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IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
In re Testosterone Replacement Therapy )
Products Liability Litigation Coordinated ) Case No. 14 C 1748
Pretrial Proceedings ) MDL No. 2545
)
(This document applies to all cases and to )
Martin v. Actavis, Inc., Case No. 15 C 4292) )
CASE MANAGEMENT ORDER NO. 185
(Rulings on plaintiff's motion to amend a prior ruling,
plaintiff's motion for sanctions, and certain motions in limine in
Martin v. Actavis, Inc., Case No. 15 C 4292)
MATTHEW F. KENNELLY, District Judge:
Plaintiff Brad Martin's primary care physician, Dr. Stephen Firestone, prescribed
him Androderm—a testosterone replacement therapy (TRT) drug—in October 2012.
Martin suffered a heart attack in May 2013, when he was 52 years old. Martin alleges
that his use of Androderm caused the heart attack. He sues Actavis, Inc., Actavis
Pharma, Inc., and Actavis Laboratories UT, Inc. (collectively, Actavis), which
manufacture or sell the drug.1
Martin's case is part of a multidistrict litigation (MDL) proceeding brought against
several manufacturers and sellers of TRT drugs. The plaintiffs in the MDL proceeding
allege that they suffered serious cardiovascular injuries or injuries related to blood clots
in the veins (venous thromboembolisms) as a result of taking the defendants' TRT
drugs. In July 2018, the parties executed a Master Settlement Agreement covering
cases involving Actavis. In August 2019, Martin informed the Court that he elected not
1 Actavis maintains that Actavis, Inc. is a holding company that does not manufacture or
sell the drug.
to settle his claims. The following claims survived Actavis's motion for summary
judgment: failure to warn, design defect, negligence, breach of express warranty,
fraudulent misrepresentation, violation of the Minnesota Deceptive Trade Practices Act
(MDPTA), Minn. Stat. § 325D.44(13), and punitive damages. See In re Testosterone
Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, 430 F.
Supp. 3d 516 (N.D. Ill. 2019) (Martin SJ/Daubert Order). The parties agree that
Minnesota law governs the claims. Martin's case is scheduled for trial beginning on
August 2, 2021.
In this order, the Court rules on Martin's motion amend a prior ruling, his motion
for sanctions, and certain of the parties' motions in limine. At the final pretrial
conference set for April 26, 2021, the Court will hear argument on the remaining
motions.
A. Martin's motion to amend a prior ruling
Martin asks the Court to amend a prior ruling in which it struck certain opinions
offered by Martin's regulatory expert, Dr. Joshua Sharlin. The stricken opinions concern
the number of adverse cardiovascular events (MACE events) for TRT drugs logged in
the FDA's adverse event reporting system (the FAERS database) between 2004 and
2011. The Court denies the motion.
In January 2020, the Court granted Martin's motion to substitute Dr. Sharlin for
Dr. Peggy Pence, a regulatory expert who withdrew from Martin's case for reasons that
are not relevant here. Consistent with Federal Rule of Civil Procedure 26, Martin
represented that Dr. Sharlin would limit his opinions to the subjects and testimony that
Dr. Pence had offered. The Court granted Actavis's motion to strike the FAERS-related
opinions because they went "significantly beyond" what Dr. Pence disclosed. Actavis
Opp. to Mot. to Amend, Ex. A (Feb. 14, 2020 Hr'g. Tr.) [dkt. no. 177-1] at 6:23-7:7. The
Court determined that Martin did not show substantial justification for the late disclosure
because the FAERS-related information was not new or previously unavailable. See id.
at 7:8-12 (applying FED. R. CIV. P. 37(c)(1)). The Court also determined that the late
disclosure was not harmless "given the proximity to the trial date," which at the time was
about two months away. Id. at 7:12-13 (applying same).
After the Court issued that ruling, it had to postpone the trial date several times
because of the coronavirus pandemic. According to Martin, the parties now have plenty
of time to prepare for trial, so Actavis will not be prejudiced if the Court allows Dr.
Sharlin to offer the previously stricken testimony. The Court disagrees. First, the fast-
approaching trial date was not the primary reason for the Court's ruling. Just as
significant was Martin's failure to show that the FAERS-related opinions are based on
new or previously unavailable information. That circumstance has not changed.
Second, although the parties now have more time to prepare for trial, amending
the ruling would still cause unfair prejudice to Actavis. Relying on the Court's prior
order, Actavis took Dr. Sharlin's deposition and filed a motion to exclude his opinions
under Daubert v. Merrell Dow Pharmaceuticals, Inc. 509 U.S. 579 (1993). If the Court
amends its ruling about the permissible scope of Dr. Sharlin's opinions, Actavis will
likely need to depose Dr. Sharlin again and, perhaps, file another Daubert motion. The
fact that Actavis's regulatory expert, Dr. David Feigal, discusses Dr. Sharlin's FAERS
opinions in his report does not persuade the Court otherwise. An expert's criticism of
the opposing expert's opinions does not necessarily serve the same purpose as the
opposing expert's deposition testimony about his own opinions. And it is certainly no
substitute for the possibility of excluding an opposing expert's testimony under Daubert.
In short, amending the prior ruling would create extra work for Actavis and unfairly
detract from its trial preparations.
Martin also fails to explain why he waited so long to file his motion. The Court
granted Actavis's motion to strike Dr. Sharlin's FAERS-related opinions on February 14,
2020. The parties filed a motion to continue the trial date because of the pandemic (and
the Northern District's General Order concerning the pandemic) on March 17, 2020. In
July 2020, the Court reset the trial to begin in November 2020. The Court had to reset
the trial two more times. Martin could have filed his motion to amend at any point but
instead delayed until February 22, 2021. That is reason enough to deny the motion.
Finally, Martin argues that the Court should permit Dr. Sharlin to offer his
FAERS-related opinions because Actavis plans to offer evidence about the number of
Androderm-related MACE events in its internal pharmacovigilance database during the
relevant time. For reasons the Court explains in its ruling on Martin's sixth motion in
limine, this argument is misplaced. The Court denies Martin's motion to amend.2
B. Martin's motion for sanctions
Martin has moved to impose sanctions upon Actavis on the ground that its
counsel improperly coached Christopher Cassarino—a former Actavis sales
representative—during his deposition for this case. The relevant testimony and attorney
2 In the briefing on Martin's motion to amend, both sides allude to a possibility that Dr.
Sharlin will offer his FAERS-related opinions at trial in another case that is part of this
MDL proceeding (Davis v. Actavis, Inc., No. 17 C 3775). The Court has not decided
whether that would be appropriate. The instant ruling applies to Martin's case only.
objections relate to marketing materials and methods for training Actavis sales
representatives under a 2006 co-promotion agreement between Actavis and Solvay. As
part of the co-promotion agreement, Actavis sales representatives promoted Solvay's
TRT drug, AndroGel, to urologists. (Solvay later became AbbVie.) Martin argues that
improper coaching from Actavis's counsel caused Cassarino to change his testimony
about (among other things) whether Actavis used unbranded disease state awareness
materials from Solvay to train its sales representatives. At the same time, Martin says
that he eventually obtained truthful testimony from Cassarino.
Cassarino is not going to testify in person at trial. Rather, the parties will play
portions of his videotaped deposition for the jury. Martin asks the Court to sanction
Actavis by allowing him to play the objections and attorney colloquy that demonstrate
witness coaching. That will help the jury understand why Cassarino apparently
changed his testimony during his deposition. Martin also asks the Court to prohibit
Actavis from playing the testimony that Cassarino changed because of coaching. And
Martin asks the Court to impose other, unspecified sanctions.
The Court agrees with Martin that Actavis's attorney improperly coached
Cassarino. The following objection from Actavis's attorney is a representative example:
"Well, I don't want—your question should not create the false impression for Mr.
Cassarino or the jury that [disease state awareness] materials for Androderm were
supplied by Solvay to Watson, and your question very much so creates that inaccurate
set of circumstances and facts." Martin Mot. for Sanctions, Ex. 1 (Cassarino Dep.) [dkt.
no. 172-1] at 74:10-17. This and other similar objections essentially told Cassarino how
to respond, and one may fairly infer (and the Court does infer) from the repeated
making of similar objections that Actavis's counsel made the objections exactly for this
reason. This conduct frustrated the purpose of the deposition. The Court may "impose
an appropriate sanction" for impeding, delaying, or frustrating "the fair examination of
the deponent." FED. R. CIV. P. 30(d)(2). On the other hand, as noted, Martin states that
Cassarino gave truthful answers during re-examination that followed the coaching.
Given Martin's statement that he eventually obtained a truthful answer despite
the interference by Actavis's counsel, the Court believes that the following is the
appropriate way to deal with counsel's inappropriate conduct. If testimony is designated
from the deposition that was given following an inappropriate "speaking" or suggestive
objection by Actavis's counsel, the Court will allow Martin to play for the jury the
improper objections and colloquy identified in his motion. That is the best way to
explain the apparent shift in Cassarino's testimony. Although attorney objections and
colloquy are not evidence, the Court routinely instructs juries to that effect and will do so
in this situation as well.
The Court notes that it is asking the parties to provide argument at the final
pretrial conference on Actavis's sixth motion in limine, which requests exclusion of all
evidence concerning the 2006 co-promotion agreement. That evidence includes the
Cassarino testimony and attorney objections at issue in Martin's motion for sanctions.
The Court's ruling on Actavis's sixth motion in limine could render moot or alter the
scope of its ruling on Martin's motion for sanctions.
