In Re: Testosterone Replacement Therapy Products Liability Litigation
Filing
1897
CASE MANAGEMENT ORDER NO. 48 (Rulings on AbbVie's motion for summary judgment on "off-label" marketing claims and motion to exclude testimony and AbbVie's motions to exclude opinions of Dr. Steven Woloshin and Dr. Curt Furberg (dkt. 1727, 1731 & 1746)), signed by the Honorable Matthew F. Kennelly on 5/8/2017. (mk)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
In re Testosterone Replacement Therapy
Products Liability Litigation Coordinated
Pretrial Proceedings
(This order applies to all cases)
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Case No. 14 C 1748
MDL No. 2545
CASE MANAGEMENT ORDER NO. 48
(Rulings on AbbVie's motion for summary judgment on "off-label" marketing
claims and motion to exclude testimony and AbbVie's motions to exclude
opinions of Dr. Steven Woloshin and Dr. Curt Furberg (dkt. 1727, 1731 & 1746))
MATTHEW F. KENNELLY, District Judge:
Plaintiffs in this multidistrict litigation proceeding allege that they have suffered
either arterial cardiovascular injuries or injuries related to blood clots in the veins
(venous thromboembolisms, or VTEs) as a result of taking prescription testosterone
replacement therapy (TRT) drugs. Defendants AbbVie Inc., Abbott Laboratories,
AbbVie Products LLC, and Unimed Pharmaceuticals, LLC (collectively, AbbVie)
manufacture AndroGel, one of the TRT drugs at issue in this litigation. Seven plaintiffs
who have sued AbbVie have been selected to proceed with bellwether trials beginning
June 2017.
Each bellwether plaintiff—Edward Cribbs, Cecile Frost, Jeffrey Konrad, Jesse
Mitchell, Arthur Myers, Robert Nolte, and Robert Rowley—alleges that AndroGel
caused him to suffer either a cardiovascular or VTE injury. AbbVie has filed three
motions for summary judgment, each one addressing different claims or issues. In this
opinion, the Court addresses AbbVie's motion for summary judgment on what it calls
plaintiffs' "off-label marketing claims"—more precisely, plaintiffs' claims of fraud,
negligent misrepresentation, violation of consumer protection statutes, breach of
express warranty, breach of implied warranty of merchantability, and negligence. The
Court also addresses AbbVie's motions to exclude the testimony of certain experts
retained by plaintiffs, specifically, Drs. David A. Kessler, Peggy Pence, Steven
Woloshin, David J. Handelsman, Hossein Ardehali, and Curt Furberg.
Background
The Court takes the following factual background from the parties' briefs and
exhibits on summary judgment. Where facts are in dispute, the Court takes them in the
light most favorable to plaintiffs, the non-moving parties.
1.
Hypogonadism
In men, testosterone is a hormone produced by the Leydig cells in the testicles.
Testosterone is the primary androgenic hormone responsible for normal male physical
and sexual development.
Male hypogonadism is an absence or deficiency of testosterone resulting from a
pathological condition of the testes, the hypothalamus, or the pituitary. It is generally
characterized as "primary" or "secondary" hypogonadism. Primary hypogonadism is the
result of testicular failure to produce adequate levels of testosterone. Secondary
hypogonadism results from a disorder of the pituitary gland or the hypothalamus.
Hypogonadism in adult males can result in decreased sexual interest and desire,
erectile dysfunction, benign breast enlargement, decreased muscular strength, sparse
body hair, and reduced bone mass. Primary and secondary hypogonadism are
sometimes called "classical" hypogonadism.
As men age, it is normal for their testosterone levels to decline. This is not a
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result of any pathology, and it has not generally been considered to be a medical
condition that requires treatment. The plaintiffs in this litigation contend that AbbVie
(along with other pharmaceutical manufacturers) engaged in a concerted marketing
campaign to convince physicians and the public that reduced testosterone levels
resulting from age—what has been referred to as "low T;" "andropause;" or age-related
hypogonadism—is a medical condition that is appropriately treated with testosterone
replacement therapy drugs.
2.
FDA approval of AndroGel
Testosterone replacement therapy has been used to treat hypogonadism for
more than 75 years. In April 1996, AbbVie's predecessor submitted to the FDA an
Investigational New Drug Application (INDA) for a topical testosterone gel intended for
use in treating primary and/or secondary hypogonadism in men. The INDA proposed
clinical trials designed to demonstrate the safety and efficacy of AbbVie's T-gel product
to raise testosterone levels to that of a male with healthy and functioning testes. In April
1999, AbbVie submitted a New Drug Application for its T-gel product, which was named
AndroGel 1%. The FDA approved AndroGel 1% on February 28, 2000. The FDA
approved AndroGel 1% as "safe and effective for use as recommended in the agreed
upon labeling text." Defs.' Ex. 30.
On September 15, 2006, AbbVie submitted an INDA for AndroGel 1.62%. The
FDA's determination to approve AndroGel 1.62% was based on a two-phase, 364-day
controlled clinical study. AbbVie later submitted an NDA for AndroGel 1.62%. On April
29, 2011, the FDA approved AndroGel 1.62% for "replacement therapy in males for
conditions associated with a deficiency or absence of endogenous testosterone" as
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described on the approved product label. Defs.' Ex. 32 at ABBVIE-FST01906236.
3.
AndroGel's indicated uses
When the FDA approves a drug, the drug is deemed effective and safe for
certain medical conditions. The use for which a drug has been approved is referred to
as an "indication." A label for an approved drug—including both the physical label and
the package inserts for physicians and patients—may indicate use only for the approved
indications. A drug manufacturer may not include a new indication on its labels without
receiving prior approval from the FDA.
In February 2000, when the FDA first approved AndroGel 1%, the indication on
the label read as follows:
AndroGel™ is indicated for replacement therapy in males for conditions
associated with a deficiency or absence of endogenous testosterone:
1. Primary hypogonadism (congenital or acquired) – testicular failure due
to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome,
orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from
alcohol or heavy metals. These men usually have low serum testosterone
levels and gonadotropins (FSH, LH) above the normal range.
2. Hypogonadotropic hypogonadism (congenital or acquired) – idiopathic
gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency
or pituitary-hypothalamic injury from tumors, trauma, or radiation. These
men have low testosterone serum levels but have gonadotropins in the
normal or low range.
Defs.' Ex. 35 at E35-003.
In April 2011, when AndroGel 1.62% was approved by the FDA, this language
was modified as follows (with new wording in bold):
AndroGel™ is indicated for replacement therapy in males for conditions
associated with a deficiency or absence of endogenous testosterone:
1. Primary hypogonadism (congenital or acquired) – testicular failure due
to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing
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testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or
toxic damage from alcohol or heavy metals. These men usually have low
serum testosterone concentrations and gonadotropins (folliclestimulating hormone [FSH], luteinizing hormone [LH]) above the
normal range.
2. Hypogonadotropic hypogonadism (congenital or acquired) – idiopathic
gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency
or pituitary-hypothalamic injury from tumors, trauma, or radiation. These
men have low testosterone serum levels but have gonadotropins in the
normal or low range.
Defs.' Ex. 36 at E36-003.
In 2006, AbbVie requested an indication for a third type of hypogonadism:
"hypogonadism due to multiple defects in the hypothalamus-pituitary-gonadal (HPG)
axis in men – e.g. DAX-1 mutations, hemochromatosis, sickle disease, glucocorticoid,
age, alcoholism, HIV-infected, or chronic opioid use." Pls.' Ex. 17 at Vol. 1, p. 0003
(emphasis added). AbbVie referred to this type of hypogonadism as "combined primary
and secondary hypogonadism" and/or mixed hypogonadism. Pls.' Ex. 45 at AbbVieFST06104728. In effect, AbbVie sought an indication for what it now calls non-classical
hypogonadism. The FDA rejected AbbVie's proposed third indication, stating that "[t]he
indications for AndroGel 1.62% will be the same as for all previously approved products
in this class. No specific claims for the treatment of age-related hypogonadism
(‘andropause’) will be allowed in the labeling." Pls.' Ex.18 at ABBVIEFST00009098.
4.
AndroGel promotional materials
On March 21, 2000, AbbVie submitted its planned introductory promotional
materials for AndroGel 1% to the FDA for advisory review and comment prior to
disseminating them. The FDA provided AbbVie with its comments on April 12, 2000.
The FDA took issue with AbbVie's claims that AndroGel was an appropriate treatment
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for age-related hypogonadism. The proposed materials stated that AndroGel delivers
"[n]ormal 24-hour serum testosterone levels—[r]egardless of hypogonadal causes
(primary, secondary, age-associated)." Defs.' Ex. 42 at E42-004. The materials also
claimed that "[g]reater than 60% of men over 65 have free testosterone levels below
normal values of men aged 30-35." Id. The FDA said that this language should be
removed from the proposed promotional materials because "[c]laims and
representations that suggest AndroGel is indicated for men with 'age-associated'
hypogonadism or 'andropause' are misleading." Id. The FDA explained that AndroGel
is only "indicated in males with primary hypogonadism or hypogonadotropic
hypogonadism." Id. The FDA also took issue with AbbVie's claim that AndroGel will
"increase muscle strength and stamina," commenting that the claim was misleading
because it "has not been demonstrated by substantial evidence." Id. The FDA noted
that its "comments on a particular claim or representation should be applied to all future
materials that contain similar claims and representations." Id. at E42-002.
