Johnson v. Hologic, Inc., et al.
Filing
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FINDINGS AND RECOMMENDATIONS signed by Magistrate Judge Kendall J. Newman on 1/5/2015 RECOMMENDING that the 16 Motion for Judgment on the Pleadings be granted; RECOMMENDING that the claims asserted in the 15 First Amended Complaint be dismissed with prejudice; RECOMMENDING that the Clerk of Court be directed to close this case and vacate all dates ;REFERRING this matter to Judge John A. Mendez; ORDERING that any objections be filed within fourteen (14) days. (Michel, G)
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UNITED STATES DISTRICT COURT
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FOR THE EASTERN DISTRICT OF CALIFORNIA
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MELBA JOHNSON,
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No. 2:14-cv-0794-JAM-KJN-PS
Plaintiff,
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v.
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HOLOGIC, INC.,
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FINDINGS AND RECOMMENDATIONS
Defendant.
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Plaintiff Melba Johnson (“plaintiff”), proceeding without the assistance of counsel,
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originally filed this products liability action in the Sacramento County Superior Court on
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February 10, 2014.1 (ECF No. 1-1 (Sacramento County Superior Court Summons and
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Complaint).) Defendant Hologic, Inc. (“defendant”) subsequently removed the case to this court
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pursuant to the court’s diversity jurisdiction and filed a motion for judgment on the pleadings
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pursuant to Federal Rule of Civil Procedure 12(c). (ECF Nos. 1, 7.) On June 9, 2014, the court
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issued an order granting defendant’s motion for judgment on the pleadings, but granted plaintiff
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leave to amend her complaint. (ECF No. 14.) On July 7, 2014, plaintiff filed a first amended
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complaint. (ECF No. 15.) Defendant subsequently filed a motion for judgment on the pleadings
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This action proceeds before this court pursuant to Eastern District of California Local Rule
302(c)(21) and 28 U.S.C. § 636(b)(1).
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pursuant to Rule 12(c) with respect to plaintiff’s first amended complaint, which is presently
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before the court. (ECF No. 16.) Plaintiff filed an opposition to the motion and defendant filed a
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reply. (ECF Nos. 20, 22.)
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On the court’s own motion, this matter was taken under submission without a hearing.
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The undersigned has fully considered the parties’ briefs and appropriate portions of the record.
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For the reasons that follow, the court recommends that defendant’s motion for judgment on the
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pleadings be granted, and plaintiff’s claims be dismissed with prejudice.
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I.
Background
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Plaintiff filed this action in the Sacramento County Superior Court on February 10, 2014,
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asserting claims for strict products liability and negligence based on allegations that she was
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injured while using a mammography machine designed and manufactured by defendant. (ECF
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No. 1-1.) Defendant subsequently removed the case to this court on the basis of this court’s
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diversity jurisdiction and filed an answer to the complaint. (ECF Nos. 1, 3.) On May 2, 2014,
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defendant filed a motion for judgment on the pleadings pursuant to Federal Rule of Civil
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Procedure 12(c). (ECF No. 7.) On June 9, 2014, the court issued an order granting defendant’s
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motion for judgment on the pleadings on the basis that both of plaintiff’s claims were preempted
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by the Medical Device Amendments of 1976 (“MDA”) to the Food, Drug, and Cosmetic Act
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(“FDCA”), 21 U.S.C. §§ 301 et seq., 360c et seq., but granted plaintiff leave to amend her
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complaint due to the possibility that plaintiff might be able to allege a state-law tort claim that
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“parallels” the requirements set forth in the FDCA. (ECF No. 14.) On July 7, 2014, plaintiff
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filed the operative first amended complaint.
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Plaintiff alleges in the first amended complaint that on or about March 13, 2012, she was
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injured when using the “Selenia Dimensions 3D system Class III” (“Selenia System”), a
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mammography machine designed and manufactured by defendant, Hologic, Inc. (ECF No. 15 at
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1.) Plaintiff alleges that her use of the machine resulted in her suffering from “broken glands,
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severe itching and two scars.” (Id.) Plaintiff alleges that these injuries were “caused by the
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magnitude of the radiation [produced by the machine] and any relation to ‘Tomosynthesis’ [sic]
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and any formula used to make the 3d images and also the weight of the [machine’s] compressors
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that held down [her] breast.” (Id.) Plaintiff further alleges that defendant failed to follow the
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Food and Drug Administration’s (“FDA”) regulations regarding defendant’s duty to report
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adverse events, namely the requirements set forth in 21 C.F.R. § 803.50 and 21 C.F.R. § 803.52.
