Holtsclaw v. Endo Pharmaceuticals, Inc. et al

Filing 154

MOTION by Defendant Auxilium Pharmaceuticals, Inc. for judgment Under Rule 50(A) For Judgment As A Matter Of Law And Memorandum In Support (Solow, Andrew)

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
IN RE: TESTOSTERONE REPLACEMENT
THERAPY PRODUCTS LIABILITY
LITIGATION

Case No. 1:14-cv-1748
MDL No. 2545
Hon. Matthew F. Kennelly

THIS DOCUMENT RELATES TO:
Holtsclaw v. Auxilium Pharmaceuticals, LLC,
Case No. 1:15-cv-3941

DEFENDANT’S MOTION UNDER RULE 50(A)
FOR JUDGMENT AS A MATTER OF LAW
AND MEMORANDUM IN SUPPORT

TABLE OF CONTENTS
TABLE OF AUTHORITIES ......................................................................................................... ii
INTRODUCTION ......................................................................................................................... 1
I.

PLAINTIFF FAILED TO PRESENT SUFFICIENT EVIDENCE THAT HE
WOULD NOT HAVE HAD HIS HEART ATTACK BUT FOR TESTIM ..................... 2

II.

PLAINTIFF FAILED TO ESTABLISH NECESSARY ELEMENTS OF HIS
NEGLIGENCE AND STRICT LIABILITY CLAIMS..................................................... 3
A.

Plaintiff Failed to Present Sufficient Evidence that Testim was
Unreasonably Dangerous ....................................................................................... 3

B.

Plaintiff Failed To Present Sufficient Evidence that Testim’s Labeling
Caused His Injury .................................................................................................. 6

III.

PLAINTIFF FAILED TO ESTABLISH NECESSARY ELEMENTS OF HIS
MISREPRESENTATION CLAIM.................................................................................... 8

IV.

PLAINTIFF FAILED TO ESTABLISH NECESSARY ELEMENTS OF HIS
CLAIM FOR CONCEALMENT..................................................................................... 10
A.

Plaintiff Failed To Present Sufficient Evidence of Any Material Omission
that Auxilium Had a Duty to Disclose................................................................. 11

B.

Plaintiff Failed To Show that He Relied on Any Misrepresentation by
Concealment ........................................................................................................ 12

V.

THE EVIDENCE ESTABLISHES THAT PLAINTIFF’S STATE LAW CLAIMS
CHALLENGING THE ADEQUACY OF TESTIM’S LABELING ARE
PREEMPTED BY FEDERAL LAW............................................................................... 13

VI.

PLAINTIFF FAILED TO PRESENT SUFFICIENT EVIDENCE TO JUSTIFY
AN AWARD OF PUNITIVE DAMAGES ..................................................................... 14

CONCLUSION............................................................................................................................ 15

i

TABLE OF AUTHORITIES
Page(s)
CASES
Atkins v. Kirkpatrick,
823 S.W.2d 547 (Tenn. Ct. App. 1991) .....................................................................................9
B.G. Balmer & Co., Inc. v. Frank Crystal & Co., Inc.,
148 A.3d 454 (Pa. Super. Ct. 2016).........................................................................................14
Cerveny v. Aventis, Inc.,
855 F.3d 1091(10th Cir. 2017) ................................................................................................14
Chrisman v. Hill Home Dev., Inc.,
978 S.W.2d 535 (Tenn. 1998)............................................................................................10, 12
Coffey v. Foamex L.P.,
2 F.3d 157 (6th Cir. 1993) .........................................................................................................9
Davis v. McGuigan,
325 S.W.3d 149 (Tenn. 2010)....................................................................................................8
Garrett v. Barnes,
961 F.2d 629 (7th Cir. 1992) ...............................................................................................1, 15
Hall v. Forest River, Inc.,
536 F.3d 615 (7th Cir. 2008) .....................................................................................................1
Huskey v. Ethicon, Inc.,
29 F. Supp. 3d 736 (S.D.W. Va. 2014) .....................................................................................9
Hutchison ex rel. Hutchison v. Luddy,
870 A.2d 766 (Pa. 2005) ....................................................................................................14, 15
In re Testosterone Replacement Therapy Prods. Liab. Litig.,
No. 14 C 1748, 2017 WL 1833173 (N.D. Ill. May 8, 2017) ...................................................13
Jackson v. Gen. Motors Corp.,
60 S.W.3d 800 (Tenn. 2001)..................................................................................................4, 6
Kibbler v. Richards Med. Co.,
No. 02A01-9110-cv-00214, 1992 WL 233027 (Tenn. Ct. App. Sept. 23, 1992) ......................4
King v. Danek Med., Inc.,
37 S.W.3d 429 (Tenn. Ct. App. 2000) ...................................................................................4, 7
Leeper v. Cook,
688 S.W.2d 94 (Tenn. Ct. App. 1985) .....................................................................................11
ii