Following the FDA's initial approval of AndroGel 1.0%, AbbVie launched a
comprehensive advertising campaign for AndroGel. AbbVie's strategy was to "[p]ursue
age-related hypogonadism market expansion"; "[e]ducate and motivate physicians to
treat low T"; and "[e]ducate patients about the symptoms of and benefits of treating low
testosterone." Pls.' Ex. 37. AbbVie's strategy for advertising AndroGel to primary care
physicians, specifically, was to "sell market expansion first and AndroGel second." Pls.'
Ex. 38. To accomplish this, AbbVie directed its pharmaceutical representatives to talk
"in terms of low testosterone and not hypogonadism" because it found that primary care
physicians did not respond well to the term "hypogonadism." Id.
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This same strategy is reflected in AbbVie's approach towards its direct-toconsumer advertisements. AbbVie's direct consumer marketing of AndroGel during this
period generally consisted of branded and unbranded advertising. AbbVie needed the
FDA's prior authorization before disseminating a new advertisement for AndroGel.
Generally, the FDA sought to keep AbbVie's branded advertisements of AndroGel
consistent with the product's approved label. For example, in June 2003, AbbVie
submitted to the FDA a proposed television advertisement featuring a man discussing
symptoms of low testosterone. In the proposed advertisement, a man states, "I hadn’t
been feeling like myself for a while . . . I was tired, felt down and my sex drive was in
neutral. My doctor said any one of these symptoms, among others, could be a sign of
low testosterone." Defs.' Ex. 48 at E48-008. While the man makes this statement, the
language "LOW TESTOSTERONE (hypogonadism)" is superimposed on the image in
bold text. In a later shot of the advertisement, the man states that "over 4 million men
have low testosterone and . . . while AndroGel might not be right for everyone . . . your
doctor will know . . . if it's right for you." Id. In that same frame, the language "NOT
FOR EVERYONE" and "INDIVIDUAL RESULTS MAY VARY" are superimposed on the
image. Id. at E48-009. According to an AbbVie report, the FDA took no issue with this
advertisement because the agency believed the advertisement did not "differ
substantially from the material currently in use." Defs.' Ex. 49.
Unbranded advertisements do not require FDA review because the FDA
considers unbranded advertisements educational rather than promotional. AbbVie’s
unbranded advertisements focused on "disease awareness" and made no productspecific claims. Specifically, AbbVie launched a disease awareness advertising
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campaign for men with low testosterone or "Low T." AbbVie distributed direct-toconsumer advertisements through unbranded websites, third parties, and television
advertisements, encouraging aging men to ask their healthcare professionals to test
them for low testosterone or "Low T." For example, in 2001, AbbVie released an
unbranded advertisement that appeared in question-and-answer format. The
advertisement stated:
Q: Should I just accept my low testosterone as a natural part of getting
old?
A: Experts have determined that testosterone replacement therapy (TRT)
may help counter some of the more serious debilitating, effects of aging.
In addition to its known role in aiding sexual desire and function, TRT may
also help patients maintain bone mineral density (which is important for
avoiding bone fractures), increase their amount of muscle, and decrease
body fat. There is also evidence to suggest that TRT can help improve
mood. If you’re hypogonadal, TRT may help you maintain your health and
preserve your lifestyle.
Pls.' Ex. 40.
In 2005, AbbVie distributed a direct-to-consumer print advertisement showing a
coffee cup and an energy bar with the following text superimposed on the image: "For
nearly 8 million men, no amount of coffee can replace the energy they’ve lost. If fatigue,
depressed mood, or low sex drive is part of your daily grind, you have low testosterone
(Low T)." Defs.' Ex. 54 at ABBVIE-FST00383450. One page of the advertisement
invites consumers to answer a 10-question survey to identify if they suffer from low T.
The page bears the caption, "Could your thirst for energy be caused by Low T?" Id.
The advertisement suggests TRT as treatment for low T, claiming that TRT "can raise
testosterone levels, which may improve your energy, mood, and sex drive." Id.
In 2009, an AbbVie unbranded commercial encouraged men who felt they had
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less energy to investigate an unbranded website, IsItLowT.com, to consider whether
they suffered from low T. Pls.' Ex. 1 (Kessler Report) ¶ 251 & n.235. The
advertisement stated:
Millions of men 45 and older just don’t feel like they used to. Are you one
of them? Remember when you had more energy for 18 holes with your
buddies? More passion for the one you love? More fun with your family
and friends? It could be a treatable condition called low testosterone or
Low T.
Id.
AbbVie's unbranded commercials, slide kits for physicians, and other promotional
material during the relevant period encouraged physicians and patients to investigate
testosterone replacement for aging males. AbbVie's advertisements suggested that
having testosterone levels below 300 ng/dL is indicative that a patient has age-related
hypogonadism or age-related low testosterone.
Prescriptions for TRTs overall rose after the introduction of AndroGel 1%.
5.
Risks associated with AndroGel
On February 9, 2015, the FDA directed AbbVie to change its labels for AndroGel
1% and AndroGel 1.62% because it had become aware "of the risk of major adverse
cardiovascular outcomes associated with testosterone replacement therapy." Pls.' Ex.
80 at ABBVIE-FST03767438. The FDA directed AbbVie to remove "idiopathic" from
AndroGel's indication for hypogonadotropic hypogonadism, which stated, "idiopathic
gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitaryhypothalamic injury from tumors, trauma, or radiation." Pls.' Ex. 79 at ABBVIEFST02620706; Pls.' Ex. 80 at ABBVIE-FST03767441. The FDA also directed AbbVie to
add language indicating that AndroGel had not been determined to be safe and
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effective for age-related hypogonadism. For example, under AndroGel's "indications
and usage" section, the FDA directed AbbVie to add the language that, "[s]afety and
efficacy of AndroGel [1% and 1.62%] in men with age-related hypogonadism have not
been established" and that "[a]ge-related hypogonadism refers to men with serum
testosterone concentrations below the normal range for no apparent reason other than
age, and who experience signs and symptoms of aging that overlap with those of
hypogonadism." Pls.' Ex. 79 at ABBVIE-FST02620705; Pls.' Ex. 80 at ABBVIEFST03767442.
In March 2015, the FDA issued a drug safety communication for testosterone
products and cautioned medical practitioners against prescribing the drug for conditions
for which it was not indicated:
The U.S. Food and Drug Administration (FDA) cautions that prescription
testosterone products are approved only for men who have low
testosterone levels caused by certain medical conditions. The benefit
and safety of these medications have not been established for the
treatment of low testosterone levels due to aging, even if a man’s
symptoms seem related to low testosterone. We are requiring that the
manufacturers of all approved prescription testosterone products change
their labeling to clarify the approved uses of these medications. We are
also requiring these manufacturers to add information to the labeling about
a possible increased risk of heart attacks and strokes in patients taking
testosterone. Health care professionals should prescribe testosterone
therapy only for men with low testosterone levels caused by certain
medical conditions and confirmed by laboratory tests.
Testosterone is FDA-approved as replacement therapy only for men
who have low testosterone levels due to disorders of the testicles,
pituitary gland, or brain that cause a condition called hypogonadism.
Examples of these disorders include failure of the testicles to produce
testosterone because of genetic problems, or damage from chemotherapy
or infection. However, FDA has become aware that testosterone is
being used extensively in attempts to relieve symptoms in men who
have low testosterone for no apparent reason other than aging. The
benefits and safety of this use have not been established.
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Pls.' Ex. 6 (emphasis added).
Discussion
AbbVie has moved for summary judgment on what it refers to as plaintiffs' offlabel marketing claims. 1 Summary judgment is appropriate if the movant 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); Wedemeyer v. CSX Transp., Inc.,
850 F.3d 889, 894 (7th Cir. 2017). In making this determination, the Court construes all
facts and draws reasonable inferences in favor of the nonmoving party. Id.
A.
"Off-label marketing" claims
AbbVie argues that it is entitled to summary judgment on what it calls plaintiffs'
off-label marketing claims because 1) they are repackaged failure to warn claims; 2)
they constitute an improper attempt to enforce the Federal Food, Drug, and Cosmetic
Act (FDCA) via private lawsuits; 3) plaintiffs cannot show that AbbVie made any false or
misleading statements in its promotional material; 4) they cannot establish reliance on
any statements made in off-label marketing of AndroGel; 5) they cannot show that
AbbVie's off-label marketing was the proximate cause of their injuries; 6) they cannot
support their claims for breach of express warranty because there is no evidence that
AbbVie made any specific affirmations in its advertisements; 7) plaintiff Mitchell's
express and implied warranty claims are barred by Oregon Revised Statutes §
72.6070(3); 8) plaintiff Rowley's consumer protection claim is barred by the Utah
Consumer Sales Practices Act; 9) plaintiffs are not entitled to punitive damages; and 10)
Plaintiff Robert Rowley does not assert claims against AbbVie arising from off-label
marketing of AndroGel.
1
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plaintiff Cribbs cannot show that he conferred a benefit directly on AbbVie as needed to
support his unjust enrichment claim.
