United States District Court, N.D. Illinois, Eastern Division
In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings
Actavis, Inc., No. 15 C 4292 This document applies to Martin
CASE MANAGEMENT ORDER NO. 166 (MEMORANDUM OPINION AND
ORDER ON ACTAVIS, INC.'S MOTION TO
EXCLUDE EXPERT TESTIMONY AND MOTIONS FOR SUMMARY
JUDGMENT IN MARTIN V. ACTAVIS, INC., NO. 15
MATTHEW F. KENNELLY, UNITED STATES DISTRICT JUDGE.
in this multidistrict litigation (MDL) proceeding allege that
they suffered either arterial cardiovascular injuries or
injuries related to blood clots in the veins (venous
thromboembolisms) as a result of taking prescription
testosterone replacement therapy (TRT) drugs. Defendants
Actavis, Inc., Actavis Pharma, Inc., and Actavis Laboratories
UT, Inc. (collectively, Actavis) manufacture or sell
Androderm, one of the TRT products at issue in this
litigation. Plaintiff Brad Martin alleges that his use
of Androderm from October 2012 to May 2013 caused him to
suffer a myocardial infarction (heart attack) in May 2013. He
asserts claims against Actavis under Minnesota law for design
defect; failure to warn; negligence; breach of express
warranty; breach of implied warranty of merchantability;
negligent misrepresentation; fraudulent misrepresentation;
redhibition; consumer protection (specifically, violation of
the Minnesota False Statement in Advertising Act (MFSAA),
Minn. Stat. § 325F.67, and the Minnesota Deceptive Trade
Practices Act (MDPTA), Minn. Stat. § 325D.44(13));
unjust enrichment; and punitive damages.
2018, based on proposals from Actavis and the Plaintiffs'
Steering Committee, the Court selected Martin's case as
the first Actavis bellwether trial case. Before trial,
Actavis moved to exclude the testimony of several of
Martin's expert witnesses under Federal Rule of Evidence
702 and Daubert v. Merrell Dow Pharmaceuticals,
Inc., 509 U.S. 579 (1993). Actavis also moved for
summary judgment on the ground that Martin's failure to
warn, design defect, and so-called "off-label
promotion" claims are preempted by federal law. Finally,
Actavis contended that all of Martin's claims fail under
Minnesota law, which the parties agree applies. The motions
were fully briefed in June 2018, but in July 2018, the Court
terminated them as moot due to the execution of a Master
Settlement Agreement covering cases involving Actavis. In
August 2019, Martin informed the Court that he has elected
not to settle his claims. Thus Actavis's Daubert
and summary judgment motions are again before the Court.
following reasons, the Court denies Actavis's motion for
summary judgment based on federal preemption; denies
Actavis's motion to exclude Martin's expert testimony
concerning general and specific causation; and terminates as
moot Actavis's motion to exclude the expert testimony of
Robert Johnson. The Court grants Actavis's motion for
summary judgment on Martin's claims for breach of implied
warranty of merchantability, negligent misrepresentation,
unjust enrichment, redhibition, and violation of the MFSAA;
reserves judgment on Actavis's motion for summary
judgment on claims against Actavis, Inc.; and denies
Actavis's motion in all other respects.
Court has ruled on motions raising similar issues in cases
brought against AbbVie and Auxilium, other defendants in this
MDL, concerning their TRT drugs AndroGel and Testim. See
In re Testosterone Replacement Therapy Prods. Liab. Litig.
Coordinated Pretrial Proceedings, No. 14 C 1748, MDL No.
2545, 2018 WL 4030585 (N.D. Ill. Aug. 23, 2018) ("CMO
133"); In re Testosterone Replacement Therapy Prods.
Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C
1748, MDL No. 2545, 2018 WL 4030586 (N.D. Ill. Aug. 23, 2018)
("CMO 132"); In re Testosterone Replacement
Therapy Prods. Liab. Litig. Coordinated Pretrial
Proceedings, No. 14 C 1748, MDL No. 2545, 2017 WL
4772759 (N.D. Ill. Oct. 23, 2017) ("CMO 76");
In re Testosterone Replacement Therapy Prods. Liab.