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Plaintiff alleges that her claims are based on strict liability and negligence.
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Defendant now moves to for judgment on the pleadings pursuant to Federal Rule of Civil
Procedure 12(c) with respect to all claims asserted in plaintiff’s first amended complaint.
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II.
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Rule 12(c) of the Federal Rules of Civil Procedure permits a party to seek judgment on the
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Legal Standards
pleadings “[a]fter the pleadings are closed—but early enough not to delay trial.” “A motion for
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judgment on the pleadings should be granted where it appears the moving party is entitled to
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judgment as a matter of law.” Geraci v. Homestreet Bank, 347 F.3d 749, 751 (9th Cir. 2003);
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Westlands Water Dist. v. Firebaugh Canal, 10 F.3d 667, 670 (9th Cir. 1993) (“[J]udgment on the
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pleadings is appropriate when, even if all allegations in the complaint are true, the moving party
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is entitled to judgment as a matter of law.”).
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“A judgment on the pleadings is a decision on the merits.” 3550 Stevens Creek
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Associates v. Barclays Bank of California, 915 F.2d 1355, 1356 (9th Cir. 1990). In addition to
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considering the allegations of the complaint, the court may also take into account materials to
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which it can take judicial notice. Heliotrope Gen., Inc. v. Ford Motor Co., 189 F.3d 971, 981,
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n.18 (9th Cir. 1999). The central issue in considering a Rule 12(c) motion is whether the
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complaint states a valid claim for relief when considered in a light most favorable to the plaintiff.
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Hughes v. Tobacco Inst., Inc., 278 F.3d 417, 420 (5th Cir. 2001). “[A]ll allegations of fact of the
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opposing party are accepted as true.” Austad v. United States, 386 F.2d 147, 149 (9th Cir. 1967).
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A motion for judgment on the pleadings may be granted if, after assessing the complaint and
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matters for which judicial notice is proper, it appears “beyond doubt that the [non-moving party]
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cannot prove any facts that would support his claim for relief.” Morgan v. County of Yolo, 436
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F.Supp.2d 1152, 1155 (E.D. Cal. 2006), aff’d, 277 F. App’x 734 (9th Cir. 2008); R.J. Corman
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Derailment Services, LLC v. Int’l Union of Operating Engineers, Local 150, AFL-CIO, 335 F.3d
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643, 647 (7th Cir. 2003).
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“A Rule 12(c) motion challenges the legal sufficiency of the opposing party’s pleadings
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and operates in much the same manner as a motion to dismiss under Rule 12(b)(6).” Morgan v.
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County of Yolo, 436 F.Supp.2d 1152, 1154-55 (E.D. Cal. 2006). Analysis under Rule 12(c) is
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“substantially identical” to analysis under Rule 12(b)(6) because, under both rules a court
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determines whether the facts alleged in the complaint, taken as true, entitle the plaintiff to a legal
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remedy. Chavez v. U.S., 683 F.3d 1102, 1108 (9th Cir. 2012). Similar to a Rule 12(b)(6) motion
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to dismiss, when addressing a motion on the pleadings, a court must assess whether the complaint
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“contain[s] sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on
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its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550
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U.S. 544, 570 (2007)). “[A] court considering a motion to dismiss can begin by identifying
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pleadings that, because they are no more than conclusions, are not entitled to the assumption of
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truth. While legal conclusions can provide the framework of a complaint, they must be supported
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by factual allegations.” Iqbal, 556 U.S. at 679.
Mere conclusory statements in a complaint and “formulaic recitation[s] of the elements of
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a cause of action” are insufficient. Twombly, 550 U.S. at 555. Thus, a court discounts
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conclusory statements, which are not entitled to the presumption of truth, before determining
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whether a claim is plausible. Iqbal, 556 U.S. at 678. “A claim has facial plausibility when the
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plaintiff pleads factual content that allows the court to draw the reasonable inference that the
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defendant is liable for the misconduct alleged.” Id. “Determining whether a complaint states a
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plausible claim for relief will . . . be a context-specific task that requires the reviewing court to
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draw on its judicial experience and common sense.” Id. at 679.
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Courts have discretion to grant leave to amend in conjunction with motions made pursuant
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to Rule 12(c). Moran v. Peralta Cmty. Coll. Dist., 825 F.Supp. 891, 893 (N.D. Cal. 1993) (citing
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Amersbach v. City of Cleveland, 598 F.2d 1033, 1038 (6th Cir. 1979). Generally, leave to amend
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a complaint is denied only if it is clear that the deficiencies of the complaint cannot be cured by
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amendment. DeSoto v. Yellow Freight Sys., Inc., 957 F.2d 655, 658 (9th Cir. 1992).
