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From Products Liability Law Daily, May 26, 2015

Evidence supports $6.7 M award against Botox® maker in child seizure case

By Susan Lasser, J.D.

The parents of a child who developed seizures after receiving injections of the drug Botox® presented sufficient causation evidence to support their negligence claim on which a jury awarded the parents, individually and on behalf of their child, $2.8 million, a federal district court in Vermont ruled, denying the drug manufacturer’s renewed motion, following the jury verdict, for judgment as a matter of law. In addition, the court denied the manufacturer’s motion for a new trial because the evidence presented at trial was sufficient to sustain the jury’s verdict (Drake v. Allergan, Inc., May 22, 2015, Sessions, W., III).

Background. J.D. was born in 2006 with mild cerebral palsy, which included experiencing mild to moderate spasticity or tightness in his legs. At age two, his parents, Kevin and Lori Drake (the Drakes), took J.D. to see Dr. Scott Benjamin, a doctor of physical medicine and rehabilitation (physiatrist) specializing in assisting patients improve mobility and, in particular, children with cerebral palsy. The doctor recommended Botox—an injectable pharmaceutical that consists of the neurotoxin botulinum toxin type A—for J.D.’s lower limb spasticity. When injected into muscle, Botox temporarily blocks the nerve impulses that trigger muscle contractions. The Food and Drug Administration (FDA) has not approved Botox as a treatment for pediatric spasticity, making the administration of Botox for that purpose an “off-label” use.

J.D. was three-and-a-half years old when first injected with Botox. Dosages increased until he had severe reactions, including seizures. At the time of J.D.’s second Botox injection, the package insert for the drug contained a “black box” warning advising of reports indicating that the drug’s effects may “spread from the area of injection to produce symptoms consistent with botulinum toxin effects” and that the “risk of symptoms is probably greatest in children treated for spasticity.” The insert also warned that the “[s]afety and effectiveness of Botox have not been established for the treatment of upper limb spasticity in pediatric patients, and for the treatment of lower limb spasticity in adult and pediatric patients.” The Drakes brought a products liability action against Allergan, claiming that J.D. suffered injuries after receiving Botox injections to treat lower-limb spasticity. The claims before the jury were for negligence and a violation of the Vermont Consumer Fraud Act (VCFA).

Jury findings and post-trial motions. After a 13-day trial, the jury found the parents proved by a preponderance of the evidence that Allergan was negligent and that the child sustained injuries as a result of that negligence. It also determined that punitive damages were warranted. However, the jury did not find that the parents proved the manufacturer violated the VCFA. The jury awarded $2,778,881.35 in total compensatory damages and $4 million in punitive damages to the plaintiffs.

Following the trial, the parents moved for judgment incorporating the jury’s verdict. Allergan, on the other hand, renewed its motion for judgment as a matter of law or, in the alternative, moved for a new trial. The manufacturer argued that the court should enter judgment as a matter of law in its favor because the parents failed to provide sufficient evidence to support a finding of causation. The manufacturer also argued that the jury could not have reasonably found that the evidence demonstrated the culpability required to impose punitive damages.

Causation. The court held that the parents presented sufficient evidence for a reasonable jury to find in their favor on causation, proving both that Botox was the cause of the child’s seizure disorder and that negligence by Allergan caused his physician to prescribe Botox in the dose selected.

Medical causation. As to medical causation, the parents offered Dr. Anna Hristova as their medical causation expert. The court denied Allergan’s motion to exclude her testimony prior to trial and its post-trial motion to strike her testimony. Allergan argued that no reasonable jury could have found that Botox caused J.D.’s seizure disorder, primarily because a study on which Dr. Hristova relied was discredited during cross-examination. The court found, however, that although the manufacturer effectively discredited the study on cross-examination, that did not mean that a reasonable jury could not have found that Botox caused the child’s seizures or that Dr. Hristova’s opinions were too unreliable to be presented to the jury. According to the court, an expert need not back her opinion with published studies that unequivocally support her position. The court denied the post-trial motion to strike the expert’s testimony because she relied on “the totality of circumstances”—i.e., some evidence that may have been insufficient to support a finding of causation in isolation could be sufficient when considered together. The manufacturer argued that this was not a sufficiently reliable approach. However, the court disagreed, finding that the parents presented a significant amount of evidence, including other aspects of Dr. Hristova’s testimony, from which reasonable jurors could have inferred that it was more likely than not that Botox was to blame for J.D.’s seizures. The parents’ evidence included: the seizure rates in Allergan’s clinical trials; a study by H. Kerr Graham and others (the “Graham study”); adverse event and anecdotal reports; biological plausibility and theoretical mechanisms of action; FDA guidance and the Botox label; and the timing and lack of alternative explanation for the child’s seizures. Even though no single piece of evidence was conclusive in isolation, the court said, taken together the evidence painted a picture sufficient to support the jury’s finding on medical causation.

The court stated that the jury only needed to find that Botox was a substantial factor in bringing about the injury and was appropriately instructed that a pre-existing condition that would make the child more susceptible to the event did not destroy causation. Finally, the court noted that because Dr. Hristova testified that it was possible that J.D.’s cerebral palsy made him more susceptible to having a Botox-induced seizure, the jury reasonably could have concluded that the Botox either caused the seizure outright or lowered J.D.’s seizure threshold sufficiently to cause the seizure. Thus, sufficient evidence was presented by the parents to support the jury’s finding that Botox caused J.D.’s seizures.

