Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-casd-3_16-cv-01255/USCOURTS-casd-3_16-cv-01255-0/pdf.json

Nature of Suit Code: 190
Nature of Suit: Other Contract Actions
Cause of Action: 28:1332oc Diversity-Other Contract

---

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF CALIFORNIA

DINA ANDREN and SIDNEY

BLUDMAN, individually and on

behalf of other members of the general

public similarly situated,

Plaintiffs,

CASE NO. 16cv1255-GPC(NLS)

ORDER GRANTING

DEFENDANTS’ MOTION TO

DISMISS WITH LEAVE TO

AMEND

[Dkt. No. 11.]

v.

ALERE, INC., a Delaware corporation

ALERE HOME MONITORING,

INC., a Delaware Corporation;

ALERE SAN DIEGO, INC., a

Delaware corporation,

Defendants.

Before the Court is Defendants’ motion to dismiss the complaint. (Dkt. No. 11.) 

An opposition and reply were filed. (Dkt. Nos. 16, 17.) Based on the reasoning below,

the Court GRANTS Defendants’ motion to dismiss with leave to amend.

Background

On May 26, 2016, Plaintiffs Dina Andren (“Andren”) and Sidney Bludman

- 1 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 1 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

(“Bludman”) filed a purported class action complaint alleging that Defendants Alere,

Inc., Alere Home Monitoring, Inc. and Alere San Diego, Inc. (“Defendants”)

unlawfully, deceptively and misleadingly engaged in themanufacturing, marketing and

sales of the INRatio products which include “INRatio PT/INR Monitors,” “INRatio

PT/INR Test Strips,” “INRatio2 PT/INR Monitors” and “INRatio2 PT/INR Test Strips”

(collectively, the “INRatio products”). (Dkt. No. 1, Compl.) 

In the late 1990's Defendants’ predecessor, HomoSense, Inc. , developed and

1

manufactured the “INRatio products” which are electronic testing devices designed to

assist patients who have been prescribed blood-thinners, such as warfarin, to monitor

their blood clotting time at home. (Id. ¶¶ 2, 14, 20.) The INRatio monitor, paired with

the INRatio test strips are known as the “INRatio testing kit” (Id. ¶ 21.) The ability to

monitor and test their blood-clotting times and adjust patients’ blood-thinner dosages

is critical as an inappropriate amount of blood-thinners can result in serious bodily

injury and death. (Id. ¶ 2.) 

 The International Normalized Ratio (“INR”) is a standardized metric used to

determine the relative speed at which blood clots in a patient’s body. (Id. ¶ 17.) “A

patient’s INR is calculated by comparing a patient’s prothrombin time (the speed at

which the patient’s blood clots) against the normalmean prothrombin time (the average

speed for bloodclotting in the general population). The resulting contrast between a

patient’s prothrombin time and the normal mean prothrombin time is the patient’s

INR.” (Id.) Doctors and patients use the INR to monitor the blood-clotting speed for

patients who have been prescribed blood thinnersto determine whether a patient should

increase or decrease his/her dosage of blood thinners. (Id. ¶ 18.)

In October 2002, the FDA approved the INRatio testing kit for home use and

sales began in 2003. (Id. ¶ 22.) The “INRatio2" testing kit was later developed and

In August 2007, Alere, Inc. (then known as Inverness Medical Innovaction, 1

Inc.) purchased HomoSense, Inc. (Dkt. No. 1, Compl. ¶ 14.) In 2008, HomoSense,

Inc. transferred its operations to Alere, Inc’s facility in San Diego, California. (Id.) In

2013, HomoSense, Inc.’s operations were merged into the Alere San Diego corporate

entity. (Id.)

- 2 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 2 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

operated similarly to the INRatio testing kit. (Id. ¶ 23.) 

Sometime immediately after the INRatio products became available to the

public, Defendants received numerous complaints aboutthe INRatio products’ efficacy

and accuracy. (Id. ¶ 26.) For example, some consumersfound that the INR resultsthey

were getting when using the INRatio products differed from the results they obtained

when they sent blood from the same samplesto independent labs for testing. (Id.) The

deviations between the INRatio products’ test results and those of independent labs

were “clinically significant.” (Id.) Between 2002 and 2014, Defendants received over

18,000 complaints concerning malfunctions with the INRatio products, no less than 3

of which resulted in deaths. (Id. ¶ 28.)

In May 2005, after receiving numerous complaints about the INRatio products,

the FDA conducted an inspection of Defendants’ San Jose operations facility and

following the inspection, the FDA sent a warning letter admonishing them for their

failure to file Medical Device Reporting (“MDR”) reports based on failing to report

complaints about “discrepant lab results” and “generating clinically significant

erroneous values.” (Id. ¶¶ 29-33.) From May 15, 2006 through July 13, 2006, the FDA

conducted another inspection of the San Jose facility and on November 29, 2006, the

FDA sent Defendants another warning letter for numerous failure to comply with

statutory regulations. (Id. ¶¶ 34, 35.) 

