noting that the learned 13 intermediary doctrine applies to implanted medical devices
How later courts described this case
- noting that the learned 13 intermediary doctrine applies to implanted medical devices
- recognizing “an exemption from design defect strict 10 products liability for all implanted medical devices that are available only through the services of 11 a physician”
Written by the judges who cited it.
The opinion
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8 UNITED STATES DISTRICT COURT
9 FOR THE EASTERN DISTRICT OF CALIFORNIA
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11 KARIN FUSSY, No. 1:21-cv-01307-DAD-BAK
12 Plaintiff,
13 v. ORDER GRANTING DEFENDANT’S
MOTION TO DISMISS
14 RTI SURGICAL,
(Doc. No. 4)
15 Defendant.
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17 This matter is before the court on defendant RTI Surgical’s motion to dismiss filed
18 pursuant to Federal Rule of Civil Procedure 12(b)(6). (Doc. No. 4.) Pursuant to General Order
19 No. 617 addressing the public health emergency posed by the COVID-19 pandemic, defendant’s
20 motion was taken under submission on the papers. (Doc. No. 6.) For the reasons explained
21 below, the court will grant defendant’s motion to dismiss.1
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23 1 The undersigned apologizes for the excessive delay in the issuance of this order. This court’s
overwhelming caseload has been well publicized and the long-standing lack of judicial resources
24 in this district long-ago reached crisis proportion. That situation has now been partially addressed
by the U.S. Senate’s confirmation of a district judge for one of this court’s vacancies on
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December 17, 2021. Nonetheless, for over twenty-two months the undersigned was left presiding
over approximately 1,300 civil cases and criminal matters involving 735 defendants. That
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situation resulted in the court not being able to issue orders in submitted civil matters within an
27 acceptable period of time and continues even now as the undersigned works through the
predictable backlog. This has been frustrating to the court, which fully realizes how incredibly
28 frustrating it is to the parties and their counsel.
1 BACKGROUND
2 On March 17, 2021, plaintiff Karin Fussy, who is proceeding pro se in this products
3 liability action, filed her complaint initiating this case against defendant RTI Surgical in the Kern
4 County Superior Court. (Doc. No. 1-1 at 2.) On August 27, 2021, defendant removed the action
5 to this federal court based on diversity jurisdiction under 28 U.S.C. § 1332. (Doc. No. 1.)
6 Plaintiff alleges as follows in her complaint. On January 20, 2012, plaintiff underwent a
7 lumbar spine fusion. (Doc. No. 1-1 at 11.) During this operation, the assigned surgeon used
8 “Pioneer Pedicle Screws” to hold plaintiff’s spine in position while the fusion took place. (Id.)
9 Although not explicitly stated in the complaint, plaintiff appears to allege that the screws used for
10 her surgery are manufactured by defendant. In the eight years following her operation, plaintiff
11 attended many appointments with doctors after complaining of pain, but she was told that nothing
12 was wrong. (Id.) Throughout that time, plaintiff’s pain in her back increased and her ability to
13 walk and talk deteriorated. (Id.) During an emergency visit to a hospital in October 2019, an
14 emergency room doctor allegedly told plaintiff that she should get the screws removed because
15 they were “impeding on [her] spine.” (Id.)
16 On February 24, 2020, “the apparatus was removed by Dr. Wang of USC.” (Id.) Plaintiff
17 alleges that as soon as the screws were removed, she no longer suffered from any pain. (Id.)
18 (“The very next day and ever since I have not had a single bit of pain. I am off all pain
19 medication and blood pressure medication.”) According to plaintiff, “[i]t is clear to say that the
20 screws moving and impeding into my spine is what caused the damage to my back and the pain I
21 experienced.” (Id. at 12.) Plaintiff alleges that as a result of nerve damage supposedly caused by
22 the screws used in her spine fusion surgery, she has trouble walking, experiences muscle cramps,
23 has vocal trouble, and falls down a lot. (Id.) Based on the forgoing, plaintiff alleges causes of
24 action for strict product liability and negligent product liability. (Id. at 5.)
