Martin v. Medtronic, Inc., et al.

Filing 66

ORDER GRANTING Defendants' 55 Motion to Dismiss signed by District Judge Dale A. Drozd on 10/13/2017. CASE CLOSED. (Sant Agata, S)

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UNITED STATES DISTRICT COURT

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FOR THE EASTERN DISTRICT OF CALIFORNIA

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MICHAEL MARTIN,

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Plaintiff,

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No. 1:15-cv-00994-DAD-MJS

ORDER GRANTING DEFENDANTS’
MOTION TO DISMISS

v.
MEDTRONIC, INC. et al.,

(Doc. No. 55)

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Defendants.

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Plaintiff Michael Martin proceeds on his second amended complaint1 in this action,

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alleging strict liability, negligence, and breach of express warranty, against defendants Medtronic,

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Inc., Medtronic Neuromodulation, Medtronic Puerto Rico Operations, Co., and Medtronic

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Logistics, LLC (collectively, “Medtronic” or the “Medtronic defendants”). (Doc. No. 51.)
Now before the court is defendants’ motion to dismiss plaintiff’s second amended

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complaint, filed on April 14, 2017. (Doc. No. 55.) On July 11, 2017, plaintiff filed his

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opposition. (Doc. No. 57.) On July 18, 2017, defendants filed their reply. (Doc. No. 58.)

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Defendants’ motion came before the court for hearing on July 25, 2017. Attorneys Philip C.

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Bourdette and Kevin Haverty appeared on behalf of plaintiff Michael Martin, and attorneys

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Stephen J. Mackey and Rami N. Fakhouri appeared on behalf of the Medtronic defendants.

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This court previously granted defendants’ motion to dismiss plaintiff’s first amended
complaint, with leave to amend. (Doc. No. 50.)
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Having considered the parties’ briefs and heard oral argument, and for the reasons stated below,

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the court will grant defendants’ motion to dismiss.

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BACKGROUND
A.

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Plaintiff Michael Martin
According to his second amended complaint, plaintiff was diagnosed with Lumbar

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Spondylosis and Lumbar Degenerative Disc Disease in 2004. (Doc. No. 51 ¶ 13.) On February

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4, 2008, plaintiff was implanted with a Medtronic SynchroMed II implantable infusion system

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(“SynchroMed II”), consisting of a pump (model no. 8637-20, serial no. NGP315748H) and a

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catheter (model no. 8709SC, serial no. N132467011). (Id. ¶ 14.) In November 2008, during a

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trip to Arizona, plaintiff became seriously ill and was bedridden for two weeks. (Id. ¶ 15.) He

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sought medical attention when he returned home. (Id.) For the next five years, plaintiff

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underwent extensive diagnostic testing to determine the source of his illness; the testing left

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plaintiff with blurred vision, inability to walk, abdominal pain, and severe nausea, for four to five

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days a week. (Id. ¶ 16.) During this time, plaintiff experienced symptoms consistent with severe

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withdrawal-overdose cycles involving his opioid medication. (Id. ¶ 17.) Plaintiff alleges that

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defendants were aware that these symptoms were caused by his defective SynchroMed II device,

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even as plaintiff’s medical providers were unable to determine the cause. (See id. ¶¶ 17–18.)

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On July 12, 2013, after Medtronic agreed to allow for a pump replacement, plaintiff

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underwent a surgical procedure whereby his original SynchroMed II device was removed and

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replaced with a new SynchroMed II device (pump model no. 8637-20, serial no. NGP385091H;

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catheter model no. 8578). (Id. ¶¶ 19–20, 23.) During the procedure, the operating doctor

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discovered disintegration of material connecting the original pump and the catheter, as well as

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broken pieces and leakage of fluids around the pump-catheter connection site. (Id. at ¶ 21.)

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Plaintiff’s medical records indicate that such leakage caused plaintiff’s medication to flow

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directly into a pocket where the pump is located. (Id.) Plaintiff alleges he experienced pump-

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induced cycles of overdose and withdrawal: a temporary build-up of medication in the pocket

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caused overdose symptoms, followed by withdrawal symptoms as the pump emptied. (Id. at

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¶ 25.) Plaintiff alleges he suffered physical and emotional injury, including lost time with his

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children. (See id. ¶ 26.)