1.
Failure to warn
AbbVie argues that what it calls plaintiffs' off-label marketing claims involve two
types of alleged misrepresentations. The first, AbbVie contends, are alleged
misrepresentations that AndroGel was approved for age-related hypogonadism / low
T—what AbbVie calls "misbranding misrepresentations." The second, AbbVie
contends, are alleged misrepresentations that AndroGel was a safe and effective
treatment for age-related hypogonadism / low T—what AbbVie calls "safety
misrepresentations." See Defs.' Mem. in Supp. of Mot. for Summ. J. on Pls.' Off-Label
Claims (Defs.' Mem.) at 30. AbbVie argues that claims of misbranding
misrepresentations constitute an improper attempt to enforce the FDCA and are, in any
event, unsupported. See id. at 31. It argues that claims of safety misrepresentations
are "repackaged failure-to-warn claim[s]" that are preempted by federal law and are, in
any event, unsupported. See id. at 37.
Plaintiffs, however, have not asserted claims for off-label marketing of AndroGel.
Rather, they assert claims for intentional and negligent misrepresentation, breach of
warranty, and violation of state consumer protection statutes. In these claims, they
contend that AbbVie made false statements about AndroGel's efficacy and safety. It
may be that these claims involve AbbVie's marketing of AndroGel for non-indicated
uses, but that does not mean they are claims "for off-label marketing" of the drug.
In any event, the Court disagrees with AbbVie's contention that these claims
represent, in part, a mere relabeling (no pun intended) of plaintiffs' claims alleging
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failure to warn. The two are logically distinct, and even if there is overlap in their factual
or legal underpinnings, there is nothing that prevents a party from asserting multiple but
legally distinct claims that arise from the same events. And finally, even if these claims
tracked the failure to warn claims, this would not entitle AbbVie to summary judgment.
AbbVie's contention is that the failure to warn claims are deficient for reasons argued in
a separate motion for summary judgment, and thus any repackaging of those claims
fails for the same reasons. But the Court has separately denied AbbVie's motion for
summary judgment on plaintiffs' failure to warn claims, and the same reasoning would
warrant denying summary judgment on the supposedly "repackaged" claims.
For the remainder of this opinion, in referring to plaintiff's misrepresentation and
warranty-based claims, the Court will call them the "marketing claims" for ease of
reference.
2.
Preemption / private enforcement of FDCA
AbbVie asserts that it is entitled to summary judgment on plaintiffs' marketing
claims that concern "misbranding" because these claims constitute an improper attempt
to privately enforce FDA regulations that prohibit drug manufacturers from promoting
off-label uses of their drugs. AbbVie notes that plaintiffs use the term "misbranding"
throughout their complaint and make allegations that AbbVie's marketing of AndroGel
violated FDA regulations.
Regulations under the FDCA prohibit a drug manufacturer from promoting offlabel uses of its prescription drugs. See 21 C.F.R. § 202.1(e)(6). And dissemination of
an advertisement not in compliance with FDA regulations causes a drug to be
"misbranded" in violation of the FDCA. 21 C.F.R. § 202.1(j)(3); 21 U.S.C. § 352(n). But
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the statute states that "all . . . proceedings for the enforcement, or to restrain violations,
of [the FDCA] shall be by and in the name of the United States." 21 U.S.C. § 337(a).
Thus what is really at issue here is a question of federal preemption. State law
claims that seek only to enforce FDA regulations are impliedly preempted. Buckman
Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 344 (2001). In Buckman, plaintiffs brought
a fraud claim based on a misrepresentation the defendant allegedly made during the
FDA approval process for its medical device—essentially a claim of fraud on the FDA.
The Court noted that "the federal statutory scheme amply empower the FDA to punish
and deter fraud against the [agency], and . . . this authority is used by the [agency] to
achieve a somewhat delicate balance of statutory objectives." Id. at 348. This balance,
the Court concluded, "can be skewed by allowing fraud-on-the-FDA claims under state
tort law." Id. In concluding that the plaintiffs' fraud-on-the-FDA claim was preempted,
however, the Court distinguished cases in which the plaintiff's claim arises from
traditional state tort law principles and not "solely from the violation of FDCA
requirements." Id. at 352. Such claims are not preempted, even if the "state-law
causes of actions . . . parallel federal safety requirements." Id. at 353. In other words,
the Court in Buckman "specifically distinguished . . . 'fraud-on-the-agency' claims, i.e.,
claims not related to a field of law that states had traditionally occupied." Bausch v.
Stryker Corp., 630 F.3d 546, 557 (7th Cir. 2010). See also Stengel v. Medtronic Inc.,
704 F.3d 1224, 1235 (9th Cir. 2013) (the Court in Buckman held that the plaintiffs' claim
"was impliedly preempted because it sought to enforce an exclusively federal
requirement and was not grounded in traditional state tort law.").
In the present cases, plaintiffs' marketing claims are not impliedly preempted by
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the FDCA or under Buckman, because the claims are grounded in traditional state law
principles of liability, such as negligence, failure to warn, strict product liability, and fraud
that predate the relevant FDCA requirements. The claims do not depend on violations
of requirements or prohibitions imposed by the FDCA. McDaniel v. Upsher-Smith
Pharm., Inc., No. 216CV02604JPMCGC, 2017 WL 657778, at *5 (W.D. Tenn. Jan. 26,
2017) ("Plaintiff's claim of fraud and deceit is not expressly or impliedly preempted
[because] [s]tate laws traditionally prohibit fraud and deceit in advertising and marketing
as well."); Arvizu v. Medtronic Inc., 41 F. Supp. 3d 783, 791 (D. Ariz. 2014) ("But
Plaintiffs do not allege misrepresentations or omissions based on the FDA approved
label. Rather, they allege that Defendants 'fraudulently concealed and misrepresented
information' about the off-label uses of the Infuse Device. These claims lie parallel to
federal requirements.") (applying the MDA and Arizona law); Alton v. Medtronic, Inc.,
970 F. Supp. 2d 1069, 1098 (D. Or. 2013) (finding that claims based on allegations of
misrepresentation "are sufficient to state an actionable claim under the Oregon common
law of fraud, independently of the FDCA or of any other federal law."); Ramirez v.
Medtronic Inc., 961 F. Supp. 2d 977, 994-95 (D. Ariz. 2013) ("The state law claims here
exists independent of federal law. Put another way, all things being equal, [plaintiff]
could bring a claim against [defendant] for knowingly concealing information in off-label
promotion even if off-label promotion was legal under federal law.").
As plaintiffs contend and as the Court has noted, plaintiffs' off-label claims do not
depend on a finding that AbbVie violated the FDCA or FDA regulations. For example, a
reasonable jury could find AbbVie liable for making misrepresentations about the safety
and efficacy of AndroGel for treating age-related hypogonadism or for making
15
misrepresentations about the indications for which the FDA approved AndroGel. And
although plaintiffs' complaints make reference to regulations regarding misbranding,
they do so in the context of establishing the standard of care that they contend AbbVie
breached, and to help establish AbbVie's intent and motive in connection with its
marketing of AndroGel. See, e.g., Fourth Am. Master Compl. ¶¶ 494-500. The fact that
plaintiffs cannot assert claims to enforce the FDCA's prohibitions or requirements does
not preclude them from, for example, introducing evidence regarding the indications for
which the FDA approved AndroGel. "Buckman does not mean plaintiffs cannot bring
state law claims based on conduct that violates the FDCA." Eidson v. Medtronic, Inc.,
981 F. Supp. 2d 868, 880-81 (N.D. Cal. 2013).
3.
False or misleading statements
AbbVie contends that no reasonable jury could find that it made false or
misleading representations in its marketing, particularly in its "Low T" marketing
campaign. It argues that one of AndroGel's indicated uses as approved by the FDA
was to treat "idiopathic" hypogonadism, and it contends this includes age-related
hypogonadism. A reasonable jury could find, however, that this is not the case. As
indicated earlier, there is evidence that the FDA repeatedly rejected requests or
attempts by AbbVie to include age-related hypogonadism as an indicated use. And the
agency also commented, with its reviewed AbbVie's initial proposed promotional
materials, that claims suggesting AndroGel is indicated for men with age-associated
hypogonadism or "andropause" were misleading. A reasonable jury could find that
AbbVie made false or misleading representations when it marketed AndroGel with
statements to the effect that it is a safe and effective treatment for age-related "low T."
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AbbVie also contends that the FDA approved its unbranded advertising material.
It evidently submitted to the FDA a direct-to-consumer print advertisement referring to
hypogonadism as low T and including symptoms associated with age-related
hypogonadism. The ad shows a coffee cup and an energy bar with the following text
superimposed on the image: "For nearly 8 million men, no amount of coffee can
replace the energy they've lost. If fatigue, depressed mood, or low sex drive is part of
your daily grind, you have low testosterone (low T)." Defs.' Ex. 54 at ABBVIEFST00383450. The FDA did not comment, but the agency's charge does not require
review or approval of unbranded advertisements of this type. AbbVie offers no support,
and the Court is aware of none, for the proposition that the FDA's silence indicates its
approval of the ad or similar ads.
