Hawkins v. Medtronic, Inc.

• Decision Date: 20 November 2014
• Docket Number: Case No. 1:13–CV–00499 AWI SKO.
• Citation: 62 F.Supp.3d 1144
• Court: U.S. District Court — Eastern District of California
• Parties: Gary HAWKINS, Plaintiff, v. MEDTRONIC, INC.; Medtronic Sofamor Danek USA, Inc., Defendants.

62 F.Supp.3d 1144

Gary HAWKINS, Plaintiff

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

Case No. 1:13–CV–00499 AWI SKO.

United States District Court, E.D. California.

Signed Nov. 20, 2014.

Sara M. Peters, Khaldoun Baghdadi, Walkup, Melodia, Kelly & Schoenberger, San Francisco, CA, for Plaintiff.

Farah Tabibkhoei, Michael K. Brown, Reed Smith LLP, Los Angeles, CA, Courtland Chillingworth, Reed Smith LLP, San Francisco, CA, for Defendants.

ORDER DENYING DEFENDANTS' MOTION TO STRIKE AND GRANTING IN PART AND DENYING IN PART DEFENDANTS' MOTION TO DISMISS

ANTHONY W. ISHII, Senior District Judge.

I. INTRODUCTION

Defendants MEDTRONIC, INC. and MEDTRONIC SOFAMOR DANEK USA, INC. bring motions to dismiss under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim upon which relief can be granted and to strike allegedly redundant, immaterial, impertinent, or scandalous portions of Plaintiff GARY HAWKINS' complaint under Federal Rule of Civil Procedure 12(f). For the reasons set forth below, Defendants' motion to dismiss will be granted in part and denied in part. The dismissed portions of the complaint will be dismissed without leave to amend. Defendants' motion to strike will be denied.

II. BACKGROUND

Plaintiff commenced this action on April 4, 2013, bringing causes of action for 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, and 5) Products Liability—Negligence. This Court granted Defendants' motion to dismiss with prejudice as to Plaintiff's third cause of action; strict products liability for design defect. See Doc. 44 at 26. All of Plaintiff's other causes of action were dismissed with leave to amend. See Doc. 44 at 27. The remainder of the background information which predates the filing of Plaintiff's amended complaint (Doc. 48) is omitted. For the omitted information, see this Court's order granting Defendants' motion to dismiss. (See Doc. 44.)

Plaintiff filed a first amended complaint on March 31, 2014. See Doc. 48 (“FAC” ). Plaintiff's FAC contains causes of action for 1) Fraudulent Misrepresentation and Fraud in the inducement, 2) Products Liability—Failure to Warn, 3) Strict Products Liability—Misrepresentation, and 4) Products Liability—Negligence.

It is alleged that Defendants' INFUSE® Bone Graft

device (“INFUSE®” or “device”) caused Plaintiff's injuries when Plaintiff was implanted with the device in an off-label manner not approved by the U.S. Food and Drug Administration (“FDA”). FAC at ¶¶ 12, 290–293.

INFUSE® is used in spinal fusion

surgeries to stimulate bone growth. FAC at ¶ 2. INFUSE® is a Class III medical device regulated by the FDA pursuant to the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetics Act (“FDCA”). FAC at ¶¶ 40–41, 45. Class III devices receive the highest level of oversight by the FDA. Riegel v. Medtronic, Inc., 552 U.S. 312, 317, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). New devices must undergo a “rigorous” safety evaluation known as premarket approval before entry into the market. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The premarket approval process evaluates the safety and effectiveness of the device, including the proposed labeling. Riegel, 552 U.S. at 318, 128 S.Ct. 999. “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.”Riegel, 552 U.S. at 319, 128 S.Ct. 999 ; 21 U.S.C. § 360e(d)(6)(A)(i). INFUSE® was granted premarket approval by the FDA for limited uses in 2002. FAC at ¶¶ 54–55.

The device itself consists of a collagen carrier sponge soaked with liquid protein rhBMP–2 (“INFUSE® Bone Graft

Component”) and a metallic cage (“LT–Cage”). FAC at ¶¶ 54, 57. The protein-soaked sponge is placed inside the LT–Cage which is inserted into the patient's spine. FAC at ¶¶ 4, 33–35. The premarket approval specifies that the FDA-approved INFUSE® device consists of all component parts which must be used together. FAC at ¶¶ 54, 57. The INFUSE® device “was approved only for use in a single-level fusion in the L4–S1 region of the lumbar spine ... via the Anterior Lumbar Interbody Fusion (“ALIF”) procedure and in combination with a LT–Cage.” FAC at ¶ 58. Use of the device in a manner not approved by the FDA is considered an “off-label” use, but medical practitioners are not prohibited from using a legally marketed device such as INFUSE® in a manner that has not been approved by the FDA. See Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (“Buckman

” ); see 21 U.S.C. § 396.