C. Martin's motions in limine
1. Martin's alcohol use
Martin asks the Court to exclude testimony and evidence about his alcohol use,
including his history of alcoholism. According to Martin, he was not drinking alcohol in
the two years leading up to his heart attack in May 2013. That makes evidence about
his alcohol use minimally relevant and unfairly prejudicial, he contends. Martin equates
his case with Mitchell/Konrad, Myers, and Holtsclaw—MDL bellwether trial cases in
which the Court excluded evidence of the plaintiffs' alcohol and drug use because its
probative value was substantially outweighed by the risk of unfair prejudice. But those
cases are distinguishable because the defendants did not show that the evidence was
relevant to causation or to the underlying cause of the plaintiffs' hypogonadism. For
example, in Mitchell/Konrad, AbbVie did not argue that the plaintiff's alcohol use caused
his injuries. Rather, AbbVie maintained that the evidence demonstrated his "penchant
for taking risks, as well as the likelihood that he lived a sedentary lifestyle." In re
Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial
Proceedings, MDL No. 2545, Case No. 14 C 1748, 2017 WL 2313201, at *11 (N.D. Ill.
May 29, 2017) (Mitchell/Konrad MIL Rulings); see also In re Testosterone Replacement
Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, MDL No. 2545, Case No.
14 C 1748, 2018 WL 2095701, at *5 (N.D. Ill. May 5, 2018) (Myers MIL Rulings)
(similar). And in Holtsclaw, Auxilium did not identify any evidence that the plaintiff's brief
use of an unrelated prescription drug seven years before his heart attack "could have
increased his chances of a heart attack." In re Testosterone Replacement Therapy
Prods. Liab. Litig. Coordinated Pretrial Proceedings, MDL No. 2545, Case Nos. 14 C
1748, 15 C 3941, 2017 WL 5029601, at *7 (N.D. Ill. Nov. 3, 2017) (Holtsclaw MIL
Rulings).
Martin's case is more like Nolte, an MDL bellwether trial case where the parties
disputed whether the plaintiff's TRT prescription was for an on-label purpose: treatment
of hypogonadism resulting from testicular failure due to toxic damage from alcohol. See
In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial
Proceedings, MDL No. 2545, Case No. 14 C 1748, 2018 WL 305503, at *3 (N.D. Ill.
Jan. 6, 2018) (Nolte MIL Rulings). The record contained evidence that the plaintiff's
blood testosterone level was in a normal range before he suffered an episode of acute,
alcohol-related pancreatitis; the plaintiff continued using alcohol after that incident; and
a test conducted several years later showed that the plaintiff's blood testosterone level
was below normal. See id. Based on this evidence, AbbVie's expert opined that it was
"not unreasonable to assume that Mr. Nolte may have had toxic damage from alcohol to
his testicles due to his extensive drinking history." Id. The Court determined that "given
the significance of the on-label/off-label issue in this case, Dr. Khera's testimony on this
point as set forth in his expert report is relevant, and its probative value is not
substantially outweighed by the danger of unfair prejudice posed by admission of
evidence regarding Nolte's alcohol use." Id. at *4.
Like the AndroGel label at issue in Nolte, the Androderm label states that the
drug is indicated to treat a deficiency or absence of testosterone resulting from testicular
failure due to toxic damage from alcohol. Martin alleges that Actavis marketed
Androderm for an off-label purpose (treatment of age-related hypogonadism), so "the
underlying cause of [his] hypogonadism is potentially a significant issue." Id. at *3.
Actavis offers expert opinions that are relevant on this point. Dr. Bruce Corser, a
pulmonologist, considers a detailed history of Martin's alcohol use and opines that "[t]he
etiology of [Martin's] acquired hypogonadism is likely related to several factors including
alcoholism . . . ." Martin MIL, Ex. B (Dr. Corser Report) [dkt. no. 171-2] at 2, 8. He also
explains how alcohol use can cause hypogonadism. See id. at 8 ("Alcohol use affects
all three parts of the hypothalamic-pituitary-gonadal (HPG) axis, a system of endocrine
glands and hormones involved in male reproduction. Alcohol use is associated with low
testosterone and altered levels of additional reproductive hormones."). Dr. Tung-Chin
Hsieh, a urologist, offers a similar opinion. See Martin MIL, Ex. E (Dr. Hsieh Report)
[dkt. no. 171-5] at 10, 11 (noting Martin's "history of alcohol abuse" and explaining that
alcohol use affects the HPG axis).
Martin argues that his case is distinguishable from Nolte because there are no
tests tending to show that alcohol use caused his blood testosterone level to drop. He
also maintains that his medical records do not show that his alcohol use played any role
in Dr. Firestone's prescribing decision. These issues affect the weight, not the
admissibility, of Dr. Corser and Dr. Hsieh's opinions. Both experts link Martin's history
of alcohol use with scientific information about how alcohol use affects testosterone
levels. On cross-examination, Martin is free to press the experts on how the alleged
evidentiary gaps might affect their opinions or the weight to be given to them. The
issues Martin identifies, however, do not warrant exclusion of the experts' opinions or
the evidence of alcohol use on which they are based.
Martin also faults Drs. Corser and Hsieh for allegedly ignoring that he did not use
alcohol for two years before his heart attack. This criticism, too, affects only the weight
of the opinions. Dr. Corser appears to acknowledge that Martin did not drink during
those two years. See Dr. Corser Report at 2 (stating that Martin began outpatient
treatment for alcohol use in February 2011 and "relapsed" in March 2014). Dr. Hsieh
states that Martin has a "history of alcohol abuse with long-term changes in his liver
(increased iron deposition found on 2015 MRI of liver)." Dr. Hsieh Report at 10. Martin
can press the point that the experts do not explain how his alleged two years of sobriety
affect their conclusions. But the experts' lack of focus on those two years does not
warrant exclusion of their opinions—especially because there is some evidence tending
to show that Martin was drinking during the two years before his heart attack. See, e.g.,
Martin MIL, Ex. A (Martin Dep.) [dkt. no. 171-1] at 197:23-198:6 (testifying that around
the time of his heart attack, "there was [sic] occasions when I probably drank too much .
. . but I wasn't an everyday drinker"). It is up to the jury to decide which timeline of
alcohol use they believe and how it affects the weight of the expert opinions on the
cause of Martin's hypogonadism.
To summarize, Dr. Corser and Dr. Hsieh's opinions are relevant to the underlying
cause of Martin's hypogonadism—which may be a significant issue in the case—and
their probative value is not substantially outweighed by the risk of unfair prejudice posed
by admission of evidence about Martin's alcohol use. As in Nolte, however, the experts'
testimony "will be constrained by [their] report[s] and the way [they] characterize[] the
evidence there." Nolte MIL Rulings, 2018 WL 305503 at *4. Furthermore, the Court
prohibits a third Actavis expert—Dr. Milton Packer—from opining about Martin's history
of alcohol use because the cited portion of his report discusses alcohol use only in the
abstract. See Martin MIL, Ex. F (Dr. Packer Report) [dkt. no. 171-6] at 62 ("Changes in
the hypothalamic-pituitary axis as a result of . . . alcohol abuse or addiction can . . .
depress the production of testosterone."). Dr. Packer's opinion is also cumulative of
those offered by Drs. Corser and Hsieh.
Separately, Actavis offers evidence of Martin's alcohol use for its purported
relevance to (1) the cause of his heart attack and (2) his contributory negligence. Dr.
Corser states that drinking more alcohol than the American Heart Association
Recommends increases the risk of high blood pressure. See Dr. Corser Report at 6-7.
He then opines that Martin's heavy alcohol use in the years before his heart attack
"contributed substantially to his cardiovascular disease and substantially increased his
risk for a myocardial infarction." Id. He does not opine that Martin's alcohol use caused
high blood pressure, however, nor does he otherwise explain how it increased his risk of
heart attack. See id. In this context, the evidence of Martin's alcohol use has limited
probative value and is substantially outweighed by the risk of unfair prejudice. See,
e.g., Nolte MIL Rulings, 2018 WL 305503 at *3 (excluding expert testimony that alcohol
use was a potential risk factor for the plaintiff's pulmonary embolism where expert "cited
no scientific support for that claim"). The Court therefore grants Martin's motion to this
extent. The Court also excludes Dr. Packer's opinion that alcoholism is "known to lead
to myocardial infarction," Dr. Packer Report at 151-52, because Actavis does not
respond to Martin's request to exclude it.
2. Martin's tobacco use
Martin moves to exclude evidence and testimony about his tobacco use, arguing
that it is far more prejudicial than probative. Actavis's cardiology expert, Dr. Packer,
states that a heart attack is "typically the result of coronary atherosclerosis" and that
smoking tobacco is one of the "primary causal conditions for the development of
coronary atherosclerosis." Dr. Packer Report at 68; see also id. at 151 (stating that
Martin's history of smoking is a "well-documented condition[] that [is] known to lead to
myocardial infarction" (citing medical journal)). Similarly, Dr. Corser states that
"[t]obacco use is a well-established risk factor for CVD incidence and mortality," and
that Martin "substantially contributed to his cardiovascular disease and his risk of
myocardial infarction by continuing to smoke tobacco products until 2012 . . . ." Dr.
Corser Report at 7 (citing medical journals).
Martin's primary criticism of these opinions is that they depend on the assumption
that he stopped smoking cigarettes in 2012. According to Martin, he stopped smoking
cigarettes in 2002. But like the timeline of his alcohol use, the timeline of his cigarette
use is a disputed factual issue. For example, two of Martin's medical records state that
he quit smoking cigarettes in 2012. Martin argues that the records are incorrect, but
that is an issue for the jury to decide. Moreover, Dr. Packer states that "smoking
continues its harmful effects to cause myocardial infarction for up to 20 years after total
cessation; the harmful effects of smoking are maintained at high levels for at least 3
years after quitting." Dr. Packer Report at 152. Martin, for his part, admits that he used
chewing tobacco in 2012 and 2013. See Martin Dep. at 89:5-8. Accordingly, even if a
jury credits Martin's contention that he stopped smoking cigarettes in 2002, it could
reasonably credit the experts' opinions that his tobacco use was a cause of his heart
attack. What Martin characterizes as the experts' reliance on an "incorrect quit date"
affects only the weight of their opinions. Martin MIL [dkt. no. 171] at 6.
