Broge v. ALN International

Filing 70

ORDER RE 61 MOTION TO DISMISS CLAIMS 1 AND 2 OF SECOND AMENDED COMPLAINT; DENYING MOTION AS TO CLAIM 1; AND GRANTING MOTION AS TO CLAIM 2 WITHOUT LEAVE TO AMEND. Signed by Judge Beth Labson Freeman on 5/13/2019.(blflc1S, COURT STAFF) (Filed on 5/13/2019)

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UNITED STATES DISTRICT COURT

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NORTHERN DISTRICT OF CALIFORNIA

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SAN JOSE DIVISION

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SANDRA BROGE,
Plaintiff,

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v.

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ALN INTERNATIONAL, INC.,
Defendant.

United States District Court
Northern District of California

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Case No. 17-cv-07131-BLF
ORDER RE MOTION TO DISMISS
CLAIMS 1 AND 2 OF SECOND
AMENDED COMPLAINT; DENYING
MOTION AS TO CLAIM 1; AND
GRANTING MOTION AS TO CLAIM 2
WITHOUT LEAVE TO AMEND
[RE: ECF 61]

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Defendant ALN International, Inc. moves to dismiss Claims 1 and 2 of Plaintiff Sandra

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Broge’s second amended complaint (“SAC”) under Federal Rule of Civil Procedure 12(b)(6). The

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Court has vacated the hearing that was scheduled for April 17, 2019, and taken the motion under

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submission without oral argument. See Order Submitting Motion, ECF 69.

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For the reasons discussed below, the motion is DENIED as to Claim 1 and GRANTED
WITHOUT LEAVE TO AMEND as to Claim 2.
I.

BACKGROUND
Plaintiff alleges that she was implanted with a medical device designed, manufactured, and

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marketed by Defendant ALN International, Inc. (“ALN International”). The device – the ALN

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Optional Vena Cava Filter (“IVC Filter”) – was implanted on June 15, 2014 to treat deep vein

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thrombosis and pulmonary embolism. SAC ¶ 8. Those conditions can occur when blood clots

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travel from the blood vessels in the legs and pelvis through the inferior vena cava, or IVC, which

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is the vein that returns blood to the heart from the lower extremities. SAC ¶ 25. The IVC Filter is

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designed to trap and filter such blood clots. SAC ¶ 28.

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Defendant marketed the IVC Filter as safe and easy to remove after implantation. SAC ¶
66. However, when Plaintiff’s physician attempted to remove the IVC Filter on November 9,

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2015, removal was impossible because the IVC Filter had perforated, and become embedded in,

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the vena cava wall. SAC ¶ 9. Plaintiff underwent a second surgery on March 6, 2016, at which

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time the IVC Filter was successfully removed. SAC ¶ 10. Plaintiff alleges that as a result of these

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events, she suffered permanent and lift-threatening injuries and incurred significant medical

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expenses. SAC ¶ 11.
Plaintiff filed the original complaint, containing twelve claims, in the Santa Clara County

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Superior Court. Compl., Exh. A to Notice of Removal, ECF 1. Defendant removed the action to

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federal district court and filed a Rule 12(b)(6) motion. Through two rounds of motion practice and

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corresponding amendments, Plaintiffs’ claims have been whittled down to four claims set forth in

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the operative SAC: (1) strict products liability – inadequate warning; (2) strict products liability –

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United States District Court
Northern District of California

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manufacturing defect; (3) negligence; and (4) unjust enrichment. SAC, ECF 54.
Defendant seeks dismissal of Claims 1 and 2, arguing that Plaintiff has failed to cure the

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defects in those claims described in the Court’s prior dismissal orders and that further amendment

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would be futile.

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II.

LEGAL STANDARD
“A motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) for failure to state a

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claim upon which relief can be granted ‘tests the legal sufficiency of a claim.’” Conservation

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Force v. Salazar, 646 F.3d 1240, 1241-42 (9th Cir. 2011) (quoting Navarro v. Block, 250 F.3d

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729, 732 (9th Cir. 2001)). While a complaint need not contain detailed factual allegations, it

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“must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible

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

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550 U.S. 544, 570 (2007)). A claim is facially plausible when it “allows the court to draw the

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reasonable inference that the defendant is liable for the misconduct alleged.” Id.

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III.

DISCUSSION
Strict Products Liability – Inadequate Warning (Claim 1)

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A.

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Claim 1 of the SAC alleges strict products liability based on inadequate warning.