Litig. Coordinated Pretrial Proceedings, No. 14 C 1748,
MDL No. 2545, 2017 WL 1836443 (N.D. Ill. May 8, 2017)
("CMO 48"); In re Testosterone Replacement
Therapy Prods. Liab. Litig. Coordinated Pretrial
Proceedings, No. 14 C 1748, MDL No. 2545, 2017 WL
1836435 (N.D. Ill. May 8, 2017) ("CMO 47"); In
re Testosterone Replacement Therapy Prods. Liab. Litig.
Coordinated Pretrial Proceedings, No. 14 C 1748, MDL No.
2545, 2017 WL 1833173 (N.D. Ill. May 8, 2017) ("CMO
46"). The Court assumes familiarity with those orders
but discusses them as necessary throughout this order. In
addition, the Court takes the following factual background
from Martin's and Actavis's briefs and exhibits. For
summary judgment purposes, where facts are in dispute, the
Court recounts them in the light most favorable to Martin,
the non-moving party.
hypogonadism is an endocrine disorder characterized by
abnormally low levels of testosterone in the blood.
"Classical" hypogonadism falls into two categories:
"primary" and "secondary." Primary
hypogonadism is the failure of testicles to produce adequate
levels of testosterone, and it is caused by medical
conditions such as Klinefelter syndrome and physical injuries
to the testicles. Secondary hypogonadism results from a
disorder of the pituitary gland or the hypothalamus. In adult
males, hypogonadism may be accompanied by signs and symptoms
including reduced libido, fatigue, infertility, depressed
mood, and reduced muscle mass.
normal for testosterone levels to decline in men as they age.
An age-related decline in testosterone is not
"classical" hypogonadism and is generally not
considered to be a medical condition that requires treatment.
Like other plaintiffs in this proceeding, Martin contends
that Actavis (along with other TRT manufacturers) created a
fictitious condition called "age-related
hypogonadism"-also referred to as "andropause"
or "Low T"-and improperly marketed Androderm for
the treatment of that supposed condition. Martin maintains
that Androderm has never been proven safe or effective for
that use. He also argues that Androderm does not provide
significant relief for the symptoms of aging and that it
increases the risk of cardiovascular injuries such as heart
Regulatory history of Androderm
Food and Drug Administration (FDA) has approved numerous
testosterone products to treat classical hypogonadism. In
1981, it issued a Class Labeling Guideline for androgens, a
group of hormones that includes testosterone. See
Expert Report of Dr. Peggy Pence ("Pence Report"),
Ex. 2 to Martin Opp. to Actavis Mot. for Summ. J. Based on
Federal Preemption ("Martin Preemption Opp."),
¶ 147. The Class Labeling Guideline was intended to
promote consistency in labeling of drugs in the same class.
See Id. ¶ 149. Among other things, it defined
the FDA-approved uses for androgens. See Id. ¶
is a testosterone transdermal system, meaning a patch that
delivers testosterone to the body through the skin. The FDA
approved Androderm in September 1995 for the treatment of
male hypogonadism. The initial approval was for a 2.5
milligram strength. Between September 1995 and October 2011,
the FDA approved supplemental new drug applications for
Androderm in several different strengths. The FDA approved a
new label in October 2011 to reflect the new strengths, but
neither Martin nor Actavis contends that the label change is
relevant to this case. In April 2012, the FDA approved a new
label to account for the discontinuation of old strengths.
Actavis says that between September 1995 and April 2012, the
Androderm label followed the Class Labeling Guideline. Martin
contends that during that time, the label "was not
identical to the class labeling." Martin Resp. to
Actavis Local Rule 56.1 Stat. ¶ 39. But he does not
identify which portions of the Androderm label were different
or explain why the differences are relevant. The Court,
therefore, assumes that the differences, if any, are not
material to this case.
April 2012 label was in effect when Martin was prescribed and
used Androderm. Actavis points out that the label referenced
signs and symptoms of hypogonadism, as follows:
Signs/symptoms associated with male hypogonadism include
erectile dysfunction and decreased sexual desire, fatigue and
loss of energy, mood depression, regression of secondary
sexual characteristics, and osteoporosis.