25 On September 2, 2021, defendant filed a motion to dismiss all of plaintiff’s claims. (Doc.
26 No. 4.) Plaintiff failed to timely file an opposition to defendant’s motion. However, on
27 November 17, 2021, plaintiff filed her untimely opposition to defendant’s motion to dismiss.
28 (Doc. No. 16.) Defendant did not file a reply to plaintiff’s opposition.
1 LEGAL STANDARD
2 The purpose of a motion to dismiss pursuant to Rule 12(b)(6) is to test the legal
3 sufficiency of the complaint. N. Star Int’l v. Ariz. Corp. Comm’n, 720 F.2d 578, 581 (9th Cir.
4 1983). “Dismissal can be based on the lack of a cognizable legal theory or the absence of
5 sufficient facts alleged under a cognizable legal theory.” Balistreri v. Pacifica Police Dep’t, 901
6 F.2d 696, 699 (9th Cir. 1990). A claim for relief must contain “a short and plain statement of the
7 claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). Though Rule 8(a)
8 does not require detailed factual allegations, a plaintiff is required to allege “enough facts to state
9 a claim for relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570
10 (2007); Ashcroft v. Iqbal, 556 U.S. 662, 677–78 (2009). “A claim has facial plausibility when the
11 plaintiff pleads factual content that allows the court to draw the reasonable inference that the
12 defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. In determining whether a
13 complaint states a claim on which relief may be granted, the court accepts as true the allegations
14 in the complaint and construes the allegations in the light most favorable to the plaintiff. Hishon
15 v. King & Spalding, 467 U.S. 69, 73 (1984); Love v. United States, 915 F.2d 1242, 1245 (9th Cir.
16 1989). It is inappropriate to assume that the plaintiff “can prove facts that it has not alleged or
17 that the defendants have violated the . . . laws in ways that have not been alleged.” Associated
18 Gen. Contractors of Cal., Inc. v. Cal. State Council of Carpenters, 459 U.S. 519, 526 (1983).
19 “Dismissal without leave to amend is proper if it is clear that the complaint could not be
20 saved by amendment.” Kendall v. Visa U.S.A., Inc., 518 F.3d 1042, 1051 (9th Cir. 2008). To the
21 extent that the pleadings can be cured by the allegation of additional facts, courts will generally
22 grant leave to amend. Cook, Perkiss and Liehe, Inc. v. N. Cal. Collection Serv. Inc., 911 F.2d
23 242, 247 (9th Cir. 1990) (citations omitted).
24 DISCUSSION
25 Based on plaintiff’s complaint, it is not entirely clear which theory of product liability she
26 is attempting to pursue in this action. California recognizes strict liability for three types of
27 product defects––manufacturing defects, design defects, and warning defects (inadequate
28 warnings or failure to warn). Anderson v. Owens–Corning Fiberglas Co., 53 Cal. 3d 987, 995
1 (1991); Karlsson v. Ford Motor Co., 140 Cal. App. 4th 1202, 1208 (2006). In various sections of
2 her complaint and in her opposition brief, plaintiff alludes to each of these theories, as well as to a
3 negligence theory of product liability. Accordingly, out of an abundance of caution, the court
4 will conduct a short analysis with regard to each of the three separate theories of liability that can
5 support a strict product liability claim under California law. The court will then briefly address
6 any potential negligence claim that plaintiff may be attempting to bring as well.
