Martin et al v. Medtronic Incorporated et al

Filing 38

ORDER: Defendants' Rule 12(b)(6) motion to dismiss 28 is granted in part and denied in part. Defendants' motion to strike 27 is denied as moot. The court sua sponte dismisses plaintiffs' first amended complaint in its entirety . Plaintiffs are given leave to amend only as to Debra's fraud claims that are based on defendants' off-label promotion and as to Patricks loss of consortium claim. Plaintiffs' second amended complaint, should they elect to file one, shall be filed on or before December 15, 2014. Signed by Judge H Russel Holland on 11/21/2014. (See Order for details)(ALS)

WO

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA

DEBRA and PATRICK MARTIN,

)
)
Plaintiffs,
)
)
vs.
)
)
MEDTRONIC, INC., and MEDTRONIC
)
SOFAMOR DANEK USA, INC.,
)
)
Defendants.
)
__________________________________________)

No. 2:14-cv-0385-HRH

ORDER
Motion to Strike;
Motion to Dismiss
Defendants move to dismiss1 plaintiffs’ first amended complaint. This motion is
opposed.2 In the alternative, defendants move to strike portions of plaintiffs’ first amended
complaint.3 The motion to strike is opposed.4 Oral argument was requested and has been
heard on both motions.

1

Docket No. 28.

2

Docket No. 29.

3

Docket No. 27.

4

Docket No. 30.
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Background
Plaintiffs are Debra and Patrick Martin. Defendants are Medtronic, Inc. and
Medtronic Sofamor Danek USA, Inc.
Defendants manufacture and sell a Class III medical devise known as Infuse® Bone
Graft/LT-Cage Lumbar Tapered Fusion Device. The “Infuse® product consists of (1) a
metallic spinal fusion cage (the LT-Cage™); (2) Infuse® Bone Graft kit which comes with
a vial of liquid rhBMP-2 and absorbable collagen sponges (ACS), which serve as carriers
for the rhBMP-2 when the two are placed inside the LT-Cage.”5 The Infuse® device went
through the FDA’s Premarket Approval process and was approved for use on July 2, 2002,
for anterior lumbar interbody (ALIF) spinal fusion surgeries.6
“On or about July 14, 2010, the [p]laintiff Debra Martin underwent a posterolateral
lumbar fusion at L4-5 and L5-1. To achieve fusion, [Debra’s] surgeon, Dr. Yadship Pannu,
performed an unapproved procedure by utilizing a posterolateral approach and by
packing Atlas vertebral cages with Infuse® Bone Graft and placing the cages into multiple
levels of [Debra’s] spine.”7 Plaintiffs allege that “the Atlas vertebral cage was not designed

5

First Amended Complaint for Damages at 44, ¶ 197, Docket No. 26.

6

Id. at 44, ¶ 196 & 45, ¶ 200.

7

Id. at 8, ¶ 23.
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for use with a biologic, like rhBMP-2 [,]” but that Dr. Pannu “was induced by Medtronic’s
misrepresentations to perform this procedure[.]8 Plaintiffs allege that
a. [defendants] fraudulently concealed and misrepresented the
health and safety hazards, symptoms, constellation of symptoms, diseases and/or health problems associated with the
unapproved uses of Infuse®;
b. [defendants] fraudulently concealed and misrepresented
their practice of promoting and marketing to physicians,
including Plaintiff’s physicians, the practice of using Infuse®
without an LT-Cage™ and/or the practice of using unapproved
cages instead, like the cage used in [Debra’s] surgery, and
placing it via a posterolateral approach; [and]
c. [defendants] fraudulently concealed and misrepresented
information about the known comparative risks and benefits
of the use of Infuse® and the relative benefits and availability
of alternate products, treatments and/or therapies.9
More specifically, plaintiffs allege that
a. Dr. Pannu completed his residency at Loyola University in
Baltimore, Maryland from 1997 through 2003, when Infuse®
Bone Graft was just being introduced to physicians. At that
time, Loyola was what Dr. Pannu termed a “Medtronic
facility,” meaning that the hospital received various educational grants from Medtronic.
b. Dr. Pannu’s professors at Loyola first taught him how to use
Infuse® Bone Graft. Dr. Pannu was told that Infuse® was safer
and more effective than ICBG or donor bone (allograft). It was

8

Id. at ¶¶ 27-28.

