Johnson v. Hologic, Inc., et al.

Filing 14

ORDER signed by Magistrate Judge Kendall J. Newman on 6/6/14 GRANTING 8 Motion for Judgment with leave to amend. Plaintiff shall file an amended complaint or notice of voluntary dismissal within 30 days. (Manzer, C)

1
2
3
4
5
6
7
8

UNITED STATES DISTRICT COURT

9

FOR THE EASTERN DISTRICT OF CALIFORNIA

10
11

MELBA JOHNSON,

12

No. 2:14-cv-0794-LKK-KJN (PS)

Plaintiff,

13

v.

14

HOLOGIC, INC.,

15

ORDER

Defendant.

16
Plaintiff Melba Johnson (“plaintiff”), proceeding without the assistance of counsel,

17
18

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

19

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

20

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

21

pursuant to the court’s diversity jurisdiction. (ECF No. 1.) Presently before the court is

22

defendant’s Motion for Judgment on the Pleadings pursuant to Rule 12(c) of the Federal Rules of

23

Civil Procedure seeking to dismiss plaintiff’s complaint in its entirety on the basis that plaintiff’s

24

claims are preempted by federal law. (ECF No. 8.) Plaintiff filed an opposition to defendant’s

25

motion. (ECF No. 10.) Defendant filed a reply. (ECF No. 12.)

26
27

1

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).

28
1

1

The court heard this matter on its June 5, 2014 law and motion calendar. Plaintiff Melba

2

Johnson appeared on her own behalf. Attorney Sharon Mayo appeared on behalf of defendant

3

Hologic, Inc. The undersigned has fully considered the parties’ briefs, the parties’ oral

4

arguments, and appropriate portions of the record. For the reasons that follow, defendant’s

5

motion for judgment on the pleadings is granted, but with leave to amend.

6

I.

Background
Plaintiff’s state court complaint consists of a four-page “personal injury” form complaint

7
8

along with an additional form page specifically tailored to causes of action based on products

9

liability. (ECF No. 1-1 at 7-11.) Based on the boxes plaintiff has checked off on the form

10

complaint, it appears that plaintiff alleges two causes of action against defendant based on

11

products liability, one claim based on strict liability, and the other based on negligence. (Id. at

12

11.) More specifically, plaintiff alleges that “[o]n or about . . . March 13, 2012 plaintiff was

13

injured by the following product: Hologic, Inc. manufactured Selenia brand digital 3-D

14

mamography [sic] machine” and that “plaintiff was a patient treated with the device.” (Id.)

15

Plaintiff further alleges that “defendant[ ] knew the product would be purchased and used without

16

inspection for defects,” that “[t]he product was defective when it left the control of . . . defendant[

17

],” and that “[t]he product at the time of [plaintiff’s] injury was being used in a manner intended

18

by defendant[ ].” (Id.) Plaintiff also alleges that her “injury was the legal (proximate) result of . .

19

. [defendant’s] manufacture[ ] or assembl[y of] the product,” the “design[ ] and manufacture[ ]

20

[of] component parts supplied to the manufacturer,” and “[sale of] the product to the public.”

21

(Id.) Finally, plaintiff alleges that defendant owed a duty to her and that her injury was the

22

proximate result of defendant’s negligence.2 (Id.) Plaintiff requests relief in the form of

23
24
25
26
27

2

Plaintiff makes a number of additional factual allegations in her opposition to defendant’s
motion regarding her alleged injury and the specific circumstances leading to this injury. (ECF
No. 10.) However, the court cannot consider these additional factual allegations because the
court may only consider the allegations within the complaint itself as well as materials to which it
can take judicial notice when assessing a motion for judgment on the pleadings pursuant to
Federal Rule of Civil Procedure 12(c). See Heliotrope Gen., Inc. v. Ford Motor Co., 189 F.3d
971, 981 (9th Cir. 1999).

