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Blankenship v. Medtronic, Inc.

United States District Court, E.D. Missouri, Eastern Division

August 4, 2014

LAURA BLANKENSHIP, Plaintiff,
v.
MEDTRONIC, INC., et al., Defendants.

MEMORANDUM AND ORDER

CAROL E. JACKSON, District Judge.

This matter is before the Court on the motions, filed by defendants Medtronic, Inc., Medtronic Sofamor Danek USA, Inc., Medtronic Vertelink, Inc., Medtronic Sofamor Danek, Inc., and Warsaw Orthopedic, Inc. (collectively "Medtronic"), to dismiss plaintiff's third amended complaint and to strike exhibits 3 and 4, attached to plaintiff's response in opposition to the motion to dismiss. Plaintiff has responded to the motions and the issues are fully briefed.

I. Background

Medtronic is in the business of designing, manufacturing, and selling medical devices, including the InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion device (Infuse). On July 2, 2002, Infuse was approved by the Food and Drug Administration (FDA) "for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one level from L4-S1... to be implanted via an anterior open or an anterior laparoscopic approach." [Doc. ##57-1, 57-2].

On September 19, 2007, plaintiff underwent a cervical diskectomy and fusion at C4-5, C5-6 and C6-7, with instrumentation and placement of the Infuse bone graft at each level. Dr. Timothy Kuklo was plaintiff's surgeon. This surgery is considered to be "off-label" because the FDA has not approved Infuse for cervical placement.[1] Plaintiff contends that she is permanently and totally disabled from the off-label surgery.

On March 11, 2013, plaintiff filed a second amended complaint asserting claims of manufacturing defect; failure to warn; design defect; negligence; strict liability; fraud; negligence per se; intentional misrepresentation; and violations of California's unfair competition law. Medtronic moved to dismiss all of plaintiff's claims. On March 25, 2014, the Court issued an order granting defendants' motion to dismiss. Blankenship v. Medtronic, Inc., 2014 WL 1226491 (E.D. Mo. Mar. 25, 2014). However, the order also granted plaintiff leave to amend her fraud and intentional misrepresentation claims. Id. at *9-11. The Court found that while these claims escaped both express and implied preemption, plaintiff failed to plead them with the particularity required by Federal Rule of Civil Procedure 9(b). Id.

On April 8, 2014, plaintiff filed a third amended complaint alleging fraud and intentional misrepresentation (Count I) and violation of the Missouri Merchandising Practices Act, Mo. Stat. §§ 407.010, et seq. (Count II). [Doc. #97]. On May 9, 2014, defendants filed the instant motion to dismiss, arguing that plaintiff again fails to satisfy Rule 9(b)'s particularity requirement. [Doc. #101]. On May 23, 2014, plaintiff filed a response in opposition to defendants' motion to dismiss, which included four exhibits. [Doc. #108, Ex. 1-4]. On June 13, 2014, defendants filed a motion to strike, arguing that the Court should strike plaintiff's exhibits 3 and 4.

II. Discussion

A. Motion to Strike

Exhibit 3, attached to plaintiff's response in opposition to defendants' motion to dismiss, is a "Staff Report on Medtronic's Influence on Infuse Clinical Studies" prepared by the staff of the United States Senate Finance Committee in October 2012 ("Staff Report"). Exhibit 4 includes (1) a letter from Senator Charles E. Grassley to Mark Stephen Wrighton, Chancellor, Washington University in St. Louis, dated May 15, 2009; (2) a letter from Senator Charles E. Grassley to Major General Carla G. Hawley-Bowland, United States Army, dated May 15, 2009; (3) a letter from Senator Charles E. Grassley to James D. Heckman, Editor of The Journal of Bone and Joint Surgery, dated May 15, 2009; and (4) a letter from Senator Charles E. Grassley and Senator Max Baucus to Major General Carla G. Hawley-Bowland, United States Army, dated December 17, 2012 (collectively "Senate Letters").

Defendants argue that the Staff Report and the Senate Letters "are not subject to judicial notice because they are subject to reasonable dispute and are irrelevant to the questions before this Court on [defendants'] motion to dismiss." [Doc. #112]. In response, plaintiff asserts that she never requested exhibits 3 or 4 to be judicially noticed. Instead, plaintiff argues that these exhibits should not be stricken because they are highly relevant to her fraud and intentional misrepresentation claims and aid in satisfying Rule 9(b)'s particularity requirement.[2]

The Eighth Circuit has held that when considering a motion to dismiss under Fed.R.Civ.P. 12(b)(6), "the court generally must ignore materials outside the pleadings, but it may consider some materials that are part of the public record or do not contradict the complaint, as well as materials that are necessarily embraced by the pleadings." Porous Media Corp. v. Pall Corp. , 186 F.3d 1077, 1079 (8th Cir. 1999) (internal citations omitted). Materials that are necessarily embraced by the pleadings may include documents that have been incorporated by reference in the complaint. Piper Jaffray Cos. v. National Union Fire Inc. Co. , 967 F.Supp. 1148, 1152 (D. Minn. June 17, 1997).

Plaintiff's third amended complaint contains numerous references to the Senate Report and the Senate Letters in order to show that Medtronic's actions and practices were so blatantly fraudulent that the U.S. Senate was prompted to conduct a 16-month investigation into the company's conduct. See Pl.'s Comp. ¶¶ 34, 160, 216, 219, 229, 350-377, 389-418. Plaintiff further references the Senate Report and Senate Letters throughout the complaint in order to support her allegations that Medtronic manipulated medical literature in order to conceal the serious side effects and health risks related to the off-label use of Infuse and entered into consulting and royalty agreements with physicians, including Dr. Kuklo, for the purpose of perpetrating fraud on the medical community.

Thus, the Court finds that exhibits 3 and 4, which do not contradict plaintiff's allegations and are incorporated by reference, are "necessarily embraced" by the third amended complaint. Furthermore, exhibits 3 and 4 are relevant in supporting plaintiff's allegations and providing the requisite particularity required to show that Medtronic was engaged in a fraudulent scheme, ...


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