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Defendant’s Motion for Judgment on the Pleadings
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III.
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Defendant argues that it should be entitled to judgment on the pleadings in this matter
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because plaintiff’s allegations in the first amended complaint demonstrate that there is no causal
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connection between the alleged violation of FDA regulations and the injuries plaintiff alleges she
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sustained when using the Selenia System. Defendant’s argument is well-taken.
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As noted in the court’s earlier order granting defendant’s motion for judgment on the
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pleadings with respect to plaintiff’s original complaint, the judicially-noticed documents provided
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by defendants in connection with its previous motion for judgment on the pleadings demonstrate
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that the Selenia System is a Class III Medical Device that was evaluated under the FDA’s
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premarket approval process. Accordingly, this device falls within the MDA regulatory regime,
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including the MDA’s preemption provision.
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The MDA’s preemption provision provides:
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Except as provided in subsection (b) of this section, no State or political
subdivision of a State may establish or continue in effect with respect to a device
intended for human use any requirement—
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(1) which is different from, or in addition to, any requirement applicable under this
chapter to the device, and
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(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.
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21 U.S.C. § 360k(a). Section 360(k) expressly preempts a state-law claim where specific federal
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requirements apply to the particular medical device that is the subject of claim, and the state-law
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claim imposes a standard of care or behavior that is “different from, or in addition to” the specific
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federal requirements relating to the safety and effectiveness of the device. Riegel v. Medtronic,
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552 U.S. 312, 322 (2008). Furthermore, a claim may be subject to implied preemption under the
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MDA when it “seek[s] to enforce an exclusively federal requirement not grounded in traditional
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state tort law.” Kashani-Matts v. Medtronic, Inc., 2014 WL 819392, at *2 (C.D. Cal. Feb. 14,
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2014) (citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 352-53 (2001)).
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“Together, express preemption and implied preemption leave only a ‘narrow gap’ through which
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the plaintiff’s claims must fit in order to survive.” Id. (citing Perez v. Nidek Co., 711 F.3d 1109,
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1120 (9th Cir. 2013)).
“[T]he MDA does not preempt state-law causes of action for damages in which the state-
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law duty ‘parallels’ the federal-law duty under the MDA.” Stengel v. Medtronic Inc., 704 F.3d
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1224, 1231 (9th Cir. 2013) cert. denied, 134 S. Ct. 2839 (U.S. 2014); Riegel, 552 U.S. at 330
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(“[Section] 360k does not prevent a State from providing a damages remedy for claims premised
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on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to,
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federal requirements.”). “In order for a state requirement to be parallel to a federal requirement,
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and thus not expressly preempted under [Section] 360k(a), the plaintiff must show that the
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requirements are genuinely equivalent. State and federal requirements are not genuinely
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equivalent if a manufacturer could be held liable under the state law without having violated the
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federal law.” Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1300 (11th Cir. 2011) (internal
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quotations omitted). Accordingly, in order to properly plead “parallel” claims that survive
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preemption, the plaintiff “must demonstrate facts (1) showing an alleged violation of FDA
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regulations or requirements related to [the device], and (2) establishing a causal nexus between
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the alleged injury and the violation.” Cohen v. Guidant Corp., 2011 WL 637472, at *1 (C.D. Cal.
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2011).
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Here, plaintiff bases her state-law products liability claims on the allegation that defendant
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failed to report the adverse event causing plaintiff’s injuries to the FDA in violation of 21 C.F.R.
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§ 803.50 and 21 C.F.R. § 803.52. “Manufacturers are required by the FDCA to report to the FDA
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adverse events where an approved device may have caused or contributed to a death or serious
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injury, or where a recurring malfunction would likely cause or contribute to a death or serious
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injury.” Hawkins v. Medtronic, Inc., 2014 WL 346622, at *8 (E.D. Cal. Jan. 30, 2014) (citing
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Stengel, 704 F.3d at 1226-27); 21 C.F.R. § 803.50(a); see 21 U.S.C. § 360i(a). Furthermore, the
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regulations also require manufacturers to include certain information in such reports. 21 C.F.R. §
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803.52 (listing the information a manufacturer must include in a report submitted to the FDA
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pursuant to 21 C.F.R. § 803.50). Because plaintiff alleges that defendant completely failed to
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report her injuries caused by the Selenia System to the FDA, she properly alleges violations of 21
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C.F.R. § 803.50 and 21 C.F.R. § 803.52. Therefore, the first amended complaint satisfies the first
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pleading requirement for a “parallel” claim.