On April 16, 2014, Defendants issued a voluntary “Class 1" recall notice for the

INRatio2 test strips, citing the disparity between INR results obtained with the

INRatio2 systemversussignificantly higher INR results when re-testing was performed

by an independent laboratory. (Id. ¶ 38.) Defendants’ recall notice requested that

customers immediately cease using the INRatio2 PT/INR test strips and instead use

alternate methods to perform INR testing. (Id.) Despite the recall, Defendants did not

reimburse consumersfor the purchase of these dangerous devices. (Id.) On December

5, 2014, Defendants issued a voluntary recall letter for the INRatio PT/INR Monitor

and INRatio2 PT/INR Monitor, as well as the INRatio PT/INR Test Strips. The letter

- 3 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 3 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

stated, “[i]n certain cases an INRatio PT/INR Testing kit may provide an INR result

that is significantly lower than a result obtained using a laboratory INR system.” (Id.

¶ 40.) The letter also instructed customers, inter alia, to discuss the contents of the

letter with their doctors and “arrange with your doctor to have your INR measured

using a laboratory method.” (Id.) 

Despite receiving numerous complaints from users and multiple warning letters

from the FDA, notifying them that the results produced by the INRatio products

differed from those produced by independent laboratories, Defendants continued

selling the INRatio products and marketed and advertised them as “accurate,”

“convenient,” “effective,” “reliable,” “optimal” and “safe. (Id. ¶ 3.) As a result, due

to the erroneous results produced by the products, patients have been misled and have

caused them to improperly adjust their blood-thinner dosages increasing the risk and

likelihood of serious bodily injury or death. (Id. ¶ 4.)

Plaintiffs allege that Defendants misrepresented in its marketing advertising and

promotional materials that the INRatio products were “accurate” “convenient,”

“effective,” “reliable,” “optimal,” and “safe” and Defendants made further 

misrepresentations to consumers by omitting material information, particularly by

failing to disclose that the INRatio products produce false and misleading results, from

the packaging and marketing materials of the INRatio testing kit. (Id. ¶ 21.) 

Plaintiff Dina Andren suffers from a medical condition that requires her to

regularly take warfarin. (Id. ¶ 53.) As a result, Andren closely monitors her INR with

an INRatio2 PT/INR testing kit she bought from a pharmacy on April 30, 2015 for

$375 and which requires her to buy numerous boxes of replacement INRatio teststrips,

that range in price from $240-285 per box, to continue monitoring the INR. (Id. ¶¶ 53-

55.) “When purchasing her INRatio products, she relied on Alere’s representations that

the products were accurate, convenient, effective, reliable, optimal and safe.” (Id. ¶

56.) Were it not for these representations or had she known that Alere was omitting that

it knew its products produced erroneous INR results,Andren would not have purchased

- 4 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 4 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

or used the INRatio products. (Id.)

On the morning of May 24, 2015, Andren tested her INR using her INRatio2

testing kit. (Id. ¶ 57.) The test results indicated an INR of 2.7 and believing her INR

was above 2.5, Plaintiff Andren did not take Lovenox. (Id.) Later that day, Plaintiff

Andren wasrushed to the hospital where doctors determined she had suffered a stroke. 

(Id. ¶ 58.) Following her stroke, Andren continued using her INRatio2 and

accompanying test strips to closely monitor her INR and adjust her warfarin dosage

accordingly. (Id. ¶ 59.) In July of 2015, after having carefullymonitored and regulated

her INR with the INRatio 2 testing kit for over a month following her stroke, Andren

suffered a Transient Ischemic Attack (“TIA”), otherwise known as a “mini-stroke.” 

(Id. ¶ 60.) When Andren returned home, she continued to use her INRatio2 testing kit

to monitor her INR and had another TIA in March 2016. (Id. ¶¶ 61, 62.) While at the

hospital, Andren wasinformed, for the first time, that her INRatio2 testing kit had been

the subject of a Class 1 recall. (Id. ¶ 63)

Plaintiff Sidney Bludman has suffered from a medical condition that requires

him to regularly take warfarin for 28 years. (Id. ¶ 65.) For approximately 26 years,

Bludman would have his INR tested once a month in a laboratory. (Id. ¶ 66.) For all

26 years, his INR remained fairly consistent and required very infrequent minor

adjustments of his warfarin dosage. (Id.)

Bludman began using an INRatio2 PT/INR testing kit to regularly monitor his

INR at home in 2013 and he was required to purchase boxes of replacement INRatio2

test strips in order to continue with his periodic INR testing and each contained 24

replacement test trips that costs about $120. (Id. ¶¶ 67, 68.) “In using the INRatio

products, Bludman relied on Alere’s representations that the products were accurate,

convenient, effective, reliable, optimal and safe.” (Id. ¶ 69.) Were it not for these

representations, and the omission of material information that INRatio products

produced erroneous results, Bludman would not have purchased or used the INRatio

products. (Id.)