Nye v. Bayer Cropscience, Inc.,
347 S.W. 3d 686 (Tenn. 2011)...................................................................................................6
Pittman v. Upjohn Co.,
890 S.W.2d 425 (Tenn. 1994)....................................................................................................6
Ray by Holman v. BIC Corp.,
925 S.W.2d 527 (Tenn. 1996)................................................................................................4, 5
Reeves v. Sanderson Plumbing Prods., Inc.,
530 U.S. 133 (2000)...................................................................................................................1
Robinson v. McNeil Consumer Healthcare,
615 F.3d 861 (7th Cir. 2010) ...................................................................................................13
Strayhorn v. Wyeth Pharm., Inc.,
737 F.3d 378 (6th Cir. 2013) .....................................................................................................4
Walker v. Sunrise Pontiac-GMC Truck, Inc.,
249 S.W.3d 301 (Tenn. 2008)....................................................................................................9
Wyeth v. Levine,
555 U.S. 555 (2009).................................................................................................................13
STATUTES
Tenn. Code Ann. § 29-28-102(8).....................................................................................................4
OTHER AUTHORITIES
Fed. R. Civ. P. 50(a)(1)....................................................................................................................1

iii

INTRODUCTION
Pursuant to Federal Rule of Civil Procedure 50(a), Defendant Auxilium Pharmaceuticals,
LLC (f/k/a Auxilium Pharmaceuticals, Inc.) (“Auxilium”) respectfully moves for judgment as a
matter of law for the reasons set forth in this memorandum. After six days of trial, having called
11 witnesses (three live witnesses and eight video deposition designations) and introduced close
to 100 exhibits, Plaintiff has failed to present evidence sufficient to permit a reasonable jury to
find in his favor on any of his claims, or to award punitive damages. “Rule 50 requires a court to
render judgment as a matter of law when a party has been fully heard on an issue, and there is no
legally sufficient evidentiary basis for a reasonable jury to find for that party on that issue.”
Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 135 (2000); Fed. R. Civ. P. 50(a)(1).
“[T]he question is simply whether the evidence as a whole, when combined with all reasonable
inferences permissibly drawn from that evidence, is sufficient to allow a reasonable jury to find
in favor of the plaintiff.” Hall v. Forest River, Inc., 536 F.3d 615, 619 (7th Cir. 2008). “A mere
scintilla of evidence … will not suffice” to prevent judgment as a matter of law. Id. (quotation
marks omitted). Judgment as a matter of law is properly granted against a party that relies only
on “sheer speculation and conjecture.” Garrett v. Barnes, 961 F.2d 629, 632, 634 (7th Cir. 1992)
(granting judgment as a matter of law, as “speculation cannot be the basis of a jury verdict”).
Plaintiff has failed to show that Testim caused his heart attack. Plaintiff concedes—and
his expert witnesses and all of Plaintiff’s treating physicians agree—that he had multiple known
risk factors for a heart attack. Plaintiff has offered no evidence to show that Testim, rather than a
constellation of those undeniable risk factors, caused his heart attack on July 3, 2014. This
deficiency in Plaintiff’s evidence warrants judgment for Auxilium on all claims, but Plaintiff’s
evidence is also insufficient for claim-specific reasons. Plaintiff’s failure to establish necessary
elements of each of his claims requires entry of judgment as a matter of law for Auxilium.
1

ARGUMENT
I.

PLAINTIFF FAILED TO PRESENT SUFFICIENT EVIDENCE THAT HE
WOULD NOT HAVE HAD HIS HEART ATTACK BUT FOR TESTIM
Plaintiff cannot prevail on any of his claims because he failed to establish by a

preponderance of the evidence that he would not have suffered his heart attack had he not taken
Testim. Plaintiff had several known risk factors for a heart attack long before he began taking
Testim, including high cholesterol, diabetes, obesity, and obstructive sleep apnea. See Tr. 281:46; 282:14-17; 283:11-13; 283:20-284:1 (Holtsclaw); 558:2-5 (Ardehali); accord Smith Dep.
55:18-56:20; McLaughlin Dep. 33:23-38:8. Plaintiff’s expert witness, Dr. Hossein Ardehali,
agreed that if a person with these risk factors had a heart attack and was not on other
medications, he would tell the person that those risk factors caused the heart attack. Tr. 558:21559:4. Plaintiff’s treating cardiologist, Dr. Steven Smith, likewise testified that there was
nothing unusual about Plaintiff’s arteries, or the fact or nature of Plaintiff’s heart attack, that
would distinguish his illness from that of a typical patient with the same risk factors. Smith Dep.
59:20-61:1; 62:19-63:18; 68:22-69:24.
Plaintiff’s sole evidence that Testim was a medical cause of his injury was select
testimony of Dr. Ardehali, who testified that “but for his use of the testosterone product,
[Plaintiff] would not have had a heart attack on July 3rd, 2014,” and that “Plaintiff’s use of the
Testim product, the testosterone product, was a substantial factor in causing his heart attack.”
Tr. 508:3-12. Dr. Ardehali opined that all the other risk factors “push you to the edge, and it was
Testim that was the last push, that pushed you over and caused your heart attack.” Tr. 559:4-11.
But Dr. Ardehali provided no opinion about the actual mechanism of Plaintiff’s injury. Dr.
Ardehali testified at length about five “biologically plausible” mechanisms for his theory that
“testosterone can cause heart attacks in men.” Tr. 351:18-437:20. But after giving six hours of
2