7 A. Manufacturing Defect
8 Under California law, a manufacturing defect “is readily identifiable because a defective
9 product is one that differs from the manufacturer’s intended result or from other ostensibly
10 identical units of the same product line.” Barker v. Lull, 20 Cal. 3d 413, 429 (1978). The
11 manufacturing defect theory posits that “a suitable design is in place, but that the manufacturing
12 process has in some way deviated from that design.” In re Coordinated Latex Glove Litig., 99
13 Cal. App. 4th 594, 613 (2002).
14 In her complaint, plaintiff has not listed any allegations to support a manufacturing defect
15 claim. If plaintiff intends to allege a manufacturing defect, she must state allegations identifying
16 and explaining how the pedicle screws either deviated from defendant’s intended result/design or
17 how the screws deviated from other identical products. See Barker, 20 Cal. 3d at 429. Plaintiff
18 has not done so in her complaint and indeed appears to concede in her opposition to the pending
19 motion that she “did not allege that the pedicle screws [] used by the plaintiff’s physician in her
20 fusion procedure differed from RTI’s intended design.” (Doc. No. 16 at 4.) Accordingly, the
21 court will grant defendant’s motion to dismiss plaintiff’s strict product liability claim to the extent
22 it is predicated on an alleged manufacturing defect.
23 B. Design Defect
24 To be actionable under the design defect theory of product liability, a product design must
25 be defective in one of two ways. Soule v. Gen. Motors Corp., 8 Cal. 4th 548, 566–67 (1994);
26 Karlsson, 140 Cal. App.4th at 1208. First, under the “consumer expectation test,” a product’s
27 design is defective if it has failed to perform as safely as its ordinary consumers would expect
28 when used in an intended or reasonably foreseeable manner. Barker, 20 Cal. 3d at 413. Second,
1 under the “risk-benefit test,” a product’s design is defective if the design embodies “excessive
2 preventable danger,” that is, the risk of danger inherent in the design outweighs the benefits of
3 such design. Id. at 430; Ford v. Polaris Indus., Inc., 139 Cal. App. 4th 755, 766 (2006). “The
4 two tests provide alternative means for a plaintiff to prove design defect and do not serve as
5 defenses to one another.” McCabe v. Am. Hondo Motor Co., Inc., 100 Cal. App. 4th 1111, 1121
6 (2002). Moreover, particularly relevant here, California law precludes strict liability predicated
7 on design defects with respect to manufacturers of prescription medical devices, including
8 implanted devices such as the screws at issue in this case. See Garrett v. Howmedica Osteonics
9 Corp., 214 Cal. App. 4th 173, 182 (2013) (recognizing “an exemption from design defect strict
10 products liability for all implanted medical devices that are available only through the services of
11 a physician”). Rather, under California law, “the appropriate test for determining a prescription
12 [medical device] manufacturer’s liability for a design defect involves an application of the
13 ordinary negligence standard.” Id. Under the negligence standard . . . , a manufacturer is liable
14 for a design defect only if it failed to warn of a defect that it either knew or should have known
15 existed.” Id.
16 As with plaintiff’s manufacturing defect claim, dismissal of any design defect claim is
17 appropriate here because plaintiff’s complaint contains no factual allegations identifying what
18 aspect of the pedicle screws’ design made them defective or how defendant failed to warn about
19 said defect. Accordingly, the court will likewise grant defendant’s motion to dismiss plaintiff’s
20 strict product liability claim to the extent it is predicated on an alleged design defect.
21 C. Failure to Warn
22 Because a manufacturer generally has a duty to warn consumers about the hazards of its
23 product, a product may be dangerous because it lacks adequate warnings or instructions. Webb v.
24 Special Elec. Co. Inc., 63 Cal. 4th 167, 180–81 (2016). Under California law, a failure-to-warn
25 claim may be brought under either a theory of negligence or a theory of strict liability. Hannan v.
26 Boston Sci. Corp., No. 19-cv-08453-PJH, 2020 WL 2128841, at *6 (N.D. Cal. May 6, 2020).
27 Although not entirely clear, it appears that plaintiff’s failure to warn claim may be rooted in strict
28 liability. Manufacturers are strictly liable for injuries caused by their failure to provide adequate
1 warnings of known or reasonably scientifically knowable dangers at the time they manufactured
2 and distributed their product. Johnson v. Am. Standard, Inc., 43 Cal. 4th 56, 64 (2008); Carlin v.