Plaintiff underwent three surgeries wherein he was implanted with INFUSE®. FAC at ¶¶ 290–292. These surgeries occurred on July 17, 2006, February 25, 2010, and August 2, 2010. FAC at ¶¶ 290–292. All three surgeries were performed in an off-label manner not approved by the FDA. FAC at ¶¶ 290–292. Specifically, Plaintiff was implanted with INFUSE® without the use of the LT–Cage and using a posterior approach. FAC at ¶¶ 290–292. Thereafter, Plaintiff experienced ectopic bone growth with resulting nerve impingement and permanent nerve damage. FAC at ¶ 293.

III. LEGAL STANDARD

A. Rule 12(b)(6)

A complaint may be dismissed under Rule 12(b)(6) of the Federal Rules of Civil Procedure if it appears beyond doubt that a plaintiff can prove no set of facts in support of the claim that would entitle her to relief. Hishon v. King & Spalding, 467 U.S. 69, 73, 104 S.Ct. 2229, 81 L.Ed.2d 59 (1984) ; Balistreri v. Pacifica Police Department, 901 F.2d 696, 699 (9th Cir.1990). To survive a motion to dismiss, “[f]actual allegations must be enough to raise a right to relief above the speculative level, on the assumption that all allegations in the complaint are true even if doubtful in fact.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (internal citations omitted). A complaint must contain sufficient factual matter, accepted as true, to “state a claim to relief that is plausible on its face.” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (internal citations omitted). A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the alleged misconduct. Iqbal, 556 U.S. at 663, 129 S.Ct. 1937.

When deciding a motion to dismiss, all allegations of material fact in the complaint are taken as true and construed in the light most favorable to the plaintiff. Western Mining Council v. Watt, 643 F.2d 618, 624 (9th Cir.1981). However, the court is not required to accept conclusory allegations, allegations contradicted by exhibits attached to the complaint, matters not subject to judicial notice, unwarranted deductions of fact, or unreasonable inferences. Daniels–Hall v. National Educ. Ass'n, 629 F.3d 992, 998 (9th Cir.2010). “A district court should grant leave to amend even if no request to amend the pleading was made, unless it determines that the pleading could not possibly be cured by the allegation of other facts.”Lopez v. Smith, 203 F.3d 1122, 1127 (9th Cir.2000). “Dismissal with prejudice and without leave to amend is not appropriate unless it is clear ... that the complaint could not be saved by amendment.” Eminence Capital, LLC v. Aspeon, Inc., 316 F.3d 1048, 1052 (9th Cir.2003).

In alleging fraud or mistake, Rule 9(b) requires a party to “state with particularity the circumstances constituting fraud or mistake,” including “the who, what, when, where, and how of the misconduct charged.” Vess v. Ciba–Geigy Corp. USA, 317 F.3d 1097, 1106 (9th Cir.2003) (internal quotation marks omitted). The “time, place, and specific content of the false representations” must be set forth in the complaint. Edwards v. Marin Park, Inc., 356 F.3d 1058, 1066 (9th Cir.2004) (citation omitted). In addition, “ ‘[t]he plaintiff must set forth what is false or misleading about a statement, and why it is false.’ ” Vess, 317 F.3d at 1106 (quoting Decker v. GlenFed, Inc. (In re GlenFed, Inc. Sec. Litig.), 42 F.3d 1541, 1548 (9th Cir.1994) (en banc)).

B. Rule 12(f)

Rule 12(f) of the Federal Rules of Civil Procedure allows the court to strike from “any pleading any insufficient defense or any redundant, immaterial, impertinent, or scandalous matter.” Fed.R.Civ.P. 12(f). The purpose of a Rule 12(f) motion is to avoid the costs that arise from litigating spurious issues by dispensing with those issues prior to trial. See Whittlestone, Inc. v. Handi–Craft Co., 618 F.3d 970, 973 (9th Cir.2010) ; Sidney–Vinstein v. A.H. Robins Co., 697 F.2d 880, 885 (9th Cir.1983). Immaterial matter is defined as matter that “has no essential or important relationship to the claim for relief or the defenses being pleaded.” Whittlestone, 618 F.3d at 974. Impertinent matter is defined as “statements that do not pertain, and are not necessary, to the issues in question.” Id. Scandalous matters are allegations “that unnecessarily reflects on the moral character of an individual or states anything in repulsive language that detracts from the dignity of the court,” and “includes allegations that cast a cruelly derogatory light on a party or other person.” Quatela v. Stryker Corp., 820 F.Supp.2d 1045, 1050 (N.D.Cal.2010). Redundant allegations are allegations that “constitute a needless repetition of other averments or are foreign to the issue.” Wilkerson v. Butler, 229 F.R.D. 166, 170 (E.D.Cal.2005).

Granting a motion to strike may be proper if it will make the trial less complicated or if allegations being challenged are so unrelated to plaintiff's claims as to be unworthy of any consideration as a defense and that their presence in the pleading will be prejudicial to...