Hutchens et al v. Abbott Laboratories Inc.

Filing 206

Order. Defendants' Motion in Limine to Preclude Admission of a Document Titled "Neurology Consultant Meeting" and Other Suggestions that Depakote Should Have Been Contraindicated for the Treatment of Epilepsy in Women of Childbearing Years (Related Doc # 118 ) is granted. Judge Christopher A. Boyko on 1/10/2017.(H,CM)

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF OHIO
EASTERN DIVISION
Z.H. by and through KEVIN
HUTCHENS and CHRISTIN
HUTCHENS, individually, and as )
parents and next friends of Z.H.
Plaintiffs,
Vs.
ABBOTT LABORATORIES, INC.
and ABBVIE, INC.
Defendant.

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CASE NO.1:14CV176

JUDGE CHRISTOPHER A. BOYKO

ORDER

CHRISTOPHER A. BOYKO, J:
This matter is before the Court on Defendants’ Motion in Limine to Preclude Admission
of a Document Titled “Neurology Consultant Meeting” and Other Suggestions that Depakote
Should Have Been Contraindicated for the Treatment of Epilepsy in Women of Childbearing
Years. (ECF # 118). For the following reasons, the Court grants Defendants’ Motion.
“Motions in Limine are generally used to ensure evenhanded and expeditious
management of trials by eliminating evidence that is clearly inadmissible for any purpose.”
Indiana Insurance Co. v. General Electric Co., 326 F.Supp. 2d 844, 846 (N.D.Ohio 2004) (citing
Jonasson v. Lutheran Child and Family Serv., 115 F.3d 436, 440 (7th Cir.1997)). A “motion in
limine, if granted, is a tentative, interlocutory, precautionary ruling by the trial court reflecting its
anticipatory treatment of the evidentiary issue . . . the trial court is certainly at liberty ‘* * * to
consider the admissibility of the disputed evidence in its actual context.’” State v. Grubb, 28
Ohio St.3d 199, 201-202 (1986) (citing State v. White, 6 Ohio App.3d 1, 4 (1982)). “Indeed,
even if nothing unexpected happens at trial, the district judge is free, in the exercise of sound

judicial discretion, to alter a previous in limine ruling.” Luce v. United States, 469 U.S. 38, 41
(1984).
The Sixth Circuit has instructed that the “better practice” is to address questions
regarding the admissibility of broad categories of evidence “as they arise.” Sperberg v.
Goodyear Tire & Rubber Co., 519 R.2d 708, 712 (6th Cir. 1975). “[A] court is almost always
better situated during the actual trial to assess the value and utility of evidence.” OwnerOperator Independent Drivers Ass’n v. Comerica Bank, No. 05-CV-0056, 2011 WL 4625359, at
*1 (S.D.Ohio Oct.3, 2011). It is noteworthy that denial of a motion in limine does not
necessarily mean that the evidence, which is the subject of the motion, will be admissible at trial.
Ind. Ins. Co. v. Gen. Elec. Co., 326 F.Supp. 2d 844, 846 (N.D.Ohio 2004).
Fed.R.Evid. 401 defines relevant evidence as evidence tending to make the existence of
any fact that is of consequence to the determination of the action more probable or less probable
than it would be without the evidence. Moreover, Fed.R.Evid. 402 provides that evidence that
“is not relevant is not admissible.”
For purposes of this Motion the Court adopts Defendants’ label of the document in
question as Carbone 921. Carbone 921 is a two-page document titled “Neurology Consultant
Meeting, June 2, 2001 Chicago, Illinois.” Of particular interest in this case is discussion point
number four, which reads:
4) Discuss and develop a flowchart for the treatment of adult epilepsies and comorbid conditions (eg behavioral disorders).
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Not use Depakote in female of child bearing years due to
teratogenic potential. Many not aware of the actual risk. Dr.
Hughes quoted 1-2% risk of neural tube defects, just not sure with
new AEDS.”
Defendants concede there is evidence that Defendants’ personnel convened a neurology
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consultants meeting in Chicago on or about June 2, 2001. They further acknowledge that they
produced the document in the course of discovery in this case. However, Plaintiffs have not
produced one witness that has been able to lay a foundation for the document’s admissibility.
Defendants contend Plaintiffs are unable to locate any witness present at the 2001 meeting.
Defendants produced the document when it registered as a “hit” on the parties’ agreed upon
search terms. Defendants oppose the Carbone 921's admissibility because it is irrelevant and
highly prejudicial absent other evidence establishing the identity of its author and its context.
Defendants argue that Plaintiffs want to introduce Carbone 921 for the purpose of establishing
that a consultant told Abbott in 2001 that Depakote should not be prescribed for women of child
bearing age. However, this is an interpretation that requires more context and information than
is available. In order to be admissible, Defendants contend Plaintiffs must produce information
concerning its accuracy, that it captures the opinion of the author, that it was paid for by
Defendants and was understood by Defendants’ employees who had the ability to act on it. The
sentence fragment containing the alleged warning does not divulge whether the speaker espoused
the view, merely sought to discuss it as an academic proposition or merely related it as the
practice of the consultant.
Defendants contend the document and any related suggestions on the contraindication of
Depakote is irrelevant because Plaintiffs lack any expert testimony supporting the conclusion
that Depakote should never have been prescribed to women of child bearing age regardless of
the seizure conditions for which they were being treated.
Given the fragmented composition of Carbone 921, a jury would be left to speculate on
not only who the author was, but also the intent of the author. Furthermore, Defendants argue it