9

Id. at 125-126, ¶ 550.
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at this time that Dr. Pannu said he learned about the safety and
efficacy profile of Infuse.
c. In addition to his training that he received from Loyola, Dr.
Pannu relied heavily upon the medical literature that he read
on Infuse® Bone Graft. Specifically, Dr. Pannu recalls reading
a number of articles through the “journal club” he was a part
of, where he and other physicians read and reviewed articles
on Infuse® Bone Graft, none of which disclosed any adverse
events. Dr. Pannu recalled reading the 2004 article by Dr.
Haid,[10] wherein the results of the 1999 PLIF study ... were
published in a distorted, false, and misleading manner.
d. Dr. Pannu relied upon this and other articles to ascertain
how safe Infuse® Bone Graft was for his patients like Debra
Martin.
e. After completing his residency, Dr. Pannu began working at
Midwest Neurosciences in 2003, where he continues to work
today. While there, Dr. Pannu continued to educate himself on
Infuse®. Specifically, Dr. Pannu relied upon information he
received from his colleagues, particularly Dr. Arvind Ahuja.
Dr. Ahuja, according to a published article in The Milwaukee
Journal Sentinel,[11] similarly relied upon the medical literature
on Infuse® Bone Graft to ascertain the safety and efficacy
profile of the product and was likewise misled by the false
statements contained therein.

10

Plaintiffs allege that Dr. Haid “was a co-author of one of the principal studies
published on Infuse®” and that he failed to report “the true findings of” the 1999 PLIF
study, the results of which were “disastrous”, reporting instead that the use of Infuse® in
a posterior lumbar interbody fusion (PLIF) were “encouraging.” Id. at 94-95, ¶ 396.
Plaintiffs allege that Haid was defendants’ agent and that in his article he “downplayed
the bone overgrowth complications, claiming that while bony overgrowth showed up on
CT scans, patients did not suffer ill effects.” Id. at 55, ¶¶ 245-246.
11

Plaintiffs have attached this article to their complaint as Exhibit 7.
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f. Dr. Pannu’s Medtronic sales representative was Kris
Boetcher. Mr. Boetcher was frequently in the operating room
with Dr. Pannu, and during these procedures, he would assist
Dr. Pannu and his nurses with the appropriate doses for
unapproved procedures, such as Debra Martin’s. Dr. Pannu
believed that the unapproved procedures he was performing
were safe, because Mr. Boetcher was helping to ensure patients
received a proper dose of rhBMP-2.
g. Ultimately, Dr. Pannu decided to use Infuse® on Debra
Martin, because he believed that it was safer and more effective
than ICBG, based upon the misrepresentations outlined
herein.[12]
Plaintiffs allege that “on or around August 2013, [Debra] was diagnosed with bony
overgrowth at L5-S1. A CT-scan also revealed the formation of a cyst near the cage, which
had become displaced. As a result, [Debra] has required extensive medical treatment.”13
Plaintiffs further allege that Debra “continues to suffer daily, disabling pain that prevents
her from performing many basic activities of daily living.”14 In short, plaintiffs allege that
defendants’ misrepresentations led to Dr. Pannu’s off-label use of the Infuse® device,
which led to bony overgrowth in Debra’s spine, which has caused her debilitating pain.
On February 27, 2014, plaintiffs commenced this action. In their original complaint,
Debra asserted seven state law causes of action against defendants:

1) fraudulent

12

First Amended Complaint for Damages at 126-127, ¶ 551, Docket No. 26.

13

Id. at 9, ¶ 29.