See Actavis Mot. for Summ. J. Based on Federal
Preemption ("Actavis Preemption Mot.") at 4
(quoting April 2012 Androderm Label, Ex. 9 to Actavis Mot.
for Summ. J. Based on State Law ("Actavis Mot. for Summ.
J."), Full Prescribing Information § 12.1).
has, at various times, considered requiring TRT manufacturers
and sellers, including Actavis, to warn about the risk of
cardiovascular injuries that might accompany TRT use. The
regulatory history is recounted in detail in the Court's
prior orders. See, e.g., CMO 76, 2017 WL 4772759, at
*3-4; CMO 47, 2017 WL 18366435, at *1-4. In May 2015, the FDA
required Actavis to add the following warning to the Warnings
and Precautions section of the Full Prescribing Information
in the Androderm label:
5.4 Cardiovascular Risk
Long term clinical safety trials have not been conducted to
assess the cardiovascular outcomes of testosterone
replacement therapy in men. To date, epidemiologic studies
and randomized controlled trials have been inconclusive for
determining the risk of major adverse cardiovascular events
(MACE) such as non-fatal myocardial infarction, non-fatal
stroke, and cardiovascular death, with the use of
testosterone compared to non-use. Some studies, but not all,
have reported an increased risk of MACE in association with
use of testosterone replacement therapy in men. Patients
should be informed of this possible risk when deciding
whether to use or continue to use ANDRODERM.
2015 Androderm Label, Ex. 10 to Actavis Mot. for Summ. J.,
Full Prescribing Information § 5.4; see Actavis
Preemption Mot. at 4, 9. The FDA also required Actavis to add
the following language to the Limitations of Use section of
the Full Prescribing Information: "Safety and efficacy
of ANDRODERM in men with 'age-related hypogonadism'
(also referred to as 'late-onset hypogonadism') have
not been established." May 2015 Androderm Label, Full
Prescribing Information § 1; see Actavis
Preemption Mot. at 9. The "Highlights of Prescribing
Information" section of the May 2015 Androderm label
cross-references the FDA-mandated changes. Martin contends
that Actavis should have made similar changes to the Full
Prescribing Information before he was prescribed Androderm in
Martin's use of Androderm
was a Minnesota resident at all times relevant to this
dispute. Before he began taking Androderm in October 2012, he
suffered from various health problems. According to medical
records from 2006, for example, Martin had hyperlipidemia (a
high concentration of fats or lipids in the blood),
hypercholesterolemia (high cholesterol), hypertension (high
blood pressure), and elevated blood sugar. He took
medications for some of these conditions, but the parties
dispute the extent to which Martin managed them. Martin
concedes that he is a former smoker and a recovering
alcoholic. He also acknowledges that some of his close family
members have had cardiovascular problems: his father had an
angioplasty to clear clogged arteries in his heart; his
mother had coronary artery bypass surgery; and one of his
brothers had a stroke.
testified during his deposition that beginning in 2011 or
2012, he felt "fatigued all the time." Dep. of Brad
Martin ("Martin Dep."), Ex. 3 to Martin Summ. J.
Opp., at 135:19-136:8. Martin's medical records indicate
that he discussed the fatigue with his primary care
physician, Dr. Stephen Firestone, during an annual physical
in August 2012. See Martin St. Cloud VA Health
System Records ("Martin Medical Records"), Ex. 2 to
Martin Summ. J. Opp., at 000148-49. On October 15, 2012, Amy
Hopkins-the nurse that worked with Dr. Firestone-spoke with
Martin about his fatigue and a new medication he had started.
See Id. at 000141. According to Ms. Hopkins's
notes in the records, Martin told her, "I don't feel
like I should. I still have no energy, no motivation to do
things. I don't feel depressed. I just feel fatigued all
the time. I was wondering if it could be related to my
testosterone level?" Id. Ms. Hopkins's
notes also state, in relevant part: "[V]eteran
requesting testosterone level check. Plan: Will consult with
PCP Firestone on above. Will return call to veteran with
further orders or instructions." Id. at 000143.