- 5 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 5 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

In February of 2016, his INR, tested on his INRatio2 testing kit, became

exceedingly high and based on the high INR, Bludman reduced his warfarin dosage

which caused him to suffer a TIA on February 10, 2016. (Id. ¶¶ 70, 71.) Upon

returning home from the hospital, Bludman began monitoring his INR with his

INRatio2 testing kit and compared those results with the results of blood tests

conducted by a laboratory at his hospital. (Id. ¶ 72.) He found that his INR, as

indicated by his INRatio2 testing kit, was consistently .4-.6 higher than his INR, as

indicated by the results of the lab tests. (Id.) As a result of his TIA, Bludman is now

at a higher risk for future ischemic attacks. (Id. ¶ 73.) 

Plaintiff alleges four causes of action for violations of California’s Consumers

Legal Remedies Act (“CLRA”), California’s Unfair Competition Law pursuant to

California Business & Professions Code section 17200 et seq. (“UCL”), fraud and

unjust enrichment. (Dkt. No. 1. Compl.) Defendants move to dismiss all four causes

of action based on Plaintiffs’ failure to satisfy the pleading requirements of Federal

Rule of Civil Procedure 9(b) for their allegations of material misrepresentations and

fraudulent omissions. 

A. Defendants’ Request for Judicial Notice

In their opposition, Defendants request judicial notice of numerous documents

arguing that either they are referenced in the Complaint or they are matters of public

record and not subject to reasonable dispute. (Dkt. No. 11-1.) In response, Plaintiffs

object as to Exhibit B, “Alere INRatio2 Self-Test User Guide”, and Exhibit A, “FDA

501(k) Substantial Equivalence Determination Decision Summary” (“501(k)

Summary”). (Dkt. No. 17.) Plaintiffs object because Defendants are not using the

existence of these documents to attack the Complaint on its face but are relying on the

contents of the documents to assert merits-based defenses to Plaintiffs’ allegations. 

They also object because the User Guide is not authenticated. In reply, Defendants

argue that these documents are proper for judicial notice. 

As a general rule, “a district court may not consider any material beyond the

- 6 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 6 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

pleadings in ruling on a Rule 12(b)(6) motion.” Lee v. City of Los Angeles, 250 F.3d

668, 688 (9th Cir. 2001). However, two exceptions exist where a district court may

take consider “material which is properly submitted as part of the complaint” or if the

documents are not attached to the complaint, they may be considered if the documents’

“authenticity . . . is not contested” and “the plaintiff’s complaint necessarily relies” on

them. Id. (citations omitted). In addition, a court may take judicial notice of “matters

of public record” under Federal Rule of Civil Procedure (“Rule”) 201. Id. at 688-89. 

Under Rule 201, a court may not take judicial notice of a fact that is “subject to

reasonable dispute.” Fed. R. Evid. 201(b). If the contents of a matter of public record

are in dispute, the court may take notice of the fact of the document at issue but not of

the disputed information contained within. See Lee, 250 F.3d at 689-90. 

Here, as to Exhibit B, the Complaint does not cite to or rely on the User Guide,

the User Guide is not a matter of public record and Plaintiffs challenge its authenticity. 

Therefore, judicial notice of the User Guide is not proper and the Court DENIES

Defendants’ request for judicial notice as to Exhibit B. Furthermore, as Plaintiffs note

and the Court agrees, Defendants ask the Court to consider documents outside the

complaint and to rule on a factual issue not proper on a motion to dismiss. In their

motion, Defendants seek dismissal of the complaint arguing that the User Guide

provides sufficient disclosures concerning the INRatio products and that they did not

omit material information. While Defendants argue that their disclosures were

sufficient, such a ruling is not proper at the motion to dismiss stage. 

As to Exhibit A, Plaintiffs argue that Defendants improperly cite to the contents

of the 510(k) Summary asserting in their motion that “Patients can obtain these devices

only with a prescription.” (Dkt. No. 11, Ds’ Mot. at 8.) Plaintiffs dispute that Alere

INRatio2 PT/INR can be only be obtained with a prescription and state they allege, in

their complaint, that Andren purchased the product from a pharmacy absent a

prescription. (Dkt. No. 17 at 4.) Contrary to Plaintiffs’ argument, the Complaint does

not allege Andren purchased the INRatio2 PT/INR “absent a prescription.” Despite

- 7 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 7 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

Plaintiffs’ failure to assert that Andren purchased the product without a prescription,

because Plaintiffs dispute their contents, the Court can only take judicial notice of the

fact of the document and not the contents contained in the document. See Lee, 250

F.3d at 689-90. Accordingly, the Court DENIES Defendants’ request for judicial

notice of Exhibits A & B. The Court GRANTS Defendants’ request for judicial notice

of Exhibits C through G as they are matters of public record and are unopposed. 