14

Id. at ¶ 30.
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misrepresentation/fraud in the inducement, 2) strict products liability - failure to warn, 3)
strict products liability - design defect, 4) strict products liability - misrepresentation, 5)
product liability - negligence, 6) breach of express warranty, and 7) violation of Arizona’s
Consumer Protection statutes.

Debra’s claims were based on her contention that

defendants “should not have violated federal law by falsely and misleadingly promoting
and marketing new designs and uses for a product that were never considered or approved
by the FDA.”15 Patrick asserted a loss of consortium claim.
Defendants moved to dismiss plaintiffs’ original complaint, and on July 23, 2014, the
court granted that motion and all of plaintiff’s claims were dismissed.16 The majority of
Debra’s claims were dismissed because they were preempted by the Medical Device
Amendments of 1976. “A state law claim will be expressly preempted ... when 1) there are
federal requirements applicable to the medical device and 2) the state law claim seeks to
impose requirements that relate to safety and effectiveness of the device that are ‘different
from, or in addition to’ those federal requirements.” Hawkins v. Medtronic, Inc., Case No.
1:13–CV–00499 AWI SKO, 2014 WL 346622, at *3 (E.D. Cal. Jan. 30, 2014) (quoting Riegel
v. Medtronic, Inc., 552 U.S. 312, 321-22 (2008)). “A state law claim will be impliedly
preempted when it is not based on a violation of state law tort duties.” Id. at *4. The court

15

Memorandum in Opposition to Defendants’ Motion to Dismiss at 3, Docket No.
15 (emphasis omitted).
16

Order re Motion to Dismiss at 37, Docket No. 25.
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held that the following claims were preempted: 1) Debra’s fraud claims based on
allegations that defendants made misrepresentations and omissions in the labeling of the
Infuse device; 2) Debra’s product liability failure to warn claim based on defendants’ offlabel promotion, 3) Debra’s design defect claim, 4) Debra’s negligence claim based on a
failure to provide warnings on the labeling of the Infuse Device, 5) Debra’s negligence
claim based on the design and manufacture of the Infuse Device, and 6) Debra’s negligence
claim based on defendant’s off-label promotion of the Infuse Device.17 Debra’s remaining
fraud claims (those based on defendants’ off-label promotion) were dismissed because they
had not been pled with the required particularity.18 Debra’s breach of express warranty
claim and her products liability and negligence claims based on a failure to report adverse
events to the FDA were dismissed because she had failed to state plausible claims.19
Patrick’s loss of consortium claim was dismissed because all of Debra’s claims were
dismissed.20 Plaintiffs were given leave to amend
1) Debra’s fraud claims based on defendants’ misrepresentations in off-label promotion, 2) Debra’s failure to warn claim
based on a failure to report adverse events to the FDA, 3)
Debra’s negligence claim based on a failure to report adverse

17

Id. at 20, 25, 31, & 32-33.

18

Id. at 29.

19

Id. at 29, 34 & 36.

20

Id. at 36.
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events to the FDA, 4) Debra’s breach of express warranty
claim, and 5) Patrick’s loss of consortium claim.[21]
On August 13, 2014, plaintiffs filed their first amended complaint. In the amended
complaint, Debra again asserts seven state law causes of action: 1) fraudulent misrepresentation/fraud in the inducement, 2) strict products liability - failure to warn, 3) strict
products liability - design defect, 4) strict products liability - misrepresentation, 5) product
liability - negligence, 6) breach of express warranty, and 7) violation of Arizona’s Consumer
Protection statutes. Patrick again asserts a claim for loss of consortium. Plaintiffs also
appear to be asserting a claim for punitive damages.
Pursuant to Rules 9(b) and 12(b)(6), Federal Rules of Civil Procedure, defendants
now move to dismiss plaintiffs’ amended complaint. Should the court not dismiss all of
plaintiffs’ claims, defendants move to strike certain portions of plaintiffs’ amended
complaint.
Discussion
“Rule 12(b)(6) authorizes courts to dismiss a complaint for ‘failure to state a claim
upon which relief can be granted.’” In re Rigel Pharmaceuticals, Inc. Securities Litig., 697
F.3d 869, 875 (9th Cir. 2012) (quoting Fed. R. Civ. P. 12(b)(6)). “To avoid dismissal, the
complaint must provide ‘more than labels and conclusions, and a formulaic recitation of
the elements of a cause of action will not do.’” Id. (quoting Bell Atl. Corp. v. Twombly, 550
21

