Hutchens et al v. Abbott Laboratories Inc.
Order. Defendants' Motion in Limine to Exclude References to Scientific and Medical Data Relating to Injuries other Than Those Alleged by Plaintiffs and Post-Dating the Minor Plaintiff's June 2003 Birth (Related Doc # 100 ) is denied. Defendants' Motion in limine to Exclude References to Off-Label Marketing or Promotion (Related Doc # 105 ) is granted in part. 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.
JUDGE CHRISTOPHER A. BOYKO
CHRISTOPHER A. BOYKO, J:
This matter is before the Court on Defendants’ Motion in Limine to Exclude References
to Off-Label Marketing or Promotion (ECF # 105) and Defendants’ Motion to Exclude
References to Scientific and Medical Data Relating to Injuries other Than Those Alleged by
Plaintiffs and Post-Dating the Minor Plaintiff’s June 2003 Birth. (ECF # 100). For the
following reasons, the Court grants, in part, Defendants’ Motion on off-label use and denies
Defendants’ Motion on post-birth data.
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
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.”
Off-Label Marketing and Promotion
Defendants seek to exclude any argument, testimony and evidence regarding Defendants’
alleged off-label promotional/marketing activities and materials. Christin Hutchens was
prescribed Depakote by Dr. Foldvary to treat her for an FDA approved on label use; to control
her seizures. There is no evidence any off-label promotional or marketing materials affected her
decision to prescribe Depakote to Christin. Defendants contend that any testimony concerning
its off-label marketing and promotion of Depakote is irrelevant and could simply confuse the
jury. Its prejudicial impact greatly outweighs any relevance and should therefore, be excluded
under Fed. R. Evid. 401 and 403.
In opposing Defendants’ Motion, Plaintiffs argue that Defendants’ off-label marketing
and promotion of Depakote is relevant to show Defendants’ disregard for the safety of the
public, thus, it is relevant to Plaintiffs’ punitive damages claim.
The Court agrees with Defendants that any testimony regarding Defendants’ marketing
and promotion of Depakote for off-label uses is irrelevant and, even if relevant, its prejudicial
value outweighs its probative value. Christin Hutchens was not prescribed Depakote for an offlabel use therefore, any such testimony is irrelevant to Plaintiffs’ failure to warn claim. The
Court has already allowed Plaintiffs to proffer evidence and testimony regarding marketing and
promotion of Depakote as an AED.
Therefore, the Court excludes any evidence or testimony on Depakote’ promotion and
marketing of Depakote for off-label uses for Plaintiffs’ case-in-chief. The Court may revisit the
issue of promotion and marketing of Depakote for off label use as it relates to Plaintiffs’ punitive
damage claim, however, the only information to be considered will be materials and promotions
prior to Z.H.’s birth.
Injuries other than those suffered by Plaintiffs
Defendants move the Court to exclude post-birth AED risk data about injuries other than
those suffered by Z.H. Defendants argue any such evidence is irrelevant to causation in this case
because it has no bearing on the actual harm suffered by Plaintiffs for which they seek to
Plaintiffs oppose the Motion contending that post birth AED risk data is relevant to
causation because it relates directly to Defendants ongoing duty to study and warn of all
Depakote risks. Post-birth risk data is relevant to what Defendants knew or should have known
about the risks of Depakote and both the Illinois and Southern District of Ohio courts that have
held Depakote trials have determined the information is relevant. Plaintiffs allege that because
Depakote’s formulation has not changed since it was introduced, Plaintiffs’ expert may rely on
such evidence to opine on what Defendants should have known at the time of Z.H.’s birth.
Comparative studies would be essential to Dr. Foldvary’s prescribing decision even if the label
had warned of injuries not suffered by Z.H.
Judge Dlott in the Rheinfranck case allowed post-birth risk data to be proffered holding:
[S]cientific and medical data issued after [the minor plaintiff’s] 2004 birth may be
relevant and probative of data that could have and should have been known before
[the minor plaintiff] was conceived. This evidence is also relevant to the issue of
causation, because it is undisputed that Depakote’s formulation has not changed
since it was marketed in 1983. As such, Plaintiffs will be allowed to introduce
medical and scientific evidence, with proper foundation, if that evidence can be
linked to the causation issues in the case.
The Court agrees with Judge Dlott that post-birth data may be relevant to causation as it
relates to what Defendants should have known about the risks of birth defects from Depakote use
on women of child bearing age. Plaintiffs may offer such evidence, provided that Plaintiffs
demonstrate by expert testimony, to a reasonable degree of expert certainty, that the post-birth
data on birth defects and comparatively increased teratogenicity of Depakote should have been
known by Defendants prior to Z.H.’s birth.
IT IS SO ORDERED.
s/ Christopher A. Boyko
CHRISTOPHER A. BOYKO
United States District Judge
Dated: January 10, 2017
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