testimony and discussing no fewer than fifteen studies about these five possible mechanisms, Dr.
Ardehali ultimately admitted that there is no actual evidence that any of these mechanisms
caused Plaintiff’s heart attack. See Tr. 525:9-21 (hematocrit); 525:22-24, 526:8-22 (estradiol);
536:16-537:1 (VCAM); 537:10-538:1 (reactive oxygen species); 536:4-7, 536:11-15
(thromboxane).
Based on Plaintiff’s preexisting risk factors and the lack of evidence to support that
Testim was a medical cause of his heart attack, no reasonable jury could conclude that Plaintiff
would not have suffered his injury had he not taken Testim. Because Plaintiff’s claims all
require him to prove that Testim was a cause in fact of his injury, Plaintiff cannot prevail on any
of his claims. The Court should therefore enter judgment as a matter of law for Auxilium.
II.

PLAINTIFF FAILED TO ESTABLISH NECESSARY ELEMENTS OF HIS
NEGLIGENCE AND STRICT LIABILITY CLAIMS
To prevail on his negligence and strict liability claims, Plaintiff must prove that Testim’s

label was inadequate and rendered Testim unreasonably dangerous, and that the inadequate
labeling caused his heart attack. Plaintiff’s evidence fails to satisfy any of these necessary
elements, and so the Court should enter judgment for Auxilium on these claims.
A.

Plaintiff Failed to Present Sufficient Evidence that Testim was Unreasonably
Dangerous

Plaintiff’s evidence fails to establish that Testim was unreasonably dangerous under
Tennessee law. Tennessee law recognizes two tests for determining whether a product is
unreasonably dangerous: first, the “consumer expectation test,” which asks whether the product
“is dangerous to an extent beyond that which would be contemplated by the ordinary consumer
who purchases it, with the ordinary knowledge common to the community as to its
characteristics,” and second, the “prudent manufacturer test,” which asks whether the product
“because of its dangerous condition would not be put on the market by a reasonably prudent
3

manufacturer or seller, assuming that the manufacturer or seller knew of its dangerous
condition.” Tenn. Code Ann. § 29-28-102(8). But Tennessee courts have acknowledged that
“the consumer expectation test will be inapplicable, by definition, to certain products about
which an ordinary consumer can have no expectation.” Ray by Holman v. BIC Corp., 925
S.W.2d 527, 530 (Tenn. 1996). In such cases, the prudent manufacturer test will often be “the
only appropriate means” to determine whether a product is unreasonably dangerous. Id. at 531;
accord Jackson v. Gen. Motors Corp., 60 S.W.3d 800, 806 (Tenn. 2001) (affirming BIC and
agreeing that the consumer expectation test may be unsuited to cases involving highly complex
products).
Pharmaceuticals are highly complex products. The ordinary consumer does not possess
the medical or scientific knowledge required for a full understanding of their purposes, risks, or
benefits. Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378, 397 (6th Cir. 2013) (applying
Tennessee law). That is why the prudent manufacturer test, rather than the ordinary consumer
test, is the appropriate test in this case. Id. Based on the record evidence, Plaintiff fails to satisfy
that standard. “[E]xpert testimony about the prudence of the decision to market [Testim] would
be essential.” King v. Danek Med., Inc., 37 S.W.3d 429, 436 (Tenn. Ct. App. 2000) (quoting
BIC, 915 S.W.2d at 531); see also, e.g., Kibbler v. Richards Med. Co., No. 02A01-9110-cv00214, 1992 WL 233027, at *3 (Tenn. Ct. App. Sept. 23, 1992) (directed verdict for defendant in
a products liability case warranted in the absence of expert testimony that the medical device was
defective or unreasonably dangerous). But Plaintiff has presented no evidence that a prudent
manufacturer would not have “put [Testim] on the market” in light of the alleged cardiovascular
risks. Tenn. Code Ann. § 29-28-102(8).