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B.

Regulatory and Legal Action Involving the SynchroMed II Device

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Plaintiff’s claims against the Medtronic defendants are largely based on defendants’

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alleged “pattern of delayed responses to known safety violations” and disregard toward the

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“FDA’s repeated warnings to comply with mandated manufacturing requirements.” (See id. ¶ 1.)

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As alleged in plaintiff’s second amended complaint, the SynchroMed II device is a Class III

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medical device, first approved through a pre-market approval (“PMA”) process in 1988, by the

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U.S. Food and Drug Administration (“FDA”). (Id. ¶ 27.) In 2006, 2007, 2009, and 2012, the

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FDA issued warning letters concerning the manufacture of SynchroMed II devices and potential

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violations of federal regulations. (See id. ¶¶ 32, 34, 36, 40, Exs. 1, 3, 4, 6.)

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In April 2013, the FDA determined that starting in September 2012, certain Medtronic

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catheters failed to comply with the approved specification, which allowed unintended

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disconnection of the catheter from the pump, failure of the catheter connector, leakage, or

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occlusion. (See id. ¶ 39, Ex. 5.) On June 3, 2013, a Class I recall was issued for certain

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SynchroMed II Sutureless Connector Intrathecal Catheters (model nos. 8709SC and 8731SC), and

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Sutureless Revision Kits (model nos. 8596SC and 8578), with a “use by” date prior to August 25,

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2014. (Id. ¶ 45, see also id., Ex. 7.)

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In 2015, the federal government filed a complaint against Medtronic for repeatedly failing

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to correct violations related to SynchroMed II devices. (See id. ¶¶ 49–54.) On April 27, 2015, a

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consent decree was approved in the U.S. District Court for the District of Minnesota enjoining

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Medtronic from further manufacture and distribution of certain defective SynchroMed II devices.

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(Id. ¶ 55.)

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LEGAL STANDARD

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The purpose of a motion to dismiss pursuant to Rule 12(b)(6) is to test the legal

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sufficiency of the complaint. N. Star Int’l v. Ariz. Corp. Comm’n, 720 F.2d 578, 581 (9th Cir.

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1983). “Dismissal can be based on the lack of a cognizable legal theory or the absence of

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sufficient facts alleged under a cognizable legal theory.” Balistreri v. Pacifica Police Dep’t, 901
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F.2d 696, 699 (9th Cir. 1990). A claim for relief must contain “a short and plain statement of the

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claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). Though Rule 8(a)

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does not require detailed factual allegations, a plaintiff is required to allege “enough facts to state

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a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570

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(2007); Ashcroft v. Iqbal, 556 U.S. 662, 677–78 (2009). “A claim has facial plausibility when the

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pleaded factual content allows the court to draw the reasonable inference that the defendant is

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liable for the misconduct alleged.” Iqbal, 556 U.S. at 678.

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In determining whether a complaint states a claim on which relief may be granted, the

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court accepts as true the allegations in the complaint and construes the allegations in the light

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most favorable to the plaintiff. Hishon v. King & Spalding, 467 U.S. 69, 73 (1984); Novak v.

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United States, 795 F.3d 1012, 1017 (9th Cir. 2015). It is inappropriate to assume that the plaintiff

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“can prove facts that it has not alleged or that the defendants have violated the . . . laws in ways

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that have not been alleged.” Associated Gen. Contractors of Cal., Inc. v. Cal. State Council of

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Carpenters, 459 U.S. 519, 526 (1983).

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DISCUSSION

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The Medtronic defendants move to dismiss plaintiff’s second amended complaint on

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grounds that each of plaintiff’s state law claims is preempted by the Medical Device Amendment

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(“MDA”) to the federal Food, Drug, and Cosmetic Act (“FDCA”). Defendants also contend that

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plaintiff’s second amended complaint fails to adequately allege facts to support plausible claims

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for relief, even if such claims are not preempted. The court addresses each of these arguments in

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turn below.