Negligent promotion and proximate causation. The jury also was required to find that the manufacturer’s promotional activities were the proximate cause of J.D.’s injuries. Allergan contended that proximate cause could be established only if the manufacturer caused or played a substantial part in causing the child’s doctor to treat him with Botox in May of 2012 and to select a dose above 12 u/kg. The jury was instructed that the law recognized that there could be more than one proximate cause of an injury and that many factors could operate to cause the injury and each could be a proximate cause. The court concluded that the parents presented evidence from which a jury reasonably could have found proximate cause sufficient to find in their favor. To Allergan’s argument that the physician’s treatment of juvenile cerebral palsy patients with high doses of Botox was because of his training and clinical experience, not because of anything Allergan said or did or failed to say or do, the court said this was one possibility and not the only reasonable conclusion the jury could have reached. The jury also could have concluded, based on a variety of evidence, that the manufacturer’s promotional efforts over the years played a substantial part in the child’s doctor’s choice of treatment and dose selection. Another reasonable inference based on the evidence was that doctors, including J.D.’s doctor, may have been influenced by drug promotion but may not have been consciously aware of how the promotion influenced their behavior. Thus, the court held the jury could have reasonably concluded that Allergan’s promotional activities were a substantial factor influencing the doctor’s practice and the manufacturer’s influence was a substantial factor in the doctor’s choice to increase the doses above 10-12 u/kg to 15 u/kg. As such, the court concluded there was no reason to disturb any of the jury’s findings on causation.

Punitive damages. The court, finding sufficient evidence to support the jury’s verdict, also rejected Allergan’s contention that it was entitled to judgment as a matter of law on the issue of punitive damages. The purpose of punitive damages under Vermont law is to “punish conduct that is morally culpable to the degree of outrage frequently associated with crime.” A plaintiff must show (1) “wrongful conduct that is outrageously reprehensible” and (2) malice, “defined variously as bad motive, ill will, personal spite or hatred, reckless disregard, and the like,” in order to prove punitive damages. In the current case, the parents were required to prove that Allergan’s conduct was outrageously reprehensible and that the manufacturer acted with malice. While the parents did not allege, nor could they prove, that the manufacturer had any ill will, personal spite, or hatred towards the Drakes individually, the question was whether the parents proved that Allergan’s conduct was outrageously reprehensible and demonstrated a “bad motive” or “reckless disregard” sufficient to constitute malice in the state of Vermont. The court concluded that there was sufficient evidence for the jury to make these conclusions.

The jury considered the manufacturer’s promotional activities that reached the child’s doctor in some form. Evidence it considered included Allergan’s having pleaded guilty to a criminal prosecution by the U. S. government in 2010 for promoting Botox for off-label uses, including pediatric spasticity, from 2000 to 2005. The parents also introduced evidence supporting an inference that doses above 8 u/kg were less safe, but that Allergan promoted higher doses anyway. The court concluded that from this and other evidence, the jury reasonably could have inferred that the manufacturer had significant evidence in its possession suggesting that doses above 8 u/kg were more dangerous and also reasonably could have found that Allergan promoted doses above 8 u/kg based on evidence suggesting that the manufacturer’s marketing personnel and executives sought to increase sales by encouraging doctors to inject patients with higher doses. Moreover, the record also included evidence upon which the inference could have been made that Allergan’s promotional efforts reached the child’s doctor. Therefore, the court concluded that the evidence was sufficient to support the jury’s conclusion that Allergan’s promotional activities were outrageously reprehensible, especially in light of the evidence of its promotion of higher doses.

Further, the court determined that evidence presented by the parents reasonably suggested that the manufacturer was motived by financial gain and knowingly encouraged risky doses despite the real possibility that children could be injured because the toxin was more likely to spread in doses above 8 u/kg. Thus, the court found that the facts presented a case in which malice could be inferred. Even if malice could not be inferred, the court said, sufficient evidence was presented from which a jury could find that Allergan’s promotional campaign was undertaken “in conscious and deliberate disregard of a known, substantial and intolerable risk of harm to the plaintiff, with the knowledge that the acts or omissions were substantially certain to result in the threatened harm”—a standard set forth in a Vermont Supreme Court decision. While the court noted it was a closer question as to whether Allergan knew that promoting Botox at high doses was substantially certain to result in harm to patients, in the light most favorable to the parents, the court found it was a reasonable conclusion. Thus, the court concluded that the evidence was sufficient to support the jury’s award of punitive damages.

New trial. Finally, the court could not conclude that the jury reached a seriously erroneous result or that the verdict was a miscarriage of justice. Rather, it found that the evidence presented was sufficient to sustain the jury’s verdict and there was no reason to disturb the jury’s credibility determinations in the case by ordering a new trial. Thus, the court denied the manufacturer’s motion for a new trial.

The case is No. 2:13-cv-234.

Attorneys: Andrew M. Edge (McGinnis, Lochridge & Kilgore, LLP) for Kevin Drake. Christopher D. Landgraff (Bartlit Beck Herman Palenchar & Scott LLP) for Allergan, Inc.

Companies: Allergan, Inc.

MainStory: TopStory DamagesNews JuryVerdictsNewsStory EvidentiaryNews ExpertEvidenceNews DrugsNews VermontNews

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