Ramirez v. Medtronic Inc.

961 F.Supp.2d 977

Cristina RAMIREZ, Plaintiff,

v.MEDTRONIC INCORPORATED, a Minnesota corporation; and Medtronic Sofamor Danek USA Incorporated, Defendants.

No. CV–13–00512–PHX–GMS.

United States District Court, D. Arizona.

Aug. 21, 2013.

Order Clarifying Denial of Reconsideration Oct. 24, 2013.

Cecilia Han, Kent L. Klaudt, Lisa J. Cisneros, Lieff Cabraser Heimann & Bernstein LLP, San Francisco, CA, Michael P. Stark, Stark Williamson & Clausen LLP, Phoenix, AZ, Wendy R. Fleishman, Lieff Cabraser Heimann & Bernstein LLP, New York, NY, for Plaintiff.

Michael Kevin Brown, Reed Smith LLP, Los Angeles, CA, Stephen M. Bressler, Kathleen Kelly Kahn, Lewis & Roca LLP, Phoenix, AZ, for Defendants.

ORDER

G. MURRAY SNOW, District Judge.

Cristina Ramirez. (Doc. 24.) The briefing on that Motion has also produced a Motion to Strike. (Doc. 37.) The Court held oral argument on August 13, 2013. For reasons discussed below, the Court grants in part and denies in part both Motions.

BACKGROUND¹

Ramirez has brought several tort claims against Medtronic that challenge how Medtronic has produced and promoted its Infuse device. Ramirez underwent a lumbar fusion procedure to alleviate her back pain on March 2, 2009. (Doc. 1 ¶ 246.) Her surgeon, Dr. Wang, used Infuse, a bio-engineered liquid bone graft substitute, during the procedure. ( Id. ¶¶ 1, 246.)

Infuse is one of Medtronic's products. ( Id. ¶ 2.) Its purpose is to “foster fusion between the vertebrae without implanting a patient's own bone or cadaver bone between the vertebrae in the spine, obviating the necessity of harvesting bone from the patient's own hip or risking rejection of cadaver bone.” ( Id.) The Infuse device consists of three components: (1) a metallic spinal fusion cage (the LT–Cage), (2) the bone graft substitute, which consists of liquid rhBMP–2, and (3) a spongy carrier or scaffold for the protein that resides in the fusion cage. ( Id. ¶ 56.) During surgery, the doctor attaches the fusion cage to the diseased spinal region to stabilize the area, soaks the collagen sponge with the rhBMP–2, and applies it to the diseased region. ( Id. ¶¶ 57–59.) In time, the sponge dissolves while the rhBMP–2 stimulates the spinal cells to grow new bone in place of the diseased area. ( Id.)

Infuse is a Class III device under the Medical Device Amendments of 1976 (MDA), which updated the Food, Drug, and Cosmetic Act of 1938 (FDCA). ( Id. ¶ 64.) A Class III device poses the highest level of risk and consequently receives the highest level of regulatory scrutiny before marketing. See21 U.S.C. §§ 360c, 360e. A major aspect of that scrutiny is the Premarket Approval Application (PMA) that a manufacturer of a Class III device must submit to the FDA prior to distribution and marketing. See id. Among other things, the application must specify the “intended use” of the product. Id. § 360e(c)(2)(A)(iv). The FDA then analyzes studies and data to measure the safety and effectiveness of the device for that use. See id. § 360e(c).

Medtronic submitted a PMA to the FDA for Infuse on January 12, 2001. (Doc. 1 ¶ 70.) Infuse was intended for a single-level anterior lumbar interbody fusion performed with all three components in a specific spinal region. ( Id. ¶¶ 72–74.) On July 2, 2002, the FDA approved Infuse to treat degenerative disc disease in the procedure specified by Medtronic. ( Id. ¶ 73.) With the exception of two non-spinal uses not relevant here, the FDA has never approved any other use of Infuse, including the posterior approach used on Ramirez. ² ( Id. ¶¶ 72, 76–77.) The FDA was concerned about the potential adverse effects, such as bone overgrowth, that occurred when Infuse was used in posterior procedures. ( Id. ¶¶ 79–86.) Despite the limited nature of the FDA's approval of Infuse, physicians are free to use FDA-approved medical devices either “on-label” (in accordance with the FDA approval) or “off-label” (for other uses). ( Id. ¶ 78.)

Off-label uses of Infuse by physicians made up close to 90% of the $800 million dollars in revenue that Infuse generated in 2011. ( Id. ¶¶ 126–30.) Medtronic allegedly promoted those off-label uses through its sales personnel and by establishing consulting/royalty agreements with physicians who advocated off-label uses to fellow surgeons. ( Id. ¶¶ 131–32, 136–40, 166–71.) Yet Medtronic knew a number of studies showed that off-label use of Infuse often produced severe side effects. ( Id. ¶¶ 87–125.) Medtronic allegedly tried to conceal these risks by funding biased studies and articles by opinion leaders in key medical journals that showed a lower incidence of off-label adverse effects. ( Id. ¶¶ 113, 131–32, 136–40, 172–214.) In addition, Medtronic allegedly failed to report certain adverse events to the FDA. ( Id. ¶¶ 28, 112, 147–49, 166q, 224, 228, 245, 355.)