No more persuasive is Martin's argument that the Court should exclude Dr.
Packer's opinion because he does not state that tobacco use was a substantial factor in
causing his heart attack. Actavis "does not carry the same burden to establish
conclusively that any one factor caused [Martin's] injury, and thus an opinion from one
of its experts that some factor may have contributed to the injury could be relevant and
admissible." Nolte MIL Rulings, 2018 WL 305503 at *2. Dr. Packer and Dr. Corser's
opinions about Martin's tobacco use are relevant to the issue of causation, and Martin
has not shown that their probative value would be substantially outweighed by the risk
of unfair prejudice. The Court denies Martin's motion to exclude the opinions and the
evidence on which they are based.
3. Selected objections in deposition clips
Rather than providing in-person testimony at trial, current and former Actavis
employees (such as Cassarino) are testifying by videotaped deposition. Martin asks the
Court for permission to play objections that Actavis's attorneys made during the
depositions. According to Martin, the objections show that Actavis coached the
witnesses and caused them to alter their testimony. But Martin cites only the Cassarino
deposition as an example, and the Court has resolved Martin's request as it relates to
Cassarino. Without context from the other depositions, the Court cannot rule on
Martins' request. Therefore, it denies Martin's third motion in limine. Martin may re-
raise his request on a case-by-case basis at trial.
4. Contradictory testimony after alleged coaching of Cassarino
Martin asks the Court to prohibit Actavis from designating testimony that
Cassarino gave in response to coaching by Actavis's attorney. As indicated in its ruling
on the motion for sanctions, the Court has determined that if testimony following an
improper objection is designated for trial, the Court will allow Martin to play attorney
objections and colloquy from the deposition to explain apparent shifts in Cassarino's
testimony. This remedy is sufficient to resolve the motion in limine.
5. Number of adverse events logged in FAERS database before 2011
This motion overlaps entirely with Martin's motion to amend the Court's order
striking Dr. Sharlin's FAERS-related opinions. The Court denied that motion, so it
denies this one as well.
6. Actavis's evidence of adverse cardiovascular risk signals
Because the Court has denied Martin's fifth motion in limine, Dr. Sharlin will be
barred from testifying about the number of MACE events logged in the FAERS
database before 2011. That testimony would have been relevant to whether and when
Actavis was on notice of a potential cardiovascular risk signal for Androderm. Martin
argues that, because he cannot present Dr. Sharlin's FAERS-related testimony, the
Court should prohibit Actavis from presenting evidence that it learned of only two MACE
events while monitoring Androderm during the relevant time. Relatedly, Martin argues
that the Court should prohibit Actavis from arguing that it was not on notice of a
potential cardiovascular risk signal for Androderm because it knew of only those two
MACE events.
The Court denies Martin's motion. Martin knew about the evidence he seeks to
exclude before his previous regulatory expert, Dr. Pence, withdrew from the case. See
Actavis Opp. to Martin Mot. to Amend [dkt. no. 177] at 7 (explaining that Dr. Pence
testified during her deposition in Martin's case about Actavis's count of MACE events).
The Court permitted Martin to substitute Dr. Sharlin for Dr. Pence so long as Dr.
Sharlin's opinions did not go beyond the opinions Dr. Pence disclosed. Thus to rebut
Actavis's contention that it knew of only two Androderm-related MACE events, Dr.
Sharlin was restricted to whatever opinions Dr. Pence offered on that score. Dr. Sharlin
significantly exceeded Dr. Pence's opinions with his discussion of the MACE event
count in the FAERS database, and the Court struck the discussion. Adding to this,
Actavis's regulatory expert (Dr. Feigal) discussed Actavis's MACE event count in his
expert report, but Martin did not challenge his opinions under Daubert. Martin must live
with his strategic choices. He cannot now argue that his purported inability to rebut
Actavis's arguments about MACE event counts through Dr. Sharlin is unfair or
prejudicial.3
It also bears mention that Martin draws an inapt comparison between Actavis's
MACE event count and Dr. Sharlin's. As Actavis explains, the two MACE events that
Dr. Feigal discusses are Androderm-related and were recorded in Actavis's internal
pharmacovigilance database. By contrast, Dr. Sharlin's MACE event count comes from
FAERS, which is an FDA database that collects reports from patients using all TRT
drugs. Given these differences, it is not unfair or unduly prejudicial to allow Actavis to
present evidence about the number of Androderm MACE event reports it allegedly
received while barring Martin from presenting evidence about the total number of MACE
event reports in the FAERS database.
7. Hemochromatosis
Martin moves to exclude evidence that he was evaluated for and has a family
history of hemochromatosis, a genetic condition that causes one's body to retain too
much iron. Hemochromatosis is a cause of secondary hypogonadism. Martin's genetic
testing showed that although he is a carrier of the gene for hemochromatosis, the
3 It is conceivable that Martin may be able to address this point through cross-
examination of Actavis's experts. That is outside the scope of the present motion.
disease does not affect him. Actavis admits that its experts do not conclude that
hemochromatosis was a cause of Martin's heart attack or of his low-end normal
testosterone level. As a result, Martin argues, evidence about hemochromatosis has
minimal probative value and poses a substantial risk of confusing or misleading the jury.
Actavis responds that the evidence is relevant to show that its experts "did not rely on
conditions" that would support Actavis's case "when those conditions were not
supported by reliable evidence." Actavis Opp. to Martin MIL [dkt. no. 178] at 11.
Whatever relevance the hemochromatosis evidence might have to Actavis's
experts' methodology, it is minimal compared to the potential for the evidence to
confuse the jury and waste trial time. See, e.g., Mitchell/Konrad MIL Rulings, 2017 WL
2313201 at *10 (evidence that the plaintiff's father had prostate cancer and his mother
had a fatty liver was inadmissible where neither the defendant nor its expert "explain[ed]
why that history [was] relevant for assessing the cause of [the plaintiff's] heart attack").
The jury will be able to assess the integrity of Actavis's experts' methodology based on
their testimony about the factors they do consider relevant to causation, and about why
they believe Martin's causation theories are incorrect. The Court grants Martin's motion
to exclude all evidence about hemochromatosis.
8. Responsibility for the conduct of predecessor entities
In bellwether trial cases where AbbVie was a defendant, the Court instructed the
jury (without objection by AbbVie) that AbbVie is legally responsible for the conduct of
its predecessor entities. See Case Management Order No. 99 (Mitchell II MIL Rulings),
MDL No. 2545, Case No. 14 C 1748, Dkt. No. 2378 ¶ 3(c). The Court also precluded
evidence or argument that was inconsistent with that instruction. See id. Martin asks
the Court to give a similar instruction here.
Actavis contends that the instruction is unnecessary because, according to
Actavis, there were no predecessor entities during the relevant time. Specifically,
Actavis states that Defendants Actavis Laboratories UT, Inc. and Actavis Pharma, Inc.
are the only entities that manufactured or sold Androderm while Martin was taking the
drug. Likewise, Actavis states that while Martin was taking Androderm, Actavis, Inc.
was a holding company and the parent company of the other Defendants. According to
Actavis, Actavis, Inc. became a "predecessor entity" only after Martin stopped taking
Androderm. See Actavis Opp. to Martin MIL at 11 (stating that Actavis, Inc. was
converted to a limited liability company called Allergan Finance, LLC sometime after
April 8, 2013). Because there are no relevant "predecessor entities," Actavis argues,
the Court should deny Martin's motion for an instruction concerning predecessor entity
liability. At the same time, Actavis admits that Actavis Laboratories UT, Inc. and Actavis
Pharma, Inc. were "at one time" named Watson Laboratories, Inc. and Watson Pharma,
Inc. Id. at 11 n.3. At a minimum, therefore, it would seem that the requested instruction
is necessary as it relates to the Watson entities. Actavis is directed to clarify its contrary
position at the final pretrial conference.
Actavis also states that it "intend[s] to argue that Actavis, Inc., was a holding
company that did not manufacture or sell Androderm and has no liability to Plaintiff." Id.
at 12. The Court submits that this argument would violate the spirit of the predecessor
entity instruction and could confuse the jury. The allocation of liability among the
Actavis Defendants is an issue better resolved between the parties and outside the
jury's presence. Significantly, Actavis moved for summary judgment on the claims
against Actavis, Inc. on the ground that that entity does not manufacture or sell
Androderm. The Court ordered the parties to attempt to reach a stipulation that would
resolve the motion. See Martin SJ/Daubert Order, 430 F. Supp. 3d at 548. The Court
stated that if the parties could not reach an agreement, it would order Actavis to
produce a 30(b)(6) witness who could provide relevant testimony, and would then order
the parties to file simultaneous supplemental briefs on the issue. See id. As far as the
Court can tell, the parties neither reached a stipulation nor informed the Court of their
failure to do so. At the final pretrial conference, the parties are directed to discuss their
efforts to reach a stipulation. They should also be prepared to discuss whether the
argument Actavis forecasts will confuse or mislead the jury. Until then, the Court defers
ruling on Martin's eighth motion in limine.
9. Family history unrelated to cardiovascular events
Martin moves to exclude evidence of family medical history unrelated to
cardiovascular events. But he does not provide any examples of the evidence he seeks
to exclude. (The only exception is evidence about hemochromatosis, which the Court
addressed above.) The Court agrees with Actavis that Martin's motion is too vague to
enable Actavis (or the Court) to respond meaningfully. Accordingly, the Court denies
Martin's motion. If, at trial, Actavis attempts to introduce evidence of family medical
history that Martin considers inappropriate, he should object and request a sidebar. The
Court will then consider whether Actavis can lay a foundation showing that it is relevant
for assessing the cause of Martin's heart attack.