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A.

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Federal Preemption
Under the Supremacy Clause, Congress has the power to preempt state law. U.S. Const.

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art. VI, cl. 2. Preemption may be express or implied. Shaw v. Delta Airlines, 463 U.S. 85, 97

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(1983) (citations omitted); Montalvo v. Spirit Airlines, 508 F.3d 464, 470 (9th Cir. 2007).

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Express preemption occurs if a federal statute explicitly indicates that federal law is to

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supersede state law. CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664 (1993) (observing that

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“the task of statutory construction must in the first instance focus on the plain wording of the
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clause, which necessarily contains the best evidence of Congress’ preemptive intent”); Chicanos

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Por La Causa, Inc. v. Napolitano, 558 F.3d 856, 863 (9th Cir. 2008). As the court previously

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noted, the MDA and its implementing regulations contain provisions expressly preempting

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certain state or local requirements that are “different from, or in addition to,” an existing FDA

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requirement relating to a particular medical device. See 21 U.S.C. § 360k(a); 21 C.F.R.

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§ 808.1(d). (See also Doc. No. 50 at 7–9 (explaining the MDA’s regulatory regime).) For a state

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cause of action to be expressly preempted under the MDA, two conditions must be met. First, the

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FDA must have established specific requirements relating to a particular medical device at issue.

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See Medtronic, Inc. v. Lohr, 518 U.S. 470, 496 (1996) (noting that state law will be preempted

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“only to the extent that the FDA has promulgated a federal ‘requirement’”); Perez v. Nidek Co.,

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Ltd., 711 F.3d 1109, 1117 (9th Cir. 2013). The PMA process under the MDA imposes such a

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device-specific requirement. Riegel v. Medtronic, Inc., 552 U.S. 312, 322–23 (2008). Second,

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the state law claim must rely on a requirement that is “different from, or in addition to,” the

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FDA’s requirement, and must relate to the device’s safety or effectiveness. See id. at 323; Lohr,

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518 U.S. at 500; Perez, 711 F.3d at 1117; see also Papike v. Tambrands Inc, 107 F.3d 737, 741

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(9th Cir. 1997) (holding that state common law claims can also impose “requirements” for

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preemption purposes). Conversely, the MDA does not preempt a “parallel” state law claim

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premised on a violation of FDA regulations. See Riegel, 552 U.S. at 330; Stengel v. Medtronic

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Inc., 704 F.3d 1224, 1228 (9th Cir. 2013). Allegations that a defendant failed to comply with the

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FDA’s Current Good Manufacturing Practices (“CGMPs”) may support a parallel state law claim,

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but such noncompliance must be tied to the particular device at issue. See, e.g., Frere v.

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Medtronic, Inc., No. EDCV 15-02338-BRO (DTBx), 2016 WL 1533524, at *7 (C.D. Cal. Apr. 6,

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2016) (finding that while “alleged violations of CGMPs alone may be insufficient to establish a

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parallel claim,” plaintiff’s claim was not expressly preempted where she cited the FDA’s

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investigation of defendants’ CGMP violations and alleged her device was manufactured during a

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time defendants were cited for failure to comply with CGMPs).

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Implied preemption, by contrast, occurs if congressional intent to preempt is “implicitly

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contained in [the] structure and purpose” of a federal law. Montalvo, 508 F.3d at 470 (quoting
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Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 516 (1992)). The MDA impliedly preempts claims

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that are based solely on violations of federal requirements, and not on state law requirements that

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could exist independently of any federal rules. Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S.

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341, 352–53 (2001); Perez, 711 F.3d at 1119; cf. Lohr, 518 U.S. at 500–502 (finding no

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preemption of plaintiff’s state law claims because they arose from the manufacturer’s alleged

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failure to use reasonable care in the production of the product, not solely from the violation of

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FDCA requirements); Stengel, 704 F.3d at 1230–33 (finding that a state law negligence claim

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escaped implied preemption because it could exist separately from any federal requirement to

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report adverse events to the FDA). Implied preemption under the MDA is rooted in the intent of

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Congress to vest exclusive authority over enforcement of the FDCA’s provisions in the federal

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government. See 21 U.S.C. § 337(a); accord Buckman, 531 U.S. at 352; Perez, 711 F.3d at 1119.