B. Legal Standard on Federal Rule of Civil Procedure 12(b)(6)

Federal Rule of Civil Procedure (“Rule”) 12(b)(6) permits dismissal for “failure

to state a claim upon which relief can be granted.” Fed. R. Civ. P. 12(b)(6). Dismissal

under Rule 12(b)(6) is appropriate where the complaint lacks a cognizable legal theory

orsufficient facts to support a cognizable legal theory. See Balistreri v. Pacifica Police

Dep’t., 901 F.2d 696, 699 (9th Cir. 1990). Under Rule 8(a)(2), the plaintiff is required

only to set forth a “short and plain statement of the claim showing that the pleader is

entitled to relief,” and “give the defendant fair notice of what the . . . claim is and the

grounds upon which it rests.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555

(2007). 

A complaint may survive a motion to dismiss only if, taking all well-pleaded

factual allegations as true, it contains enough facts to “state a claim to relief that is

plausible on its face.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Twombly,

550 U.S. at 570). “A claim has facial plausibility when the plaintiff pleads factual

content that allows the court to draw the reasonable inference that the defendant is

liable for the misconduct alleged.” Id. “Threadbare recitals of the elements of a cause

of action, supported by mere conclusory statements, do not suffice.” Id. “In sum, for

a complaint to survive a motion to dismiss, the non-conclusory factual content, and

reasonable inferences from that content, must be plausibly suggestive of a claim

entitling the plaintiff to relief.” Moss v. U.S. Secret Serv., 572 F.3d 962, 969 (9th Cir.

2009) (quotations omitted). In reviewing a Rule 12(b)(6) motion, the Court accepts as

true all facts alleged in the complaint, and draws all reasonable inferences in favor of

- 8 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 8 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

the plaintiff. al-Kidd v. Ashcroft, 580 F.3d 949, 956 (9th Cir. 2009). 

Where a motion to dismiss is granted, “leave to amend should be granted ‘unless

the court determines that the allegation of other facts consistent with the challenged

pleading could not possibly cure the deficiency.’” DeSoto v. Yellow Freight Sys., Inc.,

957 F.2d 655, 658 (9th Cir. 1992) (quoting Schreiber Distrib. Co. v. Serv-Well

Furniture Co., 806 F.2d 1393, 1401 (9th Cir. 1986)). In other words, where leave to

amend would be futile, the Court may deny leave to amend. See Desoto, 957 F.2d at

658; Schreiber, 806 F.2d at 1401. 

C. Legal Standard as to Federal Rule of Civil Procedure 9(b)

Where a plaintiff alleges fraud in the complaint, Rule 9(b) requires a plaintiff to

“statewith particularity the circumstances constituting fraud ormistake. Malice, intent,

knowledge, and other conditions of a person’s mind may be alleged generally.” Fed.

R. Civ. P. 9(b). A party must set forth “the time, place, and specific content of the false

representations as well as the identities of the parties to the misrepresentation.” Odom

v. Microsoft Corp., 486 F.3d 541, 553 (9th Cir. 2007) (internal quotation marks

omitted). Rule 9(b) also applies to claims that are “grounded in fraud” or “sound in

fraud.” Vess v. Ciba-Geigy Corp., U.S.A., 317 F.3d 1097, 1103-04 (9th Cir. 2003). 

Asserting that the defendant “‘knowingly and purposefully failed to disclose’” the

alleged defect issubject to Rule 9(b), since that amounts to an allegation of knowledge

of falsity and intent to defraud.” Shin v. BMW of North America, No. CV 09-00395

AHM (AJWx), 2009 WL 2163509, at *4 (C.D. Cal. July 16, 2009).

Defendants argue that the complaint fails to meet the heightened pleading

requirements under Rule 9(b) for failing to allege that they made any affirmative

representations specifically to Plaintiffs, that Plaintiffs relied on any such

misrepresentations or that Alere had any duty to disclose information not already

disclosed by the Alere entities. Plaintiffs do not dispute that the heightened pleading

requirement applies but argue that they have sufficiently alleged particularity as to the

alleged affirmative misrepresentations and omissions. 

- 9 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 9 of 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

Plaintiffs allege four causes of action for violations of the CLRA, the UCL,

fraud, and unjust enrichment. (Dkt. No. 1. Compl.) All causes of action in the

Complaint either allege fraud or sound in fraud where Plaintiffs’ allegations are

premised on a uniform course of fraudulent conduct, (Dkt. No. 1. Compl. ¶¶ 93, 94, 99

(CLRA), ¶¶ 104, 110 (UCL), ¶¶ 113-121 (fraud), and ¶ 125 (unjust enrichment));

therefore, all claims are subject to the heightened pleading standard of Rule 9(b). See

Vess, 317 F.3d at 1103-04 (holding that when a plaintiff “allege[s] a unified course of

fraudulent conduct and rely entirely on that course of conduct as the basis of a claim.