10. "Good company" and "good industry" evidence or argument
Martin asks the Court to exclude any evidence or argument about Actavis's
"service to society, other drugs, research, philanthropic work, [or] charitable donations,"
maintaining that it is improper character evidence. Martin MIL at 13. Actavis responds
that it does not intend to introduce evidence about its charitable donations or
philanthropic activity. Nonetheless, it argues that the Court should deny Martin's motion
because it is overly broad and vague. Actavis also contends that if Martin elicits
evidence about alleged bad conduct, it should be able to present rebuttal evidence of
good conduct.
The categories of evidence Martin identifies are likely inadmissible character
evidence. See, e.g., Martin/Konrad MIL Rulings, 2017 WL 2313201 at *9 (discussing
evidence about benefits of other drugs the defendant produces, charitable donations,
and philanthropic activity). But it is possible that certain evidence characterized as
"good conduct" evidence may be admissible to rebut contentions that Actavis engaged
in bad conduct, such as putting profits over people. See id. As in other MDL bellwether
trial cases, "whether [Martin] open[s] the door to any such 'good conduct' evidence is an
issue better left for determination at trial." Id. Actavis must, however, raise any such
contention outside the jury's presence before attempting to elicit good conduct evidence
at trial.
11. Martin's residence in Minnesota
Martin asks the Court to bar excessive questioning or argument about the fact
that he lives in Minnesota. See Myers MIL Rulings, 2018 WL 2095701 at *7 ("Excessive
questioning or argument concerning the fact that Myers lives in and was treated in
Arizona is barred."). In the alternative, he asks for permission to tell the jury that his
case is being tried in Chicago because it was selected as a bellwether trial case in the
MDL proceeding and the parties signed Lexecon waivers. Actavis responds that the
Court should deny the motion because Martin does not explain what he means by
"excessive." It also argues that Martin's proposed explanation for why the case is being
tried in Chicago would be unfairly prejudicial because the jury would learn that other
plaintiffs have sued Actavis for injuries allegedly caused by Androderm. According to
Actavis, it would be especially unfair to tell the jury that the trial location relates to the
MDL proceeding because Martin asked to have the case tried in Chicago when he
submitted it for consideration as a bellwether case.
Martin's failure to define "excessive" is not a proper reason for denying his
motion. Both sides appear to agree that because Martin obtained medical treatment in
Minnesota, the jury will learn that he lives there. Beyond this, additional evidence
regarding Martin's state of residence is irrelevant and prejudicial, and it is barred, as is
any argument on this point. If questioning or argument violates this order, the Court will
instruct the jury appropriately. And if Martin wants the Court to explain why the case is
proceeding here, the Court proposes that the parties prepare an instruction stating that
the case is being tried in Chicago because of an agreement between them.
12. Mrs. Martin's absence from the courtroom
Martin's wife, LuAnn Martin, will testify at trial as a fact witness. Actavis intends
to ask the Court to exclude her from the courtroom before she has testified under
Federal Rule of Evidence 615. Martin asks the Court to permit him to tell the jury why
she is absent. Actavis does not object. The Court authorizes Martin to make this point
before the jury.
D. Actavis's motions in limine
1. Marketing and promotional materials
Actavis moves to exclude all evidence of Androderm marketing materials and
promotional activities. That includes: Actavis's internal materials about marketing
messaging and strategy; drafts of branded and unbranded marketing materials; internal
training materials; promotional or disease awareness materials discussing symptoms
that Martin did not have; and materials and communications from Actavis's Promotional
Review Committee (PRC), which reviews marketing materials for Actavis drugs to
ensure that they comply with the language in the drugs' package inserts. See Actavis
MIL [dkt. no. 168] at 4-5.
Actavis states that it expects Martin to present such evidence to support his
express warranty and fraudulent misrepresentation claims. According to Actavis, there
is no evidence that Martin or Dr. Firestone saw or relied on Androderm marketing
materials. Actavis also contends that in the summary judgment order, the Court
recognized this evidentiary deficit and determined that the express warranty and
fraudulent misrepresentation claims "survived based only on statements allegedly made
in the Androderm label." Id. at 2. As a result, Actavis argues, evidence about
Androderm marketing materials and promotional activities is irrelevant to the claims,
confusing, unfairly prejudicial, and unnecessarily time-consuming.
In addition, Actavis argues that fraudulent misrepresentation is the only claim for
which intent is an element. It maintains that because the Court made no finding that
Androderm marketing materials or promotional activities support the claim, its alleged
intent in marketing Androderm is irrelevant. Actavis argues that Martin's case is
therefore distinguishable from other MDL bellwether trial cases in which the Court
determined that TRT marketing materials and promotional activity were admissible.
See, e.g., Mitchell/Konrad MIL Rulings, 2017 WL 2313201 at *2 ("[E]ven if certain
marketing materials played no direct causal role in plaintiffs' use of the drug, those
materials may still be relevant on the question of AbbVie's knowledge that its marketing
was misleading or its intent to create an off-label market.").4
Martin responds that evidence about Androderm marketing and promotion—and
specifically, evidence about off-label marketing—"is relevant to every claim" in the case.
Martin Opp. to Actavis MIL [dkt. no. 179] at 5. He does not anchor this argument in a
discussion of the elements of the claims. Nor does he dispute that there is no evidence
confirming that he or Dr. Firestone saw Androderm marketing materials, relied on such
materials, or met with Actavis sales representatives. Instead, Martin argues that a
reasonable jury could infer from the evidence that it is "highly likely" that each of these
things happened. Id. at 3. For example, he states that during a deposition for this case,
former Actavis sales representative Christopher Cassarino testified that Actavis
negotiated with VA hospitals about Androderm's position on their prescription drug
formularies. Martin also offers evidence that Actavis placed Androderm advertisements
on websites that doctors query for information about TRT drugs. It is true that Martin
4 Actavis also asserts a broader challenge to the Court's determinations about the
admissibility of marketing and promotional evidence in those cases. See Actavis MIL at
3-4 ("Federal courts across the country have consistently held that marketing materials
not relied upon by plaintiffs and their prescribing physicians are to be excluded as
irrelevant." (citing cases)). This point is unavailing; the cited cases do not bind this
Court and do not persuade the Court that it erred in its earlier rulings. Nor is it clear
from Actavis's description of the cases whether the evidence had relevance to the
defendants' intent, as this Court determined it did in other MDL bellwether trial cases.
obtained his Androderm prescription at a VA hospital. And it is plausible that Dr.
Firestone consulted websites to obtain information about prescription drugs. Martin,
therefore, has identified some circumstantial evidence tending to show that Dr.
Firestone could have seen Androderm marketing materials.
Actavis correctly observes that the Court discussed only evidence about the
Androderm label when it denied its motion for summary judgment on the express
warranty and fraudulent misrepresentation claims. See Martin SJ/Daubert Order, 430
F. Supp. 3d at 545-47. That said, the Court did not rule out the possibility that other
evidence could support those claims. The circumstantial evidence discussed in the
previous paragraph may be enough to lay a foundation for consideration of Androderm
marketing and promotion evidence for the fraudulent misrepresentation and express
warranty claims. But because the connection is tenuous, this determination does not
provide a basis to broaden the scope admissible marketing and promotion evidence
beyond what the Court discusses below.
Specifically, the Court concludes that a limited amount of evidence about
Androderm marketing material and promotional activity, including alleged off-label
promotion, is relevant and admissible on Martin's other claims. For example, for design
defect claims, Minnesota courts consider whether the manufacturer exercised
"'reasonable care' in balancing the likelihood and gravity of harm posed by [the product]
'against the burden of' taking precautions that could prevent it." Id. at 544 (quoting
Bilotta v. Kelley Co., 346 N.W.2d 616, 621 (Minn. 1984)). In the summary judgment
order, the Court explained that Actavis's alleged marketing of Androderm to treat age-
related hypogonadism may be relevant to the reasonable care balancing test. See
Martin SJ/Daubert Order, 430 F. Supp. 3d at 543-44.
Additionally, although the Court stated that the lack of evidence that Martin or Dr.
Firestone saw or relied on Androderm marketing materials was likely fatal to a negligent
marketing claim, it did not conclude that it was fatal to Martin's garden-variety
negligence claim. See id. at 544. Actavis's conduct in marketing Androderm may be
relevant to whether it owed Martin a duty of care and breached that duty. See, e.g., In
re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial
Proceedings, MDL No. 2545, Case No. 14 C 1748, 2017 WL 1836443, at *1 (N.D. Ill.
May 8, 2017) (CMO 48) (so-called "off-label marketing claims" included negligence
claims); id. at *15 (the framework that the plaintiff's regulatory expert offered for
assessing "what AbbVie intended via its marketing" was relevant to the off-label
marketing claims). Finally, the evidence may be relevant to Martin's claim for violation
of the MDPTA. And if the Court does not bifurcate the punitive damages proceedings,
the evidence may be relevant to punitive damages as well.
As it has in other cases, the Court will limit the amount of marketing and
promotion evidence that Martin can present. See, e.g., Nolte MIL Rulings, 2018 WL
305503 at *8 ("[W]hen there is little or no evidence linking the plaintiff or his physician to
particular materials, the probative value of all promotional materials is more limited. In
such cases, only a limited amount of such evidence may be admissible before the
danger for unfair prejudice begins to substantially outweigh the probative value.");
Holtsclaw MIL Rulings, 2017 WL 5029601 at *2 (similar). The Court will determine
where to draw the line at trial. See, e.g., Nolte MIL Rulings, 2018 WL 305503 at *8.
Martin should be advised that he act carefully in deciding which items of evidence to
offer at what point, because at an appropriate point the Rule 403 balance will tip against
admission of further evidence.
