Spellman v. Smith & Nephew Incorporated

Filing 23

ORDER: Defendant's motion to dismiss 16 is granted without prejudice to Plaintiff's ability to attempt to file an amended complaint that complies with the standards set out in Twombly; Plaintiff may file a motion to amend her complaint within 21 days; if she does not do so, this case will be dismissed without further notice. Signed by Judge John W Sedwick on 9/24/16.(REW)

1
2
3

UNITED STATES DISTRICT COURT

4

DISTRICT OF ARIZONA

5
6

Lori Spellman,

7
8
9

Plaintiff,
vs.
Smith & Nephew, Inc.,

10

Defendant.

)
)
)
)
)
)
)
)
)
)

3:16-cv-08080 JWS
ORDER AND OPINION
[Re: Motion at Docket 16]

11
12

I. MOTION PRESENTED

13

At docket 16, defendant Smith & Nephew, Inc. (“S&N”) moves pursuant to

14

Federal Rule of Civil Procedure 12(b)(6) for an order dismissing the complaint of

15

plaintiff Lori Spellman (“Spellman”). Spellman opposes at docket 21. S&N replies at

16

docket 22. Oral argument was requested but would not assist the court.

17
18

II. BACKGROUND
Spellman’s complaint alleges she was injured by the Birmingham Hip

19

Resurfacing (“BHR”) system, a metal-on-metal hip resurfacing prosthesis manufactured

20

by S&N that was implanted in her hips in 2009 and 2010. In 2014 Spellm an “underwent

21

revision of her right hip due to right hip pain.”1 Her doctor informed her that the BHR

22

system implanted in her right hip was defective and was causing her to suffer pain and

23

“an adverse metal reaction.”2 Spellman alleges that the BHR system installed in her left

24

hip failed as well, causing her to undergo a second revision surgery.

25
26
27

1

28

2

Doc. 1 at 9 ¶ 10.
Id. at 3-4 ¶ 11.

-1-

1

Spellman brings two Arizona-common-law causes-of-action against S&N: strict

2

liability and negligence. She alleges that S&N is liable for “designing and/or

3

manufacturing” the BHR systems in violation of the Federal Food, Drug, and Cosmetic

4

Act” (“FDCA”)3 and related federal regulations.4 Specifically, Spellman alleges the

5

following ten regulatory violations:

6

(1) failure to accurately establish the in vivo life expectancy of the BHR;

7

(2) failure to validate the anticipated wear of the acetabular cup prior to its
release into commercial distribution;

8
9

(3) failure to establish and maintain appropriate reliability assurance
testing to validate the BHR design both before and after its entry into the
marketplace;

10
11

(4) failure to conduct adequate bio-compatibility studies to determine the
BHR’s latent propensity to effuse metallic contaminants into the human
blood and tissue;

12
(5) failure to identify the component discrepancy;
13
14
15
16

(6) failure to capture the component discrepancy or defect during their
“Final Acceptance Activities;”
(7) failure to establish and maintain procedures for implementing
corrective and preventative action in response to, inter alia, complaints
regarding the BHR, returned BHR, and other quality problems associated
with the BHR;

17
18
19
20

(8) failure to appropriately respond to adverse incident reports that
strongly indicated the acetabular component was “Malfunctioning [as
defined in 21 C.F.R. 803.3],” or otherwise not responding to its “Design
Objection Intent;”
(9) failure to complete device investigations on returned BHR and
components, including the acetabular component; and

21
22
23

(10) continuing to inject BHR into the stream of interstate commerce when
it knew, or should have known, that the acetabular component was
“Malfunctioning [as defined in 21 C.F.R. 803.3]” or otherwise not
responding to its “Design Objective Intent.”

24
25
26
27

3

28

4

21 U.S.C. § 301 et seq.
Doc. 1 at 4 ¶ 12; 8 ¶ 21.

-2-

1

S&N moves for dismissal under Rule 12(b)(6), arguing that Spellman has not pleaded

2

specific, plausible facts showing that her state law claims are not preempted by federal

3

law.

4
5

III. STANDARD OF REVIEW
Rule 12(b)(6) tests the legal sufficiency of a plaintiff’s claims. In reviewing such

6

a motion, “[a]ll allegations of material fact in the complaint are taken as true and

7

construed in the light most favorable to the nonmoving party.”5 To be assumed true,

8

the allegations, “may not simply recite the elements of a cause of action, but must

9

contain sufficient allegations of underlying facts to give fair notice and to enable the

10

opposing party to defend itself effectively.”6 Dismissal for failure to state a claim can be

11

based on either “the lack of a cognizable legal theory or the absence of sufficient facts

12

alleged under a cognizable legal theory.”7 “Conclusory allegations of law . . . are

13

insufficient to defeat a motion to dismiss.”8

14

To avoid dismissal, a plaintiff must plead facts sufficient to “‘state a claim to relief

15

that is plausible on its face.’”9 “A claim has facial plausibility when the plaintiff pleads

16

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

17

defendant is liable for the misconduct alleged.”10 “The plausibility standard is not akin

18

to a ‘probability requirement,’ but it asks for more than a sheer possibility that a

19

defendant has acted unlawfully.”11 “Where a complaint pleads facts that are ‘merely

20
21

5

22

6

23

7

24

8

25

9

26

Vignolo v. Miller, 120 F.3d 1075, 1077 (9th Cir. 1997).
Starr v. Baca, 652 F.3d 1202, 1216 (9th Cir. 2011).
Balistreri v. Pacifica Police Dep’t, 901 F.2d 696, 699 (9th Cir. 1990).
Lee v. City of Los Angeles, 250 F.3d 668, 679 (9th Cir. 2001).

Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550
U.S. 544, 570 (2007)).

27

10

28

11

Id.
Id. (citing Twombly, 550 U.S. at 556).

-3-

1

consistent with’ a defendant’s liability, it ‘stops short of the line between possibility and

2

plausibility of entitlement to relief.’”12 “In sum, for a complaint to survive a motion to

3

dismiss, the non-conclusory ‘factual content,’ and reasonable inferences from that

4

content, must be plausibly suggestive of a claim entitling the plaintiff to relief.”13

5
6

IV. DISCUSSION
A.

Federal Preemption

7

1.

Express preemption

8

When Congress passed the Medical Device Amendments (“MDA”)14 to the

9

FDCA, it “imposed a regime of detailed federal oversight” from the Food and Drug

10

Administration (“FDA”) over the introduction of new medical devices into the market.15

11

The MDA contains the following clause that generally preempts states from imposing

12

their own requirements on medical device manufacturers:

13
14

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—

15

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

16
(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. 16

17
18
19
20
21
22
23

12

24

13

25

Id. (quoting Twombly, 550 U.S. at 557).
Moss v. U.S. Secret Serv., 572 F.3d 962, 969 (9th Cir. 2009); see also Starr, 652 F.3d

at 1216.

26

14

27

15

28

16

21 U.S.C. § 360c et seq.
Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008).
21 U.S.C. § 360k(a).

-4-

1

Because the MDA preempts only requirements that are “different from, or in addition to”

2

the federal requirements,17 it does not bar “a state-law claim for violating a state-law

3

duty that parallels a federal-law duty under the MDA.”18

4

2.

Implied preemption

5

The Supreme Court in Buckman Co. v. Plaintiffs’ Legal Comm., held that, in

6

addition to express preemption, the MDA also impliedly preempts “state-law fraud-on-

7

the-FDA” claims—claims that the manufacturer made fraudulent representations to the

8

FDA in the course of obtaining pre-market approval of a device.19 If plaintiffs were

9

allowed to maintain fraud-on-the-agency claims, the Court reasoned, such claims would

10

conflict with, and would therefore be impliedly preempted by, the FDA’s statutory

11

responsibility to “police fraud consistently with the Administration’s judgment and

12

objectives.”20 The Court ruled that such claims are federal in nature because they do

13

not rely on “traditional state tort law which had predated the federal enactments in

14

question[].”21

15

B.

16

Whether Spellman’s Complaint Satisfies Rule 8(a)
S&N argues that the complaint is insufficient under Rule 8(a) because it lacks

17

well-pleaded facts that show that S&N violated the FDA’s regulations. S&N contends

18

that the complaint “merely recites a laundry list of federal regulations S&N supposedly

19

violated” without connecting any of the violations to specific facts.22 Without well-

20

pleaded regulatory violations, S&N argues, the complaint cannot overcome S&N’s

21
22
17

23

Id.

18

24
25

Stengel v. Medtronic Inc., 704 F.3d 1224, 1228 (9th Cir. 2013) (en banc).

19

531 U.S. 341, 348 (2001).

26

20

27

21

28

22

Id. at 350.
Id. at 353.
Doc. 16 at 2.

-5-

1

express preemption defense.23 In response, Spellman does not point to any specific

2

facts that support her allegations that S&N violated the FDA’s regulations. As she does

3

in her complaint, she merely concludes without explanation that S&N violated the

4

regulations.24

5

As an initial matter, it should be noted that federal preemption is an affirmative

6

defense upon which the defendant bears the burden of proof.25 Rule 8(a), which states

7

that the complaint must include “a short and plain statement of the claim showing that

8

the pleader is entitled to relief,” does not apply to affirmative defenses. Affirmative

9

defenses are addressed in Rule 8(c), which states that affirmative defenses may be

10

pleaded in response to a complaint.26 Because a complaint “need not anticipate or

11

attempt to circumvent affirmative defenses,”27 Rule 8(a) does not inherently require

12

Spellman to plead any regulatory violations in order to sufficiently state her two Arizona-

13

law claims.28

14

This does not end the discussion, however, because S&N’s alleged regulatory

15

violations play a critical role in Spellman’s state-law claims. In order to establish a

16

prima facie case of strict liability under Arizona law, Spellman must show that the BHR

17

system is (1) “defective and unreasonably dangerous;” (2) “the defective condition

18

existed at the time it left [S&N’s] control;” and (3) “the defective condition is the

19
20
21

23

Id. at 1.