4

As Dr. Anthony DelConte, former Chief Medical Officer of Auxilium, testified, there
were no “real” safety signals that would have warranted a change in Testim’s label. DelConte
Dep. 477:1-11. Dr. Peggy Pence, Plaintiff’s sole “expert” on Auxilium’s conduct, conceded that
Testim’s label was repeatedly approved by FDA, which had the power to require a labeling
change, and chose not to do so while Plaintiff used Testim. Tr. 896:2-898:3. Dr. Pence
conceded that Testim’s label was adequate when Testim was approved in 2002, but opined that
the label “became inadequate” in 2004, when it allegedly should have included information
about increased risk of cardiovascular events for patients in populations other than those
encompassed in the original indications, such as men with so-called “age-related hypogonadism”
or overlapping cardiovascular risk factors. Tr. 884:1-18, 895:19-896:1; see also Tr. 779:17780:2; 831:7-832:5. But Dr. Pence also acknowledged that FDA did not require such a label
change until 2015—even in the face of all the studies and evidence on which Dr. Pence based her
opinion that the label required supplementation. And while Plaintiff has argued that Auxilium
bore the final responsibility for its product, Tr. 198:8-14; 646:19-25, the evidence reflects that
the FDA on multiple occasions rejected proposals (including a proposal from Auxilium) that
would have added cardiovascular risk warnings to Testim’s label prior to the label change in
2015. Given this, Plaintiff’s argument that Testim was unreasonably dangerous under the
prudent manufacturer test cannot withstand scrutiny.
Even if, contrary to law, the consumer expectation test applied, Plaintiff has not presented
sufficient evidence to satisfy it. That test “requires the consumer to establish what an ordinary
consumer purchasing the product would expect.” BIC, 925 S.W.2d at 531. A plaintiff “must
present evidence that the ordinary consumer has an expectation regarding the safety of the
product,” Jackson, 60 S.W.3d at 804. Here, Plaintiff testified as to his own expectations about

5

Testim, Tr. 301:18-302:5, but he presented no evidence bearing on what the ordinary consumer
would reasonably have expected from Testim, based on ordinary knowledge of the product’s
characteristics. See Jackson, 60 S.W.3d at 804.
B.

Plaintiff Failed To Present Sufficient Evidence that Testim’s Labeling
Caused His Injury

The Court should enter a directed verdict on Plaintiff’s strict liability and negligence
claims for the independent reason that Plaintiff cannot establish by a preponderance of the
evidence that Testim’s labeling was the proximate cause of his heart attack.
Under the learned intermediary doctrine, Auxilium was entitled to rely on Dr.
McLaughlin to convey Testim’s risks and benefits to Plaintiff. See Pittman v. Upjohn Co., 890
S.W.2d 425, 428 (Tenn. 1994); see also Nye v. Bayer Cropscience, Inc., 347 S.W. 3d 686, 701
(Tenn. 2011) (“[T]he learned intermediary doctrine is applicable in failure to warn suits where a
physician is the intermediary between a defendant pharmaceutical … manufacturer and an
injured patient.”). Thus, Plaintiff must show that Auxilium failed to warn Dr. McLaughlin that
Testim could increase cardiovascular risk for a patient like Mr. Holtsclaw, that Testim had not
been proven safe and effective other than to treat “classic hypogonadism,” and that Auxilium’s
failure to so warn Dr. McLaughlin was the proximate cause of Plaintiff’s heart attack.
Plaintiff has not carried his burden. Plaintiff’s evidence does not establish that the
absence of a warning regarding cardiovascular risk from Testim’s label was a substantial factor
in Dr. McLaughlin’s decision to prescribe the drug to Plaintiff. Dr. McLaughlin diagnosed Mr.
Holtsclaw with hypogonadism and prescribed Testim to treat that condition. There is no
indication that Dr. McLaughlin would have made a different decision had the label included a
cardiovascular risk warning. Indeed, Dr. McLaughlin testified in 2017—two years after FDA
required revisions to the label to warn of possible increased cardiovascular risk—that he
6