The Court recognizes that Actavis also challenges specific kinds of marketing
and promotion evidence. First, Actavis contends that in Holtsclaw, the Court excluded
materials "dated years before the plaintiff's TRT use under Rule 403." Actavis MIL at 6
(citing Actavis MIL, Ex. A (Nov. 9, 2017 Holtsclaw Trial Tr.) [dkt. no. 169-1] at 756:14-
757:21). Actavis asks the Court to do the same here. Although the Court in Holtsclaw
indeed excluded training materials from 2002, it indicated that it would allow the plaintiff
to present training materials from 2006. See Nov. 9, 2017 Holtsclaw Trial Tr. at 757:10-
21. The plaintiff's TRT use in Holtsclaw occurred in 2013. See id. at 757:20. Actavis
does not attempt to define in its submission how old is too old, and context matters.
Actavis should make specific objections, if any, at trial. To the extent Actavis argues
that materials regarding its 2006 co-promotion agreement with Solvay are too old to be
relevant, the Court defers ruling until it rules on Actavis's sixth motion in limine (which
will be after the final pretrial conference).
Actavis also argues that PRC materials are irrelevant because they are internal
documents that physicians would never have seen. But internal documents are relevant
to Actavis's intent in marketing Androderm and are therefore admissible. The Court
encourages the parties to reach an agreement regarding Actavis's concern that certain
PRC materials might be covered by attorney-client privilege. Finally, Actavis argues
that PRC documents dated after April 8, 2013 (the date of Martin's last Androderm
prescription) are irrelevant. The Court explains why that argument lacks merit in its
ruling on Actavis's second and third motions in limine.
2. Androderm label changes and regulatory activity after Martin filled
his last prescription
Martin filled his last prescription for Androderm on April 8, 2013. Actavis moves
to exclude changes to the Androderm label and related regulatory activity that occurred
after that date. The evidence that Actavis seeks to exclude includes the FDA's March 3,
2015 announcement that it was requiring all TRT drug manufacturers to add a
cardiovascular risk warning (hereinafter, the MACE language) to the Warnings and
Precautions section of their TRT drug labels.
In several MDL bellwether trial cases, the defendants sought—and the Court
denied—the exact relief Actavis requests here. See, e.g., Mitchell/Konrad MIL Rulings,
2017 WL 2313201 at *1 (denying AbbVie's motion to exclude evidence of changes to
the AndroGel label and other regulatory activity that occurred after the plaintiffs stopped
using the drug). In Mitchell/Konrad, the Court determined that, to the extent the
evidence "indicate[d] [the FDA's] views on AndroGel's ability to cause heart attacks," it
was "relevant to the issue of causation." Id. at *2. The Court also stated that "when
considered with evidence of how plaintiffs' prescribing physicians and other physicians
changed their prescribing practices in response to those revisions," the 2015 label
changes were relevant "on the question of what plaintiffs' prescribing physicians would
have done had AndroGel's label been different at the time they prescribed the drug to
plaintiffs." Id.; see also Nolte MIL Rulings, 2018 WL 305503 at *8 (same); Myers MIL
Rulings, 2018 WL 2095701 at *2 (denying motion to exclude evidence about post-injury
label revisions where prescribing physician testified that, if she had known about the
MACE language added to the 2015 label, "she would have discussed this information
with [the plaintiff]" in making her prescribing decision).
Martin's case is no different. Arguing otherwise, Actavis contends that there is no
evidence concerning how label changes and regulatory activity that post-dated Martin's
last prescription would have affected Dr. Firestone's prescribing decision. The Court
determined at the summary judgment stage that a reasonable jury could disagree. See
Martin SJ/Daubert Order, 430 F. Supp. 3d at 541 (Martin's medical records and
declaration about his doctor-patient relationship with Dr. Firestone "permit[] an inference
that Martin would not have wanted to take Androderm if he had known of the
undisclosed cardiovascular risk, as well as an inference that Dr. Firestone, knowing
Martin's wishes, would not have prescribed the drug"). Given this ruling, Actavis's first
argument for exclusion of the evidence lacks merit.
Actavis also argues that the evidence should be excluded because the FDA-
mandated 2015 label change is irrelevant to any events that occurred before April or
May 2013. In support, Actavis states that "[t]he two studies that caused FDA to issue its
first [drug safety communication] on January 31, 2014, had not been published, and the
Advisory Committee meeting and recommendations on which FDA based its 2015
actions had not occurred . . . ." Actavis MIL at 10. Actavis also emphasizes that in
February 2014, the FDA rejected a request from consumer advocacy group Public
Citizen to require TRT manufacturers to strengthen their cardiovascular risk warnings.
Id. at 9. Finally, Actavis states that, even in September 2014, an FDA Advisory
Committee characterized as "weak" the cardiovascular risk signal that had emerged
from recent epidemiologic studies of TRT drugs. Id.
Again, the Court addressed similar arguments at the summary judgment stage.
It determined that, even considering the evidence Actavis cites, a jury reasonably could
conclude that "a causal association between Androderm use and cardiovascular risk
was well-supported by the regulatory and scientific evidence" long before Martin was
prescribed Androderm. Martin SJ/Daubert Order, 430 F. Supp. 3d at 539-40. Likewise,
the Court observed that there is "[e]vidence that the FDA recognized a possible link"
between TRT use and cardiovascular risk before that time. Id. at 531. Such evidence
"reasonably indicated that the FDA would not have rejected a TRT manufacturer's
request to add a cardiovascular risk warning." Id. For these reasons, evidence of label
changes and regulatory activity that post-dated Martin's last Androderm prescription is
relevant to the issue of causation. Its probative value, moreover, is not substantially
outweighed by the risk of unfair prejudice or confusion.
Actavis's cited cases do not persuade the Court otherwise. In Giles v. Wyeth,
Inc., 556 F.3d 596 (7th Cir. 2009), the Seventh Circuit determined that the district court
was correct to exclude warning labels that post-dated the plaintiff's injury because the
warnings "focused on the risk of suicide in younger persons, not adults of [the plaintiff's]
age." Id. at 598. Furthermore, there was "no evidence that [the defendant] knew or
should have known the information contained in the later warnings at the time of [the
plaintiff's] death." Id. Here, the later warnings were relevant to Martin's demographic
group, and there is evidence from which a jury reasonably could find that Actavis was
on notice of the relevant information while Martin was taking Androderm. In Actavis's
cited portion of Chlopek v. Federal Insurance Co., 499 F.3d 692, 700 (7th Cir. 2007),
the Court determined that evidence about a subsequent remedial measure was properly
excluded under Federal Rule of Evidence 407. Actavis does not bring a Rule 407
challenge to the evidence, and any effort to do so would be unavailing. See, e.g.,
Mitchell/Konrad MIL Rulings, 2017 WL 2313201 at *1 ("Because the FDA required
AbbVie to make the 2015 changes to its label, the Court concludes that Rule 407 does
not apply.").5
Actavis also seeks to exclude evidence that, as part of the 2015 label change,
the FDA required a statement that Androderm's safety and efficacy in men with age-
related hypogonadism have not been established. According to Actavis, this evidence
is irrelevant because Martin's medical records do not show that he was diagnosed with
age-related hypogonadism or prescribed Androderm to treat that condition. As Martin
argues in response to Actavis's fifth motion in limine, however, his medical records can
reasonably be understood as showing that Dr. Firestone prescribed him Androderm to
address symptoms of aging: fatigue, lack of energy, and declining libido. In particular,
Martin asked his nurse if his fatigue could be related to his testosterone level; obtained
an Androderm prescription after a test showed his testosterone level was at the low end
of a normal range; and continued refilling prescriptions after telling his medical team that
Androderm was improving his energy level and libido. The Court concludes that the
2015 label change as it relates to age-related hypogonadism is relevant and admissible.
See, e.g., Myers MIL Rulings, 2018 WL 2095701 at *3 (denying motion to exclude
subsequent label change concerning age-related hypogonadism where, among other
things, the plaintiff's doctor prescribed him AndroGel "to treat symptoms typically
associated with aging").
Finally, the parties agree that subsequent label changes and regulatory activity
5 Actavis's other cited cases are not binding on this Court, so the Court does not
address them.
concerning the risk of venous thromboembolism (VTE) are irrelevant. Martin is
concerned, however, that redacting VTE information from otherwise relevant documents
could "make the jury suspicious." Martin Opp. to Actavis MIL [dkt. no. 179] at 10. He
proposes "minimiz[ing] the presentation" of VTE information in a way that stops short of
redaction, but he does not suggest any methods for doing so. Id. As the Court
concluded in another MDL bellwether trial case, the "appropriate remedy is redaction of
irrelevant material." Nolte MIL Rulings, 2018 WL 305503 at *8.
3. Information that allegedly should have caused Actavis to add a
MACE warning before April 8, 2013
According to Martin, Actavis could have used the FDA's changes being effected
(CBE) procedure to unilaterally add the MACE language to Androderm's label before
April 8, 2013—the date of Martin's last Androderm prescription before his heart attack.
Actavis moves to exclude evidence of information that purportedly supports this theory
"unless and until [Martin] lays a foundation that the information is Newly Acquired
Information acquired by [Actavis] after April 26, 2012." Actavis MIL at 13. April 26,
2012 is the date of the last FDA-approved revision to the Androderm label before Martin
started taking the drug.