. . the claim is said to be ‘ground in fraud’ or to ‘sound in fraud,’ and the pleading of

that claim as a whole must satisfy the particularity requirement of Rule 9(b).”). The

Ninth Circuit has held that claims of nondisclosure and omissions are subject to the

pleading standard of Rule 9(b). Kearns v. Ford Motor Co., 567 F.3d 1120, 1126-27

(9th Cir. 2009) (applying Rule 9(b) to fraud claims under the CLRA and UCL). 

All four causes of action are premised on material misrepresentations and

fraudulent omissions; therefore, the Court looks at whether Plaintiffs have satisfied

Rule 9(b) in asserting these allegations. 

1. Material Misrepresentations

First, Defendants argue that Plaintiffs failed to allege they ever viewed or relied

on a representation made by them. In responding, Plaintiffs assert that Defendants

made material misrepresentations in their packaging, marketing, advertising and

promotional materials where they claimed the INRatio products were “accurate”

“convenient” “effective” “reliable” “optimal” and “safe” when in fact they were not. 

(Dkt. No. 1, Compl. ¶¶ 21, 24-27.) Plaintiffs also argue that they do not need to prove

reliance as there is a presumption of reliance in a fraudulent omission case or

misrepresentation case.2

Plaintiffs’ citation to cases pleading reliance in federal securities fraud under

2

Rule 10b-5 case are not persuasive. See Binder v. Gillespie, 184 F.3d 1059, 1063-64

(9th Cir. 1999); Affiliated Ute Citizens v. United States, 406 U.S. 128, 153-54 (1972).

In Mirkin, the California Supreme Court rejected the application of the Ute

- 10 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 10 of

 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

A cause of action under UCL requiresthat plaintiff must plead reliance and it can

do so without alleging that those misrepresentation were the “sole or even the decisive

cause of the injury-producing conduct,” In re Tobacco II Cases, 46 Cal. 4th 298, 328

(2009). However, where there are underlying allegations of fraud, where the claim is

“grounded in fraud”, Rule 9(b) applies to California’s consumer protection statutes. 

Kearns, 567 F.3d at 1125. The pleading, as a whole, must comply with Rule 9(b). Id.

In Kearns, the plaintiff, alleged claims under the CLRA and UCL, for

defendants’ misrepresentations and fraud regarding its “certified pre owned” vehicle

program. Id. at 1122. The Ninth Circuit upheld the district court’s dismissal because

the plaintiff failed to specify when he was exposed to the representations and which

sales material he relied on in making his decision to buy the product. Id. at 1126

(concluding that plaintiff did not articulate the “who, what, when, where, and how of

the misconduct alleged”). A party must set forth “the time, place, and specific content

of the false representations as well as the identities of the parties to the

misrepresentation.” Odom v. Microsoft Corp., 486 F.3d 541, 553 (9th Cir. 2007)

(internal quotation marks omitted); Buckley v. Align Tech., Inc., No. 13cv2812-EJD,

2015 WL 5698751, at *3 (N.D. Cal. 2015) (plaintiff failed to identify any false or

misleading statements made to her by Defendant.) 

In addition,“Rule 9(b)’s particularityrequirement can be satisfied by ‘identifying

or attaching representatives samples’ if the alleged misrepresentations occur in printed

form.” Shields v. Alere Home Monitoring, Inc., No. C-15-2580 CRB, 2015 WL

7272672, at *6 (N.D. Cal. Nov. 18, 2015) (citations omitted). However, a plaintiff

must specify what the misrepresentations stated, when he or she was exposed to the

misrepresentation and which ones he or she found material. See Kearns, 567 F.3d at

presumption of reliance, to California law. Mirkin, 5 Cal. 4th 1082, 1093 (1993) (the

“body of law that has developed under Rule 10b-5 is not sufficiently analogous to the

law of fraud to justify its importation into the latter.”). The other district court cases

cited by Plaintiffs are not applicable because those cases do not assert UCL or CLRA

claims grounded in fraud. See Shin v. BMW of North America, No. CV 09-398, 2009

WL 2163509, at *4 (C.D. Cal. July 16, 2009); Delarosa v. Boiron, Inc., 275 F.R.D. 582,

586 (C.D. Cal. 2011). 

- 11 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 11 of

 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

1125-26. 

