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Hutchens v. Abbott Laboratories Inc.

United States District Court, N.D. Ohio, Eastern Division

November 22, 2017




         This 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.

         According 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.

         According 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.

         Due to 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.

         On 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.

         Plaintiffs 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.

         Standard of Review

         Fed. R. 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 party--as follows:
(A) after a jury trial, for any reason for which a new trial has heretofore been granted in an action at law in federal court;

          “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).

         The 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).[1]

         In light of the above standard of review, the Court will consider Plaintiffs' Motion.

         The Court Erroneously Excluded Evidence Contained in Scientific Studies

         Plaintiffs' 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 themselves.
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).

         “The 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).

         During 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.

         Defendants 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 sense?
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 ...

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