Products Liability Law Daily $38M award against Abbott Labs in Depakote birth defects case upheld
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Wednesday, September 13, 2017

$38M award against Abbott Labs in Depakote birth defects case upheld

By John W. Scanlan, J.D.

A $38-million award of compensatory and punitive damages against the manufacturer of Depakote brought by a minor who developed severe birth defects after her mother used the prescription antiepileptic drug while pregnant was upheld by the Missouri Supreme Court. There was sufficient evidence supporting the jury’s decision on the issues of failure to warn and punitive damages (Barron v. Abbott Laboratories, Inc., September 12, 2017, Powell, W.).

The child was born with birth defects that included spina bifida, microcephaly, ocular coloboma, brain malformations, cognitive impairment, paralysis, and neurogenic bowel and bladder. Her adoptive parents, along with 23 other families, brought strict liability, negligence, and various other claims against Abbott Laboratories, which manufactured the drug. In her case, the jury awarded her $15 million in compensatory damages and $23 million in punitive damages. Abbott’s motions for a directed verdict and for judgment notwithstanding the verdict on the issues of failure to warn and punitive damages were denied by the trial court [see Products Liability Law Daily’s November 9, 2016 analysis]. The company appealed.

Failure to warn. The jury could have reasonably drawn from the evidence an inference that the Depakote warning was not complete and accurate. Abbott argued that the Depakote label met the three requirements required under the applicable state law to make a warning legally accurate: it should attract the attention of those the product could harm, explain the mechanism and mode of injury, and give instructions on how to use the product safely to avoid injury. However, the court stated that in addition to facially satisfying these requirements, a warning must also be complete and accurate. The plaintiff provided evidence that Abbott was aware of multiple studies that found that Depakote carried a much higher risk of overall birth defects than other antiepileptic medications and should be avoided by women of childbearing potential unless all other alternatives had failed; that the overall risk of birth defects was 10 percent or greater; and that the risk of spina bifida in particular was significantly higher than the one to two percent as stated on the label and represented an increase of 20 times compared to the background rate in the general population. None of this relevant information was reflected on the label, the court observed.

Punitive damages. The jury could reasonably have drawn from the evidence a reasonable inference that Abbott deliberately disregarded the safety of Depakote users in order to pursue profit. Abbott argued that it could not be shown by clear and convincing evidence that it had acted in this manner because the drug’s label carried a "black box" warning that it said was the most serious warning mandated by the FDA, but this warning was not relevant to the issue of punitive damages. The court focused on evidence that Abbott knew of studies indicating that Depakote was riskier in terms of birth defects than its label suggested, but conducted no independent studies of its own to evaluate its actual risks. Instead, the court noted, Abbott spent $50 to $100 million per year marketing Depakote, seeking to "squeeze every last dollar" and prescription out of the market, and attempted to make it the first-choice antiepileptic drug for women despite referring it internally as a "dirty drug." The court did not analyze the size of the punitive damages award because Abbott did not raise this issue.

Venue/joinder. In a concurring opinion, Judge Wilson agreed that the judgment should be affirmed, but disagreed with the majority’s analysis of venue and joinder. The majority found that it was unnecessary to consider Abbott’s arguments that the trial court erred by refusing to sever the plaintiffs’ claims and to transfer venue because Abbott had not shown that it had been prejudiced by any error. The concurrence stated that the prejudice requirement is seldom met, if ever, and went on to find that in a multi-plaintiff, single-defendant case such as this one, the trial court had not erred in denying Abbott’s motion to sever the case and that venue in the city of St. Louis rather than in the county of St. Louis was proper. However, once the trial court had decided common questions of law and fact, and had determined that each plaintiff’s case would be tried separately, the cases should have been severed and transferred when venue was no longer proper. However, the "likely unprovable" prejudice requirement would prevent Abbott from obtaining relief, Judge Wilson said.

The case is No. SC96151.

Attorneys: Edward D. Robertson Jr. (Frickleton and Roberts PC) for Maddison Schmidt. William Ray Price Jr. (Armstrong Teasdale LLP) for Abbott Laboratories Inc.

Companies: Abbott Laboratories Inc.

MainStory: TopStory WarningsNews DamagesNews JurisdictionNews DrugsNews MissouriNews

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