October 16, 2012, Ms. Hopkins wrote in Martin's medical
records, "Consulted PCP Firestone. Chart reviewed. PCP
orders: ok to check testosterone level, will supplement if
necessary . . . . Veteran notified by phone . . . . Veteran
is agreeable to have his testosterone level checked."
Id. Martin had his testosterone level checked on
October 19, 2012. The test showed that his level was in the
"low end of [the] normal range." Id. at
000122. Ms. Hopkins reported the result to Martin and noted
in his chart:
Veteran reports "I have been doing some research on my
own, trying to weigh the benefits versus risk of
supplementing testosterone levels. All I really could find is
the risk for prostate cancer, really."
Today's lab results reviewed with veteran.
Testosterone 345 10/19/2012
Veteran inquires if Dr. Firestone would consider trialing
supplementation, even though his result is low end of normal
range. Verbalizes understanding of risks.
Plan: Discussed with PCP Firestone. PCP orders: ok to trial
low dose testosterone 2mg patch. Recheck level in 1-2 months.
Veteran notified of above, and is agreeable with plan. Will
schedule lab only appt in 1-2 months, to recheck testosterone
level and effects.
Firestone prescribed Androderm to Martin on October 19, 2012,
and Martin filled his first prescription that day.
Approximately one month later, on November 15, 2012, Martin
visited Ms. Hopkins for a follow-up appointment. According to
the records of that visit, Martin "report[ed] compliance
with testosterone patches," stated that his "energy
level [was] so much better," reported improvements in
his libido, and "denie[d] any side effects or concerns
with . . . use/application" of Androderm. Id.
at 000121. Ms. Hopkins noted, "Therapeutic medication
regimen, effective r/t management of testosterone level,
libido and fatigue. Plan: Veteran would like to continue with
testosterone patches at this time. Offers no further concerns
or questions. . . . Will update PCP of above."
Id. Martin refilled Androderm prescriptions in
November 2012, December 2012, February 2013, and April 2013.
On May 25, 2013, when Martin was 52 years old, he had a heart
attack. It is undisputed that Dr. Firestone is deceased and
has not given a deposition in this action.
judgment is appropriate if the moving party "shows that
there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law."
Fed.R.Civ.P. 56(a). There is a genuine issue of material
fact, and summary judgment is precluded, "if the
evidence is such that a reasonable jury could return a
verdict for the nonmoving party." Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). When
ruling on a motion for summary judgment, a court views the
record in the light most favorable to the non-moving party
and draws all reasonable inferences in that party's
favor. Id. at 255; see also Driveline Sys., LLC
v. Arctic Cat, Inc., 936 F.3d 576, 579 (7th Cir. 2019).
"The court does not assess the credibility of witnesses,
choose between competing reasonable inferences, or balance
the relative weight of conflicting evidence."
Driveline Sys., 936 F.3d at 579 (internal quotation
contends that Martin's failure to warn, design defect,
and so-called "off-label promotion" claims are
preempted by federal law. As discussed below, the Court
Failure to warn
preemption "occurs when a state law is invalidated
because it conflicts with a federal law." Mason v.
SmithKline Beecham Corp., 596 F.3d 387, 390 (7th Cir.
2010). Courts have identified three forms of preemption: (1)
express preemption, which occurs when Congress clearly
declares its intent to preempt state law; (2) implied
preemption, which occurs when the structure and purpose of
federal law demonstrates Congress's intent to preempt
state law; and (3) conflict preemption, which occurs when
there is "an actual conflict between state and federal
law such that it is impossible for a person to obey
both." Dolin v. GlaxoSmithKline LLC, 901 F.3d
803, 811 (7th Cir. 2018) (internal quotation marks omitted);
see also Mason, 596 F.3d at 390. Actavis relies on
conflict preemption; it contends that Martin's failure to
warn claims are preempted because it would be impossible to
comply with both FDA labeling requirements and state-law
duties on which the claims are premised.