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“California law places a duty on manufacturers to warn of a particular risk if it is known or

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knowable in light of the generally recognized and prevailing best scientific and medical
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knowledge available at the time of manufacture and distribution.” Rosa v. Taser Int’l, Inc., 684

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F.3d 941, 946 (9th Cir. 2012) (internal quotation marks, citation, and emphasis omitted). Under

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this standard, “the manufacturer is held to the knowledge and skill of an expert in the field; it is

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obliged to keep abreast of any scientific discoveries and is presumed to know the results of all

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such advances.” Carlin v. Superior Court, 13 Cal. 4th 1104, 1113 n.3 (1996). “A manufacturer

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cannot defeat liability because it did not review the relevant scientific literature.” Rosa, 684 F.3d

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at 946. However, “a manufacturer is not under a duty to warn of every report of a possible risk, no

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matter how speculative, conjectural, or tentative, because inundating the public indiscriminately

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with notice of any and every hint of danger would inevitably dilute the force of any specific

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warning given.” Id. (internal quotation marks, citation, and brackets omitted).

United States District Court
Northern District of California

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“In cases involving medical devices, California applies the ‘learned intermediary’ doctrine

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which provides that the duty to warn runs to the physician, not the patient.” Hammarlund v. C.R.

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Bard, Inc., No. 2:15-CV-05506-SVW-JEM, 2015 WL 5826780, at *4 (C.D. Cal. Oct. 2, 2015).

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Thus a plaintiff alleging failure to warn regarding a medical device must allege that an adequate

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warning would have changed the physician’s decision to prescribe the product. Id.

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The Court previously dismissed this claim because Plaintiff focused on Defendant’s

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knowledge at the time she was implanted with the IVC Filter rather than the relevant time period

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when the IVC Filter was manufactured or distributed; Plaintiff’s allegations regarding Defendant’s

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knowledge were not supported by any facts showing that Defendants knew or should have known

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about the alleged risks in implanting the IVC Filter; and Plaintiff’s allegation that a warning would

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have altered her physician’s decision to prescribe the IVC Filter was wholly conclusory. Order

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Granting Motion to Dismiss FAC at 4, ECF 51. Defendant contends that SAC does not cure these

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deficiencies. The Court concludes that Plaintiff has added facts which are sufficient to state a

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claim for relief.

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Plaintiff now focuses on the correct time frame, when the IVC Filter was manufactured

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and distributed, rather than when it was implanted. SAC ¶ 86. Additionally, she now alleges

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factual bases for her assertion that Defendant knew or should have known that the IVC Filter

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posed a significant risk of failure. SAC ¶¶ 86-88. Specifically, she alleges that Defendant knew
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or should have known of risks posed by their product based on a July 9, 2009 “incident event

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report” and a 2013 case report published in The Journal of Vascular Medicine and Surgery. SAC

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¶¶ 86-87. The 2009 incident event report described “an injury where the ALN filter had

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malfunctioned, requiring multiple snares to be used in attempts to retrieve the filter. Due to the

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defective design of the device, the specially designed hooks were not able to retrieve the device,

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and it was deemed unremovable after an exhaustive surgical attempt to do so.” SAC ¶ 88. The

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2013 case report described an incident in which an IVC Filter implanted in a Japanese man

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migrated to the right ventricle, causing new thrombi that were potentially fatal. SAC ¶ 87.

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Plaintiff’s allegations that an adequate warning would have altered her physician’s decision to
prescribe the IVC Filter are still conclusory, but given Plaintiff’s other amendments to the claim

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United States District Court
Northern District of California

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and her allegation that she herself would not have consented to implantation of the device had her

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physician passed on a warning from Defendant, the Court is satisfied that the claim is adequately

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pled.

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Defendant argues that Plaintiff’s amendments are inadequate to show that Defendant knew

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or should have known that the IVC Filter put patients at risk, because the 2009 incident involved a

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design defect and the Court previously dismissed Plaintiff’s claim for design defect, and the 2013

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article described migration of the IVC Filter rather than the embedding of the IVC Filter in the

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vena cava wall, as happened to Plaintiff. The Court is not prepared to draw the distinctions argued

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by Defendant at the Rule 12(b)(6) stage. It may be that Defendant can show in appropriate motion

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or at trial that Defendant did not have actual or constructive knowledge of a risk sufficient to

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trigger a duty to warn. Those are questions for another day. At this stage, the Court concludes

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that Plaintiff’s factual allegations give rise to a reasonable inference that Defendant knew or

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should have known of risks created by its product which triggered a duty to warn.

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The motion to dismiss Claim 1 is DENIED.

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B.

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Claim 2 of the SAC alleges strict products liability based on manufacturing defect. “Under

Strict Products Liability – Manufacturing Defect (Claim 2)

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a strict products liability claim based on manufacturing defect, a plaintiff must allege that while a

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‘suitable design is in place, [ ] the manufacturing process has in some way deviated from that
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design’ resulting in a defective product.” Hammarlund, 2015 WL 5826780, at *4 (citing In re

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Coordinated Latex, 99 Cal. App 4th 594, 613 (2002)). “Under the manufacturing defect theory,

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generally a manufacturing or production defect is readily identifiable because a defective product

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is one that differs from the manufacturer’s intended result or from other ostensibly identical units

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of the same product line.” Lucas v. City of Visalia, 726 F. Supp. 2d 1149, 1154 (E.D. Cal. 2010)

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(internal quotation marks and citation omitted). In order to state a claim, the plaintiff must explain

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how the product deviated from the manufacturer’s intended design or how it deviated from other

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seemingly identical products. Id. at 1155. “A bare allegation that the [product] had ‘a

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manufacturing defect’ is an insufficient legal conclusion.” Id.