Id. at 37.
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U.S. 544, 555 (2007)). “‘[A] plaintiff must ‘allege sufficient factual matter ... to state a claim
to relief that is plausible on its face.’” OSU Student Alliance v. Ray, 699 F.3d 1053, 1061 (9th
Cir. 2012) (quoting Pinnacle Armor, Inc. v. United States, 648 F.3d 708, 721 (9th Cir. 2011)).
“In evaluating a Rule 12(b)(6) motion, the court accepts the complaint’s well-pleaded
factual allegations as true and draws all reasonable inferences in the light most favorable
to the plaintiff.” Adams v. U.S. Forest Srvc., 671 F.3d 1138, 1142-43 (9th Cir. 2012). “Rule
9(b) provides that ‘[i]n alleging fraud or mistake, a party must state with particularity the
circumstances constituting fraud or mistake.’” United States ex rel. Cafasso v. General
Dynamics C4 Systems, Inc., 637 F.3d 1047, 1054-55 (9th Cir. 2011) (quoting Fed. R. Civ. P.
9(b)). “To satisfy Rule 9(b), a pleading must identify ‘the who, what, when, where, and
how of the misconduct charged,’” as well as “‘what is false or misleading about [the
purportedly fraudulent] statement, and why it is false.’” Id. at 1055 (quoting Ebeid ex rel.
United States v. Lungwitz, 616 F.3d 993, 998 (9th Cir. 2010)).
Defendants first move to dismiss the claims that this court found were preempted
but which Debra has again asserted in the amended complaint. Although they were not
given leave to amend as to these claims, plaintiffs have repleaded 1) Debra’s fraud claims
in Counts 1, 4, and 7 which are based on allegations that defendants made misrepresentations and omissions in the labeling of the Infuse device; 2) Debra’s strict products liability
claim in Count 2 that is based on the off-label promotion of the Infuse device; 3) Debra’s

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strict products liability - design defect claim in Count 3; and 4) Debra’s negligence claims
in Count 5 which were based on allegations that defendants failed to provide warnings on
the labeling of the Infuse device, were negligent during the manufacture or design of the
Infuse device, and were negligent in promoting the Infuse device for off-label use.
Plaintiffs noted that they were repleading these claims for purposes of an appeal, but there
was no reason to do so. See Lacey v. Maricopa County, 693 F.3d 896, 928 (9th Cir. 2012)
(“For claims dismissed with prejudice and without leave to amend, [the court] will not
require that they be repleaded in a subsequent amended complaint to preserve them for
appeal”). These claims are again dismissed and to the extent it was not clear in the court’s
order on defendants’ first motion to dismiss, these claims are dismissed with prejudice.
Defendants next argue that Debra’s strict products liability failure to warn claim
(Count 2) and negligence claim (Count 5) which are based on allegations that defendants
failed to warn the FDA about adverse events should be dismissed. Defendants argue that
plaintiffs have again failed to allege how the failure to warn the FDA about adverse events
caused or contributed to their damages or injuries. “Manufacturers are required by the
FDCA to report to the FDA adverse events where an approved device may have caused
or contributed to a death or serious injury, or where a recurring malfunction would likely
cause or contribute to a death or serious injury.” Hawkins, 2014 WL 346622, at *8. In order