The Complaint alleges that when Andren and Bludman purchased the INRatio2

PT/INR testing kits, they “relied on Alere’s representations that the products were

accurate, convenient, effective, reliable, optimal and safe.” (Id. ¶¶ 56, 69.) These are

merely general allegations that do not allege where Plaintiffs saw or heard the

representations, such as through Defendants’ marketing, advertising, promotional or

packaging materials, and when they saw those representations. In addition, Plaintiffs,

in the Complaint, insert a copy of a web page for the Alere INRatio2 PT/INR

Monitoring System, (Dkt. No. 1, Compl. ¶ 25), concerning the alleged

misrepresentations; however, again, Andren and Bludman do not allege that they ever

saw or relied on this web page. Therefore, Plaintiffs cannot link their injuries to those

alleged misrepresentations. The Complaint makes numerous allegations as to the

alleged material misrepresentations in Defendants’ marketing, advertising,

promotional, and packaging materials but do not specifically allege when and where 3

Andren and Bludman saw the misrepresentations. Accordingly, the Court GRANTS

Defendants’ motion to dismiss all claims under Rule 9(b) premised on material

misrepresentations. 

2. Fraudulent Omissions

Next, Defendants argue that Plaintiffs have not alleged a duty to disclose the

alleged fraudulently omitted facts. Plaintiffs contend that they have sufficiently alleged

a duty to disclose. 

“In order to state a claim of fraudulent omissions under the UCL/FAL, CLRA,

or as a claim of common law fraud, a plaintiff must allege facts either showing that the

alleged omissions are ‘contrary to a representation actually made by the defendant, or

showing an omission of a fact the defendant was obliged to disclose.’” Davidson v.

The Complaint alleges misrepresentations were also made on the packaging. 3

(Dkt. No. 1, Compl, ¶¶ 21, 24, 108, 119.) In their opposition, Plaintiffs discuss the

package insert, the “User Guide”, and state “as a matter of law, any disclosures made

to Plaintiffs after they purchased the INRatio Products are irrelevant.” (Dkt. No. 16 at

17.) It is not clear whether Plaintiffs are alleging reliance on the packaging or not. 

- 12 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 12 of

 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

Kimberly-Clark Corp., 76 F. Supp. 3d 964, 972 (N.D. Cal. 2014) (quoting Daugherty

v. Am. Honda Motor Co., Inc., 144 Cal. App. 4th 824, 835 (2006)). 

“The required elements for fraudulent concealment are (1) concealment or

suppression of a material fact; (2) by a defendant with a duty to disclose the fact to the

plaintiff; (3) the defendant intended to defraud the plaintiff by intentionally concealing

or suppressing the fact; (4) the plaintiff was unaware of the fact and would not have

acted as he or she did if he or she had known of the concealed or suppressed fact; and

(5) plaintiffsustained damage as a result ofthe concealment orsuppression ofthe fact.” 

Graham v. Bank of America, N.A., 226 Cal. App. 4th 594, 606 (2014) (citation

omitted). 

The parties argue that there are four circumstances in which an obligation to

disclose may arise “(1) when the defendant is in a fiduciary relationship with the

plaintiff; (2) when the defendant had exclusive knowledge of material facts not known

to the plaintiff; (3) when the defendant actively conceals a material fact from the

plaintiff; and (4) when the defendant makes partial representations but also suppresses

some material facts.” LiMandri v. Judkins, 52 Cal. App. 4th 326, 336 (1997). The

same duty to disclose also applies to UCL and CLRA causes of action. Baba v.

Hewlett–Packard Co., No. C 09–05946 RS, 2010 WL 2486353, at *7 (N.D. Cal. June

16, 2010).

Defendants argue that Plaintiffs have not alleged a duty to disclose. According

4

to Plaintiffs, the Complaint alleges a duty based on Defendants’ exclusive knowledge

of material facts, that INRatio products produced false and erroneous results, not

known to them and that Defendants actively concealed material facts from Plaintiffs. 

(Dkt. No. 1, Compl. ¶¶ 26-41.) 

A defendant has exclusive knowledge giving rise to a duty to disclose when

Defendants also argue that they did not fail to disclose the discrepant results of 4

the INRatio products because the User Guide disclosed such information. Since the

Court denied Defendants’ request for judicial notice of the User Guide, Defendants’

argument based on the User Guide is without merit. 

- 13 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 13 of

 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

“according to the complaint, [defendant] knew of this defect while plaintiffs did not,

and, given the nature of the defect, it was difficult to discover.” Collins v. eMachines,

Inc., 202 Cal. App. 4th 249, 256 (2011); Falk v. General Motors Corp., 496 F. Supp.

2d 1088, 1096 (N.D. Cal. 2007) (a duty to disclose exists “when the defendant [s] had

exclusive knowledge of material facts not known to plaintiff[s].”). “[G]eneralized

allegations with respect to exclusive knowledge” are insufficient to defeat a dismissal

motion. Hovsepian v. Apple, Inc., No. 08–5788 JF (PVT), 2009 WL 5069144, at *3

(N.D. Cal. Dec. 17, 2009). 

Here, Plaintiff alleges that Defendants had exclusive knowledge ofmaterial facts

and cites to paragraphs 26-37 of the Complaint. (Dkt. No. 16 at 15.) These paragraphs

do not support the allegation that Defendants had exclusive knowledge. For example,

the Complaintreferences a publication in 2007 where a study conducted testing on INR

testing devices, and the INRatio products performed the worst, with results that

deviated most significantly from the results obtained through an outside laboratory. 