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The Court previously dismissed this claim because Plaintiff had failed to allege facts from

United States District Court
Northern District of California

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which it could be inferred that the IVC Filter was suitably designed, and that her unit deviated

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from such design. Order Granting Motion to Dismiss FAC at 5, ECF 51. Plaintiff still has not

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alleged facts indicating that the IVC Filter was suitably designed. To the contrary, she alleges

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facts giving rise to a reasonable inference that the IVC Filter was not suitably designed and that

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the medical issues she suffered were due to the design rather than her particular unit’s deviation

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from the design.

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Specifically, Plaintiff alleges that “[t]he ALN Optional Vena Cava Filter is designed with

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legs (or struts) if differing lengths to avoid intertwining in the introduction catheter, however this

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feature makes the device more susceptible to post-implantation perforation, penetration, or

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intertwining with other veins and/or tissue.” SAC ¶ 48, ECF 54. Moreover, the anchoring barbs

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located on the IVC Filter’s struts “are particularly susceptible to perforation.” SAC ¶ 52.

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“Additionally, the ALN Optional Vena Cava Filter and Extraction Kit is intended as a removable

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filter with a special tool for ease of retrieval, however the device must remain in perfect

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placement, or the retrieval hook will be unable to latch properly, rending removal difficult, if not

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impossible.” Id. The IVC Filter was “designed in such way that when exposed to expected and

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reasonably foreseeable in-vivo conditions the devices will fracture, migrate, tilt, perforate internal

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organs and vasculature, and lead to the formation of thromboembolism and pulmonary embolism.”

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SAC ¶ 53. “The anchoring mechanism of the ALN Optional Vena Cava Filter is also insufficient
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to prevent tilting and migration post-placement.” SAC ¶ 54. “The configuration of the Inferior

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vena cava (‘IVC’) filters also renders them prothrombotic. This means that the ALN Optional

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Vena Cava Filter actually lead to the formation of thromboembolism and pulmonary emboli – the

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exact condition that these devices are meant to prevent.” SAC ¶ 55.
Plaintiff alleges that “[t]he ALN Vena Cava Filter implanted in plaintiff suffered a

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manufacturing defect because it did not conform to the suitable design mentioned above.” SAC ¶

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100. As discussed, no “suitable design” is identified in the SAC. Plaintiff alleges that Defendant

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“manufactured the hardware used in the device implanted in the Plaintiff, such that it failed to

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meet specifications as to the appropriate metal content, strength, and number of inclusions, which

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substantially increased the risk of fatigue failure, perforation, and migration in each device.” SAC

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United States District Court
Northern District of California

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¶ 102. However, Plaintiff provides absolutely no information regarding such specifications.

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While the Court recognizes that it can be difficult for a plaintiff to allege details regarding

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the manner in which a particular device deviated from the design, Plaintiff has not come close to

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alleging that the IVC Filter was suitably designed or how the unit implanted in her deviated from

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such design. To the contrary, all of her allegations suggest that her medical issues derived from

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the design itself. Accordingly, Claim 2 is subject to dismissal.

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Having made that determination, the Court must decide whether leave to amend is

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warranted. Leave ordinarily must be granted unless one or more of the following factors is

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present: (1) undue delay, (2) bad faith or dilatory motive, (3) repeated failure to cure deficiencies

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by amendment, (4) undue prejudice to the opposing party, and (5) futility of amendment. Foman

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v. Davis, 371 U.S. 178, 182 (1962); see also Eminence Capital, LLC v. Aspeon, Inc., 316 F.3d

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1048, 1052 (9th Cir. 2003) (discussing Foman factors). The Court finds no undue delay (factor 1)

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or bad faith (factor 2). However, despite the Court’s prior orders dismissing the original

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complaint and the FAC with guidance regarding amendment, Plaintiff still has not alleged a viable

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claims for manufacturing defect (factor 3). Granting further opportunity to amend would impose

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undue prejudice on Defendant (factor 4) where it appears that amendment would be futile (factor

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5). The Court thus concludes that further leave to amend is not warranted.

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Claim 2 is DISMISSED WITHOUT LEAVE TO AMEND.
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IV.

ORDER
Defendant’s motion to dismiss is DENIED as to Claim 1 for strict products liability based

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on inadequate warning, and GRANTED WITHOUT LEAVE TO AMEND as to Claim 2 for strict

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products liability based on manufacturing defect.

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Dated: May 13, 2019
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BETH LABSON FREEMAN
United States District Judge

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United States District Court
Northern District of California

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