24

Doc. 21 at 3.

22
25

23
24
25
26
27
28

See Bruesewitz v. Wyeth LLC, 562 U.S. 223, 251 n.2 (2011); Dilts v. Penske Logistics,
LLC, 769 F.3d 637, 649 (9th Cir. 2014); Hunter v. Philip Morris USA, 582 F.3d 1039, 1044 (9th
Cir. 2009); Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1342 n.2 (10th Cir. 2015); Bausch v.
Stryker Corp., 630 F.3d 546, 561 (7th Cir. 2010).
26

Fed. R. Civ. P. 8.

27

Bausch, 630 F.3d at 561. See also Jones v. Bock, 549 U.S. 199, 216 (2007).

28

See Bausch, 630 F.3d at 561–62; Caplinger, 784 F.3d at 1342 n.2. See also cf. Albino
v. Baca, 747 F.3d 1162, 1169 (9th Cir. 2014) (en banc).

-6-

1

proximate cause of [her] injuries and property loss.”29 To establish negligence,

2

Spellman must show “(1) a duty owed to [her], (2) a breach thereof and (3) an injury

3

proximately caused by the breach.”30 For each of these torts, Spellman has

4

incorporated S&N’s regulatory violations into the statement of her claims: her strict

5

liability cause of action alleges that the BHR system was unreasonably dangerous due

6

to S&N’s regulatory violations,31 and her negligence cause of action alleges that S&N

7

breached a duty to her by violating the FDA’s regulations.32 Thus, S&N’s alleged

8

regulatory violations are essential to Spellman’s statement of her two claims. Although

9

no heightened pleading standards apply, Rule 8(a) requires Spellman to plead sufficient

10

factual matter to render plausible the alleged regulatory violations.

11

When analyzing whether a complaint’s allegations satisfy Rule 8(a), courts

12

employ a two-step process.33 Courts “begin by identifying pleadings that, because they

13

are no more than conclusions, are not entitled to the assum ption of truth.”34 If the court

14

identifies well-pleaded factual allegations, it proceeds to the next step, under which it

15

assumes the veracity of the allegations and determines “whether they plausibly give rise

16

to an entitlement to relief.”35 Spellman’s complaint fails at the first step. The complaint

17

merely concludes, without any factual context, that S&N violated the various listed

18

regulations. On the face of Spellman’s complaint it is possible that S&N violated the

19
20
21

29

22

30

23

31

24

32

25

33

26

Dietz v. Waller, 685 P.2d 744, 747 (Ariz. 1984).
Boyle v. City of Phoenix, 563 P.2d 905, 906 (Ariz. 1977).
Doc. 1 at 4 ¶ 13.
Id. at 8 ¶ 22.
Eclectic Properties E., LLC v. Marcus & Millichap Co., 751 F.3d 990, 995–96 (9th Cir.

2014).

27

34

28

35

Iqbal, 556 U.S. at 679.
Id.

-7-

1

FDA’s regulations, but the complaint does not include any “factual enhancement” to

2

cross “the line between possibility and plausibility.”36 Dismissal is appropriate.

3

Spellman’s opposition relies primarily on Stengel and Bausch, but to no avail.

4

Stengel is inapposite because there the Ninth Circuit’s decision rested on the m erits of

5

whether the state-law claims were preempted, not whether the complaint satisfied the

6

Twombly standard.37 With regard to Bausch, Spellman correctly notes that the Seventh

7

Circuit held that Rule 8(a) does not require the complaint to identify specific federal

8

regulations that were allegedly violated.38 Even so, Bausch does not stand for the

9

proposition that the complaint need not plausibly allege regulatory violations at all. The

10

Bausch plaintiff alleged that the FDA had informed the defendant that its manufacturing

11

methods did not conform to “industry and regulatory standards.”39 According to the

12

Seventh Circuit, this allegation satisfied Rule 8(a) because it plausibly alleged

13

“regulatory violations.”40 Spellman’s complaint lacks analogous factual enhancement.

14
15

V. CONCLUSION
Based on the preceding discussion, Defendant’s motion to dismiss at docket 16

16

is GRANTED without prejudice to Plaintiff’s ability to attempt to file an amended

17

complaint that complies with the standards set out in Twombly. Plaintiff may file a

18
19
20
21
22

36

23

37

24
25

Twombly, 550 U.S. at 557.

See Stengel v. Medtronic Inc., 704 F.3d 1224, 1233 (9th Cir. 2013), rev’d on other
grounds by Stengel, 704 F.3d at 1228 (The district court “did not dismiss the Stengels’
complaint on the ground that it did not conform to the Twombly standard, but instead on the
ground that the Stengels’ claims were preempted.”).

26

38

27

39

28

40

630 F.3d at 560.
Id. at 559.
Id.

-8-

1

motion to amend her complaint within 21 days. If she does not do so, this case will be

2

dismissed without further notice.

3
4

DATED this 24th day of September 2016.
/s/ JOHN W. SEDWICK
SENIOR JUDGE, UNITED STATES DISTRICT COURT

5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
-9-