These activities (or lack thereof) have produced litigation with private parties and the federal government, and also resulted in significant media coverage in outlets like the Wall Street Journal and New York Times, ( Id. ¶¶ 133, 151–71, 178–97.) A few Senators have initiated investigations into Medtronic's promotion and marketing of Infuse. ( Id. ¶¶ 215–31, 239–42.) In addition, a recent issue of The Spine Journal focused on the “serious patient safety and ethical concerns related to the use of rhBMP–2 (Infuse®) in the spine.” ( Id. ¶ 232.) These articles questioned the accuracy of previous Medtronic sponsored trials and studies that showed a far lower incidence of adverse effects. ( Id. ¶¶ 232–38.)

The Complaint alleges that Medtronic's aggressive promotion of Infuse's off-label uses and obfuscation of the true risks has led to widespread acceptance among spinal surgeons of such uses. ( Id. ¶¶ 245.) These surgeons—including Dr. Wang, who was a paid Medtronic consultant ³ and used Infuse in an off-label manner with Ramirez—were unaware of the serious risks that off-label use entailed. ( Id. ¶ 252.) When Dr. Wang performed Ramirez's lumbar fusion operation, he used only the rhBMP–2 bone graft component of the Infuse device and employed a posterior approach. ( Id. ¶ 246.) Dr. Wang did not use the other components of the Infuse device. ( Id.) At the time of the procedure, Ramirez and her doctor were unaware of the true incidence of certain side effects that appear when Infuse was used in this manner. ( Id. ¶ 247.)

Ramirez began experiencing severe pain after surgery and later discovered that she had developed uncontrolled bone growth in the area where her surgeon had implanted Infuse. ( Id. ¶¶ 248–49.) The pain she experienced resulted from nerve impingement caused by the bone overgrowth. ( Id.) Her pain has significantly disrupted her life. ( Id. ¶¶ 254–56.)

Ramirez brought suit against Medtronic on March 11, 2013, on the basis of diversity jurisdiction. She asserts six causes of action against Medtronic that arise out of state law: fraudulent misrepresentation/fraud in the inducement, failure to warn, defective design, misrepresentation, negligence, and breach of express warranty. ( Id. ¶¶ 264–349.) Medtronic has moved to dismiss the Complaint in its entirety. (Doc. 24.) Both Parties have submitted lengthy Requests for Judicial Notice. (Docs. 25, 32.) Medtronic has moved to strike Ramirez's Request. (Doc. 37.) The Court has also reviewed the several Notices of Supplemental Authority filed by the Parties. (Docs. 40, 41, 43, 45, 46.)

DISCUSSION

I. MOTION TO STRIKE

Ramirez filed a Request for Judicial Notice that contains letters from four Senators, a Senate committee staff report, the FDA-approved label for Infuse, and a series of court decisions. (Doc. 32.) The general rule that a court may not consider evidence or documents beyond the complaint in the context of a Rule 12(b)(6) Motion to Dismiss has two exceptions. First, a court may consider documents “whose contents are alleged in a complaint and whose authenticity no party questions, but which are not physically attached to the [plaintiff's] pleading,” Knievel v. ESPN, 393 F.3d 1068, 1076 (9th Cir.2005) (alteration in original). Second, a court may take judicial notice of “matters of public record outside the pleadings.” Mack v. S. Bay Beer Distribs., Inc., 798 F.2d 1279, 1282 (9th Cir.1986), overruled on other grounds by Astoria Fed. Sav. & Loan Ass'n v. Solimino, 501 U.S. 104, 111 S.Ct. 2166, 115 L.Ed.2d 96 (1991). While matters of public record, such as prior court proceedings, are proper subjects of judicial notice, a court may take notice only of the authenticity and existence of a particular order or pleading, not the veracity or validity of its contents. Lee v. City of Los Angeles, 250 F.3d 668, 690 (9th Cir.2001); Walker v. Woodford, 454 F.Supp.2d 1007, 1022 (S.D.Cal.2006), aff'd in part,393 Fed.Appx. 513 (9th Cir.2010). Even when considering a public record, however, judicial notice is limited to those facts that are “not subject to reasonable dispute.” Fed.R.Evid. 201(b).

Thus the Court can properly take judicial notice of the FDA-approved label. It is a matter of public record and there is no dispute between the Parties about its authenticity. See In re Epogen & Aranesp Off–Label Mktg. & Sales Practices Litig., 590 F.Supp.2d 1282, 1286 (C.D.Cal.2008) (taking judicial notice of FDA label). As to the remaining documents, the Court takes judicial notice of their authenticity and existence, but not the validity of the allegations or claims made therein. To the extent Ramirez seeks to rely on those documents for the validity of their contents, the Motion to Strike is granted. In any event, the contents of those documents have no bearing on the issues presented by Medtronic's Motion. Moreover, any relevant content alleged through Ramirez's Complaint is taken as true at this point in the litigation, including allegations that Medtronic promoted Infuse for off-label use. The Motion consequently has little bearing on the decision here.

II. MOTION TO DISMISSA. Legal Standard

Rule 12(b)(6) is designed to “test the legal...