continues to prescribe Testim to men with hypogonadism. McLaughlin Dep. 27:17-19; see also
King, 37 S.W.3d at 453 (proximate cause not shown where plaintiffs failed to establish that
physicians’ decisions were influenced by any representation or omission by defendants).
Moreover, Plaintiff actively participated in the decision to take Testim. He “decided he
wanted to start it” after numerous discussions with Dr. McLaughlin about Testim’s risks and
benefits. McLaughlin Dep. 58:2-59:20. He “preferred” to use testosterone gel rather than
injectable testosterone. McLaughlin Dep. 59:7-11. Plaintiff failed to offer evidence—other than
conclusory, self-serving statements, Tr. 302:9-22—that advice about the possible cardiovascular
risk would have altered his decision. Indeed, the evidence reflects that Plaintiff disregarded clear
warnings of significant increased cardiovascular risk due to his untreated hyperlipidemia. Dr.
McLaughlin repeatedly warned Plaintiff that he needed to take cholesterol-lowering medication,
and that Plaintiff’s failure to do so placed him at “an elevated risk of a heart attack.”
McLaughlin Dep. 112:12-114:12. Nevertheless, other than taking a few samples of Crestor,
Plaintiff did not fill a prescription for a cholesterol-lowering medication until after his heart
attack. Plaintiff offered no evidence to support the conclusion that he would have heeded advice
from Dr. McLaughlin about the possible cardiovascular risks of taking Testim.
Plaintiff’s own testimony further undermines any argument that Auxilium’s failure to
include a cardiovascular risk warning on the Testim label proximately caused Plaintiff’s injury.
Plaintiff admitted he never read the medication guide for Testim. Tr. 313:14 (“I didn’t read none
of it. I done told you that.”). Thus, no additional warning could have altered Plaintiff’s decision
to take Testim. Indeed, the warning on the increased risk of prostate cancer included in the
medication guide had no effect on Plaintiff’s decision to take Testim, even though Plaintiff
viewed that risk as material to his decision whether or not to use the product. Tr. 313:15-25.

7

Based on Plaintiff’s own evidence, no reasonable jury could find that the absence of a
cardiovascular risk warning on Testim’s label in 2014 was a factor—let alone a substantial
factor—in causing Plaintiff’s heart attack. The Court should enter a directed verdict for
Auxilium on Plaintiff’s negligence and strict liability claims.
III.

PLAINTIFF FAILED TO ESTABLISH NECESSARY ELEMENTS OF HIS
MISREPRESENTATION CLAIM
To prevail on his intentional misrepresentation claim under Tennessee law, Plaintiff had

to prove that Auxilium made a false representation regarding an existing or past material fact,
that it made that representation knowingly or recklessly, and that Plaintiff relied on the
representation and was injured as a result. Davis v. McGuigan, 325 S.W.3d 149, 154 (Tenn.
2010). Plaintiff failed to demonstrate that he or Dr. McLaughlin in fact relied on any intentional,
material misrepresentation. Accordingly, the Court should enter judgment in Auxilium’s favor.
Plaintiff’s misrepresentation claim is premised on the notion that Auxilium improperly
promoted Testim for off-label uses by misleading patients and physicians into believing that
Testim was approved to treat low testosterone associated with conditions other than “classic
hypogonadism,” which Plaintiff contends was the exclusive approved use for Testim. See, e.g.
Tr. 696:12-697:4. But Plaintiff offered no evidence that Auxilium ever stated that Testim had
been approved for such purposes. The only evidence Plaintiff put forward was certain marketing
materials that at most “implied” that Testim or testosterone could be used for purposes other than
the approved use. Ex. 26; Tr. 799:25-800:2 (Pence) (“Q. What is being implied there? A. That
testosterone can be used to treat diabetes or the signs and symptoms associated with diabetes.”);
see also, e.g., Exs. 102, 866. Even assuming these “implications” amounted to
misrepresentations of material fact, the trial record is devoid of evidence that any reliance on
Auxilium’s purported marketing for off-label uses caused Plaintiff’s injury.
8

Plaintiff presented no evidence that Auxilium ever marketed Testim to Plaintiff or Dr.
McLaughlin claiming that Testim treats anything other than hypogonadism. Plaintiff himself
admitted that he never saw any marketing materials about Testim. Tr. 310:4-8. He explained,
“Even if I had, I wouldn’t have paid no attention to it.” Tr. 310:6. Plaintiff’s admission
forecloses any argument that he relied on any misrepresentation by Auxilium regarding off-label
uses of Testim, and requires judgment in Auxilium’s favor.
Likewise, Plaintiff presented no evidence that Dr. McLaughlin—on whom Auxilium
could rely as a learned intermediary to convey information about Testim for purposes of both the
intentional misrepresentation claim, and the misrepresentation by concealment claim, see infra
Part IV, as Plaintiff has framed those claims, see, e.g., Huskey v. Ethicon, Inc., 29 F. Supp. 3d
736, 743-45 (S.D.W. Va. 2014)—relied on any allegedly misleading advertisements about
Testim. See Tr. 838:22-25 (Pence) (“Q. And you’re not offering any opinions that any
testosterone promotional material specifically affected Dr. McLaughlin’s prescribing practices,
right? A. That’s correct.”). The evidence Plaintiff has introduced regarding Auxilium’s
strategies for marketing to physicians, see, e.g., Rosenberger Dep. 143:5-23, 144:2-4, 144:6146:19, 148:8-10, 148:14-20, 307:3-8, 308:4-15; 309:9-310:1, 310:11-17, 313:1-10, 313:17-22,
315:4-17, 315:21-316:3; Hess Dep. 511:5-513:11, 528:4-535:2, 535:6-7, 535:9-20, or the number
of times Testim sales representatives apparently contacted Dr. McLaughlin, see, e.g., Sturgill
Dep. 97:21-23, 98:1, 98:3-12, 98:14-99:5, 112:21-113:1, 113:11-13; Ex. 2033, is immaterial.
Even assuming reliance by Dr. McLaughlin is relevant, cf. Walker v. Sunrise PontiacGMC Truck, Inc., 249 S.W.3d 301, 311 (Tenn. 2008) (misrepresentation claims require that
“plaintiff reasonably relied on the misrepresented material fact”); Coffey v. Foamex L.P., 2 F.3d
157, 161 (6th Cir. 1993) (quoting Atkins v. Kirkpatrick, 823 S.W.2d 547, 552 (Tenn. Ct. App.