28
2

1

compensatory damages, including hospital and other medical expenses. (Id. at 10.)

2

II.

3

Requests for Judicial Notice
In support of its Motion for Judgment on the Pleadings, defendant requests that the court

4

take judicial notice of the following three documents: (1) a February 11, 2011 Premarket

5

Approval letter for the Selenia Dimensions 3D System (ECF No. 8-3, Exhibit B); (2) a Food and

6

Drug Administration (“FDA”) Summary of Safety and Effectiveness Data for the Selenia

7

Dimensions 3D System” available through the FDA’s website3; and (3) a product classification

8

listing for the digital breast tomosynthesis mammography system from the FDA’s medical device

9

classification database webpage.4 Plaintiff does not oppose defendant’s requests for judicial

10

notice.
Under Federal Rule of Evidence 201, “[t]he court may judicially notice a fact that is not

11
12

subject to reasonable dispute because it: (1) is generally known within the trial court’s territorial

13

jurisdiction; or (2) can be accurately and readily determined from sources whose accuracy cannot

14

reasonably be questioned.” Fed. R. Evid. 201(b). Courts may take judicial notice of “undisputed

15

matters of public record,” but generally may not take judicial notice of “disputed facts stated in

16

public records.” Lee v. City of Los Angeles, 250 F.3d 668, 690 (9th Cir. 2001) (emphasis in

17

original). Facts subject to judicial notice may be considered on a Rule 12(c) motion. McCain v.

18

Stockton Police Dept., 2011 WL 4710696 at *2 (C.D. Cal. Oct. 4, 2011) (citing Mullis v. U.S.

19

Bankr. Ct., 828 F.2d 1385, 1388 (9th Cir. 1987)).

20

The Court finds that the documents here meet the requirements of Federal Rule of

21

Evidence 201. The court may take judicial notice of information in government documents or

22

from a government website when the fact “is not subject to reasonable dispute because it can

23

accurately and readily be determined from sources whose accuracy cannot reasonably be

24

questioned.” Fed. R. Evid. 201; Daniels-Hall v. Nat’l Educ. Ass’n, 629 F.3d 992, 998-99 (9th

25

Cir. 2010); United States v. Head, 2013 WL 5739095 at *1, n.1 (E.D. Cal. Oct. 22, 2013);

26

3

27
28

4

This document is available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080003b.pdf.

This webpage is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/
classification.cfm?ID=OTE.
3

1

Clifford v. Regents of Univ. of California, 2012 WL 1565702 at *5 (E.D. Cal. Apr. 30, 2012); see

2

Erickson v. Boston Scientific Corp., 846 F. Supp. 2d 1085, 1089 (C.D. Cal. 2011) (granting

3

request for judicial notice of FDA’s Premarket Approval documents for defendants’ pacemaker

4

product); In re Amgen Inc. Sec. Litig., 544 F. Supp. 2d 1009, 1023 (C.D. Cal. 2008) (granting

5

requests for judicial notice of information posted on the FDA’s website). Accordingly,

6

defendant’s requests for judicial notice are granted.

7

III.

8
9

Legal Standard
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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

n.18 (9th Cir. 1999). “[T]he central issue is whether, in light most favorable to the plaintiff, the

20

complaint states a valid claim for relief.” Hughes v. Tobacco Inst., Inc., 278 F.3d 417, 420 (5th

21

Cir. 2001). “[A]ll allegations of fact of the opposing party are accepted as true.” Austad v.

22

United States, 386 F.2d 147, 149 (9th Cir. 1967). A motion for judgment on the pleadings may

23

be granted if, after assessing the complaint and matters for which judicial notice is proper, it

24

appears “beyond doubt that the [non-moving party] cannot prove any facts that would support his

25

claim for relief.” Morgan v. County of Yolo, 436 F.Supp.2d 1152, 1155 (E.D. Cal. 2006), aff’d,

26

277 F. App’x 734 (9th Cir. 2008); R.J. Corman Derailment Services, LLC v. Int’l Union of

27

Operating Engineers, Local 150, AFL-CIO, 335 F.3d 643, 647 (7th Cir. 2003).

