Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caed-2_14-cv-00794/USCOURTS-caed-2_14-cv-00794-2/pdf.json

Nature of Suit Code: 367
Nature of Suit: TORTS - Personal Injury - Health Care/Pharmaceutical Personal Injury/Product Liability
Cause of Action: 28:1332 Diversity-Petition for Removal

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UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF CALIFORNIA

MELBA JOHNSON,

Plaintiff,

v.

HOLOGIC, INC.,

Defendant.

No. 2:14-cv-0794-JAM-KJN-PS

FINDINGS AND RECOMMENDATIONS

Plaintiff Melba Johnson (“plaintiff”), proceeding without the assistance of counsel, 

originally filed this products liability action in the Sacramento County Superior Court on 

February 10, 2014.1 (ECF No. 1-1 (Sacramento County Superior Court Summons and 

Complaint).) Defendant Hologic, Inc. (“defendant”) subsequently removed the case to this court 

pursuant to the court’s diversity jurisdiction and filed a motion for judgment on the pleadings 

pursuant to Federal Rule of Civil Procedure 12(c). (ECF Nos. 1, 7.) On June 9, 2014, the court 

issued an order granting defendant’s motion for judgment on the pleadings, but granted plaintiff 

leave to amend her complaint. (ECF No. 14.) On July 7, 2014, plaintiff filed a first amended 

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 

before the court. (ECF No. 16.) Plaintiff filed an opposition to the motion and defendant filed a 

reply. (ECF Nos. 20, 22.)

On the court’s own motion, this matter was taken under submission without a hearing.

The undersigned has fully considered the parties’ briefs and appropriate portions of the record. 

For the reasons that follow, the court recommends that defendant’s motion for judgment on the 

pleadings be granted, and plaintiff’s claims be dismissed with prejudice.

I. Background

Plaintiff filed this action in the Sacramento County Superior Court on February 10, 2014,

asserting claims for strict products liability and negligence based on allegations that she was 

injured while using a mammography machine designed and manufactured by defendant. (ECF 

No. 1-1.) Defendant subsequently removed the case to this court on the basis of this court’s 

diversity jurisdiction and filed an answer to the complaint. (ECF Nos. 1, 3.) On May 2, 2014, 

defendant filed a motion for judgment on the pleadings pursuant to Federal Rule of Civil

Procedure 12(c). (ECF No. 7.) On June 9, 2014, the court issued an order granting defendant’s 

motion for judgment on the pleadings on the basis that both of plaintiff’s claims were preempted 

by the Medical Device Amendments of 1976 (“MDA”) to the Food, Drug, and Cosmetic Act 

(“FDCA”), 21 U.S.C. §§ 301 et seq., 360c et seq., but granted plaintiff leave to amend her 

complaint due to the possibility that plaintiff might be able to allege a state-law tort claim that 

“parallels” the requirements set forth in the FDCA. (ECF No. 14.) On July 7, 2014, plaintiff 

filed the operative first amended complaint.

Plaintiff alleges in the first amended complaint that on or about March 13, 2012, she was 

injured when using the “Selenia Dimensions 3D system Class III” (“Selenia System”), a 

mammography machine designed and manufactured by defendant, Hologic, Inc. (ECF No. 15 at 

1.) Plaintiff alleges that her use of the machine resulted in her suffering from “broken glands, 

severe itching and two scars.” (Id.) Plaintiff alleges that these injuries were “caused by the 

magnitude of the radiation [produced by the machine] and any relation to ‘Tomosynthesis’ [sic] 

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 

Food and Drug Administration’s (“FDA”) regulations regarding defendant’s duty to report 

adverse events, namely the requirements set forth in 21 C.F.R. § 803.50 and 21 C.F.R. § 803.52. 

Plaintiff alleges that her claims are based on strict liability and negligence.

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. 

