Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-5_17-cv-07131/USCOURTS-cand-5_17-cv-07131-2/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 28:1441 Petition for Removal- Product Liability

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United States District Court

Northern District of California

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF CALIFORNIA

SAN JOSE DIVISION

SANDRA BROGE,

Plaintiff,

v.

ALN INTERNATIONAL, INC.,

Defendant.

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]

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

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

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

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

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 

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

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

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

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

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

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

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, 

Case 5:17-cv-07131-BLF Document 70 Filed 05/13/19 Page 1 of 7
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2015, removal was impossible because the IVC Filter had perforated, and become embedded in,

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

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

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

expenses. SAC ¶ 11.

Plaintiff filed the original complaint, containing twelve claims, in the Santa Clara County 

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

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

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

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

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 

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

would be futile. 

 II. LEGAL STANDARD 

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

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

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

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

“must contain 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 claim is facially plausible when it “allows the court to draw the 

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

 III. DISCUSSION

A. Strict Products Liability – Inadequate Warning (Claim 1)

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

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

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 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

claim for relief. 

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

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

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

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 

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

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

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

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

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

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

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

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 

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

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

pled.

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

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

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

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

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

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

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

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

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

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

The motion to dismiss Claim 1 is DENIED.

B. Strict Products Liability – Manufacturing Defect (Claim 2)

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

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

‘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 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

from the design. 

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

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

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

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

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

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

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

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

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

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

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

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 

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

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

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 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 

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

products liability based on manufacturing defect.

Dated: May 13, 2019 

 ______________________________________

BETH LABSON FREEMAN

United States District Judge

Case 5:17-cv-07131-BLF Document 70 Filed 05/13/19 Page 7 of 7