3 Superior Ct., 13 Cal.4th 1104, 1108–09 (1996). “A plausible claim for a failure to warn should
4 include allegations that inter alia identify which danger was not warned against, explain that the
5 danger was substantial, and that the danger was known or reasonably knowable, or explain how
6 any warning that was given was inadequate.” Marroquin v. Pfizer, Inc., 367 F. Supp. 3d 1152,
7 1161-62 (E.D. Cal. 2019) (citing Lucas v. City of Visalia, 726 F. Supp. 2d 1149, 1156 n.1 (E.D.
8 Cal. 2010)).
9 Furthermore, although California law permits a strict liability failure to warn theory of
10 liability, it also provides that failure to warn in the prescription medical devices context must be
11 read in tandem with California’s “learned intermediary” doctrine. Hannan, 2020 WL 2128841, at
12 *7; Bigler-Engler v. Breg, Inc., 7 Cal. App. 5th 276, 319 (2017) (noting that the learned
13 intermediary doctrine applies to implanted medical devices). The learned intermediary doctrine
14 states that in the case of prescription drugs and medical devices, the duty to warn “runs to the
15 physician, not the patient.” Id. (citing Carlin, 13 Cal. 4th at 1116); see also Webb, 63 Cal. 4th at
16 187 n.10. A manufacturer discharges this duty to warn by “provid[ing] adequate warnings to the
17 physician about any known or reasonably knowable dangerous side effects, regardless of whether
18 the warning reaches the patient.” Motus v. Pfizer Inc., 196 F. Supp. 2d 984, 990–91 (C.D. Cal.
19 2001), aff’d, 358 F.3d 659 (9th Cir. 2004). The learned intermediary doctrine “applies when
20 drugs or medical devices are supplied in the context of the doctor-patient relationship[,]” Webb,
21 63 Cal. 4th at 187 n.10, but “does not apply to medical devices . . . which require the patient to
22 use and apply the medical device themselves.” Bigler-Engler, 7 Cal. App. 5th at 319. Where the
23 doctrine applies, a plaintiff who asserts a claim “based on a failure to warn must prove not only
24 that no warning was provided or the warning was inadequate, but also that the inadequacy or
25 absence of the warning caused the plaintiff’s injury.” Wendell v. GlaxoSmithKline LLC, 858 F.3d
26 1227, 1238 (9th Cir. 2017).
27 As an initial matter, nowhere in her complaint in this action does plaintiff allege that
28 defendant failed to adequately warn her about the potential risks of her procedure. Specifically,
1 plaintiff omits any mention of what danger she should have been warned against, how that danger
2 was substantial, or in what capacity defendant knew about that danger. Furthermore, the sparse
3 allegations of plaintiff’s complaint appear to suggest that a physician prescribed the lumbar spine
4 fusion plaintiff received and also prescribed using defendant’s pedicle screws to hold plaintiff’s
5 spine in place. (See Doc. No. 1-1 at 11) (“During the surgery, the surgeon (Dr. Watkins of
6 Watkins Spine Center) used Pioneer Pedicle Screws to hold the spine in place while the fusion
7 took place.”). As such, the learned intermediary doctrine would appear to apply to plaintiff’s
8 failure to warn claim, which arises from injuries allegedly caused by defendant’s medical device.
9 See Riera v. Mecta Corp, No. 2:17-cv-06686-RGK-JC, 2021 WL 2024688, at *4 (C.D. Cal. May
10 14, 2021) (“Because [plaintiffs] were treated with the Thymatron System IV by their doctors in a
11 hospital setting, the learned intermediary doctrine applies.”). Therefore, to successfully allege a
12 failure to warn claim here, plaintiff must allege facts sufficient to show that: (1) defendant did
13 not warn plaintiff’s doctors of the risks associated with the pedicle screws “or the warning was
14 inadequate,” and (2) “that the inadequacy or absence of the warning caused” plaintiff’s injuries.
15 Wendell, 858 F.3d at 1238 (citation omitted). Having failed to allege any such facts, plaintiff has
16 not adequately alleged a failure to warn claim under California law in her complaint.