Supreme Court has held that state-law failure to warn claims
concerning prescription drugs are preempted only where there
is "clear evidence" that the FDA would have
rejected the proposed label change. Wyeth v. Levine,
555 U.S. 555, 571-72 (2009); see Dolin, 901 F.3d at
812. The Court explained that typically, "a manufacturer
may only change a drug label after the FDA approves a
supplemental application." Wyeth, 555 U.S. at
568. But the FDA's "changes being effected"
(CBE) regulation makes an exception; it "permits a
manufacturer to make certain changes to its label before
receiving the agency's approval." Id. The
CBE regulation, for example, allows a manufacturer to
"add or strengthen a contraindication, warning,
precaution, or adverse reaction" without waiting for the
FDA to approve the change. Id. (citing 21 C.F.R.
§ 314.70(c)(6)(iii)(A)). This type of change must
"reflect newly acquired information" and be
supported by "reasonable evidence of a causal
association with [the] drug." 21 C.F.R. §
314.70(c)(6)(iii)(A); 21 C.F.R. § 201.57(c)(6)(i).
the standard set forth in Wyeth to failure to warn
claims asserted previously in this MDL, this Court determined
that the record lacked "clear evidence" that the
FDA would have rejected efforts by AbbVie and Auxilium to add
warnings about cardiovascular risk to their TRT drug labels.
See CMO 76, 2017 WL 4772759, at *10-11; CMO 47, 2017
WL 1836435, at *7-11. Subsequently-and after Actavis's
summary judgment and Daubert motions were fully
briefed-the Supreme Court clarified the meaning of
"clear evidence" under Wyeth. It held that
"clear evidence" means "evidence that shows
the court that the drug manufacturer fully informed the FDA
of the justifications for the warning required by state law
and that the FDA, in turn, informed the drug manufacturer
that the FDA would not approve a change to the drug's
label to include that warning." Merck Sharp &
Dohme Corp. v. Albrecht, 139 S.Ct. 1668, 1672 (2019).
The Supreme Court also stated that "the only agency
actions that can determine the answer to the pre-emption
question . . . are agency actions taken pursuant to the
FDA's congressionally delegated authority," such as
"notice-and-comment rulemaking setting forth labeling
standards" or "formally rejecting a warning label
that would have been adequate under state law."
Id. at 1679. And it held that the question of
preemption "is a legal one for the judge, not a
jury," to decide. Id.
regulatory history for Androderm is similar in all material
respects to that of AbbVie and Auxilium's TRT drugs.
Actavis advances several arguments that it contends support a
different result in Martin's case, but none is
Changes to the Highlights section of a label
Actavis argues that it would have been legally impossible to
use the CBE process to make the label changes Martin contends
were necessary: adding warnings, similar to those the FDA
required in May 2015, concerning (1) increased cardiovascular
risk and (2) lack of proven safety and efficacy for treating
age-related hypogonadism. Actavis's theory is that if it
had tried to add these warnings to the Full Prescribing
Information, it would have had to add them to the Highlights
section as well. But changes to the Highlights section,
Actavis points out, cannot be made through the CBE process;
rather, they require FDA pre-approval. See 21 C.F.R.
§ 314.70(b)(2)(v)(C) (with several exceptions that are
inapplicable here, "any change to the information
required by § 201.57(a) of this
chapter"-i.e. the Highlights
section-"require[es] supplement submission and approval
prior to distribution of the product made using the
change"). In other words, Actavis argues that "if a
change to [the] Full Prescribing Information section requires
a corresponding change to Highlights, the Full Prescribing
Information section also cannot be changed
independently." Actavis Preemption Mot. at 8. According
to Actavis, this principle applies in Martin's case-even
though Martin never alleged that Actavis should have made
changes to the Highlights section- because the Highlights
section cross-references the FDA-mandated changes to the Full
is correct that the Highlights section of the label and the
Full Prescribing Information must contain many of the same
categories of information, including "indications and
usage," "dosage and administration," and
"warnings and precautions." Compare 21
C.F.R. § 201.57(a)(6), (7), (10) with Id.
