Alton v. Medtronic, Inc.

• Decision Date: 06 September 2013
• Docket Number: No. 3:13–CV–409–PK.,3:13–CV–409–PK.
• Citation: 970 F.Supp.2d 1069
• Parties: Richard D. ALTON, Plaintiff, v. MEDTRONIC, INC., and Medtronic Sofamor Danek USA, Inc., Defendants.
• Court: U.S. District Court — District of Oregon

970 F.Supp.2d 1069

Richard D. ALTON, Plaintiff,

v.MEDTRONIC, INC., and Medtronic Sofamor Danek USA, Inc., Defendants.

No. 3:13–CV–409–PK.

United States District Court, D. Oregon.

Sept. 6, 2013.

Limited on Preemption Grounds

West's Or.Rev. Stat. Ann. §§ 30.900,30.920Cecilia Han, Kent L. Klaudt, Lisa J. Cisneros, Lieff Cabraser Heimann and Bernstein, LLP, San Francisco, CA, Todd A. Bradley, Gaylord Eyerman Bradley, P.C., Portland, OR, Wendy R. Fleishman, Lieff Cabraser Heimann and Bernstein, LLP, New York, NY, for Plaintiff.

Michael K. Brown, Reed Smith LLP, Los Angeles, CA, Nancy M. Erfle, Gordon & Rees LLP, Portland, OR, for Defendants.

OPINION AND ORDER

PAPAK, United States Magistrate Judge:

Plaintiff Richard D. Alton filed this action against defendants Medtronic, Inc., and Medtronic Sofamor Danek USA, Inc. (collectively, “Medtronic”) on March 11, 2013, alleging claims of fraudulent misrepresentation and fraud in the inducement, strict products liability for failure to warn, strict products liability for defective design, strict products liability for misrepresentation, products liability for negligence, and breach of express warranty. Each of Alton's claims arises out of complications he suffered following spine surgery in which a medical device designed, produced, and marketed by Medtronic was implanted in his cervical spine. This court has jurisdiction over Alton's claims pursuant to 28 U.S.C. § 1332, based on the complete diversity of the parties' citizenship and the amount in controversy.

Now before the court are Medtronic's motion (# 19) to dismiss Alton's claims, Medtronic's motion (# 23) for judicial notice, and Alton's motion (# 26) for judicial notice. I have considered the motions, oral argument on behalf of the parties, and all of the pleadings and papers on file. For the reasons set forth below, Medtronic's motion (# 23) and Alton's motion (# 26) for judicial notice are each granted as discussed below, and Medtronic's motion (# 19) to dismiss is granted in part and denied in part as discussed below.

LEGAL STANDARDS

I. Request for Judicial Notice

Federal Rule of Evidence 201(d) provides that “[a] court shall take judicial notice [of an adjudicative fact] if requested by a party and supplied with the necessary information.” An adjudicative fact is subject to judicial notice when the fact is “not subject to reasonable dispute in that it is either (1) generally known within the territorial jurisdiction of the trial court or (2) capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.” Fed.R.Evid. 201(b).

II. Motion to Dismiss

To survive dismissal for failure to state a claim pursuant to Rule 12(b)(6), a complaint must contain more than a “formulaic recitation of the elements of a cause of action;” specifically, it must contain factual allegations sufficient to “raise a right to relief above the speculative level.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). To raise a right to relief above the speculative level, “[t]he pleading must contain something more ... than ... a statement of facts that merely creates a suspicion [of] a legally cognizable right of action.” Id., quoting5 C. Wright & A. Miller, Federal Practice and Procedure § 1216, pp. 235–236 (3d ed.2004); see alsoFed.R.Civ.P. 8(a). Instead, the plaintiff must plead affirmative factual content, as opposed to any merely conclusory recitation that the elements of a claim have been satisfied, that “allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009). “In sum, for a complaint to survive a motion to dismiss, the non-conclusory ‘factual content,’ and reasonable inferences from that content, must be plausibly suggestive of a claim entitling the plaintiff to relief.” Moss v. United States Secret Serv., 572 F.3d 962, 970 (9th Cir.2009), citing Iqbal, 129 S.Ct. at 1949.