The Court assumes familiarity with its previous discussions of the CBE
procedure, including the definition of newly acquired information as it relates to that
procedure. See, e.g., Martin SJ/Daubert Order, 430 F. Supp. 3d at 527-31. The theory
Actavis advances here is the same one it pressed unsuccessfully in moving for
summary judgment that Martin's failure to warn, design defect, and so-called "off-label
marketing" claims are preempted by federal law. See id. at 529. In denying Actavis's
motion for summary judgment, the Court observed that the theory depends on an
assumption that "the FDA's approval of the Androderm label in April 2012 constitutes
'clear evidence' that it would have rejected an attempt by Actavis to add the relevant
warnings between 1995 and October 2012 based on the information available during
that time." Id. at 529-30. The Court explained why that assumption lacks merit, see id.,
and the same reasoning applies here. Martin is free to present information that he
contends supports his causation theory without laying a foundation that Actavis
discovered it after April 26, 2012.
Actavis cites Dolin v. GlaxoSmithKline LLC, 901 F.3d 803, 815 (7th Cir. 2018)
(Dolin I) for the proposition that newly acquired information means information obtained
after the date of the last FDA-approved revision to a drug label. But the Court in Dolin
did not articulate this bright-line rule. There, the defendant proposed adding an adult
suicidality warning to a prescription drug label in 2007. See id. at 810. The FDA
rejected the proposal that same year. See id. Specifically, it required all manufacturers
of the drug "to adopt the same class-wide warnings"—which omitted the product-
specific language that the defendant had proposed. Id. at 810, 813. It also
communicated to the defendant that it was rejecting the product-specific warning
language. See id. at 810. The Seventh Circuit determined that to show the defendant
could have used the CBE process to add the warning between 2007 and 2010, the
plaintiff had to offer evidence that the defendant acquired new information after 2007
that justified the previously-rejected warning. See id. at 815.
Later, the Seventh Circuit concluded that its decision in Dolin I "would have been
the same under" Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019),
where the Supreme Court clarified the standard for impossibility preemption. Dolin v.
GlaxoSmithKline LLC, 951 F.3d 882, 889, 891 (7th Cir. 2020) (Dolin II). That was
because the record showed that the defendant "disclosed the relevant data underlying
its desired adult-suicidality warning to the FDA in 2006," and "the FDA unambiguously
rejected" the defendant's proposed warning in 2007 "when it formally mandated that all
SSRIs carry a uniform, class-wide warning label." Dolin II, 951 F.3d at 891.
The dispositive evidence in Dolin I and Dolin II is lacking here for reasons the
Court has already explained. See, e.g., Martin SJ/Daubert Order, 430 F. Supp. 3d at
531. Accordingly, the Dolin cases do not support Actavis's argument that newly
acquired evidence must be evidence obtained after April 26, 2012. The Court denies
Actavis's third motion in limine.
4. Defendants' alleged promotion of Androderm for the treatment of
age-related hypogonadism
Actavis moves to exclude evidence that it allegedly promoted Androderm to treat
age-related hypogonadism, which Martin contends is an off-label use. According to
Actavis, the evidence is irrelevant because the record contains no evidence that
Martin's age affected his testosterone level. Actavis emphasizes that Martin's
testosterone level at the relevant time was in the low end of a normal range; his medical
records do not show that he was diagnosed with age-related hypogonadism; and he
offers no admissible expert testimony regarding the etiology of his testosterone level.
These arguments are unpersuasive because, as discussed above, a jury reasonably
could conclude based on the evidence that Martin was prescribed Androderm to treat
symptoms of aging.
The Court has also addressed Actavis's other proposed ground for exclusion:
that the evidence has no relevance because there is no record of Martin or his
prescribing physician having seen Androderm promotional materials or interacting with
Actavis sales representatives. For the reasons explained in connection with Actavis's
first motion in limine, a limited amount of evidence concerning alleged off-label
promotion is relevant to this case. The Court denies Actavis's motion to exclude
evidence of alleged promotion of Androderm for treating age-related hypogonadism.
5. Unofficial statements by FDA employees
Actavis asks the Court to exclude evidence of unofficial public statements made
by former FDA employee Dr. Daniel Shames. It maintains the statements have low
probative value because they reflect Dr. Shames's personal opinions rather than the
FDA's official views. And because the statements purportedly reflect personal opinions,
Actavis contends, they present a danger of confusing and misleading the jury. Finally,
Actavis argues that if offered for their truth, the statements are inadmissible hearsay.
In Mitchell/Konrad, AbbVie moved to exclude the same evidence for the same
reasons. The Court determined that Dr. Shames's statements were relevant to whether
AbbVie was on notice that it was marketing AndroGel for off-label purposes. See
Mitchell/Konrad MIL Rulings, 2017 WL 2313201 at *3. The Court concluded that the
probative value of the statements was not substantially outweighed by the risk of unfair
prejudice, and it denied AbbVie's motion. Id. Martin, too, offers Dr. Shames's
statements "to show that Actavis was on notice that its marketing efforts were off-label."
Martin Opp. to Actavis MIL at 14. Because the Court has determined that some
evidence of Actavis's alleged off-label promotion is admissible in Martin's case, so, too,
is evidence that Actavis was on notice regarding the same. Accordingly, the Court
denies Actavis's motion.
6. AndroGel co-promotion agreement
Actavis asks the Court to exclude all evidence about its September 2006
agreement with Solvay Pharmaceuticals, Inc. to co-promote Solvay's TRT product,
AndroGel. The Court directs the parties to provide argument on this motion at the final
pretrial conference. Among other things, the parties should be prepared to discuss
whether a reasonable solution might be to permit evidence about the co-promotion
agreement so long as it is dated 2012 or later. The Court's understanding is that before
2012, Actavis promoted only AndroGel under the co-promotion agreement. After
Actavis introduced 2mg and 4mg Androderm patches in 2012, it began promoting both
AndroGel and Androderm under the agreement.
7. Alleged fraud on the FDA and why the FDA acted or failed to act
Actavis moves to exclude evidence concerning alleged fraud on the FDA, as well
as evidence or argument that the FDA would have acted differently on the basis of
different information. The Court grants the motion for the reasons stated in numerous
orders entered in this MDL proceeding. See, e.g., CMO 48, 2017 WL 1836443 at *7
(fraud-on-FDA claims are preempted); id. at *16 (regulatory expert lacks sufficient basis
to testify "regarding the FDA's reasons for acting or failing to act"); see also
Mitchell/Konrad MIL Ruling, 2017 WL 2313201 at *1, *4 (citing same).
Martin argues that Dr. Sharlin should be able testify that, "had Actavis provided
the required information and analysis to the FDA, the agency could have taken the
action sooner." Martin Opp. to Actavis MIL at 21. The Court already granted Actavis's
Daubert motion to exclude a nearly identical opinion, explaining that it amounts to an
opinion about the FDA's intent. See In re Testosterone Replacement Therapy Prods.
Liab. Litig. Coordinated Pretrial Proceedings, MDL No. 2545, Case Nos. 14 C 1748, 15
C 4292, 2020 WL 4437829, at *6 (N.D. Ill. Aug. 2, 2020) (Dr. Sharlin Daubert Order)
(Dr. Sharlin's opinion that the "FDA otherwise could have identified the risk earlier and
initiated a labeling change before March 2015" is inadmissible). Martin identifies no
viable reason to change that ruling.
Martin also contends that Dr. Sharlin should be able to explain why the FDA
denied the 2014 Public Citizen Petition. According to Dr. Sharlin, the FDA denied the
petition because it did not have enough time to respond to it and did not want to
interfere with an upcoming Advisory Committee meeting. See Martin Opp. to Actavis
MIL at 22. Again, the Court has already granted Actavis's Daubert motion to exclude
Dr. Sharlin's opinions about the FDA's intent in denying the petition. See Dr. Sharlin
Daubert Order, 2020 WL 4437829 at *6-7; see also id. at *7 (barring Dr. Sharlin from
opining that the FDA is under-resourced because, unlike other regulatory experts in this
MDL proceeding, he cited no foundation for the opinion). Martin's contention that Dr.
Sharlin "ties in the actual text of the rejection letter with his theory" does not persuade
the Court to change its prior ruling. Martin Opp. to Actavis MIL at 23. Nor does Martin's
argument that Dr. Sharlin's opinions may be necessary to rebut Actavis's arguments
about why the FDA denied the petition. See id. at 22 (predicting that Actavis will
suggest that the FDA denied the petition because there was insufficient evidence of a
causal relationship between TRT use and cardiovascular risk). Martin's concern is
unfounded because the prohibition on offering opinions about why the FDA acted or
failed to act applies equally to Actavis.
8. Foreign regulatory actions and labeling
Actavis moves to exclude any evidence or argument about foreign regulatory
actions, communications, or labeling related to Androderm. In Mitchell/Konrad, the
Court explained that generally speaking, "foreign labeling or regulatory actions have
little relevance on the question of whether a defendant's U.S. label is adequate." See
Mitchell/Konrad MIL Rulings, 2017 WL 2313201 at *3. It added that presenting such
evidence to the jury could cause confusion and waste time. See id. But the Court
allowed the plaintiffs to offer evidence about a specific Canadian regulatory action
regarding AndroGel. See id. According to the plaintiffs, AbbVie's communications with
the Canadian agency about that regulatory action showed AbbVie's knowledge that
"hypogonadism could be separated into different categories with different corresponding
indications." Id. The Court determined that the evidence was relevant to "whether
AbbVie knew that it was engaging in off-label marketing." Id. The Court also
determined that understanding the evidence would not "require extensive understanding
of Canadian regulatory procedure." Id. In that context, the Court concluded, the
probative value of the evidence was not substantially outweighed by the danger of
misleading the jury or unfairly prejudicing AbbVie. See id.
Citing Mitchell/Konrad, Martin argues that the Court should allow him to introduce
evidence about a communication from Health Canada to Actavis in 2006. According to
Martin, the Canadian regulator told Actavis "to stop marketing Androderm for age-
related declines in testosterone because there was not proper clinical data supporting"
the drug's safety and efficacy for that purpose. Martin Opp. to Actavis MIL at 24; see
also id. (maintaining that the evidence is relevant to whether Actavis had notice that the
safety and efficacy of Androderm for aging men—the population Actavis allegedly was
"targeting"—had not been proven). Martin states that he does not intend to offer any
other evidence about foreign regulatory actions.