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for an adverse events claim to be plausible, there must be “a causal connection between
[plaintiffs’] injuries and the alleged failure to report....” Id. at *8.
Plaintiffs allege that “Medtronic ... failed to report adverse events to the FDA” and
thus Debra’s “surgeon was unable to access this information via the FDA’s adverse event
database.”22 Plaintiffs allege that the adverse
reports would have been available to [Debra’s] surgeon via the
FDA’s online database, and they would have been available to
researchers publishing independent studies on the safety and
efficacy of Infuse®. Because Medtronic negligently failed to
adequately report adverse events to the FDA, [p]laintiff’s
surgeon relied upon false and misleading information when he
decided to use Infuse® in an unapproved procedure on Debra
Martin.[23]
Plaintiffs also allege that Dr. Pannu “relied on the Medtronic Defendants’ inadequate
warnings in deciding to use Infuse® in an off-label manner. Plaintiff and Plaintiff’s
physician would not have used Infuse® off-label without an LT-Cage™ and with an Atlas
vertebral cage via a posterolateral approach, had they known of the true safety risks related
to Infuse®.”24 Plaintiffs further allege that “researchers who conducted independent
studies and who relied upon adverse event data submitted to the FDA to determine the
safety profile of Infuse® could not gain access to this information” and thus “even those

22

First Amended Complaint for Damages at 130, ¶¶ 575-76, Docket No. 26.

23

Id. at 137, ¶ 622.

24

Id. at 131, ¶ 581.
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attempting to conduct or read non-industry sponsored information concerning the safety
of Infuse® were unable to do so.”25 Plaintiffs argue that these allegations are sufficient to
state a plausible claim. Plaintiffs insist that their allegations suggest that if defendants had
properly reported adverse events, that information would have reached Dr. Pannu before
he did Debra’s surgery in 2010.
Plaintiffs’ allegations are insufficient to state a plausible claim. Plaintiffs still have
not alleged how defendants’ alleged failure to warn the FDA about adverse events
contributed to their injuries. What is missing from Debra’s adverse events claims is any
connection between defendants’ alleged failure to report adverse events and her surgery.
Plaintiffs also have not alleged any factual support for these claims, such as any details (the
date, nature of injuries, or method of implant) about any adverse events that should have
been reported. Without such factual detail, it is not possible to tell if timely reporting
would have affected the off-label use of the Infuse device during Debra’s surgery. Debra’s
adverse events claims in Count 2 and Count 5 are dismissed. These claims are dismissed
with prejudice. Plaintiffs are not given leave to amend because they have already had one
opportunity to amend these claims and they still failed to state a plausible claim. See
Cafasso, 637 F.3d at 1058 (quoting Ascon Props., Inc. v. Mobil Oil Co., 866 F.2d 1149, 1160

25

Id. at 130, ¶¶ 577-578.
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(9th Cir. 1989)) (“‘[t]he district court’s discretion to deny leave to amend is particularly
broad where plaintiff has previously amended the complaint’”).
Defendants next argue that plaintiffs have again failed to plead Debra’s off-label
promotion fraud claims with the required particularity. Defendants argue that plaintiffs
still have not pled with particularity any false promises or misrepresentations allegedly
made by defendants to Debra or her physician. Although plaintiffs have alleged that “Dr.
Pannu relied heavily upon the medical literature that he read on Infuse® Bone Graft ...
none of which disclosed any adverse events[,]”26 defendants argue that plaintiffs have not
identified any of these articles by title, date, or author, much less identified any misrepresentations that were contained in these articles. Defendants argue that plaintiffs’ fraud
claims suffer from the same problems that the Minnesota state court has found in the Infuse
cases before it. In Anderson v. Medtronic, the court explained that the plaintiffs alleged
that their doctors “relied on the available medical literature on Infuse®, which specifically
portrayed the off-label use of Infuse® ... as a safe and effective use of the product.”27 “None
of these allegations specifies which articles the individual treating physicians allegedly read
or relied upon in making their treating decisions. None of these allegations specifies any
authors, journals, or date ranges for the articles allegedly read. None of these allegations

26

Id. at 126, ¶ 551c.