Finally, AbbVie argues that it used in its unbranded ads only language that the
FDA had approved for branded advertising. But context matters, and the Court is
unpersuaded that AbbVie can bootstrap the FDA's okaying of language for one purpose
into a determination that, as a matter of law, the company's use of the same language
for another purpose and in a different context was not false or misleading.
4.
Reliance / causation
AbbVie argues that plaintiffs cannot establish the necessary reliance on any false
or misleading statements in its advertising. Assuming plaintiffs are, as AbbVie
contends, required to prove that their prescribing physicians relied on the
misstatements—a proposition for which AbbVie provides only scant support, see Defs.'
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Mem. at 42-43 2—a reasonable jury could make the requisite finding in plaintiffs' favor.
The state laws governing the bellwether trial cases use some variation of the
definition of reliance found in the Restatement of Torts: "In order to justify recovery, the
recipient of a misrepresentation must rely upon the truth of the misrepresentation itself,
and his reliance upon its truth must be a substantial factor in inducing him to refrain
from action." Restatement (2d) of Torts § 548. A plaintiff need not show that his (or, if
AbbVie is right, his physician's) reliance was the sole or even the predominant
influence; rather, "[i]t is enough that the representation has played a substantial part,
and so has been a substantial factor, in influencing his decision." Whiteley v. Philip
Morris Inc., 117 Cal. App. 4th 635, 678, 11 Cal. Rptr. 3d 807, 843 (2004) (internal
citations and quotation marks omitted). "Except in the rare case where the undisputed
facts leave no room for a reasonable difference of opinion, the question of whether a
plaintiff's reliance is justified is a question of fact." Parrish v. Wells Fargo Bank, N.A.,
No. D070686, 2017 WL 411052, at *6 (Cal. Ct. App. Jan. 31, 2017) (internal quotation
marks omitted).
Though the Court need not decide the point definitively at this juncture, it has serious
doubt regarding whether the learned intermediary doctrine, which most commonly
applied in connection with failure to warn claims, also applies to the types of claims
addressed in this ruling. Under the doctrine, a manufacturer or supplier of a prescription
drug has no legal duty to warn a consumer of the drug's dangerous propensities, so
long as it provides adequate warnings to the prescribing physician. See, e.g., Carlin v.
Superior Court, 13 Cal. 4th 1104, 1126, 920 P.2d 1347, 1360 (1996). But here AbbVie
directed its marketing not only to physicians but also to the general public. If false or
misleading representations in the direct-to-consumer advertising influenced an
individual to request the drug in the first instance or to decide to take it once prescribed,
it is not all that easy to see why the learned intermediary doctrine should govern in a
way that would bar his claim. It would seem that if a misrepresentation was a
substantial factor vis-à-vis either the decision by a physician to prescribe the drug or the
decision by a plaintiff to request or take it, that should be enough. The Court likely will
require further briefing on this topic in connection with the upcoming trials.
2
18
The evidence is sufficient to support a reasonable finding by a jury that each of
the prescribing physicians relied on AbbVie's alleged misrepresentations regarding the
safety and efficacy of testosterone replacement therapy in general and AndroGel
specifically in prescribing the drug for the plaintiffs. Each of the physicians testified
regarding "low T" marketing efforts by AbbVie sales representatives, and a reasonable
jury could find in each instance that AbbVie's marketing of the drug for age-related
hypogonadism or other non-indicated uses was a substantial factor in the prescribing
decision. Some of them testified that they did not base their decisions entirely on
information from sales representatives, but as noted earlier, that is not the issue—
"substantial factor" is the standard, not total and complete reliance to the exclusion of
everything else. And this same analysis requires overruling AbbVie's argument
regarding causation.
5.
Express warranty
AbbVie argues that plaintiffs' breach of express warranty claims fail because
there is no evidence that the company made any specific affirmations in its marketing.
AbbVie also singles out plaintiff Konrad, arguing that his express warranty claim fails
because Tennessee law requires actual reliance and the evidence would not permit a
finding that Konrad relied on any express warranty. AbbVie has not explained why for
breach of express warranty should be treated differently under Tennessee law than
under the law of the other states at issue. The Court has previously ruled that, to state
a claim for breach of express warranty in every state at issue, plaintiffs must point to a
specific affirmation or promise on which the plaintiffs relied. In re Testosterone
Replacement Therapy Prod. Liab. Litig., No. 14 C 1748, 2014 WL 7365872, at *8 (N.D.
19
Ill. Dec. 23, 2014). Indeed, the Court initially dismissed plaintiffs' express warranty
claims because they failed to specify affirmations or promises from AbbVie on which
they relied. Now, after having amended their complaint to cure the pleading defect,
plaintiffs have presented evidence sufficient for a reasonable jury to find that AbbVie,
through its marketing, specifically affirmed and represented to consumers that 1) "low T"
was a condition in need of treatment and 2) AndroGel was a safe and an effective
treatment for age-related reduced testosterone levels.
To summarize, plaintiffs have presented evidence sufficient for a jury to find that
AbbVie attempted to create and market "low T" as, in effect, a disease requiring
treatment. An example of this is AbbVie's advertisement that states, "[i[f fatigue,
depressed mood, or low sex drive is part of your daily grind, you may have low
testosterone (Low T)." Defs.' Ex. 54 at ABBVIE-FST00383450. Plaintiffs have also
provided evidence sufficient to find that AbbVie represented that AndroGel was a safe,
effective treatment for treating "low T." By way of example, one unbranded
advertisement for AbbVie states, "Testosterone replacement therapy can raise
testosterone levels, which may improve your energy, mood, and sex drive." Id. at 3.
This sort of advertising prompted Nolte, for example, to ask his doctor to prescribe
AndroGel, because he believed it would "cure" him and make him "whole again." Pls.'
Ex. 64 (Nolte Dep.) at 123:12-13. Likewise, Frost stated that AbbVie's advertisements
"made [AndroGel] sound like it was a miracle cure for testosterone problems . . . ." Pls.'
Ex. 72 (Frost Dep.) at 196:9-20. Finally, plaintiffs have also provided evidence of
specific affirmations that AbbVie representatives made to plaintiffs' prescribing
physicians, including that AndroGel was a safe, effective treatment for age-related
20
hypogonadism. AbbVie is not entitled to summary judgment on the express warranty
claims of the bellwether plaintiffs other than Mitchell, which the Court addresses below.
6.
Implied warranty
AbbVie argues that Mitchell's express and implied warranty claims are barred
because he failed to notify AbbVie of the warranty breach prior to filing his lawsuit, as
allegedly required by section 72.6070(3) of the Oregon Revised Statutes. Mitchell
argues that section 72.6070(3) does not govern because it applies to claims of
nonconforming goods initially accepted by the purchaser "presumably to provide an
opportunity to cure." Pls.' Resp. to Defs.' Mot. for Summ. J. (Pls.' Resp.) at 69.
Section 72.6070(3) provides when a tender of goods has been accepted, "[t]he
buyer must within a reasonable time after the buyer discovers or should have
discovered any breach notify the seller of breach or be barred from any remedy."
District courts in Oregon have interpreted the "notice requirement of § 72.6070(3) to
apply in warranty actions for personal injuries resulting from the purchase of a
consumer product, including an action against a contraceptive drug maker." Parkinson
v. Novartis Pharm. Corp., 5 F. Supp. 3d 1265, 1276 (D. Or. 2014) (internal quotation
marks omitted). In Allen v. G.D. Searle & Co., 708 F. Supp. 1142 (D. Or. 1989), the
court said that it "has not located any Oregon decision holding that notice is no longer
required in a warranty action for personal injuries resulting from the purchase of a
consumer product." Id. at 1160. The court noted that the Supreme Court of Oregon
stated that notice is an essential element of a claim for breach of warranty. Id. (citing
Redfield v. Mead, Johnson & Co., 266 Or. 273, 284, 512 P.2d 776, 781 (1973)). The
court concluded that, "[i]n the absence of any authority for abolishing the notice
21
requirement, and in the absence of any evidence that [the plaintiff] gave notice of her
express or implied warranty claims, this court must rule that [the plaintiff] has not
established an essential element of her warranty claims." Allen, 708 F. Supp. at 1160;
see also, e.g., Simonsen v. Ford Motor Co., 196 Or. App. 460, 463, 102 P.3d 710, 713
(2004) (acknowledging notice requirement in a product liability case); Canady v. OrthoMcNeil Pharm., Inc., No. 3:11 OE 40011, 2014 WL 4930675, at *5 (N.D. Ohio Oct. 1,
2014) (applying Or. Rev. Stat. § 72.6070); In re ConAgra Foods Inc., 908 F. Supp. 2d
1090, 1111 (C.D. Cal. 2012) (same).
Mitchell contends that section 30.900 of the Oregon Revised Statutes abolishes
the notice requirement because it "sets forth statutory product liability claims
supersedes the U.C.C. statute." Pls.' Resp. at 69. But the case in which Mitchell relies,
Phelps v. Wyeth, Inc., 857 F. Supp. 1114, 1123 (D. Or. 2012), makes no mention of
superseding the notice requirement in section 72.6070(3) or overruling the Oregon
Supreme Court's decision in Redfield.