9

1991)) (similar), Dr. McLaughlin testified that he did not recall hearing any of the purported
misrepresentations that Plaintiff attributes to Auxilium. See McLaughlin Dep. 132:24-133:3
(“Q: Do you have an image in your mind [of the Testim representatives’ brochure]? No? Okay.
A: No, ma’am.”); 133:5-12 (“Q. Do you remember hearing from Testim sales representatives
anything about which types of patients would be appropriate patients to test their testosterone
level to see if they might be hypogonadal or have hypogonadism? A. No, I don’t.”); 133:15134:12 (“Q: Do you recall hearing from any Testim sales representatives that 50 percent of men
with diabetes have low testosterone? A: No, I don’t recall that.”); 106:10-15 (“Q: You were
never told by a manufacturer’s representative that Testim can be used to treat erectile
dysfunction or diabetes or opioid addiction, were you? A: No.”); 106:17-22 (Q: You were never
told by a manufacturer’s representative that Testim was approved to treat sexual dysfunction or
to improve lean body mass; is that right? A: No.”). And while Dr. McLaughlin was familiar
with the “ADAM Questionnaire,” he stated, “[W]e don’t use them.” McLaughlin Dep. 135:5-16.
Dr. McLaughlin further testified that he was “conservative” about adopting new medicines and
consulted a variety of sources, including statements from medical organizations and current
medical literature, to inform his decision about whether to use a new medication. McLaughlin
Dep. 99:7-100:5, 101:17-102:19. Plaintiff’s inability to identify substantial evidence of reliance
on any purported misrepresentation dooms his claim.
IV.

PLAINTIFF FAILED TO ESTABLISH NECESSARY ELEMENTS OF HIS
CLAIM FOR CONCEALMENT
Tennessee law provides that “the tort of fraudulent concealment is committed when a

party who has a duty to disclose a known fact or condition fails to do so, and another party
reasonably relies upon the resulting misrepresentation, thereby suffering injury.” Chrisman v.

10

Hill Home Dev., Inc., 978 S.W.2d 535, 538-39 (Tenn. 1998). Like his misrepresentation claim,
Plaintiff’s concealment claim fails at each step for lack of sufficient evidence.
A.

Plaintiff Failed To Present Sufficient Evidence of Any Material Omission
that Auxilium Had a Duty to Disclose

Plaintiff’s concealment claim posits that Auxilium failed to disclose that Testim had not
been proven safe and effective to treat “age-related or late-onset hypogonadism” or low
testosterone associated with conditions other than “classic hypogonadism.” See, e.g., Tr. 194:917, 1044:21-45:2 (Pence) (“Q. And with respect to the safety and efficacy for use in diabetics,
should Auxilium have warned the general medical community that safety and efficacy in
diabetics had not been established? A. Absolutely, they should have. Q. And did they? A. They
did not.”); 1046:8-1047:14 (similar). But Tennessee law requires “something more than mere
silence, or a mere failure to disclose known facts.” Leeper v. Cook, 688 S.W.2d 94, 96 (Tenn.
Ct. App. 1985). The defendant must have intended to mislead the plaintiff, or failed to disclose
known facts that it had a duty to disclose. Id.
Plaintiff failed to offer substantial evidence either that Auxilium intended to mislead him,
or that it concealed any information that it had a duty to disclose. Dr. Pence disavowed the
notion that Auxilium ever failed to submit any required information to FDA, Tr. 841:11-13, hid
information from the FDA with regard to its label, Tr. 841:13-25, or ever misrepresented any
information or data related to Testim with FDA, Tr. 841:24-842:1. Dr. Pence admitted that FDA
was aware of and analyzed all the relevant studies on which she based her opinion that the label
should have included additional warnings. Tr. 898:19-899:2. At no time prior to Plaintiff’s heart
attack did any study or FDA itself recommend a change in the label. Indeed, while FDA opened
a Tracked Safety Issue (“TSI”) to review the cardiovascular risks of testosterone replacement
therapy products in the wake of the early termination of the TOM trial, it closed the TSI
11

