United States District Court, N.D. Ohio, Eastern Division
OPINION AND ORDER
CHRISTOPHER A. BOYKO JUDGE
matter is before the Court on Plaintiffs' Motion for a
New Trial (ECF # 262). The Motion is brought by Kevin and
Christin Hutchens individually and on behalf of their son
Z.H. On February 2, 2017, after two weeks of trial, the jury
returned a unanimous verdict for Defendants on all
Plaintiffs' claims. Thereafter, on March 2, 2017,
Plaintiffs moved for a new trial. For the following reasons,
the Court denies Plaintiffs' Motion.
to the First Amended Complaint, Kevin and Christin Hutchens
are parents of Z.H. Z.H. was born in 2003 with a number of
severe birth defects allegedly caused by Christin's use
of Depakote during her pregnancy. Depakote, also known as
valproic acid or valproate is an anti-seizure medication
formulated, tested, manufactured and marketed by Defendants.
Depakote has been approved and sold in the United States
since 1978 for the treatment of certain forms of epilepsy.
Depakote is promoted as an effective anti-epileptic drug
(“AED”). However, Plaintiffs alleged Depakote is
defective and dangerous for its intended use because the
primary compound in Depakote, valproic acid, is teratogenic
(of, relating to, or causing developmental malformations) -
i.e.- causes severe birth defects if taken during the first
trimester of pregnancy.
to Plaintiffs, Defendants failed to communicate the
heightened risk of birth defects to doctors and women but
instead sought to minimize the risks and downplay the dangers
in their product labeling.
Defendants' alleged breaches of their duty of reasonable
care, breaches of their express and implied warranties and
their misrepresentations and omissions concerning the known
risks of Depakote, Plaintiffs alleged they have been injured.
Z.H. was born with heart defects, hypospadias, limb defects
and developmental delay, as well as other congenital
malformations and birth defects as a result of Christin's
use of Depakote during pregnancy.
finding for Defendants, the jury indicated on the Jury
Verdict Form that Plaintiffs failed to show by a
preponderance of the evidence that Defendants provided an
inadequate warning of the risks of Depakote and further
failed to show by a preponderance of the evidence that
Depakote was defective due to its failure to conform to the
representations of Defendants.
now move for a new trial, alleging the Court erred in issuing
a limiting instruction that precluded the jury from
considering admissible evidence on causation. Plaintiffs
further argue the Court erroneously excluded admissible
evidence affecting Plaintiffs' substantial rights and
provided improper instructions to the jury on the law.
According to Plaintiffs, these allegedly erroneous rulings
require a new trial.
Civ. P. 59 provides the authority for a new trial and reads
in pertinent part:
(a) In General.
(1) Grounds for New Trial. The court may, on motion,
grant a new trial on all or some of the issues--and to any
(A) after a jury trial, for any reason for which a new trial
has heretofore been granted in an action at law in federal
“Generally courts have interpreted this language to
mean that a new trial is warranted when a jury has reached a
‘seriously erroneous result' as evidenced by: (1)
the verdict being against the weight of the evidence; (2) the
damages being excessive; or (3) the trial being unfair to the
moving party in some fashion, i.e., the proceedings
being influenced by prejudice or bias.” Holmes v.
City of Massilon, Ohio, 78 F.3d. 1041, 1045-46 (6th Cir.
1996), citing Montgomery Ward & Co. v. Duncan,
311 U.S. 243, 251 (1940). “The trial court should deny
such a motion if the verdict is one that reasonably could be
reached, regardless of whether the trial judge might have
reached a different conclusion were he the trier of
fact.” Walker v. Bain, 257 F.3d 660, 670 (6th
Cir. 2001). On motions for new trial, the trial court may
weigh the evidence. See United States v. L.E. Cooke
Co., 991 F.2d 336, 343 (6th Cir. 1993).
Sixth Circuit has held:
[w]hen reviewing a motion for a new trial, a court should
indulge all presumptions in favor of the validity of the
jury's verdict. A court should refrain from interfering
with a jury's verdict unless it is clear that the jury
reached a seriously erroneous result. The simple fact that
the grant of a new trial might result in a different outcome
is not a valid basis for disturbing a jury's verdict
which is otherwise based upon legally sufficient evidence.