28

////
4

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

“contain[s] sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on

9

its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550

10

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

11

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

12

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

13

by factual allegations.” Iqbal, 556 U.S. at 679.
Mere conclusory statements in a complaint and “formulaic recitation[s] of the elements of

14
15

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

16

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

17

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

18

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

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

////

28

////
5

1

IV.

Defendant’s Motion for Judgment on the Pleadings
Defendant argues that both of plaintiff’s claims are preempted by the Medical Device

2
3

Amendments of 1976 (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§

4

301 et seq., 360c et seq., which contains an express preemption clause.

5

The MDA’s preemption provision states that:

6

[N]o State or political subdivision of a State may establish or
continue in effect with respect to a device intended for human use
any requirement—

7
8

(1) which is different from, or in addition to, any requirement
applicable under this chapter to the device, and

9

(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.

10
11
12

21 U.S.C. § 360k(a). The MDA regulatory regime established three classes of medical devices

13

based on the level of risk they present. Riegel v. Medtronic, 552 U.S. 312, 316 (2008). Class I

14

devices, such as bandages and latex gloves, are subject to the lowest level of regulation, Class II

15

devices, such as powered wheelchairs, receive closer FDA scrutiny, and Class III devices, such as

16

replacement heart valves, receive the most intensive federal oversight. Id. at 316-17. The FDA

17

has exclusive authority to regulate and assess the safety and effectiveness of medical devices

18

through the premarket approval or an equivalent process. Id. at 316-320 (describing the

19

“rigorous” premarket approval process medical devices falling into one of the three MDA classes

20

must undergo).

21

Here, the judicially-noticed documents demonstrate that defendant manufactured the

22

Selenia Dimensions 3D System, which forms the basis for plaintiff’s products liability claims,

23

and that this machine is a Class III Medical Device that was evaluated under the FDA’s

24

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

25

including the MDA’s preemption provision.

26

////

27

////

28

////
6

1

In Riegel v. Medtronic, the United States Supreme Court held that the MDA expressly

2

preempts state law claims if “specific federal requirements apply to the particular medical device

3

that is the subject of the state law claim,” and “the state-law tort claim imposes a standard of care

4

or behavior that is ‘different from, or in addition to’ the specific federal requirements.” 552 U.S.

5

at 322 (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 498-99 (1996) (holding that MDA

6

preemption applies to common law claims such as “strict products liability, breach of implied

7

warranty, and negligence”)). District courts in the Ninth Circuit have applied Riegel to preempt a

8

broad range of state law claims brought against FDA-approved Class III medical devices,

9

including products liability claims under California state law. See, e.g., Norton v. Indep. Tech.,

10

LLC, 2011 WL 3584491 (E.D. Cal. Aug. 15, 2011) (granting defendant’s Rule 12(c) motion

11

because plaintiff’s products liability and negligence claims concerning a Class III motorized

12

wheelchair were preempted by the MDA); Cohen v. Guidant Corp., 2011 WL 637472, at *1 (C.D.

13

Cal. Feb. 15, 2011) (holding that plaintiff’s “state law claims are preempted by federal law

14

because the pacemaker at issue in this action . . . is a Class III Medical Device that was evaluated

15

under the equivalent of the FDA’s premarket approval process”).

16

Plaintiff’s claims as pled are preempted by federal law because they are each premised on

17

the impropriety of a design, manufacturing or labeling process specifically approved by the FDA

18

through its premarket approval procedures, and they thus constitute state law claims imposing

19

requirements that are “different from, or in addition to” federal requirements. Reigel, 552 U.S. at

20

322; see also Medtronic, Inc., 518 U.S. at 498-99; Norton, 2011 WL 3584491.

