Mitchell et al v. AbbVie, Inc. et al
Filing
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MDL CASE MANAGEMENT ORDER NO. 105 (Memorandum Opinion and Order on plaintiff's motion to exclude cumulative expert testimony in Mitchell v. AbbVie, No. 14 C 9178). (mk)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
In re: Testosterone Replacement
Therapy Products Liability Litigation
Coordination Pretrial Proceedings
------------------------------------------------------------(This document applies to all cases and
Mitchell v. AbbVie, Case No. 14 C 9178)
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Case No. 14 C 1748
MDL No. 2545
CASE MANAGEMENT ORDER NO. 105
(Memorandum Opinion and Order on plaintiff's motion to exclude
cumulative expert testimony in Mitchell v. AbbVie, No. 14 C 9178)
MATTHEW F. KENNELLY, District Judge:
In the first trial in the Mitchell v. AbbVie case—one of the AbbVie-only bellwether
cases selected for trial—AbbVie called four witnesses who gave expert opinion
testimony on the question of general causation, that is, whether AbbVie's drug AndroGel
causes or increases the risk of an adverse cardiovascular (CV) event in a person taking
the drug. The witnesses were Dr. William French, Dr. Mohit Khera, Dr. Linda
Scarazzini, and Dr. Laurentius Marais.
Dr. French, a cardiologist, testified at length about the results of studies
regarding testosterone replacement therapy (TRT), attempting to debunk or explain
studies that showed an increased incidence of adverse CV events, and referencing
studies that showed positive benefits from TRT. Dr. French opined that there is no
statistically significant association between TRT and CV events and thus no causation.
He also testified about the alleged biological mechanisms by which TRT is claimed to
cause an increased incidence of CV events, as well as studies about that topic. He
gave testimony regarding non-TRT risk factors that lead to an increased risk of CV
events. Dr. French also testified regarding an analysis of studies of adverse events
conducted by Dr. Marais.
Dr. Khera, a urologist, testified regarding the diagnosis and management of
"hypogonadism" and the risks and benefits of TRT. He discussed at least one of the
adverse event studies that Dr. French had addressed. Dr. Khera testified about his
involvement in the "Androgen Study Group." He also discussed the proposition that the
same or similar risk factors that lead to hypogonadism are also risk factors for
cardiovascular disease. He testified about studies regarding the risks and benefits of
TRT. He opined that TRT leads to a decreased incidence of CV events. Dr. Khera also
testified regarding medical literature about CV risks and what he tells patients before
prescribing TRT to them.
Dr. Scarazzini is a medical doctor who previously worked for the Food and Drug
Administration (FDA) and now works for AbbVie. She is in charge of
"pharmacovigilance" for AbbVie, which involves, among other things, looking for safetyrelated "signals" associated with the company's products (including AndroGel) and
evaluating reports of adverse events. She testified regarding safety findings made by
the FDA. She also gave testimony regarding a "white paper"—a detailed safety
assessment—prepared by AbbVie that included a review of literature regarding whether
TRT is safe, as well as AbbVie's response to inquiries by an FDA advisory committee.
Dr. Scarazzini also discussed some of the same literature addressed by the other
AbbVie general causation-related witnesses. She testified that she agreed with what
she characterized as conclusions (favorable to AbbVie) reached by the FDA after
evaluating reports of adverse events following use of TRT.
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Dr. Marais is a statistician. He testified about how to properly design studies to
evaluate causation and about the topic of statistical significance. During his testimony
on direct examination, plaintiff's counsel objected on the basis of cumulativeness. The
Court overruled the objection, finding that plaintiff had waited too late to assert the point.
During his ensuing testimony, Dr. Marais discussed a significant number of studies
regarding TRT usage and CV events. He opined that the studies show no statistically
significant association between TRT and CV events.
During the first Mitchell trial, AbbVie also called a separate specific-causation
witness, in other words a witness who testified regarding whether AbbVie had caused
the plaintiff's heart attack.
At the next bellwether trial in this MDL regarding a CV injury—the Konrad case—
AbbVie called the same four witnesses discussed above, and each of them again gave
testimony bearing on general causation. AbbVie called them in a different sequence,
conceivably in an effort to avoid the cumulativeness objection regarding Dr. Marais cited
in the first Mitchell trial. Specifically, Dr. Marais was called first. His testimony did not
differ significantly from his testimony in the first Mitchell trial. Dr. Scarazzini was called
second. Her testimony likewise involved the same topics as her testimony in the first
Mitchell trial.
Dr. French testified third among these witnesses. He, too, gave general
causation testimony, as he had done in the Mitchell trial. But unlike in the Mitchell trial,
Dr. French did double duty, also providing specific causation testimony regarding the
plaintiff. Defense counsel steered around some of the general causation testimony that
Dr. French had given in the Mitchell trial. Nonetheless, Dr. French again testified
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regarding what, in his opinion, scientific studies had shown regarding whether TRT
causes adverse CV events, which was plainly general causation testimony. In doing so,
Dr. French made reference to—and in effect incorporated—Dr. Marais' testimony
regarding the statistical significance of study results. Dr. French was specifically asked
about studies that relate to men like plaintiff Konrad who were under 55 years old and
had, like him, used TRT for 45 to 60 days; he stated that none of them found an
association with CV events or any statistically significant impact from TRT. Dr. French
also rendered testimony regarding studies concerning the alleged mechanisms by
which TRT is claimed to cause CV events.
Dr. Khera testified last among the defense general causation witnesses during
the Konrad trial. His testimony was very similar to the testimony he gave during the first
Mitchell trial. He also testified that the FDA agreed with the Androgen Study Group's
comments regarding TRT use and safety. His ultimate opinion was, again, that the
benefits of TRT to patients outweigh its risks.