Brooks v. Toyotomi Co., Ltd., 86 F.3d 582, 588 (6th
Cir.1996), abrogation on other grounds
recognized by United States v. Webb, 157 F.3d 451,
452-53 (6th Cir.1998) (per curiam ), abrogated
by Dillon v. United States, 184 F.3d 556 (6th Cir.1999).
The Sixth Circuit has further admonished courts “not to
set aside the verdict simply because it believes that another
outcome is more justified.” Denhof v. City of Grand
Rapids, 494 F.3d 534, 543 (6th Cir. 2007).
light of the above standard of review, the Court will
consider Plaintiffs' Motion.
Court Erroneously Excluded Evidence Contained in Scientific
first claim of error concerns the Court's ruling that
scientific studies and articles considered by Plaintiffs'
labeling and regulatory expert, Dr. Cheryl Blume, Ph.D, were
admissible only to show that Defendants were on notice of the
dangers of Depakote and not for the truth of the matters
asserted in the scientific studies themselves. The
Court's Instruction was as follows:
I previously instructed you that certain evidence, including
the charts presented through Dr. Blume listing certain
articles or studies, could only be considered by you for
purposes of notice. As I explained at that time, and now
reiterate, you may only consider those charts as evidence of
what Abbott should have been aware of and maybe what they
should have done as a result of these studies, but not for
the truth of what's contained in those studies
I am now expanding that limitation to cover your
consideration of the studies themselves. You may consider
reports of studies, or letters to the editors of journals, or
other literature references only as evidence of what was
being reported, but not as evidence of the accuracy or truth
of what was being reported. Otherwise, unless further
restricted, you may consider Dr. Blume's remaining
testimony, along with the other evidence.
(ECF # 254 at 2801:12-2802:3).
district court has broad discretion to determine questions of
admissibility; an evidentiary ruling is not to be lightly
overturned.” Decker v. GE Healthcare Inc., 770
F.3d 378, 396 (6th Cir. 2014). “An erroneous
evidentiary ruling amounts to reversible error, justifying a
new trial, only if it was not harmless; that is, only if it
affected the outcome of the trial.” Id.
(Internal citations omitted).
trial a dispute arose between the parties regarding a
limiting instruction sought by Defendants on a demonstrative
chart used by Plaintiffs. Plaintiffs were about to commence
with the direct examination of their labeling and regulatory
expert, Dr. Cheryl D. Blume Ph.D. As part of the examination,
Plaintiffs wanted to use a chart listing 27 medical studies
indicating that Depakote had the highest rate of congenital
abnormalities when compared to other AEDs. Plaintiffs contend
their claims of inadequate warnings depended upon proof of
the state of the scientific knowledge at the time of
Z.H.'s conception and birth. These studies demonstrated
the state of the scientific knowledge at the time of
Z.H's conception. According to Plaintiffs, Dr. Blume
testified on these matters, however, the Court erroneously
instructed the jury it could not consider the scientific data
and the studies offered by Plaintiffs through Dr. Blume for
the truth of the matter asserted. Because Federal Rule of
Evidence 803(18) provides a hearsay exception for learned
treatises, the limiting instruction was improper and the jury
should have been permitted to consider the studies for the
truth of the matter - i.e. that Depakote had a higher rate of
birth defects than other anti-seizure medications. Instead,
the jury was instructed it could only consider such studies
for purposes of notice.
objected to the use of the chart on the grounds that
Plaintiffs laid no foundation for the reliability of the
studies themselves. Defendants further argued the information
on the demonstrative chart was hearsay and Defendants were
unable to cross-examine Dr. Blume on the validity of the
studies due to the large number of studies listed. The
parties argued the matter to the bench as follows:
THE COURT: Mr. Strain is saying this is Rule 1006 controlled,
and you're saying it's not, Mr. Sampson?
MR. SAMPSON: Yes, Your Honor.
THE COURT: And the reason you're not saying it's
controlled by 1006, when you say demonstrative, in what
MR. SAMPSON: In the sense that I will not be offering this
summary into evidence. It is a demonstrative aid for the
witness to talk through the ...