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At bottom, there is a “narrow gap” through which a plaintiff’s state law claim must fit in

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order to escape preemption by the FDCA: “The plaintiff must be suing for conduct that violates

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the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be

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suing because the conduct violates the FDCA (such a claim would be impliedly preempted under

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Buckman).” Perez, 711 F.3d at 1120 (emphases in original) (quoting In re Medtronic, Inc., Sprint

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Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010)). In his second amended

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complaint, plaintiff has attempted to thread this narrow gap while still alleging facts sufficient to

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state a plausible claim for relief.

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Manufacturing Defect Claims

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Plaintiff first alleges, in both strict liability and negligence causes of action, that his

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original SynchroMed II device suffered from a manufacturing defect. The MDA established a

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PMA process, which imposes comprehensive safety requirements applicable to Class III medical

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devices such as the SynchroMed II device at issue in this case. See Riegel, 552 U.S. at 322.

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California law, meanwhile, imposes general duties of care on medical device manufacturers in

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manufacturing their products. Carlin v. Superior Court, 13 Cal. 4th 1104, 1110 (1996). “A

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manufacturer is strictly liable in tort when an article he places on the market, knowing that it is to

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be used without inspection for defects, proves to have a defect that causes injury to a human
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being.” Id. (quoting Greenman v. Yuba Power Prods., Inc., 59 Cal. 2d 57, 62 (1963)). In

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addition, manufacturers are subject to liability for the manufacture of defective products under

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general principles of negligence. See Anderson v. Owens-Corning Fiberglas Corp., 53 Cal. 3d

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987, 999–1000 (1991).

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Here, plaintiff alleges that defendants’ failure to properly manufacture SynchroMed II

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devices in accordance with federal requirements also constituted a violation of California law.

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(See Doc. No. 51 ¶¶ 61–62.) As this court previously concluded, plaintiff’s claims are not subject

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to express preemption to the extent they are based on violations of federal requirements resulting

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from the PMA process. (See Doc. No. 50 at 11.) Plaintiff’s second amended complaint now also

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alleges facts from which it could be inferred that the SynchroMed II device was implanted in

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plaintiff during a time when defendants were not in compliance with CGMPs. (See Doc. No. 51

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¶¶ 32–42.) Specifically, the FDA warned Medtronic in 2006 and 2007 that it may be

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manufacturing adulterated or misbranded products in breach of the FDCA as a result of these

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alleged violations. (See id. ¶¶ 32–35, Exs. 1, 3.) Thus, plaintiff’s manufacturing defect claims as

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alleged in his second amended complaint, which are based on violations of federal requirements,

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are not expressly preempted by the MDA. See, e.g., Frere, 2016 WL 1533524, at *7; De La Paz

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v. Bayer Healthcare LLC, 159 F. Supp. 3d 1085, 1094 (N.D. Cal. 2016) (“The Form 483s offer

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plausible support for the inference that [defendant] produced some adulterated devices, even if

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not conclusive.”).
The court also declines to conclude that either of plaintiff’s manufacturing defect claims

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as alleged in the second amended complaint is impliedly preempted by the MDA. While

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plaintiff’s claims rely on Medtronic’s alleged failures to comply with federal CGMPs, he now

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alleges that such instances of noncompliance independently constitute breaches of Medtronic’s

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duties under California’s strict liability and negligence laws. (See Doc. No. 51 ¶¶ 61, 90.)
Accordingly, the court concludes plaintiff’s manufacturing defect claims, brought by way

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of both strict liability and negligence causes of action in his second amended complaint, are not

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preempted by the FDA’s regulations relating to SynchroMed II devices.

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2.