indicating “insufficient evidence of a cardiovascular risk associated with TRT to warrant
regulatory action.” See Tr. 925:25- 926:18, 927:1-3 (Pence). Cf., e.g., Ex. 4303 (Institute of
Medicine report analyzed existing literature but did not recommend a label change); Tr. 557:1-16
(Ardehali) (agreeing that FDA has never identified an actual risk of heart disease associated with
testosterone use).
B.

Plaintiff Failed To Show that He Relied on Any Misrepresentation by
Concealment

Even if Plaintiff had identified a material omission, he failed to present sufficient
evidence that he relied on and was injured by the resulting misrepresentation, as Tennessee law
requires to establish the tort of fraudulent concealment. Plaintiff emphasized that he had “never
seen” any advertising or promotional material about testosterone products, Tr. 310:4-8, and
“never read” Testim’s label or medication guide, Tr. 313:5-9, let alone acted in reliance on the
impression that Testim had been proven safe and effective for particular off-label uses.
Plaintiff’s denial that he read Testim’s label dooms his concealment claim. Plaintiff
suggests that Dr. McLaughlin relied on the misrepresentation resulting from Auxilium’s
purported omission of information from Testim’s label. Tr. 212:22-213:4. But even if reliance
by Dr. McLaughlin is relevant, cf. Chrisman, 978 S.W. 2d at 538-39 (action for fraudulent
concealment lies where a party reasonably relies upon misrepresentation, thereby suffering
injury), Plaintiff presented no evidence that Dr. McLaughlin would have acted differently had he
been made aware that the product’s “safety and efficacy” for treating “age-related
hypogonadism” or anything other than “classic hypogonadism” had not been fully studied.
There is no evidence that Dr. McLaughlin diagnosed Plaintiff with “age-related hypogonadism”
or that he prescribed Testim to Plaintiff for an off-label use. Plaintiff had complained of chronic
fatigue, which Dr. McLaughlin determined was consistent with his low testosterone level.
12

More important, Plaintiff presented no evidence that Dr. McLaughlin was misled into
believing that Testim had been more widely tested, and that Plaintiff would not have taken
Testim had Auxilium disclosed the extent of the clinical evidence. To the contrary, Dr.
McLaughlin testified in 2017—two years after the information Plaintiff contends was wrongly
omitted was added to the label—that he currently prescribes Testim to patients with
hypogonadism. McLaughlin Dep. 27:17-19. That the new information has not altered his
prescribing practices disproves Plaintiff’s contention that its earlier “omission” caused his injury.
V.

THE EVIDENCE ESTABLISHES THAT PLAINTIFF’S STATE LAW CLAIMS
CHALLENGING THE ADEQUACY OF TESTIM’S LABELING ARE
PREEMPTED BY FEDERAL LAW
Auxilium renews its argument, set forth in detail in its motion for summary judgment on

preemption grounds, ECF No. 38, that federal law preempts Plaintiff’s state law claims. State
law claims based on alleged deficiencies in drug labeling are preempted if the manufacturer
provides “clear evidence that the FDA would not have approved a change” to the label of a
prescription drug. Wyeth v. Levine, 555 U.S. 555, 571 (2009). See also In re Testosterone
Replacement Therapy Prods. Liab. Litig., No. 14 C 1748, 2017 WL 1833173, at *7 (N.D. Ill.
May 8, 2017).
The “clear evidence” standard is met here. Plaintiff’s case in chief does not controvert
the fact that FDA concluded on multiple occasions—before and after Plaintiff took Testim—that
there was insufficient medical evidence supporting an association between testosterone therapy
and an increased risk of adverse cardiovascular outcomes that would require a change to
Testim’s label. Exs. 3127, 3123. Moreover, the agency rejected specific proposals to add a
cardiovascular risk warning to Testim’s label, demonstrating that an attempt by Auxilium to add
such a warning would have been futile. See Robinson v. McNeil Consumer Healthcare, 615 F.3d
861, 873 (7th Cir. 2010) (FDA’s refusal to require warning satisfies Wyeth’s “clear evidence”
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standard). In June 2013, FDA rejected Auxilium’s proposal to include a broad warning on
Testim’s label about the risk of “thrombosis and embolic events” that would have encompassed
Plaintiffs’ desired warning regarding cardiovascular risk, including heart attack. Exs. 3113,
3114, 3116. Furthermore, on July 16, 2014, just thirteen days after Plaintiff stopped using
Testim, FDA denied a citizen petition to add a warning to the label of testosterone products
(including Testim) advising of the increased risks of heart attacks and other cardiovascular
dangers. Nothing indicates that FDA would have reached a different conclusion had Auxilium
itself requested the change. Cf. Cerveny v. Aventis, Inc., 855 F.3d 1091, 1102 (manufacturer
requests for label changes receive no greater deference than citizen petitions).
VI.