(Dkt. No. 1, Compl. ¶ 27 & n. 4.) In addition, the Complaint references and attaches

an FDA warning letter of 2005 posted on its website noting the discrepant values.

(Dkt. No. 1, Compl. ¶ 30; Dkt. No. 1-2, Ex. A to Compl.) The Complaint also

references and attaches recall letters dated April 16, 2014 and December 5, 2014 that

were sent to consumers and healthcare professionals concerning the different test

results between INRatio products and INR tested in a laboratory. (Dkt. No. 1-4, Ex.

C to Compl; Dkt. No. 1-5, Ex. D to Compl.) These allegations demonstrate that the

material facts were not within the exclusive knowledge of Defendants but available to

the public. Plaintiffs’ own allegations refute their claimthat Defendants had “exclusive

knowledge of a material fact.” See Wolph v. Acer Am. Corp., No. C 09–01314 JSW,

2009 WL 2969467, at *4 (N.D. Cal. Sept. 14, 2009) (“[b]ased on Plaintiff[‘s] own

allegations, Plaintiff [has] not alleged facts that show [Defendants] had exclusive

knowledge of the [omitted] material facts and that Plaintiff[ ] could not have

reasonably discovered such facts.”); Stickrath v. Globalstar, Inc., No. C07–1941 THE,

- 14 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 14 of

 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

2008 WL 344209, at *4 (N.D. Cal. Feb. 6, 2008) (allegation in complaint do not appear

to support an allegation of exclusivity since Plaintiffs allege disclosure by Defendant

“in public filings” and in “an application with the FCC”). Therefore, Plaintiffs fails to

assert a duty to disclose based on exclusive knowledge of a material fact. 

In addition, as to Plaintiffs’ allegation that Defendants actively concealed

material facts from them, Plaintiff must allege specific “affirmative acts on the part of

the [D]efendants in hiding, concealing or covering up the matters complained of.”

Herron v. Best Buy Co. Inc., 924 F. Supp. 2d 1161, 1176 (E.D. Cal. 2013) (quoting

Lingsch v. Savage, 213 Cal. App. 2d 729 734 (1963)). As with exclusive knowledge,

“generalized allegations with respect to . . . active concealment” will not do. Id.

(citing Hovsepian v. Apple, Inc., No. 08-5788 JF (PVT), 2009 WL 5069144, at *3

(N.D. Cal. Dec. 17, 2009). 

Here, Plaintiffs make general conclusory allegations of active concealment,(Dkt.

No. 1, Compl. ¶¶ 50, 120), without specific facts that Defendants actively tried to

conceal the discrepant results; therefore, Plaintiffs have failed to assert a duty to

disclose based on active concealment. See Herron, 924 F. Supp. 2d at 1176 (granting

motion to dismiss on active concealment allegation based on general assertion that

defendants “actively concealed material facts from Plaintiff and the Class.”) 

Because Plaintiffs have failed to assert a duty to disclose, the Court GRANTS

Defendants’ motion to dismiss under Rule 9(b) all causes of action premised on

fraudulent omission.

D. Unjust Enrichment

Unjust enrichment is not a cause of action but a “principle underlying various

doctrines and remedies, including quasi-contract.” Jogani v. Superior Court, 165 Cal.

App. 4th 901, 911 (2008). A claim for unjust enrichment cannot stand alone as an

independent claim for relief. See Oestreicher v. Alienware Corp., 544 F. Supp. 2d 964,

975 (N.D. Cal. 2008) (“since plaintiff's fraud-based claims have been dismissed,

plaintiff has no basis for its unjust enrichment claim.”); Sanders v. Apple Inc., 672 F.

- 15 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 15 of

 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

Supp. 2d 978, 989 (N.D. Cal. 2009) (“[unjust enrichment] claim will depend upon the

viability of the Plaintiffs’ other claims.”).

In this case, since Plaintiffs have failed to allege a cause of action for relief, the

unjust enrichment claim also must be dismissed. 

E. Learned Intermediary Doctrine

In their moving papers, in describing that medical devices are not typical

consumer products, Defendants raise the learned intermediary doctrine asserting that

a manufacturer’s duty to warn runs to the physician and not the patient but does not

explain which cause of action is deficient based on this doctrine. In opposition,

Plaintiffs notes the deficiency in Defendants’ argument and further argue that if the

learned intermediary doctrine applied, it is a fact-based defense to be determined at

summary judgment or at trial and they also argue that the doctrine does not apply

because INRatio products are not exclusively prescription devices and can be bought

without a prescription. 

California applies the “learned intermediary” doctrine which provides that the

duty to warn in the case of medical devices runs to the physician, not the patient. 

