Houston v. Medtronic, Inc.
| Decision Date | 02 April 2014 |
| Docket Number | Case No. 2:13-cv-01679-SVW-SHx |
| Parties | Jennifer Houston v. Medtronic, Inc. et al. |
| Court | U.S. District Court — Central District of California |
CIVIL MINUTES - GENERAL
Present: The Honorable STEPHEN V. WILSON, U.S. DISTRICT JUDGE
Paul M. Cruz
Deputy Clerk
N/A
Court Reporter / Recorder
Attorneys Present for Plaintiffs:
N/A
Attorneys Present for Defendants:
N/A
Proceedings: IN CHAMBERS ORDER Re: Defendants' Motion to Dismiss Plaintiff's First Amended Complaint [39]
On March 8, 2013, plaintiff Jennifer Houston commenced this action against defendants Medtronic Inc., and Medtronic Sofamor Danek USA. (Dkt. 1). Houston alleges that she suffered harmful side effects after undergoing a lumbar back surgery in which her surgeon used Medtronic's product, the Infuse device, in an off-label manner. (FAC ¶¶ 250-51). She asserts a variety of state law claims against Medtronic, asserting that the Infuse device was defective, that Medtronic failed to warn about Infuse's risks, and that Medtronic misleadingly promoted off-label uses of Infuse.
On July 30, 2013, the Court granted Medtronic's motion to dismiss Houston's original complaint, with leave to amend. (Dkt. 36). The Court held that some of Houston's claims were expressly preempted, other claims were impliedly preempted, and that Houston had failed to plead sufficient facts to state plausible claims for those causes of action that were not preempted. (Dkt. 36); Houston v. Medtronic, Inc., — F. Supp. 2d ----, 2013 WL 3927839 (C.D. Cal. 2013). Now before the Court is Medtronic's motion to dismiss Houston's First Amendment Complaint. (Dkt. 39). For the reasons stated below, the Court GRANTS in part and DENIES in part Medtronic's motion.
The Court reviewed the background of Houston's case at length in its July 30, 2013 order. (Dkt. 36). Here, the Court briefly reviews the relevant facts: Infuse is used in spinal fusion surgeries. (FAC ¶¶ 24-36). Its active ingredient, a liquid rhBMP-2 protein, stimulates bone growth near diseased vertebrae. (Id.). In 2002, the FDA approved Infuse as a Class III medical device. (Id.). The FDA's approval was limited to the use of Infuse in anterior (front) abdomen implants, and instances where Infuse was used in conjunction with the "LT-Cage", a component that keeps Infuse's liquid protein in place. (Id.).
In October 2008, Houston underwent lumbar fusion surgery with the Infuse device. (FAC ¶¶ 250-68). Her physician performed the surgery using Infuse in an off-label manner; the device was implanted by means of a posterior, rather than anterior approach, and an LT-Cage was not used. (Id.).1 After her surgery, Houston developed uncontrolled bone growth, nerve compression, and radiculitis near where the Infuse Device was implanted. (Id.).
Houston alleges that the Infuse device, as it was used in her surgery, was defective. She also alleges that Medtronic failed to warn her or her physician of the true incidence of side effects associated with the off-label use of Infuse. Finally, she contends that Medtronic engaged in a lengthy campaign of off-label promotion of Infuse, while minimizing and/or concealing the increased safety risks associated with the device.
A complaint must "state a claim to relief that is plausible on its face." Ashcroft v. Iqbal, 556 U.S. 662, 697 (2009). When a party fails to state a claim upon which relief can be granted, a defendant may move to dismiss that claim. Fed. R. Civ. P. 12(b)(6). In deciding a 12(b)(6) motion, the Court must assume that allegations in the challenged complaint are true and construe the complaint in the light most favorable to the non-moving party. Cahill v. Liberty Mut. Ins. Co., 80 F.3d 336, 337-38 (9th Cir. 1996).
The court must then address whether the well-pleaded facts, and reasonable inferences therefrom, give rise to a plausible claim for relief. Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007). Thecourt may not dismiss "unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief." Russell v. Landrieu, 621 F.2d 1037, 1039 (9th Cir. 1980).