27

Anderson v. Medtronic, slip. op. at 5, Exhibit A, Notice of Supplemental Authority
[etc.], Docket No. 33.
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specifies which statements in the articles read by the treating physicians are claimed to be
misstatements.”28 Defendants insist that the same is true here, that plaintiffs have failed to
allege any specifics about any of the medical literature that Dr. Pannu allegedly read.
As plaintiffs are quick to point out, however, they have alleged that Dr. Pannu read
a particular article (the Haid article) that addressed using the Infuse device off-label and
that Dr. Pannu relied on the medical literature he was reading in deciding whether to use
the Infuse device off-label. They have alleged which particular statements in the Haid
article were false and they have alleged why they were false.29 As for defendants’
contention that plaintiffs have not adequately alleged that Haid was defendants’ agent,
plaintiffs support their conclusory allegation that Haid was defendants’ agent with an
allegation that “[b]etween 1996 and 2010, Dr. Haid received $25,549,813.96 in royalties and
consulting fees from Medtronic. Of that amount, Dr. Haid received $2,484,450.94 in 2004.”30
These allegations are sufficiently particular. In connection with the Haid article, Debra has
alleged the who, what, when, where, and how.
Plaintiffs’ other allegations as to how Dr. Pannu was impacted by defendants’ offlabel promotion are not, however, sufficiently particular. Plaintiffs argue that they have

28

Id. at 5-6.

29

First Amended Complaint for Damages at 55-56, ¶¶ 246-250, Docket No. 26.

30

Id. at 95, ¶ 400.
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also alleged that the medical literature influenced Dr. Pannu indirectly, as Dr. Pannu
discussed the safety and efficacy of the Infuse device with Dr. Ahuja.31 But, it is not
sufficient for plaintiffs to allege that Dr. Ahuja read some unidentified “medical literature”
and then shared this information with Dr. Pannu.

Similarly, plaintiffs’ allegations

regarding Dr. Pannu’s training lack particularity because plaintiffs have not alleged that
anyone at Loyola had the authority to speak on defendants’ behalf nor have they alleged
what specific misrepresentations were made by any of the professors or hospital staff.
Plaintiffs’ allegations that Dr. Pannu relied on misrepresentations from his Medtronic sales
rep, Kris Boetcher, come closer but still lack particularity because plaintiffs do not allege
any specific misrepresentations that Boetcher made regarding Debra’s off-label procedure
or explain how any alleged misrepresentation made by Boetcher specifically caused
plaintiffs’ injuries.
Plaintiffs also make a general argument that their amended complaint is replete with
allegations that the representations that defendants made that the Infuse device was safe
for off-label use were false32 and that defendants made these representations in order to

31

Id. at 126, ¶ 551e.

32

Id. at 17, ¶ 79 (“Defendants continued to represent that Infuse® Bone Graft was/is
safer, more effective and the best alternative for spinal fusion, all the while knowing that
this was absolutely false, even after the United States Senate report and the YODA study
were released”); 55, ¶ 245 (alleging that the Haid article “inaccurately maintained that”
patients in the 1999 PILF study “were not harmed by Infuse® Bone Graft”; 64-67, ¶¶ 282(continued...)
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induce physicians, such as Dr. Pannu, to use the Infuse device off-label.33 Plaintiffs insist
that these allegations support their contention that Dr. Pannu would not have used the
Infuse device for Debra’s surgery had he known about the significant risk of complications
associated with doing so.
But these allegations are not tied specifically to Dr. Pannu or to Debra. Rather, these
allegations suggest that what plaintiffs are attempting to do here is advance a “fraud-on-