The Court grants summary judgment in favor of defendants on Mitchell's express
warranty claim due to the absence of prior notice required by Or. Rev. Stat. §
72.6070(3). Mitchell's implied warranty claim, however, may proceed; none of the
authorities cited above apply section 72.6070(3) to implied warranty claims.
7.
Consumer protection
AbbVie argues that Rowley's consumer protection claim should be dismissed
because the Utah Consumer Sales Practices Act does not permit claims predicated on
personal injury. It is true that Utah Code Ann. § 13-11-22(1)(c) states that the statute
does not apply to a "claim for personal injury or death or claim for damage to property
22
other than the property that is the subject of the consumer transaction." But Rowley
does not seek personal injury-type damages on his consumer fraud claim; rather, he
seeks to recover economic losses, such as the costs of purchasing AndroGel. See Pls.'
Resp. at 69. This would appear to be a proper form of recovery, so the Court declines
to grant summary judgment for AbbVie on Rowley's consumer protection statutory
claim.
8.
Punitive damages
AbbVie contends that Arizona, Oregon, and Utah law bars punitive damages in
pharmaceutical products liability actions where the product was manufactured and
labeled in accordance with terms approved by the FDA or is generally recognized as
safe and effective under FDA regulations. AbbVie also argues that it is entitled to
summary judgment on the claims from the states at issue that do allow for punitive
damages—California, North Carolina, and Tennessee—because plaintiffs cannot prove
that AbbVie engaged in fraud. Plaintiffs contend that Illinois law governs punitive
damages in these cases because AbbVie is domiciled in Illinois. The Court agrees with
plaintiffs for the reasons discussed in its separate ruling regarding plaintiffs' failure to
warn and products liability claims.
Under Illinois law, "punitive damages may be awarded when the defendant acted
with fraud, actual malice, deliberate violence or oppression, or when the defendant
acted willfully, or with such gross negligence as to indicate a wanton disregard for the
rights of others." Ross v. Black & Decker, Inc., 977 F.2d 1178, 1187 (7th Cir. 1992)
(internal quotation marks omitted). Factors to be considered in determining whether the
conduct of a defendant in a products liability case warrants imposition of punitive
23
damages include the defendant's knowledge of a defect in its product and its
corresponding knowledge that the defect is likely to cause injury, and its failure to take
action to avoid the potential for injury arising from the defect. Dewick v. Maytag Corp.,
296 F. Supp. 2d 905, 907 (N.D. Ill. 2003). Thus, plaintiffs need only present evidence
that would permit a reasonable jury to find that AbbVie knew that AndroGel was not a
safe and effective treatment for age-related low testosterone and yet marketed it as if it
was.
Plaintiffs here have presented evidence sufficient to permit a reasonable jury to
find that that AbbVie had knowledge that its advertisements contained false or
misleading statements. AbbVie was told on several occasions that AndroGel was not
an appropriate treatment for age-related low testosterone. For example, the FDA
removed language in AndroGel's initial promotional material that attempted to relay the
message that AndroGel was a safe, effective treatment for age-related low testosterone.
The FDA said that this language should be removed because "[c]laims and
representations that suggest AndroGel is indicated for men with 'age-associated'
hypogonadism or 'andropause' are misleading." Defs.' Ex. 42 at E42-004. AbbVie
nonetheless launched an advertising campaign to arguably create and then capture the
age-related hypogonadism market for its product. There is evidence that it adopted a
strategy to "[p]ursue age-related hypogonadism market expansion;" "[e]ducate and
motivate physicians to treat low T;" and "[e]ducate patients about the symptoms of and
benefits of treating low testosterone." Pls.' Ex. 37. AbbVie's strategy for advertising
AndroGel to primary care physicians, specifically, was to "sell market expansion first
and AndroGel second." Pls.' Ex. 38. To accomplish this, AbbVie directed its
24
pharmaceutical representatives to talk "in terms of low testosterone and not
hypogonadism" because it found that primary care physicians did not respond well to
the term "hypogonadism." Id. AbbVie also launched a "disease awareness" advertising
campaign for men with low testosterone levels. It distributed direct-to-consumer
advertisements through unbranded websites, third parties, and television
advertisements, encouraging aging men to request that their healthcare professionals
test them for "low T."
This and other evidence offered by plaintiffs would permit a reasonable jury to
find that AbbVie acted willfully and wantonly, thus permitting an award of punitive
damages.
10.
Unjust Enrichment
The Court has separately ruled on AbbVie's request for summary judgment on
Cribbs's claim of unjust enrichment.
B.
Motions to exclude expert testimony
AbbVie has also moved to exclude the testimony of several experts that plaintiffs
have retained to support their marketing claims: Drs. David A. Kessler, Peggy Pence,
Steven Woloshin, David J. Handelsman, Hossein Ardehali, and Curt Furberg.
The admission of expert testimony is governed by Federal Rule of Evidence 702
and the principles set forth in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579
(1993). Rule 702 provides:
A witness who is qualified as an expert by knowledge, skill, experience,
training, or education may testify in the form of an opinion or otherwise if:
(a) the expert's scientific, technical, or other specialized knowledge will
help the trier of fact to understand the evidence or to determine a fact in
issue;
25
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert has reliably applied the principles and methods to the facts
of the case.
Fed. R. Evid. 702.
A district court plays the role of gatekeeper in determining whether proposed
expert testimony meets the standards of Rule 702. Daubert, 509 U.S. at 597. To fulfill
this role, the Court must determine whether 1) the expert is qualified to give the opinion
she is offering; 2) the testimony is based on a reliable methodology; and 3) whether the
testimony will assist the trier of fact in understanding the evidence or determining a fact
at issue in the case. Cummins v. Lyle Indus., 93 F.3d 362, 368 (7th Cir. 1996).
In ascertaining whether an expert is qualified, the Court asks "not whether an
expert witness is qualified in general, but whether his qualifications provide a foundation
for him to answer a specific question." Gayton v. McCoy, 593 F.3d 610, 617 (7th Cir.
2010). In making this determination, the Court is to "consider a proposed expert's full
range of practical experience as well as academic or technical training." Smith v. Ford
Motor Co., 215 F.3d 713, 718 (7th Cir. 2000).
Concerning reliability, the Supreme Court provided in Daubert a non-exhaustive
list of factors for determining whether scientific testimony is sufficiently reliable to be
admitted into evidence. Daubert, 509 U.S. at 593-94. Relevant factors for assessing
the reliability of an expert's methods include "(1) whether the scientific theory or
technique can be (and has been) tested; (2) whether the theory or technique has been
subjected to peer review and publication; (3) whether a particular technique has a
26
known potential rate of error; and (4) whether the theory or technique is generally
accepted in the relevant scientific community." Schultz v. Akzo Nobel Paints, LLC, 721
F.3d 426, 431 (7th Cir. 2013).
The thrust of the Daubert inquiry is to ensure "that an expert, whether basing
testimony upon professional studies or personal experience, employs in the courtroom
the same level of intellectual rigor that characterizes the practice of an expert in the
relevant field." Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). The inquiry is
necessarily a flexible one because the determination of whether an expert's methods
are reliable "is an individualized test whose relevant factors will depend on the type of
expertise at issue in a given case." Smith, 215 F.3d at 720. For example, though peer
reviewed publications can be relevant in assessing an expert's reliability, the "lack of
peer review will rarely, if ever, be the single dispositive factor that determines the
reliability of expert testimony." Id. An expert may draw upon a number of sources to
form a reliable opinion, including from his own professional knowledge, skill, and
expertise, so long as they are relevant to the subject on which the expert seeks to offer
his testimony. See, e.g., Walker v. Soo Line R.R. Co., 208 F.3d 581, 591 (7th Cir.
2000) ("Rule 702 specifically contemplates the admission of testimony by experts
whose knowledge is based on experience."). Indeed, experts commonly rely on their
professional experience to "offer opinion testimony regarding the standard of care and
generally-accepted industry standards." Cage v. City of Chicago, 979 F. Supp. 2d 787,
803 (N.D. Ill. 2013) (citing WH Smith Hotel Servs., Inc. v. Wendy's Int'l, Inc., 25 F.3d
422, 429 (7th Cir. 1994)).
In addition to being reliable, the expert's testimony must assist the trier of fact.
27
This is essentially a relevance inquiry. "Expert testimony which does not relate to any
issue in the case is not relevant and, ergo, non-helpful." Porter v. Whitehall Labs., Inc.,
9 F.3d 607, 613 (7th Cir. 1993) (internal quotation marks omitted). If an expert's
testimony is helpful to the jury, it is admissible even if it "cover[s] matters that are within
the average juror's comprehension." United States v. Hall, 93 F.3d 1337, 1342 (7th Cir.
1996). Testimony that would be unhelpful to a jury may be barred under Rule 702 and
can be excluded under Federal Rule of Evidence 403. See Thompson v. City of
Chicago, 472 F.3d 444, 457 (7th Cir. 2006).
Expert testimony that effectively usurps the role of the jury is generally
considered to be unhelpful. As this Court has stated, "testimony that does little more
than tell the jury what result to reach is unhelpful and thus inadmissible." Dahlin v.
Evangelical Child & Family Agency, No. 01 C 1182, 2002 WL 31834881, at *3 (N.D. Ill.