Plenger v. Alza Corp., 11 Cal. App. 4th 349, 362 (1992) (prescription implanted

medical device case);see also Carlin v. Superior Court, 13 Cal. 4th 1104, 1116 (1996). 

A manufacturer fulfills its duty to warn if it provides adequate warnings to the

physician. Plenger, 11 Cal. App. 4th at 362 n. 6 (citing cases); see also Brown v. 

Superior Court, 44 Cal.3d 1049, 1062 n. 9 (1998). In order to prove causation, a

plaintiff must allege that the inadequate warning or lack of warning about the medical

device risk would have altered the prescribing physician’s decision to use the product. 

Motus v. Pfizer, Inc., 196 F. Supp. 2d 984, 991 (C.D. Cal. 2001); Motus v. Pfizer Inc.,

358 F.3d 659, 661 (9th Cir. 2004) (“[A] product defect claim based on insufficient

warnings cannot survive summary judgment if stronger warnings would not have

altered the conduct of the prescribing physician.”). Plaintiffs must also show that the

failure to warn caused their injuries. Motus, 196 F. Supp. 2 at 991. 

- 16 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 16 of

 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

One district court has held that the learned intermediary doctrine applies to state

consumer protections laws, such as the CLRA and UCL, but only if the claims are

predicated on a failure to warn. Saavedra v. Eli Lilly and Co., No. 12cv9366-SVWMAN, 2013WL 3148923, at *3-4 (C.D. Cal. June 13, 2013). As one district court in

Texas noted, 

The gravamen of all of Plaintiffs’ causes of action, including

misrepresentation and violation of [Texas's Deceptive Trade Practices

Act, “DTPA”], is that [the defendant drug manufacturer] failed to

adequately warn of or disclose the severity of Norplant's side effects.

Therefore, the learned intermediary doctrine applies to all of Plaintiffs'

causes of action. Additionally, whether the failure to warn is couched

as an affirmative misrepresentation or a misrepresentation by

concealment, the allegation collapses into a charge that the drug

manufacturer failed to warn. If the doctrine could be avoided by

casting what is essentially a failure to warn claim under a different

cause of action such as violation of the DTPA or a claim for

misrepresentation, then the doctrine would be rendered meaningless.

In re Norplant Contraceptive Prods. Liability Litigation, 955 F. Supp. 700, 709 (E.D.

Tex. 1997). 

Here, the Complaint does not assert a failure to warn cause of action; however,

it appears that the misrepresentations and omissions claims are based on a failure to

warn of the INRatio products’ discrepant results. Plaintiffs argue, but do not allege in

the complaint, that Andren purchased the INRatio2 testing kit at a pharmacy and

therefore, the doctrine does not apply. Given that Plaintiffs are granted leave to amend,

they should clarify whether the INRatio2 was prescribed by Andren’s doctor or not. 

If INRatio2 was prescribed by a physician, then the doctrine applies to their case and

5

if so, Plaintiffs must properly allege a failure to warn Plaintiffs’ prescribing physician

in an amended complaint. See Tapia v. Davol, Inc., 116 F. Supp. 3d 1149, 1159 (S.D.

Cal. 2015) (granting motion to dismiss failure to warn cause of action because the

plaintiff failed to allege that the defendants failed to warn his prescribing physician but

only alleged “physician” in general); see Buckely v. Align Tech, Inc., No. 13cv2812-

Nonetheless, it would appear that the learned intermediarydoctrine would apply

5

as to Plaintiff Bludman because Plaintiffs do not argue that he purchased his INRatio2

PT/INR testing kit at a pharmacy.

- 17 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 17 of

 18
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

EJD, 2015 WL 5698751, at *4 (N.D. Cal. Sept. 29, 2015) (to the extent the plaintiff

alleges a failure to warn, those claims fail due to the failure to allege that her dentist

was misled by the defendant). 

F. Leave to Amend

Leave to amend, whether or not requested by the plaintiff, should be granted

unless amendment would be futile. Schreiber Distrib. Co., 806 F.2d at 1401. While

Plaintiffs do not seek leave to amend, the Court concludes that it would not be futile

to allow leave to amend and GRANTS Plaintiffs’ leave to amend their complaint. See

id. 

Conclusion

Based on the above, the Court GRANTS Defendants’ motion to dismiss with

leave to amend. If Plaintiffs seek to amend the complaint, they shall file an amended

complaint within 20 days of the filing date of this order. If Plaintiffs do not seek to file

an amended complaint, they shall file a notice of voluntary dismissal within 20 days

of the filing date of this order. The hearing date set for September 16, 2016 shall be

vacated. 

IT IS SO ORDERED.

DATED: September 13, 2016

HON. GONZALO P. CURIEL

United States District Judge

- 18 - [16cv1255-GPC(NLS)]

Case 3:16-cv-01255-GPC-AGS Document 19 Filed 09/13/16 PageID.<pageID> Page 18 of

 18