II. Legal Standards

Rule 12(c) of the Federal Rules of Civil Procedure permits a party to seek judgment on the 

pleadings “[a]fter the pleadings are closed—but early enough not to delay trial.” “A motion for 

judgment on the pleadings should be granted where it appears the moving party is entitled to 

judgment as a matter of law.” Geraci v. Homestreet Bank, 347 F.3d 749, 751 (9th Cir. 2003); 

Westlands Water Dist. v. Firebaugh Canal, 10 F.3d 667, 670 (9th Cir. 1993) (“[J]udgment on the 

pleadings is appropriate when, even if all allegations in the complaint are true, the moving party 

is entitled to judgment as a matter of law.”).

“A judgment on the pleadings is a decision on the merits.” 3550 Stevens Creek 

Associates v. Barclays Bank of California, 915 F.2d 1355, 1356 (9th Cir. 1990). In addition to 

considering the allegations of the complaint, the court may also take into account materials to 

which it can take judicial notice. Heliotrope Gen., Inc. v. Ford Motor Co., 189 F.3d 971, 981, 

n.18 (9th Cir. 1999). The central issue in considering a Rule 12(c) motion is whether the 

complaint states a valid claim for relief when considered in a light most favorable to the plaintiff. 

Hughes v. Tobacco Inst., Inc., 278 F.3d 417, 420 (5th Cir. 2001). “[A]ll allegations of fact of the 

opposing party are accepted as true.” Austad v. United States, 386 F.2d 147, 149 (9th Cir. 1967). 

A motion for judgment on the pleadings may be granted if, after assessing the complaint and 

matters for which judicial notice is proper, it appears “beyond doubt that the [non-moving party] 

cannot prove any facts that would support his claim for relief.” Morgan v. County of Yolo, 436 

F.Supp.2d 1152, 1155 (E.D. Cal. 2006), aff’d, 277 F. App’x 734 (9th Cir. 2008); R.J. Corman 

Derailment Services, LLC v. Int’l Union of Operating Engineers, Local 150, AFL-CIO, 335 F.3d 

643, 647 (7th Cir. 2003).

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“A Rule 12(c) motion challenges the legal sufficiency of the opposing party’s pleadings 

and operates in much the same manner as a motion to dismiss under Rule 12(b)(6).” Morgan v. 

County of Yolo, 436 F.Supp.2d 1152, 1154-55 (E.D. Cal. 2006). Analysis under Rule 12(c) is 

“substantially identical” to analysis under Rule 12(b)(6) because, under both rules a court 

determines whether the facts alleged in the complaint, taken as true, entitle the plaintiff to a legal 

remedy. Chavez v. U.S., 683 F.3d 1102, 1108 (9th Cir. 2012). Similar to a Rule 12(b)(6) motion 

to dismiss, when addressing a motion on the pleadings, a court must assess whether the complaint 

“contain[s] 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 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 

U.S. 544, 570 (2007)). “[A] court considering a motion to dismiss can begin by identifying 

pleadings that, because they are no more than conclusions, are not entitled to the assumption of 

truth. While legal conclusions can provide the framework of a complaint, they must be supported 

by factual allegations.” Iqbal, 556 U.S. at 679.

Mere conclusory statements in a complaint and “formulaic recitation[s] of the elements of 

a cause of action” are insufficient. Twombly, 550 U.S. at 555. Thus, a court discounts 

conclusory statements, which are not entitled to the presumption of truth, before determining 

whether a claim is plausible. Iqbal, 556 U.S. at 678. “A claim has facial plausibility when the 

plaintiff pleads factual content that allows the court to draw the reasonable inference that the 

defendant is liable for the misconduct alleged.” Id. “Determining whether a complaint states a 

plausible claim for relief will . . . be a context-specific task that requires the reviewing court to 

draw on its judicial experience and common sense.” Id. at 679.

Courts have discretion to grant leave to amend in conjunction with motions made pursuant 

to Rule 12(c). Moran v. Peralta Cmty. Coll. Dist., 825 F.Supp. 891, 893 (N.D. Cal. 1993) (citing 

Amersbach v. City of Cleveland, 598 F.2d 1033, 1038 (6th Cir. 1979). Generally, leave to amend 

a complaint is denied only if it is clear that the deficiencies of the complaint cannot be cured by 

amendment. DeSoto v. Yellow Freight Sys., Inc., 957 F.2d 655, 658 (9th Cir. 1992).