Dec. 18, 2002) (internal quotation marks omitted). For example, expert testimony
"about legal issues on which the judge will instruct the jury" is typically inadmissible
because it does not assist the finder of fact in making its ultimate decision. United
States v. Sinclair, 74 F.3d 753, 758 n.1 (7th Cir. 1996); see, e.g., Good Shepherd
Manor Found., Inc. v. City of Momence, 323 F.3d 557, 564 (7th Cir. 2003). Similarly,
"testimony regarding intent . . . is even more likely to be unhelpful to the trier of fact"
because the expert merely draws "inferences from the evidence" that the jury could
draw equally well. Dahlin, No. 01 C 1182, 2002 WL 31834881, at *3 (internal quotation
marks omitted).
Expert testimony may also be excluded under Rule 403. Rule 403 provides that
"relevant evidence may be excluded if its probative value is substantially outweighed by
28
the danger of unfair prejudice, confusion of the issues, or misleading the jury, or by
considerations of undue delay, waste of time, or needless presentation of cumulative
evidence." Fed. R. Evid. 403. Evidence is "unfairly prejudicial in the context of Rule
403 if it will induce the jury to decide the case on an improper basis, commonly an
emotional one, rather than on the evidence presented." Common v. City of Chicago,
661 F.3d 940, 947 (7th Cir. 2011) (internal quotation marks omitted).
The proponent of expert testimony bears the burden of establishing, by a
preponderance of the evidence, that the testimony satisfies Daubert's standards and is
otherwise admissible. Lewis v. CITGO Petroleum Corp., 561 F.3d 698, 705 (7th Cir.
2009). When determining whether the proponent of expert testimony has met that
burden, however, a court must be mindful that "[a] Daubert inquiry is not designed to
have the district judge take the place of the jury to decide ultimate issue of credibility
and accuracy." Lapsley v. Xtek, Inc., 689 F.3d 802, 805 (7th Cir. 2012). If the credibility
or accuracy of an expert opinion is in question, the proper remedy is not exclusion of the
testimony, but rather testing the opinion before the jury using the traditional tools of
"vigorous cross-examination, presentation of contrary evidence, and careful instruction
on the burden of proof." Daubert, 509 U.S. at 596.
1.
Dr. David A. Kessler
AbbVie has moved to exclude the testimony of plaintiffs' expert Dr. David
Kessler, contending that his opinions are unreliable, improper, and unfairly prejudicial.
Specifically, AbbVie argues that (1) Dr. Kessler is not qualified to testify about "off-label"
marketing or the risks associated with it; (2) his opinions are improper because he
bases them on an unreliable methodology; (3) he offers improper testimony regarding
29
the motives, intent, and thought processes of AbbVie and the FDA; (4) he offers
inadmissible legal conclusions regarding FDA law and policy; (5) his testimony includes
an improper factual narrative; and (6) his opinions are unfairly prejudicial, confusing,
and misleading to the jury.
First, AbbVie argues that Dr. Kessler is not qualified to offer opinions on
pharmaceutical marketing practices because he has no education or training in that
field; he has never evaluated or analyzed a pharmaceutical marketing campaign as part
of academic research; and he has never authored or commissioned a pharmaceutical
marketing report or worked in pharmaceutical marketing.
Contrary to AbbVie's contention, Dr. Kessler is amply qualified to offer his
opinions on AbbVie's’ marketing of AndroGel, including whether it marketed and
promoted the drug for non-indicated, off-label uses. Dr. Kessler is a former
Commissioner of the FDA, a position that involved the regulation of marketing by drug
manufacturers; he has taught food and drug law; he has testified before Congress on
food, drug, and consumer protection issues; he has authored numerous publications on
federal regulation of food, drugs, and medical devices; he advises companies on the
standards of care within the pharmaceutical and medical device industry; and he is a
senior advisor to a private equity firm that owns pharmaceutical and biomedical
companies. He is certainly qualified to render opinions regarding whether a drug
manufacturer is marketing its product for off-label uses.
Second, AbbVie argues that Dr. Kessler is not qualified to testify on whether
there is a causal relationship between AndroGel and the increased risks of harm to
patients. Dr. Kessler has conceded as much, but plaintiffs are not offering his testimony
30
on the issue of causation. Rather, Dr. Kessler opines that studies linking TRT to certain
increased health risks should have led AbbVie conduct further investigation regarding
the link. These opinions pertain to regulatory and pharmaceutical industry standards,
which are plainly within Dr. Kessler's area of expertise. It is appropriate for Dr. Kessler,
in offering these opinions, to rely on the testimony of plaintiffs’ causation experts
regarding what the studies showed and the risks posed by TRT.
Third, AbbVie argues that Dr. Kessler's opinions are unreliable because they are
based only on his personal experience as opposed to an independent, objective, or
scientific methodology. However, the Court has already noted that Rule 702 permits an
expert to draw on his professional experience in informing his opinion. See Walker, 208
F.3d at 591. And Dr. Kessler currently advises pharmaceutical companies on how best
to comply with FDA regulations and industry standards. When he was Commissioner of
the FDA, Dr. Kessler had to assess whether a company's practices and promotional
materials complied with FDA regulations. His professional experience provides him with
a wealth of knowledge that he appropriately may draw upon in forming his opinions for
this case.
Fourth, AbbVie contends that Dr. Kessler's testimony on the rules and
regulations governing FDA drug approval and off-label marketing, whether the FDA
approved AndroGel for certain uses, what federal regulation permitted AbbVie to say
about AndroGel in its marketing, and whether its purposed off-label marketing of
AndroGel exposed patients to increased risk all constitute legal conclusions that are
barred by Rule 702. On the last of these points, it does not appear that Dr. Kessler
purports to offer his own independent views regarding exposure to risk; he relies on
31
AbbVie's labeling (specifically, its references to health risks) and defers to opinions to
be offered by other experts. See Kessler Report ¶¶ 448-49, 452-53.
There is no per se rule barring expert testimony on matters of law. The field of
FDA regulation of pharmaceutical products and marketing is highly complex, and a jury
reasonably requires assistance to understand it. See, e.g., In re Yasmin & YAZ
(Drospirenone) Mktg., Sales Practices & Prod. Liab. Litig., No. 3:09-MD-02100-DRH,
2011 WL 6302287, at *12 (S.D. Ill. Dec. 16, 2011) (admitting Dr. Kessler's testimony in
a related area). And as the Court has discussed, plaintiffs' claims are based on state
law doctrines such as negligence, failure to warn, strict products liability, breach of
warranty, and fraud. The ultimate conclusions a jury will have to draw are rooted in
state law, not federal law. And Dr. Kessler's testimony does not cover the ultimate
issues that the jury will decide; rather, it concerns off-label marketing and FDA
regulations. This testimony is neither irrelevant, otherwise improper, or unfairly
prejudicial or confusing. 3 That said, the Court agrees with AbbVie that Dr. Kessler may
not appropriately testify about the role of state tort liability vis-à-vis the federal regulatory
scheme, as this is a purely legal determination on which the Court has made rulings and
will instruct the jury and on which it is therefore inappropriate to provide testimony.
(This does not appear to be a particularly significant aspect of Dr. Kessler's anticipated
testimony. See Kessler Report ¶ 71 ("[T]he two systems of state consumer protection
and federal food and drug regulation operate in a complementary but independent
manner.").)
Limiting instructions may be necessary, but that is a matter that can be addressed
later upon an appropriate request.
3
32
Fifth, AbbVie argues that Dr. Kessler's testimony is improper because he "simply
regurgitate[s] evidence that could be presented directly to the jury." Defs.' Mem. at 56.
This includes his anticipated testimony on the history of AndroGel's promotional
materials and its dealings with the FDA. AbbVie contends that Dr. Kessler's testimony
amounts to an improper factual narrative with a "spin" that requires no specialized
knowledge. It contends that this amounts to improper advocacy that would invade the
"fact-finding province of the jury." Id.
The Court disagrees. Dr. Kessler's testimony will assist the jury in determining its
ultimate conclusions, and it presents no danger of invading the jury's province.
Moreover, to the extent he is summarizing voluminous records and materials, as
appears to be the case, this aspect of his testimony is properly admitted under Federal
Rule of Evidence 1006 as well as Rule 702 in the sense that he is identifying what he,
given his background and expertise, considers to be the most salient aspects of those
voluminous materials. See, e.g., In re Yasmin, 2011 WL 6302287, at *13. AbbVie will
have a full and fair opportunity to address any claims of incompleteness or undue
emphasis during cross-examination and presentation of contrary evidence. See id.
(citing United States v. Pree, 408 F.3d 855, 871 (7th Cir. 2005)).
Sixth, AbbVie argues that Dr. Kessler improperly seeks to offer testimony on
AbbVie's knowledge, motivations, and intent. It takes particular issue with Dr. Kessler's
opinion regarding the "intended use" of AndroGel. Specifically, Dr. Kessler opines that
AbbVie's "intended use for AndroGel included treatment for patients with low
testosterone independent of the medical conditions for which the drug was approved."