A third bellwether trial with AbbVie as a defendant, the Nolte case, was tried in
January 2018. This case involved a pulmonary embolism allegedly caused by
AndroGel. AbbVie again called multiple witnesses who testified regarding whether
AndroGel causes adverse events—this time clotting events—specifically, five such
witnesses. Plaintiff's counsel again sought to bar Dr. Marais as cumulative—and again
did this at or around the start of his testimony—and the Court again denied the motion,
primarily based on the late timing of the request.
During closing argument in the Nolte case, AbbVie's counsel emphasized the
number of causation witnesses it had called as compared with the number the plaintiff
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had called. Counsel pointed out that AbbVie had presented testimony from five experts,
all of whom testified that AndroGel does not cause adverse events, but that the plaintiff
had called only one. Counsel also used a slide that presented this in a dramatic way:
The nature of the argument made by defense counsel during closing argument in
Nolte led the Court to consider the issue of whether AbbVie was presenting unduly
cumulative expert testimony regarding causation. In anticipation of the retrial in
Mitchell, the Court raised this issue with the parties during a case management
conference. Plaintiff included a motion to this effect in his pretrial motions in limine prior
to the second Mitchell trial. The Court made an oral ruling on that motion at the outset
of the trial and now memorializes its decision in writing.
Under Federal Rule of Evidence 403, a court may exclude relevant evidence "if
its probative value is substantially outweighed by a danger of one or more of the
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following: unfair prejudice, confusing the issues, misleading the jury, undue delay,
wasting time, or needlessly presenting cumulative evidence." Fed. R. Evid. 403. This
rule applies to expert testimony just as it applies to any other evidence. Indeed, this
district's local rules—specifically the final pretrial order form—have for decades
contained a provision stating that "[o]nly one expert witness on each subject for each
party will be permitted to testify absent good cause shown." N.D. Ill. LR 16.1.1, Final
Pretrial Order form at n.7, see
http://www.ilnd.uscourts.gov/_assets/_documents/_forms/_legal/NewRules/New00152.h
tm (last visited Mar. 11, 2018).
In both the Mitchell and Konrad trials, AbbVie presented not one, not two, but
four witnesses who gave expert testimony on the subject of general causation; in Nolte,
AbbVie presented five such witnesses. In two of the previous trials, the plaintiffs made
a last-minute objection to some of this evidence—specifically, the testimony of Dr.
Marais—but the Court overruled the objections based on their timing. In anticipation of
the Mitchell retrial, the plaintiff made a timely objection, raising the issue prior to trial.
Thus the question is properly presented.
Each of the AbbVie witnesses who testified about general causation approached
this from his or her own perspective, but that does not diminish the fact that AbbVie
called several witnesses who all gave testimony on the subject of general causation.
And, as discussed, there has been a significant amount of overlap in the testimony of
these witnesses.
The Court concludes that the presentation of this many expert witnesses on the
subject of general causation amounts to the needless presentation of cumulative
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evidence, and it also unfairly prejudices the plaintiff, who has limited himself in each of
the cases tried thus far to one general-causation expert witness. This risk of harm
significantly outweighs the probative value of the duplicative or cumulative evidence. A
trial should not reduce itself to an exercise of counting up and comparing the number of
witnesses who testify for each side on a particular topic. That, however, is what
AbbVie's presentation of cumulative general-causation expert testimony has
encouraged. AbbVie itself brought the point home in exactly this way during closing
argument in the Nolte trial, but even without that express endorsement, there is a
significant risk that a jury will perform the same calculation, consciously or
unconsciously.
Perhaps the most significant overlap in the testimony of the AbbVie witnesses
has involved testimony about studies regarding whether TRT causes an increased
incidence of CV events, and the import and significance of those studies. In this regard,
Dr. Marais' testimony has nearly completely overlapped with that of Dr. French. To put
it another way, Dr. Marais' testimony on this point has been needlessly cumulative of
that of Dr. French (and, to some extent, of other opinion witnesses called by AbbVie).
By way of example, Dr. Marais' testimony in the first Mitchell trial added nothing
material—aside from an additional voice—to the testimony of Dr. French about the
studies. The Court wishes to make it clear, however, that this particular overlap is not
the sole basis for the finding of needless cumulativeness. The Court is looking both at
the forest—the multiple witnesses testifying about general causation—and the trees—
the testimony about studies and medical literature.
With regard to the testimony of Dr. Marais, at least, AbbVie's presentation of
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expert general-causation testimony has amounted to the needless presentation of
cumulative evidence. The Court appreciates that, as a matter of trial strategy, it is more
advantageous to have two experts from different fields interpret and assess a body of
evidence. But that does not make their testimony any less needlessly cumulative or
unfairly prejudicial. Even in the Konrad trial—after the cumulativeness issue had been
raised by plaintiff in Mitchell—Dr. French, despite the carve-back of the length of his
testimony on general causation, adopted and supplemented Dr. Marais' conclusions
regarding scientific studies on causation of CV events and statistical significance.
There is nothing at all wrong with one expert relying on and incorporating another
expert's analysis if a reasonable expert would do so, see Fed. R. Evid. 703, but that
does not mean that both of them can appropriately testify at trial on the same subject.
Nor can AbbVie avoid this by calling Dr. Marais first, as it did in the Konrad trial.
Conclusion
For the reasons stated above, the Court excludes Dr. Marais as a witness. The
Court reserves the right to make additional cumulativeness findings as the MDL
bellwether trial process progresses. The Court also acknowledges that the exact same
general causation witnesses will not necessarily be called in each bellwether trial, so if
clarification is required for subsequent trials regarding which witnesses may be called, it
will be incumbent upon the parties to seek such clarification.
Date: March 14, 2018
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MATTHEW F. KENNELLY
United States District Judge
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