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III. Defendant’s Motion for Judgment on the Pleadings

Defendant argues that it should be entitled to judgment on the pleadings in this matter 

because plaintiff’s allegations in the first amended complaint demonstrate that there is no causal 

connection between the alleged violation of FDA regulations and the injuries plaintiff alleges she 

sustained when using the Selenia System. Defendant’s argument is well-taken.

As noted in the court’s earlier order granting defendant’s motion for judgment on the 

pleadings with respect to plaintiff’s original complaint, the judicially-noticed documents provided 

by defendants in connection with its previous motion for judgment on the pleadings demonstrate

that the Selenia System is a Class III Medical Device that was evaluated under the FDA’s 

premarket approval process. Accordingly, this device falls within the MDA regulatory regime, 

including the MDA’s preemption provision.

The MDA’s preemption provision provides:

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—

(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). Section 360(k) expressly preempts a state-law claim where specific federal 

requirements apply to the particular medical device that is the subject of claim, and the state-law 

claim imposes a standard of care or behavior that is “different from, or in addition to” the specific 

federal requirements relating to the safety and effectiveness of the device. Riegel v. Medtronic,

552 U.S. 312, 322 (2008). Furthermore, a claim may be subject to implied preemption under the 

MDA when it “seek[s] to enforce an exclusively federal requirement not grounded in traditional 

state tort law.” Kashani-Matts v. Medtronic, Inc., 2014 WL 819392, at *2 (C.D. Cal. Feb. 14, 

2014) (citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 352-53 (2001)). 

“Together, express preemption and implied preemption leave only a ‘narrow gap’ through which 

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 statelaw duty ‘parallels’ the federal-law duty under the MDA.” Stengel v. Medtronic Inc., 704 F.3d 

1224, 1231 (9th Cir. 2013) cert. denied, 134 S. Ct. 2839 (U.S. 2014); Riegel, 552 U.S. at 330 

(“[Section] 360k does not prevent a State from providing a damages remedy for claims premised 

on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, 

federal requirements.”). “In order for a state requirement to be parallel to a federal requirement, 

and thus not expressly preempted under [Section] 360k(a), the plaintiff must show that the 

requirements are genuinely equivalent. State and federal requirements are not genuinely 

equivalent if a manufacturer could be held liable under the state law without having violated the 

federal law.” Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1300 (11th Cir. 2011) (internal 

quotations omitted). Accordingly, in order to properly plead “parallel” claims that survive 

preemption, the plaintiff “must demonstrate facts (1) showing an alleged violation of FDA 

regulations or requirements related to [the device], and (2) establishing a causal nexus between 

the alleged injury and the violation.” Cohen v. Guidant Corp., 2011 WL 637472, at *1 (C.D. Cal. 

2011). 

Here, plaintiff bases her state-law products liability claims on the allegation that defendant 

failed to report the adverse event causing plaintiff’s injuries to the FDA in violation of 21 C.F.R. 

§ 803.50 and 21 C.F.R. § 803.52. “Manufacturers are required by the FDCA to report to the FDA 

adverse events where an approved device may have caused or contributed to a death or serious 

injury, or where a recurring malfunction would likely cause or contribute to a death or serious 

injury.” Hawkins v. Medtronic, Inc., 2014 WL 346622, at *8 (E.D. Cal. Jan. 30, 2014) (citing 

Stengel, 704 F.3d at 1226-27); 21 C.F.R. § 803.50(a); see 21 U.S.C. § 360i(a). Furthermore, the 

regulations also require manufacturers to include certain information in such reports. 21 C.F.R. § 

803.52 (listing the information a manufacturer must include in a report submitted to the FDA 

pursuant to 21 C.F.R. § 803.50). Because plaintiff alleges that defendant completely failed to 

report her injuries caused by the Selenia System to the FDA, she properly alleges violations of 21 