Houston advances six claims against Medtronic related to the injuries she suffered from her physician's use of the Infuse device: (1) fraudulent misrepresentation and fraud in the inducement; (2) strict products liability—failure to warn; (3) strict products liability—design defect; (4) strict products liability—misrepresentation; (5) products liability—negligence; and (6) breach of express warranty.
In the Court's July 30, 2013 order dismissing Houston's original complaint, the Court made the following holdings related to these claims:
• Claim (2), Houston's strict products liability—failure to warn claim, was expressly preempted by 21 U.S.C. § 360k(a) of the Medical Device Amendments ("MDA") to the Food, Drug, and Cosmetic Act of 1938 ("FDCA") to the extent that the claim was premised on Medtronic's failure to provide Houston or her physician with post-sale warnings, or warnings in addition to those required by MDA labeling requirements.
• Claim (3), Houston's strict products liability—design defect claim was expressly preempted by § 360k(a).
• Claim (5), Houston's products liability—negligence claim, was expressly preempted under § 360k(a) to the extent it relied on Medtronic's failure to warn Houston or her physician, and impliedly preempted by 21 U.S.C. § 337(a) and Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) to the extent it relied exclusively on non-compliance with FDA promotion regulations.
• Claims (1), (4) and (6), Houston's fraudulent misrepresentation and fraudulent inducement claim; strict products liability—misrepresentation claim; and breach of express warranty claim were not expressly or impliedly preempted. However, Houston's complaint did not include sufficient allegations to support these claims.
(Dkt. 36); Houston, 2013 WL 3927839, at *7-8.
On August 29, 2013, Houston filed an amended complaint. (Dkt. 39). Her opposition toMedtronic's motion to dismiss her amended complaint proceeds as follows: First, Houston asks the Court to reconsider its express preemption holding for her (2), (3), and (5) claims in light of Ramirez v. Medtronic, Inc., --- F. Supp.2d ----, 2013 WL 4446913 (D. Ariz. Aug. 21, 2013). In Ramirez, the district court held that identical claims were not expressly preempted in a similar factual scenario.2 Second, even if her failure-to-warn claim premised on Medtronic's failure to provide additional warnings to Houston or her physician is preempted, Houston contends that her amended complaint includes a failure-to-warn claim that escapes preemption, premised on Medtronic's failure to warn the FDA about Infuse's adverse effects. Finally, Houston asserts that her amended complaint includes additional factual allegations to support plausible claims for fraudulent misrepresentation and fraudulent inducement, strict products liability—misrepresentation, and breach of an express warranty. The Court considers Houston's arguments in turn below.
21 U.S.C. § 360k(a).
The Supreme Court has applied a two-step analysis to determine whether the MDA expressly preempts a state law claim within the meaning of § 360k(a). Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). First, a court must determine whether the MDA has established federal "requirements" applicable to the particular medical device at issue. Id. at 321. If the MDA does establish federal requirements, a court must then determine whether the state law claims are based on state requirements that are "different from, or in addition to" the federal requirements, and relate to safety and effectiveness. Id. at 321-22.
As a Class III FDA approved device, the Court previously held that Infuse was clearly subject to MDA "requirements." (Dkt. 36); Houston, 2013 WL 3927839, at *6-7. Class III devices are subjected to a rigorous premarket approval regime, and the Supreme Court clearly stated in Riegel that "[p]remarket approval . . . imposes 'requirements' under the MDA." See 552 U.S. at 323.
This Court also held in its previous order that Houston's strict liability and negligent failure to warn claims imposed requirements "different from, or in addition to" the MDA's requirements, and thus violated the second prong of Riegel. Houston's failure to warn claims were based on allegations that Medtronic failed to warn Houston or her physician of the incidence of certain side effects related to the off-label use of Infuse. For Houston to prevail on these claims, the Court held that she would have to establish that Medtronic was either required to include warnings beyond those on the FDA-approved label for Infuse, or that Medtronic was obligated to issue post-sale warnings about the potential adverse effects from using Infuse in an off-label manner. These additional warnings are not required by the MDA and thus would impose state requirements that are "different from, or in addition to" federal requirements. See Houston, 2013 WL 3927839, at *7-9 (citing Stengel v. Medtronic, 704 F.3d 1224, 1234 (9th Cir. 2013) (Watford, J., concurring)). Similarly, the Court held that Houston's design...
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