“In ruling on a 12(b)(6) motion, a court may generally consider only allegations contained in the pleadings, exhibits attached to the complaint, and matters properly subject to judicial notice.” Swartz v. KPMG LLP, 476 F.3d 756, 763 (9th Cir.2007). In considering a motion to dismiss, this court accepts all of the allegations in the complaint as true and construes them in the light most favorable to the plaintiff. See Kahle v. Gonzales, 474 F.3d 665, 667 (9th Cir.2007). Moreover, the court “presume[s] that general allegations embrace those specific facts that are necessary to support the claim.” Nat'l Org. for Women v. Scheidler, 510 U.S. 249, 256, 114 S.Ct. 798, 127 L.Ed.2d 99 (1994), quoting Lujan v. Defenders of Wildlife, 504 U.S. 555, 561, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). The court need not, however, accept legal conclusions “cast in the form of factual allegations.” Western Mining Council v. Watt, 643 F.2d 618, 624 (9th Cir.1981).

FACTUAL BACKGROUND¹

Alton's complaint in this matter is voluminous, as are the materials submitted to the court as fit matters for judicial notice. In consequence, I provide here only a brief summary of the material allegations and facts.

On July 2, 2002, Medtronic received pre-market approval (“PMA”) from the federal Food and Drug Administration (the “FDA”) for its Infuse device (a “Class III” medical device under the classification framework of the Medical Device Amendments of 1976). The Infuse device approved by the FDA consists of a recombinant bone morphogenetic protein referred to as rhBMP–2 used in connection with a collagen scaffold (sponge) and a tapered metallic spinal fusion cage (interbody cage). The Infuse device was specifically approved as of July 2, 2002, for use in surgery on the lumbar spine performed through the abdomen (an anterior approach; this procedure is referred to as anterior lumbar interbody fusion surgery, or “ALIF”). Certain alternate interbody cage designs were approved by the FDA on December 1, 2003. The FDA subsequently approved the Infuse device for use in repairing certain tibia fractures and certain oromaxillary surgeries, and approved the Infuse rhBMP–2 protein component for use in the absence of the sponge or any interbody cage in certain sinus augmentations and alveolar ridge augmentations.

At or around the time it obtained initial FDA approval for the Infuse device, Medtronic began expending large sums of money in efforts to promote so-called “off-label” uses of the device, namely, any application other than those specifically approved by the FDA. These off-label applications included the use of the rhBMP protein without the specific interbody cage approved by the FDA as part of the Infuse device in connection with lumbar spine surgeries with a transforaminal or posterior approach (referred to as posterior lumbar interbody fusion or “PLIF” surgery).

Even before it obtained FDA approval for any application of the Infuse device, Medtronic was aware of studies demonstrating that applications of the device other than those ultimately approved by the FDA were associated with significant adverse consequences, sometimes resulting in conditions of the spine that were worse than the condition necessitating surgical intervention in the first instance, in some cases life-threatening conditions. Specifically, off-label applications of the device such as PLIF surgery resulted, in a high percentage of applications, in “exuberant bone growth” (sometimes referred to as “ectopic bone growth”) in the location where the bone protein component of the device was applied. Medtronic did not report these adverse results to the FDA, and to the contrary suppressed information regarding adverse consequences in the course of its efforts to promote off-label applications such as PLIF.

As a result of Medtronic's efforts to promote off-label applications of the device and applications of components of the device and of Medtronic's efforts to suppress reports of adverse consequences from such applications, by 2010 the Infuse device and its protein component were more frequently used off label than for approved applications, and became a huge source of profit for Medtronic.

On April 7, 2010, Alton underwent PLIF surgery in which the protein component of the Infuse device was implanted in his lumbar spine without the appropriate interbody cage. At the time he conducted the surgery, Alton's surgeon was unaware of known risks associated with such application of the protein component of the device, due to Medtronic's suppression of information regarding such risks. Alton subsequently developed uncontrolled exuberant bone growth in his lumbar spine, necessitating further surgery and resulting in significant pain symptoms.

ANALYSIS

I. Parties' Requests for Judicial Notice

By and through its motion (# 23) for judicial notice, Medtronic requests that the court take notice of documents constituting: (i) the FDA PMA database listing for the Infuse device indicating a July 2, 2002, decision date approving the device for spinal fusion procedures in skeletally mature patients with degenerative disc disease at one level from L4–S1; (ii) the FDA's PMA letter for the Infuse device dated July 2, 2002, approving the device for spinal fusion procedures in skeletally mature patients with degenerative disc disease at one level from L4–S1; (iii) a supplemental FDA PMA database listing for the Infuse device indicating a March 27, 2013, supplemental decision date approving a modification to the process for using the device, specifically the addition of an alternate water supplier; (iv) a supplemental FDA PMA database listing for the Infuse device indicating a December 1, 2003, supplemental decision date approving a modification to the device, specifically the addition of alternate interbody cage designs; (v) the FDA's PMA letter for the rhBMP–2 protein dated April 30, 2004, approving the protein for the treatment of...