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 

connection between defendant’s alleged failure to report in conformance with FDA regulations 

and plaintiff’s injuries. Plaintiff generally alleges that defendant failed to report the adverse event 

giving rise to her injuries to the FDA and that she suffered injuries in the form of “broken glands, 

severe itching and two scars.” (ECF No. 15 at 1.) Plaintiff’s allegations clearly show that 

plaintiff’s injuries were caused by her use of the Selenia Dimensions 3D System, not defendant’s 

failure to report to the FDA that this device caused those injuries. Any failure to report this 

particular adverse event to the FDA could not have caused the injuries alleged in the first 

amended complaint because it was necessary for plaintiff’s injuries to have occurred before 

defendant’s duty to report that event could arise. Accordingly, when the allegations of plaintiff’s 

first amended complaint are taken as true, plaintiff cannot show the existence of “a causal nexus 

between the alleged injury and the violation.” Cohen, 2011 WL 637472, at *1.

Furthermore, while allegations of a violation of the FDA’s regulations concerning a 

failure to report to the FDA adverse events that occurred prior to the plaintiff’s alleged injurycausing event involving the medical device at issue may support a “parallel” state-law claim 

based on a failure-to-warn or negligence theory under certain circumstances, see Stengel, 704 

F.3d at 1226-27 (holding that the plaintiff’s state-law negligence claim based on allegations that 

the defendant failed to report to the FDA adverse incidents involving the use of its device despite 

defendant’s knowledge of those incidents and duty to report under the FDA’s regulations was a 

“parallel” claim and, therefore, not preempted by the MDA); Martin v. Medtronic, Inc., 2014 WL 

3635292, at *12 (D. Ariz. July 23, 2014) (“Courts have held that failure-to-warn claims based on 

failure to report adverse events to the FDA escape[ ] both express and implied preemption.” 

(internal quotations omitted)); Houston v. Medtronic, Inc. (Houston II), 2014 WL 1364455, at *8 

(C.D. Cal. Apr. 2, 2014), plaintiff’s first amended complaint contains no allegations indicating 

that plaintiff premises her products liability claims on the existence of such previous violations. 

To the contrary, plaintiff makes it clear in both the allegations of the first amended complaint and 

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 

Selenia System after the injury-causing event had already occurred. There is no mention by 

plaintiff in the first amended complaint that defendant failed to report to the FDA the occurrence 

of similar adverse incidents that occurred prior to her use of the machine, that her claims are 

based on a failure-to-warn theory of products liability, or that her negligence claim is premised on 

defendant’s failure to report adverse events other than the one that caused her alleged injuries.

Because plaintiff’s first amended complaint fails to allege state-law claims that parallel 

the federal requirements under the MDA, those claims are preempted. Accordingly, defendant’s 

motion for judgment on the pleadings should be granted. Furthermore, defendant’s motion 

should be granted without leave to further amend the complaint because plaintiff has previously 

been given the opportunity to amend and her amended pleading contains the same defects as the 

prior complaint and no additional facts that could possibly support a cognizable “parallel” statelaw claim that could escape preemption by the MDA.

IV. Conclusion

Based on the foregoing, IT IS HEREBY RECOMMENDED that:

1. Defendant’s motion for judgment on the pleadings (ECF No. 16) be granted;

2. Plaintiff’s claims asserted in the first amended complaint be dismissed with 

prejudice; and

3. The Clerk of Court be directed to close this case and vacate all dates.

These findings and recommendations are submitted to the United States District Judge 

assigned to the case, pursuant to the provisions of 28 U.S.C. § 636(b)(l). Within fourteen (14) 

days after being served with these findings and recommendations, any party may file written 

objections with the court and serve a copy on all parties. Such a document should be captioned 

“Objections to Magistrate Judge’s Findings and Recommendations.” Any reply to the objections 

shall be served on all parties and filed with the court within fourteen (14) days after service of the 

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 

Cir. 1998); Martinez v. Ylst, 951 F.2d 1153, 1156-57 (9th Cir. 1991).

IT IS SO RECOMMENDED.

Dated: January 5, 2015

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