Kessler Report ¶ 313; see also, e.g., id. ¶¶ 466-68. The testimony surrounding this
33
particular terminology is properly admissible. Dr. Kessler evaluates AbbVie's marketing
materials and internal memoranda to assess whether and to what extent it was targeting
persons with conditions outside of AndroGel's indicated use. He also offers a
framework by which the jury can assess what AbbVie intended via its marketing. But
although Dr. Kessler may walk up to this line, he may not cross it; he cannot offer an
opinion or conclusion about what AbbVie intended, as that is a function properly
reserved to the jury.
Finally, AbbVie argues that Dr. Kessler's expert testimony should be excluded
because it is unfairly prejudicial. Specifically, it suggests that based on his background,
plaintiffs will be able to portray him as the ultimate authority in his field. The Court is
somewhat perplexed by this objection; AbbVie seems to be arguing that Dr. Kessler is
too qualified to testify. Regardless, the Court overrules the objection. In the Court's
experience, if an expert comes across as a know-it-all, he tends not to be believed, and
cross-examination is a sufficient check. That aside, AbbVie may raise this point if
appropriate before closing argument in addressing what plaintiffs' counsel may and may
not say in arguing Dr. Kessler's level of authoritativeness.
2.
Dr. Peggy Pence
Next, AbbVie seeks to exclude the testimony of Dr. Peggy Pence. AbbVie takes
issue with Dr. Pence's opinions that AbbVie improperly marketed AndroGel for off-label
uses, violated the FDA's regulations against misbranding, and violated industry
standards of care in marketing of AndroGel for off-label uses.
AbbVie argues that certain of Dr. Pence's opinions are unreliable. Specifically, it
argues that Dr. Pence's testimony regarding an "industry standard of care" is a product
34
of nothing other than her own speculation. Defs.' Mem. at 58. But in making this
argument, AbbVie cites only to a single heading in Dr. Pence's report that uses this
term; it does not reference any opinions rendered in the body of the report or during her
deposition. 4 Without more, the argument is too bare-boned for consideration.
Perfunctory arguments are forfeited. That said, it appears that Dr. Pence's 40-plus
years of experience in research and development of pharmaceutical products and her
concurrent 25 years of experience in consulting on testing, clinical trials, and FDA
regulatory matters gives her a sufficient basis to testify regarding industry standards in
these areas.
AbbVie also argues that Dr. Pence's opinion that the company contravened FDA
regulations on misbranding constitutes an improper legal conclusion. The Court
overrules this argument for the reasons discussed with regard to the parallel contention
regarding Dr. Kessler. The Court likewise overrules AbbVie's argument that Dr. Pence's
report contains an improper factual narrative, for the reasons discussed with regard to
Dr. Kessler. AbbVie will have a full and fair opportunity at trial to cross-examine Dr.
Pence on the accuracy and completeness of her summary of relevant events and to
make appropriate objections under Rule 403 regarding the use of pejorative
terminology.
AbbVie further argues that Dr. Pence's testimony is improper to the extent she
intends to testify regarding the FDA's reasons for acting or failing to act, specifically, her
opinion that the FDA did not issue AbbVie a warning for its off-label promotion of
To be fair, plaintiffs' response, in which they argue that Dr. Pence has a sufficient
basis to testify about industry standards, likewise does not cite to the record.
4
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AndroGel because the FDA "lacked the resources to enforce its own rules." Defs.'
Mem. at 60. The Court agrees that Dr. Pence lacks a sufficient basis to testify
regarding why the FDA acted (or failed to act) and that this particular opinion would be
inadmissible in any event, either as speculative, unhelpful to the jury, or unfairly
prejudicial under Rule 403.
Finally, AbbVie makes an objection to the testimony of Dr. Pence that it made
with respect to Dr. Kessler—plaintiffs will portray her as the ultimate authority, and this
is unfairly prejudicial. The Court overrules this argument for the reasons discussed with
regard to Dr. Kessler.
3.
Dr. Steven Woloshin
AbbVie seeks to exclude the testimony of Dr. Steven Woloshin, arguing that he is
not qualified to render opinions on the propriety or effect of drug advertising or what he
calls "disease mongering" because he has no degree in marketing and is not wellversed in federal regulations on pharmaceutical marketing. AbbVie also argues that Dr.
Woloshin's testimony is unreliable and unfairly prejudicial.
Dr. Woloshin has the requisite knowledge, skill, and experience to offer his
opinions, with the limitations noted below. He uses the term "disease mongering" to
describe efforts to convince people that they are sick and need a medical treatment for
this sickness. He is a professor at Geisel School of Medicine at Dartmouth, New
Hampshire and co-directs the Dartmouth Institute for Health Policy and Clinical
Practices. Besides being board-certified in internal medicine, he is a widely published
author, including in peer reviewed journals regarding over-diagnosis and over-promotion
of drugs. He is sufficiently qualified to render his opinions; AbbVie's arguments about
36
his level of expertise go to the weight to be given his testimony, not its admissibility.
AbbVie also argues that Dr. Woloshin has not identified a reliable, scientific basis
for his opinion that AbbVie engaged in "disease mongering" in relation to its "Is it LowT?" campaign. But nothing in Daubert or its progeny requires an expert to have or
create a scientific test before he can give his opinion on a subject that he has studied
for more than a decade. See Hill v. Brass Eagle, Inc., No. 15 C 368, 2016 WL 4505170,
at *6 (N.D. Ill. Aug. 29, 2016) (Kennelly, J.). Though Dr. Woloshin conceded a test
might be conceived, there is no basis for determining that such a test would be any
more reliable or accurate than the review he conducted of AbbVie’ marketing and
promotional plans. Dr. Woloshin identifies whether a company is engaged in "disease
mongering" by reviewing the company's internal documents, FDA materials, peerreviewed journal articles, and expert reports, and that is what he did here. In addition,
Dr. Woloshin's prior opinions using similar methodology have been tested through his
own work on randomized, controlled experiments that have evaluated drug advertising,
as well as various other forms of communications designed to convey drug information
to consumers. The Court concludes that the methodology Dr. Woloshin employed is
sufficiently reliable to meet the requirements of Daubert and Rule 702.
AbbVie also argues that Dr. Woloshin’s opinions effectively amount to
speculation about AbbVie's motives and intentions in marketing and promoting
AndroGel. But Dr. Woloshin is not offering testimony suggesting that he knows
AbbVie's intent. Instead, he relies largely on AbbVie's internal marketing materials to
illustrate that they track the strategies for "disease mongering" that he has researched,
observed, and written about (including in a peer-reviewed editorial published in the
37
Journal of the American Medical Association's JAMA-Internal Medicine publication
before he was approached or retained as an expert in this proceeding). The strategies
he has identified are to lower the bar for diagnosis of the purported "disease," raise the
stakes of not being diagnosed so that people want to get tested and treated, and pitch
the evidence about the purported benefits of treatment in such a way that failure to be
diagnosed and treated might threaten one's health. Dr. Woloshin has analyzed
AbbVie's marketing practices with these strategies in mind to opine on whether it
engaged in behavior indicative of a company employing a disease mongering strategy.
Like Dr. Kessler, because Dr. Woloshin is offering the jury a framework by which to
analyze AbbVie's off-label marketing practices, not testimony purporting to describe
AbbVie's actual intent, his testimony on the matter is permissible.
Finally, AbbVie argues that some of the terms Dr. Woloshin uses, such as
"disease mongering," "predatory practice," and "unconscionable" are inflammatory and
should be barred under Rule 403 as unfairly prejudicial. The Court agrees. Testimony
that AbbVie acted in an "unconscionable" way is a value judgment and a conclusion that
the jury can draw—or not draw—without being told to draw it. "Disease mongering"
may be a catchy term, but if it is a term of art, it is one that Dr. Woloshin apparently
created himself, and it carries a pejorative connotation that, again, strays beyond what
an expert may appropriately say. He will have to use a less loaded phrase when
addressing this topic during his testimony (unless, of course, AbbVie opens the door).
The same is true of testimony calling a particular practice "predatory." That term may
have an accepted meaning in the antitrust context, but this is not an antitrust case. Like
"unconscionable," it represents in this context a value judgment, as opposed to a point
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on which an expert appropriately may opine.
4.
Dr. David Handelsman
AbbVie seeks to exclude the testimony of plaintiffs' expert Dr. David
Handelsman. Dr. Handelsman discusses in his report why having an age-related low
testosterone level is not an indication for testosterone replacement therapy; he (like Dr.
Woloshin) concludes that AbbVie engaged in "disease mongering" by promoting TRT
for non-pathological hypogonadism; and he offers opinions regarding the dangers of
testosterone supplementation.
AbbVie contends that Dr. Handelsman, who lives and works in Australia, is not
qualified to offer opinions regarding "disease mongering" or AbbVie's marketing
strategies. AbbVie points out that that he has never authored or commissioned a report
on pharmaceutical marketing, has no training in pharmaceutical sales or marketing, and
has no clinical experience in the United States.
Dr. Handelsman is a medical doctor and medical school professor who
specializes in reproductive endocrinology and andrology. He is a highly-published and
highly-cited author worldwide on testosterone and androgens. The relevance of his
knowledge and expertise regarding endocrinology and andrology is not diminished by
the fact that he has not practiced in the United States; there is no basis to believe that
the study or science of these topics is any different in Australia as compared with the
United States.