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Plaintiff’s second amended complaint also alleges a strict liability cause of action based

Failure to Warn Claim

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on a failure to warn of the dangers associated with plaintiff’s original SynchroMed II device. The

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MDA requires medical device manufacturers seeking PMA to disclose certain safety risks to the

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FDA, and imposes a continuing duty on PMA holders to report individual adverse events

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associated with those medical devices. See 21 U.S.C. § 360i(a); 21 C.F.R. § 803.10(c); see also

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Stengel, 704 F.3d at 1226–27 (explaining the PMA process and observing that, after approval,

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manufacturers are required to report adverse events to the FDA). California law imposes a

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general duty of reasonable care on manufacturers, and provides a strict products liability cause of

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action for failure to warn. See Johnson v. Am. Standard, Inc., 43 Cal. 4th 56, 64–65 (2008); Hufft

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v. Horowitz, 4 Cal. App. 4th 8, 13 (1992) (“A manufacturer is strictly liable for injuries caused by

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a product that is . . . distributed without adequate instructions or warnings of its potential for

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harm.”). A failure to warn claim brought under state law will not be expressly preempted by the

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FDA so long as it “demand[s] the same conduct of manufacturers that federal law [does].” Frere,

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2016 WL 1533524, at *5; see also Stengel, 704 F.3d at 1233 (holding that a state law negligence

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claim based on failure to warn was not expressly preempted because the “state-law duty

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parallel[ed the] federal-law duty” to report events to the FDA).

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Here, plaintiff’s second amended complaint clarifies that its failure to warn claim is

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premised on defendants’ failure to report adverse events associated with the SynchroMed II

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device to the FDA, in accordance with requirements under the MDA—rather than a failure to

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report such events directly to medical providers and consumers. (See Doc. No. 51 ¶¶ 75–77, 82.)

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Accordingly, the court now concludes that this claim as alleged in plaintiff’s second amended

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complaint is not preempted under the MDA.

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3.

Breach of Express Warranty Claim

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Finally, plaintiff alleges a breach of express warranty claim. State law claims based on

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breach of express warranty can survive preemption under the MDA only to the extent that they

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seek to impose liability for misleading warranties voluntarily made outside the label. See De La

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Paz, 159 F. Supp. 3d at 1097–98 (“[T]he only claims for breach of the express warranty that have
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survived preemption are those that went ‘beyond’ statements approved by the FDA.”); Houston v.

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Medtronic, Inc., 957 F. Supp. 2d 1166, 1181 (C.D. Cal. 2013) (noting that such claims are not

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preempted because where a defendant voluntarily makes misleading warranties outside the label,

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a plaintiff “is not imposing any requirement different from or additional to what federal law

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already requires”).

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Here, plaintiff alleges only that defendants expressly warranted that the pump and catheter

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in plaintiff’s SynchroMed II device were safe and fit for use. (Doc. No. 51 ¶¶ 112–13.) Just as

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this court previously concluded, plaintiff’s state law claim for breach of express warranty, as pled

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in his second amended complaint, is expressly preempted under the MDA because it fails to

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plausibly allege that defendants breached any warranty made beyond FDA-approved statements.

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See De La Paz, 159 F. Supp. 3d at 1098 (“Any claim for breach of express warranty based on

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[FDA-approved] statements would require a determination that [defendant] did not conform to

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the descriptions approved by the FDA. Such claims are preempted.”). Moreover, plaintiff has

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failed to specifically allege whether defendants’ purported liability is based on a deviation from

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the FDA’s requirement, rather than misleading voluntary off-label warranties. As a result,

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plaintiff’s breach of express warranty claim is preempted under the MDA.

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B.

Sufficiency of Pleadings

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To the extent the court has concluded that plaintiff’s claims are not preempted under

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federal law, however, the court also finds that plaintiff has failed to allege facts sufficient to

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support plausible claims for relief.

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1.