The Health Canada communication that Martin seeks to introduce at trial appears
related to the Canadian regulatory communications that the Court concluded were
admissible in Mitchell/Konrad. Both occurred in 2006 and expressed concern about
suggestions in TRT drug labels that the drugs were indicated to treat "andropause."
Compare Martin Opp. to Actavis MIL, Ex. 19 (July 2006 Health Canada Ltr. re:
Androderm) [dkt. no. 180-8]6 with PSC Opp. to AbbVie MIL, Ex. 19 [Case No. 14 C
1748, dkt. no. 1941-11] (Minutes of Feb. 2006 Meeting Between Solvay and Health
Canada). Moreover, Actavis does not address the 2006 Health Canada Letter in its
motion in limine despite that (according to Martin) he told Actavis in a meet-and-confer
that he intended to present it at trial. See Martin Opp. to Actavis MIL at 23-24. For the
same reasons stated in Mitchell/Konrad, the Court concludes that the 2006 Health
Canada Letter is admissible. The Court grants Actavis's motion to exclude all other
evidence of foreign regulatory actions.
9. Communications with other TRT drug manufacturers
Actavis moves to exclude evidence about the FDA's communications with other
TRT drug manufacturers about their TRT drugs. Actavis provides only one example: a
March 24, 2010 letter from the FDA to Slate Pharmaceuticals about certain promotional
materials for its TRT drug, Testopel. In the letter, the FDA informed Slate that the
6 The July 2006 Health Canada Letter is addressed to "Pharmascience Inc.," not
Actavis, but it discusses Androderm.
materials misleadingly implied that Testopel could be used to (1) treat symptoms of
depression, erectile dysfunction, type 2 diabetes, HIV, mood disorders, and loss in
sexual interest, and (2) increase muscle mass and bone strength. The FDA stated that
it was unaware of any data supporting such claims. Actavis argues that the letter is
irrelevant because the FDA-approved Androderm label in effect at the time "cited and
summarized data from trials of Androderm" that showed the drug improved fatigue,
mood, and sexual function. Actavis MIL at 24 (citing Actavis MIL, Ex. G (Androderm
Label rev. Nov. 2005) [dkt. no. 169-7]). Actavis maintains that the Slate letter would
mislead and prejudice the jury by suggesting there was no data to support the relevant
symptom claims in the Androderm label. In addition, Actavis contends that introducing
the letter would waste time.
In Mitchell/Konrad, the Court granted in part AbbVie's motion to exclude evidence
regarding other manufacturers of TRT drugs. The Court explained that other TRT drugs
"have different marketing and regulatory histories, and thus testimony or other evidence
about those products may be misleading unless it is placed in the proper context."
Mitchell/Konrad MIL Rulings, 2017 WL 2313201 at *3. Establishing the proper context
would take an undue amount of time, the Court determined. See id. It would also be
unfairly prejudicial to AbbVie because, through discovery with other defendants in the
MDL, the plaintiffs had access "to information about other TRT manufacturers that
AbbVie lack[ed]." Id. But the Court made an exception for the same FDA letter to Slate
that is at issue here. See id. The plaintiffs in Mitchell/Konrad argued that Slate's
"alleged improper marketing was parallel to AbbVie's marketing and that AbbVie
received a copy of the letter soon after Slate did, thus giving AbbVie notice that its own
off-label marketing was inappropriate." Id. The Court determined that a jury would be
able to understand the letter introduced for that purpose "without the need for extended
background on Slate's TRT drug." Id. Therefore, the Court concluded that the letter
was admissible. Id.
Martin argues that the letter put Slate's competitors—including Actavis—on
notice that they could not promote TRT drugs for improving mood, depression, libido,
and erectile dysfunction. He emphasizes that Actavis knew about and relied on the
Slate letter when drafting Androderm marketing materials in 2011. Specifically, an
Actavis employee cited the letter in an August 2011 internal document for the
proposition that "[l]inking Androderm to treatment of osteoporosis, depression, and ED
seems overreaching and risky." Martin Opp. to Actavis MIL, Ex. 20 [dkt. no. 180-9] at
WLI-MDL2545-00753379. This document tends to show that, like AbbVie, Actavis
received a copy of the Slate letter long ago and independent of this MDL proceeding.
See Mitchell/Konrad MIL Rulings, 2017 WL 2313201 at *3. The document also tends to
show that Actavis thought the Slate letter was relevant to its Androderm marketing
activities in 2011. This point significantly weakens Actavis main argument for exclusion:
that, unlike the Slate promotional materials addressed in the letter, a 2005 version of the
Androderm label cited data that purportedly supported the relevant symptom relief
claims. Whatever the data in the 2005 Androderm label, the internal document Martin
cites can be understood as recognition by Actavis in 2011 that the Slate letter should
guide its Androderm promotional activities.
Two other factors further diminish the significance of the 2005 Androderm label
to Actavis's request to exclude the Slate letter. First, Martin contends that Actavis did
not repeat the study that allegedly provided supporting data for the sexual side effect
claims in the 2005 label. Second, according to Martin, the FDA required Actavis to
remove the sexual side effect claims from the next label revision, which occurred in
2011.
The FDA's March 24, 2010 letter to Slate is relevant to the question whether
Actavis had notice that it could not properly market Androderm for improving mood,
depression, libido, and erectile dysfunction. The letter's probative value is not
substantially outweighed by the risk of misleading the jury, prejudicing Actavis, or
wasting trial time. The Court grants Actavis's motion to exclude all evidence of
communications with other manufacturers of TRT drugs, except for the FDA's March 24,
2010 letter to Slate.
10. Total number of lawsuits
Actavis asks the Court to prohibit Martin from introducing evidence about the
number of Androderm-related lawsuits filed against it and the number of lawsuits filed
against all TRT manufacturers in the MDL. Actavis appears to contend that it would not
open the door to this evidence by asking Martin's medical expert, Dr. Ardehali, about his
compensation. See Actavis MIL at 25 n.15. In previous bellwether trial cases, the
Court determined that the defendants could ask the plaintiffs' experts about their hourly
compensation rates without opening the door. See, e.g., Nov. 8, 2017 Holtsclaw Trial
Tr. at 564:9-14. But the Court warned that if the defendants elicited testimony about the
experts' overall compensation, it would permit the plaintiffs to introduce evidence about
the total number of lawsuits to "explain[] the overall number." Id. at 564:15-19. The
Court will apply the same principles in Martin's trial, but it urges the parties to confer and
agree on a solution in advance.
In response to Actavis's motion, Martin argues that Actavis could open the door
to evidence about other cases in the MDL not only by asking experts about total
compensation, but also by suggesting that Dr. Ardehali "finds causation in every case
he reviews." Martin Opp. to Actavis MIL at 26. Martin contends that the Court should
allow him to rebut such an argument with evidence about how Dr. Ardehali approached
other cases he reviewed. Ruling on Martin's request would be premature, but the Court
warns Actavis that it may be difficult to get into this area without opening a door in some
way. The Court also advises that asking Dr. Ardehali about his findings "as a paid
expert in litigation" and in specific cases other that Martin's could indeed open the door
to evidence about other cases in the MDL. See Nov. 8, 2017 Holtsclaw Trial Tr. at
561:10-567:25. Again, the Court urges the parties to confer and agree on a solution
before trial.
Martin also maintains that if Actavis "portray[s] [him] as an outlier whose heart
attack cannot be blamed on Androderm," the Court should allow him to present
evidence that other Androderm patients have sued Actavis for heart attacks allegedly
caused by the drug. Martin Opp. to Actavis MIL at 26. Ruling on this request in the
abstract would be improper, but the Court encourages both sides to tailor their
presentations, wherever possible, to Martin's individual circumstances.
11. Inflammatory language
Actavis moves to exclude any evidence or argument that it promoted and sold
Androderm "to a population of patients who were participants in 'a mass uncontrolled
experiment.'" Actavis MIL at 26. In another MDL bellwether trial case, the Court
permitted the plaintiff's regulatory expert to compare defendant Auxilium's marketing
practices for its TRT drug to a "mass, uncontrolled experiment." Holtsclaw MIL Rulings,
2017 WL 5029601 at *4 (internal quotation marks omitted) (determining that the
comparison was "not so inflammatory or prejudicial to warrant exclusion"). Actavis
advocates a different result here because it contends that, unlike in Holtsclaw, none of
Martin's experts disclosed such an opinion about Actavis's marketing practices.
Martin admits that his regulatory expert, Dr. Sharlin, did not use the phrase
"mass uncontrolled experiment" in his report or deposition testimony. But he argues
that the Court should allow Dr. Sharlin to use that phrase (or similar language) because
he disclosed opinions that Actavis marketed Androderm for uses that have not been
proven safe and effective in controlled clinical trials. The Court agrees and denies
Actavis's motion.
12. Androderm sales figures
Actavis moves to exclude evidence of Androderm sales figures. In Holtsclaw, the
Court permitted the plaintiff to introduce evidence about the profits that defendant
Auxilium earned from sales of its TRT drug, Testim. See Holtsclaw MIL Rulings, 2017
WL 5029601 at *2. The Court determined that the evidence was relevant on the issue
of Auxilium's alleged motive to market Testim for off-label purposes. See id. On the
other hand, the Court excluded evidence of sales figures for Testim because it could be
misleading without context, such as what it costs Auxilium to produce the drug. See id.
Later, in Nolte, the Court allowed the plaintiff to introduce sales figures for AndroGel.