However, plaintiff does not plead facts sufficient to show the existence of a causal
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connection between defendant’s alleged failure to report in conformance with FDA regulations
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and plaintiff’s injuries. Plaintiff generally alleges that defendant failed to report the adverse event
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giving rise to her injuries to the FDA and that she suffered injuries in the form of “broken glands,
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severe itching and two scars.” (ECF No. 15 at 1.) Plaintiff’s allegations clearly show that
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plaintiff’s injuries were caused by her use of the Selenia Dimensions 3D System, not defendant’s
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failure to report to the FDA that this device caused those injuries. Any failure to report this
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particular adverse event to the FDA could not have caused the injuries alleged in the first
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amended complaint because it was necessary for plaintiff’s injuries to have occurred before
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defendant’s duty to report that event could arise. Accordingly, when the allegations of plaintiff’s
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first amended complaint are taken as true, plaintiff cannot show the existence of “a causal nexus
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between the alleged injury and the violation.” Cohen, 2011 WL 637472, at *1.
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Furthermore, while allegations of a violation of the FDA’s regulations concerning a
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failure to report to the FDA adverse events that occurred prior to the plaintiff’s alleged injury-
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causing event involving the medical device at issue may support a “parallel” state-law claim
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based on a failure-to-warn or negligence theory under certain circumstances, see Stengel, 704
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F.3d at 1226-27 (holding that the plaintiff’s state-law negligence claim based on allegations that
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the defendant failed to report to the FDA adverse incidents involving the use of its device despite
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defendant’s knowledge of those incidents and duty to report under the FDA’s regulations was a
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“parallel” claim and, therefore, not preempted by the MDA); Martin v. Medtronic, Inc., 2014 WL
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3635292, at *12 (D. Ariz. July 23, 2014) (“Courts have held that failure-to-warn claims based on
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failure to report adverse events to the FDA escape[ ] both express and implied preemption.”
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(internal quotations omitted)); Houston v. Medtronic, Inc. (Houston II), 2014 WL 1364455, at *8
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(C.D. Cal. Apr. 2, 2014), plaintiff’s first amended complaint contains no allegations indicating
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that plaintiff premises her products liability claims on the existence of such previous violations.
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To the contrary, plaintiff makes it clear in both the allegations of the first amended complaint and
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in the arguments she asserts in her opposition to defendant’s present motion that she bases her
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claims solely on the allegation that defendant failed to report her injuries caused by her use of the
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Selenia System after the injury-causing event had already occurred. There is no mention by
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plaintiff in the first amended complaint that defendant failed to report to the FDA the occurrence
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of similar adverse incidents that occurred prior to her use of the machine, that her claims are
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based on a failure-to-warn theory of products liability, or that her negligence claim is premised on
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defendant’s failure to report adverse events other than the one that caused her alleged injuries.
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Because plaintiff’s first amended complaint fails to allege state-law claims that parallel
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the federal requirements under the MDA, those claims are preempted. Accordingly, defendant’s
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motion for judgment on the pleadings should be granted. Furthermore, defendant’s motion
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should be granted without leave to further amend the complaint because plaintiff has previously
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been given the opportunity to amend and her amended pleading contains the same defects as the
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prior complaint and no additional facts that could possibly support a cognizable “parallel” state-
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law claim that could escape preemption by the MDA.
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IV.
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Based on the foregoing, IT IS HEREBY RECOMMENDED that:
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Defendant’s motion for judgment on the pleadings (ECF No. 16) be granted;
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Plaintiff’s claims asserted in the first amended complaint be dismissed with
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Conclusion
prejudice; and
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The Clerk of Court be directed to close this case and vacate all dates.
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These findings and recommendations are submitted to the United States District Judge
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assigned to the case, pursuant to the provisions of 28 U.S.C. § 636(b)(l). Within fourteen (14)
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days after being served with these findings and recommendations, any party may file written
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objections with the court and serve a copy on all parties. Such a document should be captioned
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“Objections to Magistrate Judge’s Findings and Recommendations.” Any reply to the objections
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shall be served on all parties and filed with the court within fourteen (14) days after service of the
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objections. The parties are advised that failure to file objections within the specified time may
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waive the right to appeal the District Court’s order. Turner v. Duncan, 158 F.3d 449, 455 (9th
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Cir. 1998); Martinez v. Ylst, 951 F.2d 1153, 1156-57 (9th Cir. 1991).
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IT IS SO RECOMMENDED.
Dated: January 5, 2015
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