17 Accordingly, defendant’s motion to dismiss plaintiff’s failure-to-warn product liability
18 claim will be granted.
19 D. Negligence
20 Plaintiff also appears to assert a claim for “negligence,” although she does not expand on
21 such a claim beyond that. (See Doc. No. 1-1 at 5.) Based on plaintiff’s allegations, it appears that
22 plaintiff may be attempting to assert a negligence product liability claim.
23 A negligence claim under California law requires plaintiff to allege that defendant “owed
24 [plaintiff] a legal duty, breached the duty, and that the breach was a proximate or legal cause of
25 [plaintiff’s] injury.” Gonzalez v. Autoliv ASP, Inc., 154 Cal. App. 4th 780, 793 (2007). “In the
26 context of a products liability lawsuit, ‘[u]nder a negligence theory, a plaintiff must also prove . . .
27 that the defect in the product was due to negligence of the defendant.’” Id. (quoting Merrill v.
28 Navegar, Inc., 26 Cal. 4th 465, 479 (2001)) (quotations omitted).
1 Here, plaintiff appears to allege that the product at issue in this case was dangerous and
2 harmed her, but she does not advance allegations explaining how the product created the alleged
3 danger, the nature of that danger, or how that danger caused her injury. Moreover, plaintiff
4 alleges no facts as to how defendant owed her a duty or how defendant’s actions are connected to
5 any purported defect in the product. Put simply, the allegations in the complaint fall far short of
6 stating a cognizable cause of action for negligence. Accordingly, defendant’s motion to dismiss
7 plaintiff’s negligence claim will also be granted.
8 E. Leave to Amend
9 The undersigned acknowledges that federal courts must liberally construe the “inartful
10 pleading” of pro se litigants. Eldridge v. Block, 832 F.2d 1132, 1137 (9th Cir. 1987).
11 Nonetheless, plaintiff has failed to sufficiently state any cognizable claim for relief, and the court
12 will therefore dismiss her complaint in its entirety. The court will now consider whether to grant
13 plaintiff leave to amend.
14 Generally, “[c]ourts are free to grant a party leave to amend whenever ‘justice so
15 requires,’ and requests for leave should be granted with ‘extreme liberality.’” Moss v. U.S. Secret
16 Serv., 572 F.3d 962, 972 (9th Cir. 2009). There are several factors a district court considers in
17 whether to grant leave to amend, including undue delay, the movant’s bad faith or dilatory
18 motive, repeated failure to cure deficiencies by amendments previously allowed, undue prejudice
19 to the opposing party, and futility. Brown v. Stored Value Cards, Inc., 953 F.3d 567, 574 (9th
20 Cir. 2020) (citing Foman v. Davis, 371 U.S. 178, 182 (1962)).
21 Given plaintiff’s pro se status and the lack of any identifiable prejudice to defendant, the
22 court will grant plaintiff leave to file an amended complaint if she is able to do so in good faith.
23 Plaintiff is advised that the court cannot refer to a prior pleading in order to make an amended
24 complaint complete. Local Rule 220 requires any amended complaint to be complete in itself
25 without reference to prior pleadings. An amended complaint will supersede the original
26 complaint. See Loux v. Rhay, 375 F.2d 55, 57 (9th Cir. 1967). Thus, in any amended complaint
27 that plaintiff elects to file, she must include concise but complete factual allegations describing
28 the conduct and events that underlie her claims. She must clearly identify her causes of action
1 and the legal basis for each claim, and she must attempt to cure the various deficiencies the court
2 | has identified in this order if she wishes to pursue these claims.
3 CONCLUSION
4 For the reasons set forth above, defendant’s motion to dismiss (Doc. No. 4) is granted.
5 | Any amended complaint plaintiff may elect to file shall be filed within twenty-one (21) days of
6 | service of this order.
7 | ORDERED. a "
8 Li. wh F
Dated: _ April 13, 2022 Aa oe
9 UNITED STATES DISTRICT JUDGE
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