See Nolte MIL Rulings, 2018 WL 305503 at *9 (evidence was relevant to AbbVie's
alleged motive to promote AndroGel off-label, and its probative value was not
substantially outweighed by danger of unfair prejudice). The Court permitted the
plaintiff to offer sales figures—rather than profits figures—because specific data about
profits derived from AndroGel sales was unavailable. See id.
Actavis contends that the Court should depart from these rulings because its
alleged motive to promote Androderm for an off-label purpose—to treat age-related
hypogonadism—is irrelevant to every claim in Martin's case. In support, Actavis
reiterates that the record contains no direct evidence that Martin or Dr. Firestone saw or
relied upon Androderm marketing materials. As already discussed, the Court has
concluded that Actavis's alleged off-label promotion and its motive for the same are
relevant even in the absence of such evidence. Actavis also repeats its contention that
there is no evidence that Dr. Firestone diagnosed Martin with age-related
hypogonadism or that Martin took Androderm to treat that condition. The Court
explained above, however, that Martin's medical records can be understood as
suggesting otherwise. For these reasons, Actavis's cited cases—where intent was
irrelevant to all claims and profits figures were untethered to the evidence—provide no
assistance.
The Court's rulings in Holtsclaw and Nolte about the admissibility of sales and
profit figures apply equally here. Actavis, moreover, does not suggest that it would be
feasible for Martin to offer profit figures in lieu of sales figures. Accordingly, the Court
denies Actavis's motion to exclude evidence about Androderm sales figures.
13. Testimony about what Martin would have done had he known of
MACE risk
Actavis moves to exclude Martin's testimony that he would not have taken
Androderm if, at the time of his first prescription, he had known about the MACE
language eventually added to the 2015 label. Martin provided testimony along these
lines in a declaration he submitted at the summary judgment stage. Actavis contends
that the testimony is "pure speculation." Actavis MIL at 28 (citing FED. R. EVID. 602 (fact
witness testimony must be based on personal knowledge); Widmar v. Sun Chem. Corp.,
772 F.3d 457, 460 (7th Cir. 2014) ("Personal knowledge can include reasonable
inferences, but it does not include speculating . . . or other intuitions, hunches, or
rumors.")). In Widmar, the plaintiff ran afoul of Rule 602 by making guesses about his
"employer's state of mind." See 772 F.3d at 461. By contrast, Martin invokes his
personal experience to testify about what he would have done with different risk
information. His testimony is not improper speculation.
Actavis also argues that Martin's testimony is irrelevant because of the learned
intermediary doctrine, which provides that a manufacturer's duty to warn about a drug's
risks runs to the physician, not the patient. Minnesota courts follow the learned
intermediary doctrine. To prove causation, therefore, "Martin must show that (1) Actavis
failed to adequately warn" Dr. Firestone "about cardiovascular risk associated with
Androderm, and (2) Dr. Firestone would not have prescribed Androderm for Martin if
Actavis had provided an adequate warning." Martin SJ/Daubert Order, 430 F. Supp. 3d
at 540. Actavis maintains that because of the learned intermediary doctrine, a patient's
preferences or conversations with his doctor play no causal role in the doctor's
prescribing physician. See, e.g., Actavis MIL Opp. at 28-29 (arguing that if Dr.
Firestone had received the MACE language, he would have "already . . . made" his
prescribing decision before discussing Androderm's risks and benefits with Martin).
Actavis's theory finds no support in the law. The learned intermediary doctrine
governs only the manufacturer's duty to warn. It says nothing about how physicians
make their prescribing decisions. Mulder v. Parke Davis & Co., 181 N.W.2d 882, 885,
288 Minn. 332, 335 (1970), cited by Actavis, does not provide otherwise. See id.
(manufacturer not liable for doctor's failure to communicate warning to patient, so long
as "doctor was fully aware of the facts which were the subject of the warning"). Nor
does Bruzer v. Danek Med., Inc., No. CIV. 3-95-971/RHKJMM, 1999 WL 613329, at *6
(D. Minn. Mar. 8, 1999), where the "fatal problem" with the plaintiffs' claims was their
doctor's testimony that "he would have recommended [the medical device] regardless of
the existence or content of any warnings provided by the Defendants." Dr. Firestone
provided no such testimony here. Finally, this Court has previously credited the theory
that a doctor's conversation with his or her patient can affect the prescribing physician.
See Martin SJ/Daubert Order, 430 F. Supp. 3d at 541 (denying Actavis's motion for
summary judgment on Martin's failure to warn claim because the evidence "permits an
inference that Martin would not have wanted to take Androderm if he had known of the
undisclosed cardiovascular risk, as well as an inference that Dr. Firestone, knowing
Martin's wishes, would not have prescribed the drug"); Myers MIL Rulings, 2018 WL
2095701 at *2 (evidence of post-injury label change was relevant where prescribing
physician testified that, had she known about the MACE language added to the 2015
label, "she would have discussed this information with [the plaintiff]" in making her
prescribing decision).
The Court denies Actavis's motion.
14. Dr. Firestone's habits
In the declaration Martin provided for summary judgment purposes, he discussed
Dr. Firestone's practices in the nearly seven years he served as Martin's prescribing
physician. See Martin SJ/Daubert Order, 430 F. Supp. 3d at 541. The Court cited the
declaration as among the evidence permitting a reasonable inference that, had Actavis
provided an adequate cardiovascular risk warning to Dr. Firestone, he would have made
a different prescribing decision. See id. The Court considered and overruled Actavis's
objection that Martin's statements about Dr. Firestone's practices are inadmissible
evidence of habit under Federal Rule of Evidence 406. See id. at 541-42 (determining
that Martin's declaration supplies the foundation for habit evidence that Rule 406
requires). Actavis now moves to exclude the same evidence under Rule 406. It
presents the same arguments and case law as it did as the summary judgment stage.
The Court reaffirms its ruling that testimony consistent with Martin's declaration is
admissible under Rule 406.
Actavis also contends that the habit evidence is irrelevant and unfairly prejudicial,
and it asks the Court to exclude the evidence under Federal Rules of Evidence 402 and
403. Actavis again repeats unsuccessful arguments from its summary judgment
motion. First, it maintains that Dr. Firestone's habits are irrelevant because Martin
spoke only with Nurse Hopkins about his Androderm prescription. The Court has
determined, however, that the evidence permits a reasonable inference that "Dr.
Firestone was actively involved in Martin's treatment with Androderm." Martin
SJ/Daubert Order, 430 F. Supp. 3d at 541; see also id. at 542 (although Martin may not
have spoken directly to Dr. Firestone about Androderm, evidence about Dr. Firestone's
habits is admissible because a jury reasonably could conclude that "Martin was
communicating with Dr. Firestone through Ms. Hopkins").
Second, Actavis maintains that the relevance and probative value of the habit
evidence depends on the unsupported inference that Dr. Firestone read the Androderm
label before prescribing the drug to Martin. See Actavis MIL at 31 (stating that an
alleged omission in a label cannot proximately cause a plaintiff's injury if the doctor
prescribed the drug without reading the label (citing cases)); id. at 32 (citing Broesch v.
Gagnon, 817 F.2d 37, 38 (7th Cir. 1987) (State must prove "predicate facts" in order for
jury to draw a permissive inference) (internal quotation marks omitted)). Actavis's
argument is unavailing because the Court has determined that, based on Martin's
medical records, a jury reasonably could infer that Dr. Firestone read the Androderm
label before he made his prescribing decision. See Martin SJ/Daubert Order, 430 F.
Supp. 3d at 540. Finally, Actavis contends that a jury could not reasonably conclude
based on the evidence about Dr. Firestone's habits that different cardiovascular risk
information would have caused him to make a different prescribing decision. As
referenced above, the Court disagrees. See, e.g., id. at 541.
The evidence about Dr. Firestone's habits is admissible under Rule 406 and is
relevant to causation. Furthermore, its probative value is not substantially outweighed
by the danger of prejudice, confusion, or misleading the jury. The Court denies
Actavis's motion to exclude it.
15. Actavis's financial condition
Actavis moves to exclude "from the compensatory damages proceeding"
evidence about its financial condition and evidence relevant only to punitive damages.
Actavis MIL at 33. This request is interrelated with Actavis's motion for bifurcation of the
punitive damages stage of Martin's trial [dkt. no. 211]. Martin does not oppose the
motion to bifurcate. See Martin Resp. to Mot. to Bifurcate [dkt. no. 244] at 1. And he
agrees that, if the Court grants the motion, evidence about Actavis's financial condition
should be admitted only during the punitive damages stage. But Martin asks the Court
to prohibit Actavis from using bifurcation to keep evidence about off-label promotion out
of the compensatory damages stage of the trial. He also asks the Court to allow him to
enter evidence about Actavis's financial condition through an expert rather than by
stipulation about Actavis's net worth.
As discussed above, marketing and promotion evidence may be relevant to
several claims in this case—including, but not limited to, Martin's claim for punitive
damages. Accordingly, if the Court grants the motion to bifurcate, it will not preclude
Martin from introducing a limited amount of evidence about off-label marketing of
Androderm during liability phase, as discussed earlier. And so long as the punitive
damages proceeding is bifurcated, the Court will grant Actavis's motion to exclude
evidence about its financial condition from the compensatory damages stage.
The Court requests argument regarding Martin's request to offer evidence about
Actavis's financial condition through an expert. Martin should be aware, however, that
because the Court has required the parties to enter the evidence via stipulation in other
MDL bellwether trials, it is hesitant to change course here. The parties should also be
prepared to discuss (1) whether Minnesota's rule concerning bifurcation is substantive
or procedural, and (2) if the rule is procedural, why the Court should bifurcate Martin's
trial when it did not do so for the other MDL bellwether trials.
United States District Judge
Date: April 25, 2021
48 Case Information
- Court
- N.D. Ill.
- Decision Date
- April 25, 2021
- Status
- Precedential