Manufacturing Defect & Failure to Warn Claims

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Generally speaking, in order to state a parallel claim premised on a violation of FDA

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regulations, a plaintiff must allege (1) the violation of a specific federal requirement applicable to

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the device, and (2) a causal nexus between the violation and the alleged injury. See, e.g., Wolicki-

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Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1300–02 (11th Cir. 2011); Eidson v. Medtronic, Inc.,

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40 F. Supp. 3d 1202, 1215 (N.D. Cal. 2014); Hawkins v. Medtronic, Inc., No. 1:13-cv-00499-

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AWI-SKO, 2014 WL 346622, at *5 (E.D. Cal. Jan. 30, 2014); Knoppel v. St. Jude Med., Inc., No.

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SACV 13-383 JVS (ANx), 2013 WL 12116393, at *3 (C.D. Cal. Sept. 24, 2013). To state a
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manufacturing defect claim by way of either a strict products liability or a negligence cause of

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action, a plaintiff must allege, and eventually prove, a particular manufacturing defect which

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caused injury to the plaintiff. See County of Santa Clara v. Atl. Richfield Co., 137 Cal. App. 4th

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292, 318 (2006) (describing the elements of a strict products liability cause of action); Marlene F.

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v. Affiliated Psychiatric Med. Clinic, Inc., 48 Cal. 3d 583, 588 (1989) (reciting the traditional

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elements of negligence). Likewise, “[t]o state a claim for strict products liability for failure to

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warn, a plaintiff must allege that the defendant failed to adequately warn of a known or knowable

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risk where that failure caused the plaintiff’s injuries.” Hawkins, 2014 WL 346622, at *13 (citing

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Carlin, 13 Cal. 4th at 1112).

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Plaintiff’s second amended complaint, however, fails to identify a particular

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manufacturing defect violative of the MDA that caused plaintiff’s injury. As he did in his first

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amended complaint, plaintiff again merely points to a series of regulatory and legal actions taken

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by the FDA between 2006 and 2015 (see Doc. No. 51 ¶¶ 32–56), involving noncompliance with

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the FDA’s CGMPs. But the allegations of the second amended complaint fail to link any of these

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actions or instances of noncompliance to plaintiff’s particular SynchroMed II device, originally

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implanted in plaintiff in 2008. For example, the FDA sent Medtronic warning letters in 2006 and

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2007, but neither of these letters references the models or components of plaintiff’s device that he

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alleges were defective. (See id. ¶¶ 32, 34, Exs. 1, 3.) The FDA also sent other warning letters in

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2009 and 2012, after plaintiff’s original device was implanted. (See id. ¶¶ 36, 40, Exs. 4, 6.)

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Those letters also fail to identify the specific models or components of plaintiff’s device.

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Furthermore, neither the June 2013 recall nor the April 2015 consent decree reference or pertain

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to the models or components linked to plaintiff’s original SynchroMed II device. (See id. ¶¶ 45,

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55, Ex. 7.) Instead, plaintiff appears to proceed on a generalized theory that documented

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noncompliance with respect to certain models of, or issues involving, the SynchroMed II device

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necessarily rendered plaintiff’s original device also defective. Simply put, the court cannot

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plausibly infer a link between these documented incidents and plaintiff’s original SynchroMed II

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device. Nor can it infer a causal connection between any alleged manufacturing defect and

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plaintiff’s injury. See, e.g., De La Paz, 159 F. Supp. 3d at 1095 (“[Plaintiff’s] failure to allege a
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causal link between any adulteration of [defendants’] device and her injuries is fatal to her

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manufacturing-defect claims.”); Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011) (finding

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“impermissibly conclusory and vague” allegations stating that “the [device] contained a

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manufacturing defect in that it was manufactured in such a manner that impurities, residues, and

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bacteria remained on the [device] in violation of the FDA standards and requirements and in

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violation of the manufacturing processes and design approved by the FDA”). Thus, while

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plaintiff’s manufacturing defect claims may not be preempted, they must be dismissed for failure

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to sufficiently state a claim.

