medtronic “such that he actively promoted the use of that company's products.” Compl. ¶ 17.

After conducting its premarket approval (PMA) review,¹ on July 2, 2002, the FDA approved Medtronic's Infuse Bone Graft/LT–Cage Lumbar Tapered Fusion Device (“Infuse”), a Class III device, as safe and effective for its intended use. See Doc. 55–1 at 5 (pointing the Court to publicly available documents as evidence of Infuse's FDA approval). Each change or modification to Infuse—37 total—has undergone a supplemental PMA process. Id. Infuse, an implantable device used to help fuse the spine, is comprised of three components: a genetically engineered protein (rhBMP) capable of initiating bone growth; an absorbable collagen sponge; and a titanium cage. See Compl. ¶ 72; Doc. 55–1 at 1 n. 1. The “intended use” of the device is spinal fusion procedures in skeletally mature patients with degenerative disc disease at one level from L4 to S1 and is to be implanted through an anterior open or anterior laparoscopic approach.

Ms. Otis–Wisher had immediate relief of discomfort for two days following the surgery but her pain gradually increased. She was prescribed pain medication, muscle relaxants and physical therapy. She experienced neck pain and spasm, pain and numbness in her left arm, trouble sleeping and occasionally swallowing liquids, and hoarseness. Her neck range of motion was very limited laterally and was flexed forward into a swan neck deformity. In June 2009, she saw a spinal surgeon at Massachusetts General Hospital (MGH) who determined she had a “robust fusion mass about her posterior cervical spine extending from the occiput to C3 that had fused in a kyphotic position.” Compl. ¶ 50. To alleviate her chronic muscle strain and improve her swallowing ability, Ms. Otis–Wisher underwent a two-stage surgery in October 2009. On October 1, Dr. Wood of MGH performed an anterior cervical discectomy. On October 5, he performed a posterior spine fusion. The surgeries revealed exuberant bone growth in Ms. Otis–Wisher's cervical spine that she alleges was caused by the off-label use of Infuse. She continues to suffer neck pain and spasms, limited neck range of motion, excess bone growth, voice issues and difficulty swallowing.

Ms. Otis–Wisher alleges the use of Infuse posteriorly in her cervical spine surgery was not approved by the FDA, i.e., an “off label” use; Physicians may use FDA approved medical devices for off-label uses with a patient's informed consent. She alleges Medtronic promoted and sold Infuse to be used off label though it was “not permitted to promote off label use or to provide doctors inducements to promote off label uses.” Compl. ¶ 74. Use of Infusein a cervical spine surgery can cause ectopic or exuberant bone growth on or around the spinal cord which can compress nerves and cause side effects such as intractable pain, spasms, difficulty swallowing, and voice issues. Ms. Otis–Wisher alleges Medtronic represented Infuse was a safe and effective device for spinal fusion surgery but that it knew Infuse was not safe for off-label use and failed to alert her of the extreme danger to patients of off-label use.

III. DiscussionA. Legal Standard

A motion to dismiss tests the legal rather than the factual sufficiency of a complaint. See, e.g., Sims v. Artuz, 230 F.3d 14, 20 (2d Cir.2000). The Court will grant a motion to dismiss only if the pleader fails to show a “plausible entitlement to relief.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). The Court accepts the facts alleged in the pleading as true, draws all reasonable inferences in favor of the pleader, and dismisses only “if the facts as alleged are insufficient to raise a right to relief above the speculative level.” Price v. N.Y. State Bd. of Elections, 540 F.3d 101, 107 (2d Cir.2008) (citation and internal quotation marks omitted). A complaint must state a plausible—not just possible—claim for relief to survive a motion to dismiss. Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949–50, 173 L.Ed.2d 868 (2009). Determining whether a complaint survives a motion to dismiss requires the court to make a “context-specific” analysis and “draw on its judicial experience and common sense.” Id. at 1950 (internal citations omitted).

B. Medtronic's Motion to Dismiss

1. The Medical Device Amendments

The Medical Device Amendments (MDA) to the Federal Food, Drug & Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., imposed detailed federal oversight for medical devices and swept back state oversight schemes. Riegel v. Medtronic, Inc., 552 U.S. 312, 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). New Class III devices, such as Medtronic's Infuse Bone Graft, receive the most intense federal oversight and are subject to a “rigorous” premarket approval process. Id. at 317, 128 S.Ct. 999;see also21 U.S.C. § 360c(a)(1)(C)(ii).

The FDA spends an average of 1,200 hours reviewing an application and grants premarket approval only if it finds reasonable assurance of the device's safety and effectiveness. 21 U.S.C. § 360e(d). The PMA process includes review of the device's proposed labeling, id. § 360e(d)(1)(A), and a grant of PMA may include restrictions upon the sale or distribution of the device or compliance with other requirements, 21 C.F.R. § 814.82.

After approval, the MDA forbids the manufacturer from making any changes in design specifications, manufacturing processes, labeling, or any other attribute that would affect safety or effectiveness without FDA permission. 21 U.S.C. § 360e(d)(6)(A)(1). To make such a change, the manufacturer must receive FDA approval of an application for supplemental premarket approval. Id. § 360e(d)(6).

The MDA also imposes post-approval reporting requirements on the medical device manufacturer. 21 U.S.C. § 360i. These include obligations to inform the FDA of new clinical investigations or scientific studies concerning the device, which the manufacturer knows or reasonably should know of, 21 C.F.R. § 814.84(b)(2), and to report incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred, id. § 803.50(a).

Finally, the FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines a device is unsafe or ineffective under the conditions in its labeling. 21 U.S.C. § 360e(e)(1), § 360h(e). It can also order a labeling change based on newly acquired information. Id. § 360f(a)(2).

2. MDA Preemption Clause

The MDA contains an explicit preemption clause:

Except as provided in subsection (b) of this section, 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)...