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Hawkins v. Medtronic, Inc.

United States District Court, E.D. California

November 20, 2014

GARY HAWKINS, Plaintiff,

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[Copyrighted Material Omitted]

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For Gary Hawkins, Plaintiff: Sara M. Peters, LEAD ATTORNEY, Walkup, Melodia, Kelly & Schoenberger, San Francisco, CA; Khaldoun Baghdadi, Walkup Melodia, San Francisco, CA.

For Medtronic, Inc., Medtronic Sofamor Danek USA Inc, Defendants: Farah Tabibkhoei, Michael K Brown, LEAD ATTORNEYS, Reed Smith LLP, Los Angeles, CA; Courtland Chillingworth, Reed Smith LLP, San Francisco, CA.

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(Docs. 49, 50)



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.


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 Plaintiffs 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" ). Plaintiffs 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 Plaintiffs 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

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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. " 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; 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.


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

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reasonable inference that the defendant is liable for the alleged misconduct. Iqbal, 556 U.S. at 663.

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 the moving party. See Fantasy, Inc. v. Fogerty, 984 F.2d 1524, 1527-28 (9th Cir. 1993).[1] Motions to strike

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are generally viewed with disfavor " because of the limited importance of pleadings in federal practice," and will usually be denied unless the allegations in the pleading have no possible relation to the controversy. Bureerong v. Uvawas, 922 F.Supp. 1450, 1478 (C.D. Cal. 1996); accord Sliger v. Prospect Mortgage, LLC, 789 F.Supp.2d 1212, 1216 (E.D. Cal. 2011); see also Buick v. World Sav. Bank, 637 F.Supp.2d 765, 771 (E.D. Cal. 2008).


A. Federal Preemption Framework

As this Court discussed in its previous order, the MDA contains express and implied preemption provisions which provide only a " 'narrow gap' through which a state-law claim must fit to escape preemption." Hawkins v. Medtronic, Inc., 2014 WL 346622, *5 (E.D. Cal. Jan. 30, 2014) (quoting Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1120 (9th Cir. 2013). " The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman)." Perez, 711 F.3d at 1120 (citing In re Medtronic, Inc., Sprint Fidelis Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010)) (emphasis in both).

a. Express Preemption

The MDA's express preemption provision reads, in relevant part:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. 360k(a). In Riegel, the Supreme Court articulated a two-part test for determining whether a claim is expressly preempted based on section 360k: (1) whether the federal government established requirements applicable to the device in question, and, if so, (2) whether the state common law claims are based on state law requirements regarding the " safety and effectiveness" of the device " that are different from, or in addition to the federal [requirements]." Riegel 552 U.S. at 321-322 (citing § 360k(a)); see Hawkins, 2014 WL 346622, *3.

Since INFUSE® is a Class III FDA approved device, it is subject to MDA requirements. Hawkins, 2014 WL 346622 at *5-6. If any of Plaintiff's state law claims impose requirements different from or in addition to the federal requirements they are expressly preempted.

b. Implied Preemption

The implied preemption provision found in 21 U.S.C. Section 337(a) requires that any action to enforce the provisions of the FDCA " be by and in the name of the United States." 21 U.S.C. § 337(a). As the Supreme Court explained in Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854, actions which seek to enforce an exclusively federal requirement not grounded in traditional state tort law are impliedly preempted by section 337(a). Claims that " exist solely by virtue of the FDCA ... requirements" are impliedly preempted. Buckman, 531 U.S. at 353.

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c. Off-Label Promotion

This Court has reviewed the recent decisions regarding whether off-label promotion violates the FDCA and whether the truth or falsity of the off-label promotion plays a role in that determination. The Ninth Circuit has not issued any published opinion directly addressing this issue but the district courts in this circuit have, for the most part, taken one of three positions. First, at least one district court in this circuit has held that off-label promotion is not prohibited by federal law, thus concluding that claims alleging off-label promotion (regardless of the truth or falsity of the promotion) are expressly preempted. See, e.g. Schuler v. Medtronic, Inc., 2014 WL 988516, *1 (C.D. Cal. March 12, 2014) (relying on United States v. Caronia, 703 F.3d 149 (2nd. Cir. 2012), where the Second Circuit found that the FDCA does not criminalize the simple promotion of off-label use because such an interpretation would raise First Amendment concerns but off-label promotion could constitute " evidence of [a drug's] intended use" ). This position has gained little traction in this circuit. Second, several district courts held that off-label promotion violates Section 311 of the FDCA -- prohibiting misbranding of class III medical devices -- where the off-label promotion is false or misleading. See Martin v. Medtronic, 32 F.Supp.3d 1026, 2014 WL 3635292,*9-10 (D. Ariz. 2014) (holding that the FDCA does prohibit untruthful off-label promotion, discussing but not deciding whether truthful off-label promotion violates the FDCA, and finding that plaintiff's fraud in off-label marketing claim escaped preemption); Eidson v. Medtronic, Inc., 40 F.Supp.3d 1202, 2014 WL 1996024, at *15 (N.D. Cal. May 13, 2014) (" Eidson II" ) (same). Third, several district courts, including this Court, have indicated that off-label promotion -- regardless of its truth or falsity -- violates the FDCA. See Beavers-Gabriel v. Medtronic, Inc., 15 F.Supp.3d 1021, 2014 WL 1396582, *9 (D. Haw. 2014) (holding that " the FDCA prohibits 'misbranding' of medical devices, which includes either misleading labeling or misleading advertising of the medical device, and 21 C.F.R. § 814.80 prohibits Defendants from advertising the INFUSE® Device for uses beyond what is provided in the PMA approval)[2] Hawkins, 2014 WL 346622 at *7; see also, Houston v. Medtronic, Inc., 957 F.Supp.2d 1166, 1179 (C.D. Cal. 2013) (" Houston I" ) (concluding that " federal law forbids device manufacturers to promote any off-label uses, and certainly prohibits false or misleading off-label promotion" ); Ramirez v. Medtronic, Inc., 961 F.Supp.2d 977, 990 (D. Ariz. 2013) (citing, inter alia, Carson v. Depuy Spine, Inc., 365 F.App'x 812, 815 (9th Cir. 2010) (observing that " while doctors may use a drug or device off-label, the marketing and promotion of a Class III device for unapproved use violates Section 331 of the FDCA" )).

Courts appear split on two issues which separate the three separate positions: (1) whether off-label promotion -- by itself -- constitutes misbranding in violation of 21 U.S.C. ยง 331 and (2) whether off-label promotion of the device " advertised in a manner that [was] inconsistent with any condition to approval specified in the PMA ...

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