32

(...continued)
290 (allegations related to the June 2011 issue of The Spine Journal which was “a special
edition dedicated to addressing serious patient safety and ethical concerns related to the
use of RhBMP-2 ... in the spine”); 91, ¶ 376 (“In a published interview with
SpineUniverse.com ..., Dr. Burkus said that he was ‘using rhBMP-2 in anterior and
posterior lumbar spinal fusion surgeries’ and falsely stated that ‘no adverse events have
been linked to the use of rhBMP-2'”); 92, ¶ 381 (“Dr. Zdeblick was an author or co-author
of ... articles [that] were either edited or heavily drafted by Medtronic employees and
exaggerated the benefits of Infuse® Bone Graft, while deliberately omitting adverse events
and playing up any side effects associated with using ICBG”); 99, ¶ 418 (“Dr. Kuklo’s
Medtronic-sponsored study was false, the falsity only uncovered when one of the study’s
supposed, ‘co-authors,’ Lt. Col. Romney C. Andersen, was congratulated on its publication
by a colleague. After his discovery, Lt. Col. Anderson alerted Army investigators to the
false claims”); 103, ¶ 439 (“[i]n all of the principal studies cited in the Baucus-Grassley
report released by the Senate Committee on Finance (as well as in many others), Medtronic
officials inserted language into studies that promoted Infuse® as a better technique than
harvesting bone from the patient’s iliac crest by emphasizing the pain associated with using
autograft, actively concealing adverse events and/or manipulating success criteria to falsely
inflate the benefits of Infuse®”; 112, ¶ 463 (“The Medtronics Defendants, through their
website, www.Medtronic.com, falsely claim that ‘[b]one formation remote from the site of
the implantation was not seen in the clinic trials’”)” 117, ¶ 497 (“the Medtronic Defendants
promoted not only the use of its Infuse® Bone Graft into markets unapproved for Infuse®
but also falsely reassured physicians and patients that Class II surgical cages, such as the
Atlas verterbral cage, could safely and effectively be used with a biologic”).
33

Id. at 127, ¶¶ 553-554.
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the-market” theory, with the “market” being the medical community at large. But courts
have generally found such theories inapplicable to product liability cases. See, e.g.,
Chudasama v. Mazda Motor Corp., 123 F.3d 1353, 1369 n.39 (11th Cir. 1997) (“The fraud
on the market theory of securities law, however, is based on concepts and policies that
simply do not apply in a products liability case”). Plaintiffs cannot pursue a “fraud of the
market” theory.
Defendants next argue that Debra’s breach of express warranty claim should be
dismissed because it is not adequately pled and it is barred by the Infuse warranty
disclaimer. “Under Arizona law, ‘[a]ny affirmation of fact or promise made by the seller
to the buyer which relates to the goods and becomes part of the basis of the bargain creates
an express warranty that the goods shall conform to the affirmation or promise.’” Arvizu
v. Medtronic Inc., --- F. Supp. 2d ---, 2014 WL 4204933, at *9 (D. Ariz. 2014) (quoting Dillon
v. Zeneca Corp., 42 P.3d 598, 602 (Ariz. Ct. App. 2002)). “‘[A]ny affirmation that forms the
basis of an express warranty must be between the seller and the buyer.’” Id. (quoting
Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977, 1001 (D. Ariz. 2013)).
Plaintiffs allege that defendants “utilized journal articles, advertising media, sales
representatives/consultants, and paid Key Opinion Leaders to urge the use, purchase, and
utilization of unapproved uses of Infuse® Bone Graft” to “expressly warrant[] to
physicians, including [Debra’s] physician and other members of the general public and

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medical community, that such off-label uses, including uses in lumbar fusion procedures,
were safe and effective.”34 Plaintiffs also allege that Debra’s “treating surgeon relied on
Defendants’ express warranty representations regarding the safety and efficacy of
unapproved uses of Infuse®, but such off-label uses, including uses in lumbar fusion
procedures, were not effective, safe, and proper for the use as warranted in that Infuse®
was dangerous when put to these promoted uses.”35
Debra has still failed to state a plausible breach of express warranty claim. Debra’s
vague allegations that there were affirmations made by defendants and defendants’ agents
that the Infuse device was safe and effective when used off-label are insufficient. In order
to state a plausible claim, plaintiffs needed to allege that defendants made affirmations
directly to Debra, which they have not done. Thus, Debra’s breach of express warranty
claim is dismissed. This claim is dismissed with prejudice. Plaintiffs are not given leave
to amend as they have had an opportunity to amend this claim and still failed to state a
plausible claim.
Defendants next argue that Patrick’s loss of consortium claim should be dismissed.
But, Patrick’s loss of consortium claim survives defendants’ motion to dismiss because
Debra’s fraud claims based on defendants’ off-label promotion survive.