21

Nevertheless, the MDA “does not prevent a State from providing a damages remedy for

22

claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather

23

than add to, federal requirements.” Reigel, 552 U.S. at 322. In order to properly plead “parallel”

24

claims that survive preemption, however, a plaintiff “must demonstrate facts (1) showing an

25

alleged violation of FDA regulations or requirements related to [the device], and (2) establishing

26

a causal nexus between the alleged injury and the violation.” Cohen v. Guidant Corp., 2011 WL

27

637472 at *1 (C.D. Cal. 2011). However, plaintiff does not allege in her complaint that defendant

28

violated FDA requirements in the design, manufacture or labeling of the Selenia Dimensions 3D
7

1

System. Accordingly, defendant’s motion for judgment on the pleadings is granted, but with

2

leave to amend because plaintiff could conceivably allege facts supporting the existence of viable

3

“parallel claims” based on defendant’s failure to comply with the FDA-approved standards.5

4

If plaintiff elects to file an amended complaint, it shall be captioned “First Amended

5

Complaint” and shall not exceed 20 pages. Furthermore, the first amended complaint shall be

6

limited to asserting “parallel” claims against defendant, meaning that plaintiff must be able to

7

make good faith factual allegations showing that defendant violated FDA regulations or

8

requirements related to the Selenia Dimensions 3D System and that there was a causal

9

relationship between plaintiff’s alleged injury and defendant’s violation.6 See Cohen, 2011 WL

10

637472 at *1.

11

Plaintiff is informed that the court cannot refer to a prior complaint, brief, exhibits, or

12

other filing to make plaintiff’s first amended complaint complete. Local Rule 220 requires that

13

an amended complaint be complete in itself without reference to any prior pleading. Thus, once

14

the first amended complaint is filed, it supersedes the original complaint, which no longer serves

15

any function in the case.

16

Importantly, nothing in this order requires plaintiff to file a first amended complaint. If

17

plaintiff determines that she does not wish to pursue the action at this juncture, she may instead

18

file a request for voluntary dismissal of the action without prejudice pursuant to Federal Rule of

19

Civil Procedure 41(a)(1)(A)(i).

20

////

21

////

22
23
24
25
26
27
28

5

Defendant also argues that plaintiff’s allegations are not adequately pled under the Federal Rule
of Civil Procedure 8(a) standards announced in Bell Atl. Corp. v. Twombly, 550 U.S. 544, 545
(2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009). While the court agrees that plaintiff’s form
complaint lacks the factual support necessary to undergird a plausible claim under this standard,
the court declines to address this argument at this time because defendant’s motion for judgment
on the pleadings is granted with leave to amend on the basis of preemption.
6

Plaintiff is cautioned that if she chooses to file an amended complaint, she must have a good
faith factual basis for the allegations asserted in that pleading. Failure to make allegations in
good faith could result in the imposition of sanctions. See Fed. R. Civ. P. 11(b), (c).
8

1

V.

Conclusion

2

For the foregoing reasons, IT IS HEREBY ORDERED THAT:

3

1.

4

leave to amend.

5

2.

Defendant’s motion for judgment on the pleadings (ECF No. 8) is granted with

Within 30 days of this order, plaintiff shall file either (a) a first amended complaint

6

in compliance with this order or (b) a request for voluntary dismissal of the action without

7

prejudice pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(i).

8
9
10

3.

Defendants shall file a response to any first amended complaint within 30 days of

service with that pleading.
4.

Failure to file either a first amended complaint or a request for voluntary dismissal

11

by the required deadline may result in the imposition of any appropriate sanctions, including

12

monetary sanctions and/or potential dismissal of the action with prejudice pursuant to Federal

13

Rule of Civil Procedure 41(b).

14
15

IT IS SO ORDERED.
Dated: June 6, 2014

16
17
18
19
20
21
22
23
24
25
26
27
28
9