PLAINTIFF FAILED TO PRESENT SUFFICIENT EVIDENCE TO JUSTIFY AN
AWARD OF PUNITIVE DAMAGES
Under Pennsylvania law, “[p]unitive damages may be awarded for conduct that is

outrageous, because of the defendant's evil motive or his reckless indifference to the rights of
others. As the name suggests, punitive damages are penal in nature and are proper only in cases
where the defendant's actions are so outrageous as to demonstrate willful, wanton or reckless
conduct.” Hutchison ex rel. Hutchison v. Luddy, 870 A.2d 766, 770 (Pa. 2005) (internal
quotation marks and citations omitted).
“Conduct is considered outrageous where a defendant’s action shows either an evil
motive or reckless indifference to the rights of others. Reckless indifference to the interests of
others, or as it is sometimes referred to, wanton misconduct, means that the actor has
intentionally done an act of an unreasonable character, in disregard of a risk known to him or so
obvious that he must be taken to have been aware of it, and so great as to make it highly probable
that harm would follow.” B.G. Balmer & Co., Inc. v. Frank Crystal & Co., Inc., 148 A.3d 454,
463 (Pa. Super. Ct. 2016) (citation omitted). “Thus, in Pennsylvania, a punitive damages claim
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must be supported by evidence sufficient to establish that (1) a defendant had a subjective
appreciation of the risk of harm to which the plaintiff was exposed and that (2) he acted, or failed
to act, as the case may be, in conscious disregard of that risk.” Hutchinson, 870 A.2d at 772.
Plaintiff’s evidence fails to satisfy this stringent standard. Plaintiff’s own expert
conceded that FDA has never stated that there is an actual risk of heart disease associated with
testosterone use, and that Testim’s current label says only that the evidence of a “possible” risk is
“inconclusive.” Tr. 557:1-16 (Ardehali). Dr. Ardehali acknowledged the existence of numerous
peer-reviewed studies contradicting his opinions about the risks of testosterone products, Tr.
541-53, as well as the lack of consensus among the professional medical community and medical
associations about whether testosterone replacement therapy can increase cardiovascular risk, Tr.
554:3-555:12; 556:22-25. This necessarily precludes a finding that Auxilium acted in disregard
of a “known” or “obvious” risk, and forecloses an award of punitive damages.
At bottom, Plaintiff’s claim for punitive damages rests on the bold and unsupported claim
that Auxilium engaged in a “mass uncontrolled experiment.” Tr. 194:18-20, 207:13-15, 219:1517. But “speculation cannot be the basis of a jury verdict.” Garrett v. Barnes, 961 F.2d 629, 634
(7th Cir. 1992). Plaintiff has presented no evidence of an opinion that Auxilium conducted a
“mass uncontrolled experiment.” Plaintiff’s rhetoric is further belied by the evidence that
Auxilium complied at every turn with FDA’s directives, and that FDA did not see fit to require
alterations to Testim’s label until 2015. Because the record contains no evidence sufficient to
establish that Auxilium engaged in wanton, willful, or reckless conduct, the Court should grant a
directed verdict for Auxilium on Plaintiff’s claim for punitive damages.
CONCLUSION
For all the foregoing reasons, the Court should enter judgment as a matter of law for
Auxilium on all of Plaintiff’s claims.
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Respectfully submitted,
/s/ Andrew K. Solow
Andrew K. Solow
James D. Herschlein
ARNOLD & PORTER
KAYE SCHOLER LLP
250 West 55th Street
New York, NY 10019-9710
[phone]
Email: [e-mail]
Email: [e-mail]
Pamela J. Yates
ARNOLD & PORTER
KAYE SCHOLER LLP
777 South Figueroa Street, 44th Floor
Los Angeles, CA 90017-5844
[phone]
Email: [e-mail]
Counsel for Defendant Auxilium
Pharmaceuticals, LLC (f/k/a Auxilium
Pharmaceuticals, Inc.)

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CERTIFICATE OF SERVICE
I, Andrew K. Solow, hereby certify that on November 14, 2017, the foregoing Motion
Under Rule 50(a) for Judgment as a Matter of Law and Memorandum in Support was filed
via the Court’s CM/ECF system, which will automatically serve and send notification of such
filing to all registered attorneys of record.

Dated: November 14, 2017

/s/ Andrew K. Solow
Andrew K. Solow

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