34

First Amended Complaint for Damages at 139, ¶ 635, Docket No. 26.

35

Id. at ¶ 637.
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Lastly, defendants argue that plaintiffs’ punitive damages claim should be dismissed
because punitive damages are a remedy, not a claim. See Allen v. Quest Online, LLC, Case
No. CV–11–138–PHX–GMS, 2011 WL 4403674, at *11 (D. Ariz. Sept. 22, 2011) (“Damages
cannot stand alone as a separate claim”).

Plaintiffs may seek punitive damages as a

remedy, but it is not a substantive claim for relief.

To the extent that plaintiffs have

asserted a separate claim for punitive damages, that claim is dismissed.
Although the court has determined that Debra’s fraud claims based on defendants’
off-label promotion survive defendants’ Rule 12(b)(6) motion and that Patrick’s loss of
consortium claim also survives, plaintiffs’ amended complaint is nonetheless dismissed in
its entirety for failure to comply with Rule 8(a)(2). “When a complaint fails to comply
with” Rule 8(a)(2), “the district court has the power, on motion or sua sponte, to dismiss
the complaint....” Simmons v. Abruzzo, 49 F.3d 83, 86 (2d Cir. 1995). “Rule 8(a)(2) of the
Federal Rules of Civil Procedure requires that each claim in a pleading be supported by
‘a short and plain statement of the claim showing that the pleader is entitled to relief....’”
Landers v. Quality Communications, Inc., --- F.3d ---, 2014 WL 5840039, at *2 (9th Cir. 2014).
Plaintiffs’ amended complaint is 146 pages long and contains 675 numbered paragraphs
and has seven exhibits attached. Quite simply, it “says too much.” Knapp v. Hogan, 738
F.3d 1106, 1109 (9th Cir. 2013). It is “prolix, replete with redundancy, and largely
irrelevant....” McHenry v. Renne, 84 F.3d 1172, 1177 (9th Cir. 1996). Even with the majority

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of Debra’s claims dismissed, it would be unfair to require defendants to answer the
amended complaint. See Cafasso, 637 F.3d at 1059 (quoting Mendez v. Draham, 182 F.
Supp. 2d 430, 433 (D.N.J. 2002) (“‘Only through superhuman patience, effort, and insight,
could any attorney review the allegations of the Complaint and make paragraph-by-paragraph responses.’”).
However, plaintiffs are given leave to file a second amended complaint but only as
to Debra’s fraud claims which are based on defendants’ off-label promotion and as to
Patrick’s loss of consortium claim.

Plaintiffs’ allegations in their second amended

complaint must be limited to those necessary to support these few remaining claims.
Although the court is denying defendants’ motion to strike as moot, plaintiffs would do
well to consider the objections raised in that motion when drafting their second amended
complaint as most of defendants’ objections were well taken. Any further failure to comply
with Rule 8(a)(2) could result in the dismissal of this action with prejudice.
Conclusion
Defendants’ Rule 12(b)(6) motion to dismiss36 is granted in part and denied in part.
Defendants’ motion to strike37 is denied as moot. The court sua sponte dismisses plaintiffs’
first amended complaint in its entirety. Plaintiffs are given leave to amend only as to

36

Docket No. 28.

37

Docket No. 27.
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Debra’s fraud claims that are based on defendants’ off-label promotion and as to Patrick’s
loss of consortium claim. Plaintiffs’ second amended complaint, should they elect to file
one, shall be filed on or before December 15, 2014.
DATED at Anchorage, Alaska, this 21st day of November, 2014.
/s/ H. Russel Holland
United States District Judge

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