Given his background and experience, Dr. Handelsman is sufficiently qualified to
offer most of the opinions addressed in his report. For example, his expertise as an
endocrinologist qualifies him to opine regarding the rarity of idiopathic hypogonadism
39
and whether age-related hypogonadism is considered a form of idiopathic
hypogonadism. For the same reason, he is sufficiently qualified to testify regarding the
accuracy of statements about "low T" in AbbVie's marketing materials and whether
these materials focused on conditions for which the drug was indicated or rather on
other conditions like age-related low testosterone levels.
Dr. Handelsman is not qualified, however, to opine about whether the evidence
indicates that AbbVie was engaged in "disease mongering;" he has no background and
appears not to have done any study or writing in this area. The Court also notes that
this particular opinion from Dr. Handelsman likely would be subject to exclusion under
Federal Rule of Evidence 403 on the basis of cumulativeness given that plaintiffs intend
to elicit the same opinion from Dr. Woloshin.
AbbVie also seeks to exclude certain of Dr. Handelsman's opinions on the basis
of unreliability or unfair prejudice. His testimony regarding overprescribing of TRT—that
is, for conditions for which it is medically unwarranted—is sufficiently reliable to be
admissible, and it is not unfairly prejudicial. Dr. Handelsman examined data regarding
the estimated population of men with classical or idiopathic hypogonadism and
compared that with data regarding the number of men being treated with TRT,
concluding that the latter number far exceeds the likely population of those who have a
medical need for TRT.
AbbVie asks to preclude plaintiffs from eliciting opinions from Dr. Handelsman on
the cause-and-effect relationship between AbbVie's marketing campaigns for AndroGel
and overprescribing. It does not appear, however, that plaintiffs intend to elicit this from
Dr. Handelsman (and the Court agrees this is outside his area of expertise). Rather,
40
this testimony, to the extent it is being offered, will come from Dr. Woloshin.
Finally, Dr. Handelsman may testify regarding the proposition that prescribing
TRT for men for whom the drug is not indicated subjects them to increased health risks.
That is within the scope of his relevant expertise. The Court notes that plaintiffs have
disavowed calling Dr. Handelsman as a causation expert; causation testimony will be
elicited from other expert witnesses. The Court also overrules AbbVie's unfair prejudice
objection, except to the extent it concerns cumulativeness, an issue the Court will
address later.
To be more specific, with reference to the 20-point summary of opinions at the
outset of his report, Dr. Handelsman may testify regarding the opinions described in
paragraphs 1 through 10. Opinion 11 is likewise admissible, except without the
pejorative adjectives "aggressive," "flamboyant," "opportunistic," and "irresponsible,"
which are precluded for the reasons discussed with regard to Dr. Woloshin's use of
similar terminology. Opinions 12 and 13 are a conclusion that AbbVie engaged in
disease mongering, which the Court excludes for the reasons discussed. Opinion 14 is
admissible to the extent it concerns "extending . . . [the] disease definition
('hypogonadism') to include age-related reductions in circulating testosterone" (etc.), but
without the reference to disease mongering. Opinions 15, 16, 17, and 19 are
admissible. Opinion 18 is basically a value judgment regarding AbbVie's conduct and is
excluded.
5.
Dr. Hossein Ardehali
AbbVie seeks to exclude certain testimony by plaintiffs' expert Dr. Hossein
Ardehali. Specifically, it challenges two of Dr. Ardehali's opinions:
41
The totality of the evidence demonstrates that the administration of
exogenous testosterone to middle-aged and older men who are diagnosed
with testosterone declines unrelated to classical hypogonadism is
dangerous because it increases the risk of coronary artery and
cerebrovascular occlusive events (heart attack and stroke). The use of
testosterone products in this population for the treatment of non-classical
hypogonadism is unapproved.
The promotion and marketing of testosterone therapy in this population of
men by AndroGel companies was unreasonable in the absence of
adequate safety data, and based on the approved indication for use, and
in the presence of a body of evidence which, in its totality, demonstrated
that the administration of testosterone was unsafe.
The first of these opinions is also targeted in AbbVie's motion for summary
judgment on causation, and the Court has addressed this opinion in its ruling on that
motion. Plaintiffs agree that the second opinion, concerning the reasonableness of
AbbVie's marketing, is outside the scope of Dr. Ardehali’s expertise; they do not intend
to offer his testimony on this topic. Thus no further discussion of Dr. Ardehali is
necessary.
6.
Dr. Curt Furberg
Finally, AbbVie has filed a separate motion to exclude the testimony of plaintiffs'
expert Dr. Curt Furberg, whose Rule 26(a)(2) disclosure includes opinions regarding the
sufficiency of the clinical trials conducted on AndroGel prior to its approval by the FDA;
the effects of AbbVie's marketing; and the content of the AndroGel labels. AbbVie
argue that Dr. Furberg lacks sufficient expertise to render these opinions and they are
otherwise inadmissible under Daubert and Rule 702. In response to the motion,
plaintiffs state that they will not be offering Dr. Furberg as an expert on advertising or
marketing, so AbbVie' motion is moot to that extent.
Dr. Furberg unquestionably has sufficient expertise to evaluate AbbVie's clinical
42
trials. He served with the National Heart, Lung, and Blood Institute and eventually
became chief of its clinical trials branch; he was director of Wake Forest University
School of Medicine's Center for Prevention Research and Biometry; and he was a
longtime member of the FDA's Drug Safety and Risk Management Advisory Committee.
He has authored or coauthored over 400 articles and 60 book chapters, mainly in the
fields of epidemiology and clinical trials, and he has coauthored a textbook regarding
clinical trials. The Court could go on, but it need not.
The primary topic of Dr. Furberg's anticipated testimony appears to be the
sufficiency and adequacy of the clinical trials that led to the FDA's approval of AndroGel
1% and AndroGel 1.62%. AbbVie's main argument is that plaintiffs are intending to use
Dr. Furberg's testimony to contend that the FDA should not have approved AndroGel
because the clinical trials were inadequate to demonstrate its safety and efficacy.
Plaintiffs say they are not challenging the FDA's approvals or to support a claim of fraud
on the FDA, and the Court agrees that plaintiffs cannot advance claims along these
lines. But the testimony is properly admissible, in the Court's view, to attempt to show
that AbbVie and its predecessors conveyed misleading information to physicians and
patients concerning the safety and efficacy of the product. For example, one of Dr.
Furberg's opinions is that the studies (and other reports) do not establish AndroGel's
efficacy and safety in men with "low T" or "andropause." See Defs.' Mot. to Exclude
Testimony of Pls.' Expert Dr. Furberg, Ex. 4 (Furberg Report) at 39. This, when
considered with other evidence that plaintiffs will offer, is relevant and admissible to
assist in establishing, among other things, that AbbVie made false representations
regarding AndroGel.
43
The Court also overrules AbbVie's attack on Dr. Furberg's methodology—more
specifically, its contention that he has none. Dr. Furberg's report and deposition
sufficiently lay the basis for his critique of the studies in question in a way that has a
sufficiently reliable foundation in the relevant literature.
Finally, the Court overrules AbbVie's argument that plaintiffs should be precluded
from offering Dr. Furberg's opinion that the labeling on AndroGel reflects that it is
indicated only for certain types of hypogonadism, and not for "low T" or "andropause."
Dr. Furberg's experience gives him a sufficient basis and background to describe what
the labels mean and what they do not mean, a matter on which the jury appropriately
may need assistance. This testimony is relevant and admissible regarding a number of
the misrepresentation and warranty-based claims advanced by plaintiffs.
Because these are the only opinions that plaintiffs say they will attempt to elicit
from Dr. Furberg—in other words, not his opinions regarding the propriety or effect of
AbbVie's marketing of AndroGel, the Court need not address the other arguments made
in AbbVie's motion. The motion [dkt. 1727] is denied for the reasons described.
7.
A final comment on expert testimony
The Court has the impression from its review of the motions addressed in this
decision that plaintiffs may intend to offer testimony by multiple expert witnesses on
particular topics in a given bellwether trial. The Court does not intend to permit this by
either side absent a prior showing of good cause. See N.D. Ill. LR Form 16.1.4 (final
pretrial order form) at 2 n.7 ("Only one F.R. Evid. 702 witness on each subject for each
party will be permitted to testify absent good cause shown."); Fed. R. Evid. 403. As the
Court explained to counsel at a recent case management conference, if a party
44
attempts to present duplicative expert testimony without obtaining prior permission, it
risks preclusion or striking of the second or following experts on a particular topic. Thus
any party intending to present overlapping and potentially duplicative testimony would
be well advised to seek guidance before doing so.
Conclusion
For the foregoing reasons, the Court denies defendants' motions to exclude the
opinions of Dr. Curt Furberg and Dr. Steven Woloshin [dkt. nos. 1727 & 1731]. The
Court also denies defendants' motion for summary judgment on plaintiffs' "off-label
marketing" claims and to exclude testimony [dkt. no. 1746], except as to the breach of
express warranty claim by plaintiff Mitchell, on which the Court grants summary
judgment for defendants, and except as to various items of expert testimony as
discussed in the body of this opinion.
________________________________
MATTHEW F. KENNELLY
United States District Judge
Date: May 8, 2017
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