United States District Court, N.D. Illinois, Eastern Division
In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings (This document applies to all cases) MDL No. 2545
CASE MANAGEMENT ORDER NO. 64 RULING ON MOTION FOR
RECONSIDERATION OF DAUBERT RULING CONCERNING DR.
MATTHEW F. KENNELLY United States District Judge.
a mistrial in the first bellwether trial (Konrad)
and just before the start of the second bellwether trial
(Mitchell), defendants AbbVie Inc. and Abbott
Laboratories (AbbVie) filed a motion seeking to preclude
plaintiffs' expert Dr. Hossein Ardehali from relying on
certain adverse event reports in his trial testimony. AbbVie
characterizes its filing as partly a motion to enforce one of
the Court's prior rulings and partly a request to
reconsider a prior ruling.
to the bellwether trials against AbbVie, the Court denied
AbbVie's motions to exclude Dr. Ardehali's testimony
concerning general causation (whether AbbVie's
testosterone replacement therapy (TRT) drug AndroGel causes
the cardiovascular injuries plaintiffs allege) and notice
(whether, and at what point, AbbVie should have been aware
that a causal association existed between AndroGel and
cardiovascular injuries). AbbVie maintains that it would be
inappropriate for Dr. Ardehali to rely on certain adverse
event reports referred to as "Medwatch forms" in
support of either his causation or his notice opinion.
respect to his causation opinion, AbbVie argues that the
Court's ruling already precluded Dr. Ardehali from
referencing the Medwatch forms, because the Court relied on
plaintiffs' representation that those forms did not
inform Dr. Ardehali's opinion and his consideration of
them thus did not render his opinion unreliable. See In
re Testosterone Replacement Therapy Prod. Liab. Litig.
Coordinated Pretrial Proceedings, No. 14 C 1748, 2017 WL
1833173, at *12 (N.D. Ill. May 8, 2017) (denying motion to
exclude Dr. Ardehali's causation opinion and noting
plaintiff's representation that adverse event reports did
not inform that opinion). AbbVie now seeks enforcement of
respect to Dr. Ardehali's notice opinion, AbbVie argues
that the Court's prior ruling focused on whether Dr.
Ardehali's reliance on adverse event reports was
sufficient to create a genuine dispute of fact for trial but
that the Court failed to consider whether his notice opinion
was based on a reliable methodology. AbbVie also argues that
Dr. Ardehali's testimony in the Konrad trial
provides new evidence demonstrating that he is unqualified to
offer an opinion about notice and that the opinion he does
offer is not based on a reliable methodology.
Court disagrees with AbbVie that the prior ruling precludes
Dr. Ardehali from testifying about how the data in the
Medwatch forms impact his opinion regarding causation. The
Court made clear in its ruling that an expert's causation
opinion may rely on relatively weak sources of evidence, such
as case reports and adverse event reports, as long as those
are not the only sources on which the expert relies. See
Id. at *15. Indeed, under the "totality of the
evidence" approach employed by Dr. Ardehali in this
case, an expert may properly consider different sources of
scientific evidence, of varying weight and reliability, as
long as the expert "explains how the weight of the
various pieces of evidence led him to his conclusion."
Id. at *9.
be the case, as plaintiffs represented to the Court in their
response to AbbVie's Daubert motion, that Dr.
Ardehali did not initially consider the Medwatch forms for
the purpose of forming his causation opinion and that he
would reach the same opinion whether or not he considered any
adverse event reports. But that would not preclude Dr.
Ardehali from opining on how the adverse event reports he did
ultimately consider would fit into the "totality of
evidence" concerning the causal relationship between TRT
and cardiovascular injuries.
respect to Dr. Ardehali's notice opinion, the Court is
not persuaded that its prior ruling was based on a
misunderstanding of AbbVie's position or that Dr.
Ardehali's testimony in the Konrad trial
provides new evidence warranting reconsideration. In its
ruling on AbbVie's motion concerning plaintiffs'
failure-to-warn claims, the Court considered whether it was
permissible for a witness who is not an expert in
pharmacovigilance to review adverse event reports in forming
an opinion that a defendant was on notice of a causal
association. The Court rejected AbbVie's argument that
Dr. Ardehali's lack of training in pharmacovigilance or
adherence to FDA guidelines rendered his analysis of adverse
event reports unreliable. See In re Testosterone
Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial
Proceedings, No. 14 C 1748, 2017 WL 1836435, at *13
(N.D. Ill. May 8, 2017). Though with respect to Dr.
Ardehali's opinion, the Court said that those purported
deficiencies in his opinion did not "prevent Dr.
Ardehali's opinion from giving rise to a genuine dispute
of fact, " id., its discussion of Dr. Henry
Rinder's opinion made clear that those same purported
deficiencies did not render an expert's notice opinion
inadmissible. See Id. at *15. As with Dr.
Ardehali's causation opinion, the Court determined that
his notice opinion, based on his review of "both the
scientific literature and the adverse event reports that
would have been available to AbbVie" provided a
sufficiently reliable basis for the opinion he offered: an
expert in the field reasonably should have known in 2007 that
there was a causal association between AndroGel and increased
cardiovascular risk. Id. at *13.
the testimony from the Konrad trial that AbbVie
cites qualifies as the kind of new evidence that would
warrant reconsideration. Dr. Ardehali testified during the
Konrad trial that he was not an expert in
pharmacovigilance and did not adhere to the FDA guidelines
for analyzing the adverse event reports, but that was known
to the parties and to the Court at the time of the initial
ruling. AbbVie points to other testimony from Dr. Ardehali
that it says undermines his analysis of the Medwatch
forms-such as his admission that he received the reports from
counsel or that medical records are more reliable than the
adverse event reports he reviewed-but that testimony goes to
the weight to be given to his testimony, not its
AbbVie contends that Dr. Ardehali's opinion does not
"fit" the law and facts of this case because he
does not opine about whether the method AbbVie used to
analyze the adverse event reports was reasonable. But as
plaintiffs point out, this is an argument AbbVie could have
made in its initial motion. "A motion for
reconsideration is not an opportunity for a party to plug
gaps in its earlier briefing." Valero Energy Corp.
v. United States, No. 06 C 6730, 2008 WL 4104367, at *3
(N.D. Ill. Aug. 26, 2008) (Kennelly, J.).
reasons discussed above, the Court denies AbbVie's motion