Hutchens et al v. Abbott Laboratories Inc.
Order. Defendants' Motion in Limine to Exclude References to Depakote as "First-Line" Drug (Related Doc # 107 ) is denied. Defendants' Motion in Limine to Exclude References to Pre-1996 Depakote Promotional and Marketing Activities (Related Doc # 109 ) is denied. Defendants' Motion in Limine to Exclude Argument Regarding August 2002 Memorandum from the North American Antiepileptic Drug Pregnancy Registry (Related Doc # 110 ) is denied. Judge Christopher A. Boyko on 1/10/2017.(H,CM)
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF OHIO
Z.H. by and through KEVIN
HUTCHENS AND CHRISTIN
HUTCHENS, individually, and as
parents and next friends of Z.H.,
ABBOTT LABORATORIES, INC.
And ABBVIE, INC.,
CASE NO. 1:14CV176
JUDGE CHRISTOPHER A. BOYKO
CHRISTOPHER A. BOYKO, J.:
This matter comes before the Court upon Defendants’ Motions in Limine (ECF DKT
#107, #109 and #110).
Plaintiff Z.H. is a minor child who suffers from serious birth defects. Z.H.’s injuries
were allegedly caused by in utero exposure to Depakote, an antiepileptic drug prescribed to
his mother, Christin Hutchens. Plaintiffs allege that Defendants, Abbott Laboratories, Inc.
and Abbvie, Inc. (“Abbott”), failed to provide adequate warnings regarding the risk of birth
defects associated with Depakote use.
II. LAW AND ANALYSIS
Motions in Limine
“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.”
With these precepts in mind, and upon consideration of the parties’ briefs and
arguments, the Court rules as follows:
DEFENDANTS’ ABBOTT LABORATORIES INC. AND ABBVIE INC.’S MOTION IN
LIMINE (NO. 8) TO EXCLUDE TESTIMONY, EVIDENCE OR OTHER
REFERENCES TO ABBOTT’S PROMOTION OR MARKETING OF DEPAKOTE AS
A “FIRST-LINE” DRUG (ECF DKT #107)
Certain antiepileptic drugs (“AED’s”) may be preferred by prescribers as “first-line”
treatments for patients suffering from a type or combination of types of seizures. If the “firstline” AED’s do not adequately control seizures in a given patient, the prescriber may try
another “first-line” drug or move on to “second-line” therapies, etc. Depakote was promoted
as a “first-line” option for some patients. However, in Mrs. Hutchens’ case, Depakote was
the eighth and not the first AED prescribed to control her seizures. So, Defendants argue that
the whole discussion of Depakote as a “first-line” therapy is irrelevant and will confuse and
distract the jury in this case.
Plaintiffs counter that Abbott’s primary sales and marketing message from 1986
through 2008 was promoting Depakote as a “first-line” therapy, a “first choice” for doctors,
specifically for female patients of childbearing years. Although Mrs. Hutchens’ treating
physicians did not prescribe Depakote as their “first choice” for her treatment, Plaintiffs
believe that Abbott’s promotional materials are relevant to what Abbott knew and when it
knew about the extent of the birth defect risks and the proper use in women of childbearing
In keeping with the previous ruling on Abbott’s promotional, sales and marketing
evidence (ECF DKT #198 at 9), the Court finds that evidence of Abbott’s promotion of
Depakote as a “first-line” drug, prior to Z.H.’s birth, is relevant to the failure-to-warn claim
and to punitive damages.
Therefore, Defendants’ Motion (ECF DKT#107) is DENIED.
DEFENDANTS ABBOTT LABORATORIES INC. AND ABBVIE INC.’S MOTION IN
LIMINE (NO. 9) TO EXCLUDE REFERENCES TO PRE-1996 DEPAKOTE
PROMOTIONAL ACTIVITIES AND MATERIALS (ECF DKT #109)
Defendants move the Court for an order precluding references to pre-1996 Depakote
promotional activity and materials as too remote in time, subject matter and probative value.
Defendants argue that it would be unduly prejudicial to suggest to the jury that Mrs.
Hutchens’ treating physician was “swayed by long-past promotional, marketing, and sales
activities that she never saw or relied on and that significantly pre-date Mrs. Hutchens’s
initial prescription for Depakote and Z.H.’s conception.” (ECF DKT #109 at 4).
Plaintiffs point out that Abbott has manufactured, marketed and sold Depakote in the
United States since 1978. Plaintiffs argue that marketing materials and promotional efforts
any time after 1978 show what Abbott knew, when Abbott knew it and what Abbott told the
medical community. Plaintiffs note that Abbott produced evidence reflecting that Abbott’s
sales representatives visited two of Mrs. Hutchens’ doctors nearly two hundred times in an
eight-year period. Thus, Plaintiffs should be allowed to show the potential cumulative effect
of Abbott’s marketing on the ultimate prescription of Depakote in this case.
The Court agrees that Abbott’s pre-1996 Depakote promotional, marketing and sales
activities and materials are relevant to what Abbott knew, when Abbott knew it, what was
communicated to the medical community and how Abbott’s labeling decisions were
Therefore, Defendants’ Motion (ECF DKT #109) is DENIED.
ABBOTT LABORATORIES INC. AND ABBVIE INC.’S MOTION IN LIMINE (NO.
10) TO PRECLUDE EVIDENCE AND ARGUMENT REGARDING THE AUGUST 30,
2002 MEMORANDUM FROM THE NORTH AMERICAN ANTIEPILEPTIC DRUG
PREGNANCY REGISTRY (ECF DKT #110)
The evidence at issue concerns an August 30, 2002 Memorandum from Lewis Holmes
and the North American Antiepileptic Drug Pregnancy Registry to Abbott regarding the
Registry’s findings in pregnancies in which the infants had been exposed to valproic acid.
The purpose of the Registry was to study women taking AED’s during pregnancy, to obtain
information on their pregnancy outcomes and to analyze the occurrence of major
malformation with specific AED’s.
Defendants argue that the Registry’s findings are irrelevant because the information in
the Memorandum would have had no effect on the prescribing decision of Mrs. Hutchens’
physician. Mrs. Hutchens consulted with Dr. Foldvary prior to the Memorandum’s issuance
in August 2002; and she did not return for treatment and care until December 20, 2002, after
she became pregnant. Abbott contends that the August 2002 document would have had no
effect on Dr. Foldvary’s prescribing decisions or on Mrs. Hutchens’ decision to take
Plaintiffs insist that Abbott could have communicated the Registry’s findings
immediately by a “Dear Doctor” letter or otherwise, and Dr. Foldvary could have contacted
Mrs. Hutchens without waiting for the next scheduled in-office visit.
Defendants may indeed offer testimony that only a small window of opportunity
existed to forward the August 2002 information to Dr. Foldvary and other physicians
prescribing Depakote. Nevertheless, the Court finds that the Holmes Memorandum is
relevant to Abbott’s duty as a reasonable manufacturer to warn of risks associated with its
drug and also to its obligation to ensure that warnings remain adequate for the entire time that
a drug is on the market.
Therefore, Defendants’ Motion (ECF DKT #110) is DENIED.
IT IS SO ORDERED.
s/ Christopher A. Boyko
CHRISTOPHER A. BOYKO
United States District Judge
Dated: January 10, 2017
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