United States District Court, D. Vermont
[Copyrighted Material Omitted]
For Koleen Otis-Wisher, Plaintiff: Carey C. Rose, Michael J. Gannon, Affolter Gannon & Rose, Ltd., Essex Junction, VT.
For Fletcher Allen Health Care, Inc., also known as Fletcher Allen Health Care, Defendant: David M. Pocius, John T. Sartore, Paul Frank Collins PC, Burlington, VT.
For Medtronic Inc, Medtronic Sofamor Danek USA, Inc., Defendants: Andrew E. Tauber, Esq., PRO HAC VICE, Mayer Brown LLP, Washington, DC; Potter Stewart, Jr., Potter Stewart, Jr. Law Offices, P.C., Brattleboro, VT.
RULING ON MEDTRONIC DEFENDANTS' MOTION TO DISMISS (Docs. 55, 58)
Honorable J. Garvan Murtha, United States District Judge.
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.
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, 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 Infuse
in 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.
A. Legal Standard