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Similarly, plaintiff’s failure to warn claim also lacks a sufficient factual basis from which

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to infer causation or liability. As noted above, plaintiff’s failure to warn claim escapes

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preemption only to the extent it is premised on Medtronic’s failure to report certain adverse

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events to the FDA. However, in his second amended complaint, plaintiff has not alleged facts

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identifying the nature of any such adverse events or addressing how any such failure to report

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ultimately caused plaintiff’s injury. Thus, the court cannot draw a plausible inference that in the

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absence of such a failure to report, the FDA would have alerted plaintiff’s doctors or plaintiff

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himself such that plaintiff would have refused implantation of his original SynchroMed II device.

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See Hawkins, 2014 WL 346622, at *8 (“Plaintiff generally alleges that Defendants failed to report

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adverse events to the FDA. He also generally alleges that these failures caused or contributed to

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his injuries. What is not alleged is any factual content that would support the causal nexus.”).

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Because plaintiff fails to plead sufficient facts to support liability stemming from a failure to

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warn, this claim must also be dismissed.

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2.

Breach of Express Warranty Claim

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As the court concluded above, plaintiff’s breach of express warranty claim is preempted

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under the MDA. Even assuming plaintiff’s claim were not to be preempted, his second amended

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complaint again falls far short of pleading facts sufficient to raise an inference of liability with

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respect to such a claim. To state a claim for relief for a breach of express warranty, plaintiff must

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allege that: (i) defendants made an “affirmation or promise” or provided a “description” of the

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device; (ii) the statement was “part of the basis of the bargain;” and (iii) defendants breached the
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warranty. Weinstat v. Dentsply Int’l, Inc., 180 Cal. App. 4th 1213, 1227 (2010) (citing Cal. Com.

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Code § 2313(1)). “[A]n affirmation merely of the value of the goods or a statement purporting to

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be merely the seller’s opinion or commendation of the goods does not create a warranty.” Cal.

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Com. Code § 2313(2). Plaintiff’s second amended complaint fails to allege the contents of any

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express warranty made by defendants. Moreover, it remains unclear from the allegations of the

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second amended complaint whether the alleged warranty contained affirmations of fact sufficient

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to form the basis of an express warranty claim, or whether they simply reflected opinions or

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commendations regarding plaintiff’s SynchroMed II device. Plaintiff also fails to plead any non-

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conclusory allegations as to how any warranties were made to him or his physician, and whether

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any alleged warranties were relied upon by either. See Hammarlund v. C.R. Bard, Inc., 2:15-cv-

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05506-SVW-JEM, 2015 WL 5826780, at *5 (C.D. Cal. Oct. 2, 2015). As a result, plaintiff’s

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express warranty claim must be dismissed, in the alternative, for failure to state a claim.

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C.

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Leave to Amend
The undersigned has carefully considered whether plaintiff should be granted further leave

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to amend. “Valid reasons for denying leave to amend include undue delay, bad faith, prejudice,

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and futility.” Cal. Architectural Bldg. Prods., Inc. v. Franciscan Ceramics, Inc., 818 F.2d 1466,

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1472 (9th Cir. 1988); see also Klamath–Lake Pharm. Ass’n v. Klamath Med. Serv. Bureau, 701

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F.2d 1276, 1293 (9th Cir. 1983) (holding that while leave to amend shall be freely given, the

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court need not allow futile amendments). Here, plaintiff has, in the court’s view, been unable to

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cure all of the deficiencies noted in the order dismissing his first amended complaint. At the

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hearing on this motion to dismiss, plaintiff’s counsel indicated that plaintiff had alleged all of the

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available facts in support of his claims and did not argue for the granting of further leave to

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amend. The court has concluded, as set forth above, that the allegations of the second amended

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complaint fail to state a plausible claim for relief. Accordingly, the undersigned concludes that

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the granting of further leave to amend would be futile.

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CONCLUSION

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For the reasons set forth above,

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1. Defendants’ motion to dismiss plaintiff’s second amended complaint (Doc. No. 55) is

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granted;

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2. Plaintiff’s second amended complaint (Doc. No. 51) is dismissed with prejudice; and

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3. The Clerk of the Court is directed to close this case.

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IT IS SO ORDERED.
Dated:

October 13, 2017
UNITED STATES DISTRICT JUDGE

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