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is inadmissible hearsay within hearsay. Plaintiffs, in questioning witnesses on Carbone 921,
have regarded it as the statement of a third party witness and not an employee of Defendants.
Therefore, it cannot be an admission of Defendants and even if it were, it is inadmissible
hearsay.
Nor is it a business record as there is no custodian to testify that it was kept in the
ordinary course of business, recorded a regularly conducted activity or was a record of a regular
practice of Defendants.
Plaintiffs oppose Defendants’ Motion, contending that they do not intend to offer
Carbone 921 for the truth of the matter asserted - i.e. -that Defendants failed to warn the medical
community of the risks of birth defects from the use of Depakote by women of child bearing age.
Instead, they seek to offer it as evidence to show notice; when Defendants knew of the risks.
According to Plaintiffs, Defendants admit their employees convened the 2001 meeting, admit
that one or more of their employees received the document and that it was found in Defendants’
electronic files. This alone is sufficient to demonstrate its admissibility.
According to Plaintiffs, Carbone 921 is relevant as it directly addresses the issue that
Defendants knew of the risks of Depakote in 2001. It is also not hearsay because it is offered
only for notice, not for the truth of the statement itself.
Defendants respond that Plaintiffs’ experts do not opine that Depakote should never have
been prescribed to women of childbearing age. Neither do Plaintiffs contest Defendants
representation that, if offered for the truth of the matter asserted it is inadmissible hearsay.
Whether such a warning could have been on the label is beside the point because Defendants
contend such a warning is not relevant to the issues in this case. Furthermore, absent some

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foundation or testimony on the context of the meeting, the jury can only speculate what was
actually discussed at the 2001 meeting and whether the author of the Carbone 921 document was
actually advocating for the contraindication on Depakote. In short, without further elucidation
on the unknown author’s intent of the Carbone 921 document, any evidence presented on the
author’s intent and context is mere speculation.
Having reviewed the Motion, Opposition and Reply, the Court grants Defendants’
Motion to Exclude the Carbone 921 document and any reference that Depakote should have been
contraindicated for the treatment of epilepsy in women of childbearing age. Absent any expert
testimony supporting such a conclusion, it is mere speculation, irrelevant and highly prejudicial.
The same can be said for the Carbone 921 document. Because there will be no testimony
regarding the author’s intent, the basis for the statement and the subsequent discussion held at
the 2001 meeting, the trier of fact would be left to impermissibly speculate on its meaning.
IT IS SO ORDERED.

s/ Christopher A. Boyko
CHRISTOPHER A. BOYKO
United States District Judge
Dated: January 10, 2017

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