§ 201.57(c)(2), (3), (6). But the Highlights section
does not contain all of the information that appears
in the Full Prescribing Information. See Id. §
201.57(a)(1) (providing that the Highlights section must
state, "These highlights do not include all the
information needed to use [the drug] safely and effectively.
See full prescribing information for [the drug].");
see also Id. § 201.57(a)(6) (the Highlights
section must reference "[m]ajor limitations of
use" (emphasis added)); id. §
201.57(a)(10) (the Highlights section must provide "[a]
concise summary of the most clinically
significant information required under" the
warnings and precautions section of the Full Prescribing
Information, "including information that would affect
decisions about whether to prescribe a drug . . . ."
(emphasis added)). Actavis's argument thus appears to be
that when changes to the Full Prescribing Information are so
critical that they must also appear, in some form, in the
Highlights section, the FDA prohibits manufacturers from
using the CBE process to change the Full Prescribing
cites no case law that supports its theory, and the Court
concludes that it is misguided. Actavis, for example, does
not cite any authority providing that the Highlights section
and the Full Prescribing Information must be changed
simultaneously. The relevant regulation, moreover, appears to
contemplate a temporal gap between "major" label
changes and corresponding updates to the Highlights section.
See 21 C.F.R. § 201.57(a)(5) (Highlights
section must contain a "list of the section(s) of the
full prescribing information . . . that contain(s)
substantive labeling changes that have been approved
by FDA or authorized under §
314.70(c)(6)" and must contain "the date . . . on
which the change was incorporated in labeling" (emphasis
added)). The Court thus sees no reason why a drug
manufacturer could not first make a change to the Full
Prescribing Information using the CBE process and later seek
FDA approval to make a corresponding change to the Highlights
section if the FDA determines that a corresponding change is
theory is also problematic because it would severely limit
the scope of the CBE process. The CBE provision at issue does
reiterate that changes to the Highlights section cannot be
made without FDA pre-approval. See 21 C.F.R. §
314.70(c)(6)(iii) (citing 21 C.F.R. §
314.70(b)(2)(v)(C)). But that same CBE provision expressly
permits a manufacturer to change the label "to reflect
newly acquired information . . . to accomplish" several
purposes-including to "add or strengthen a
contraindication, warning, precaution, or adverse
reaction" for which there is reasonable evidence of a
causal association, "add or strengthen a statement about
drug abuse," "add or strengthen an instruction
about dosage and administration that is intended to increase
the safe use of the drug product," and "delete
false, misleading, or unsupported indications for use or
claims for effectiveness." 21 C.F.R. §
purposes directly implicate consumer safety. One could argue
that almost any change made to accomplish these purposes
concerns a "major" limitation of use or adds
"information that would affect" a prescribing
decision-and as noted, such a change must be referenced in
the Highlights section. 21 C.F.R. §§ 201.57(a)(6),
(a)(10). Under Actavis's logic, a drug manufacturer would
not be able to use the CBE process to make this kind of
change. This would mean that the CBE process would be
available only for minor label changes that are
inconsequential for safety and efficacy. But the plain
language of the CBE provision at issue suggests the opposite,
not least because it permits a manufacturer to add or
strengthen a contraindication or warning. See 21
C.F.R. § 314.70(c)(6)(iii)(A). The case law, too,
indicates that the CBE process has broader applicability. In
Wyeth, for example, the Supreme Court determined
that "the CBE regulation permitted" a drug
manufacturer to warn about "the risk of gangrene from
IV-push injection" of the drug "before receiving
the FDA's approval." 555 U.S. at 571. That warning
was hardly inconsequential.
these reasons, and absent controlling authority providing
otherwise, the Court declines to adopt a statutory
interpretation that would prevent drug manufacturers from
making significant safety- and efficacy-related label changes
using the CBE process. See Gracia v. Sessions, 873
F.3d 553, 557 (7th Cir. 2017) ("Canons of statutory
construction discourage an interpretation that would render a
statute meaningless . . . ."); Scherr v. Marriott
Int'l, Inc., 703 F.3d 1069, 1078 (7th Cir. 2013)
(declining to "construe regulations in such a way as to
render other provisions of the regulations meaningless or