United States District Court, D. Vermont
KEVIN DRAKE and LORI DRAKE, individually and as next friend of J.D., Plaintiffs,
ALLERGAN, INC., Defendant.
OPINION AND ORDER
WILLIAM K. SESSIONS, III, District Judge.
Plaintiff J.D. is a minor whose parents, Kevin and Lori Drake, filed claims individually and as next friend of J.D. against Defendant Allergan, Inc. ("Allergan"), the manufacturer of Botox. J.D. has cerebral palsy. His doctor injected Botox into his calves to treat his lower limb spasticity. The Plaintiffs claimed that these injections caused J.D. to develop a seizure disorder.
After a thirteen-day trial, the jury found that the Plaintiffs had proven that Allergan was negligent and that J.D. suffered injuries as a result of that negligence. ECF No. 201 (jury verdict form). The jury also found that punitive damages should be awarded. Id. The jury did not find, however, that the Plaintiffs had proven that Allergan violated the Vermont Consumer Fraud Act. Id.
The parties have filed post-trial motions. Plaintiffs move for judgment incorporating the jury's verdict. ECF No. 206. Allergan renews its motion for judgment as a matter of law or, in the alternative, moves for a new trial. ECF No. 207. For the reasons described in detail below, the Court grants Plaintiffs' motion and denies Allergan's motions. The Court will enter judgment in favor of the Plaintiffs incorporating the jury's verdict.
I. Relevant Background
Allergan manufactures Botox, an injectable prescription drug that includes botulinum toxin type A as its active ingredient. When injected into a muscle, Botox temporarily blocks the nerve impulses that trigger muscle contractions.
Individuals with cerebral palsy often experience spasticity, or tightness in their limbs. The Food and Drug Administration ("FDA") has not approved Botox as a treatment for pediatric spasticity. Any administration of Botox for that purpose is known as "off-label" use. Doctors are free to prescribe drugs for off-label use but pharmaceutical companies are generally prohibited from promoting off-label uses of their products. Allergan pled guilty to a criminal prosecution by the United States government in 2010 for promoting Botox for off-label uses in the years 2000 to 2005. Technically Allergan was charged with misbranding, which is how off-label promotion can be prosecuted. Juvenile cerebral palsy and spasticity were two of the off-label indications to which Allergan pled guilty.
J.D. was born in 2006 with cerebral palsy. He has experienced mild to moderate spasticity in his lower limbs. When J.D. was about two, his parents took him to see Dr. Scott Benjamin at Fletcher Allen Health Care. Dr. Benjamin is a doctor of physical medicine and rehabilitation, also known as a physiatrist. J.D. saw Dr. Benjamin every three or four months after his initial visit.
Dr. Benjamin first treated J.D. with Botox on April 22, 2010 when J.D. was three-and-a-half years old. At that time, he selected a dose of either 6.5 or 6.7 u/kg and injected it into J.D.'s calves. Mrs. Drake testified that she did not think that the initial Botox injections resulted in much improvement or benefit for J.D. ECF No. 161 at 40. On April 25, 2012, when J.D. was almost five-and-a-half years old, Dr. Benjamin suggested additional Botox treatments at a higher dose. J.D.'s parents agreed to the treatment and on May 24, 2012 Dr. Benjamin injected J.D. with a dose of either 12.33 or 12.6 u/kg.
The next day J.D. experienced facial swelling and reddening but it seemed to improve after Mrs. Drake gave J.D. some Benadryl. The day after that his ears were also red. Eventually, J.D.'s head dropped and his tongue darted around his mouth extremely quickly. Mrs. Drake also noticed thick saliva coming out of his mouth. Next, J.D. vomited and different parts of his body began to twitch, including his eyes. He became unresponsive and was diagnosed as status epilepticus when the Drakes brought him to the emergency room. Status epilepticus is a seizure or series of seizures that lasts for more than thirty minutes. After being discharged from the hospital, J.D. eventually returned to normal.
J.D. had another odd episode in August of 2012 that included red ears. The next major event was in September of 2012 when J.D. had red ears and swollen cheeks. In October of 2012 the Drakes brought J.D. to the emergency room after he vomited. J.D.'s doctors eventually put him on anti-seizure medications and diagnosed him with epilepsy after an EEG revealed significant seizure activity. There was also one other incident in February 2013.
When patients experience an adverse event while taking a prescription drug they are encouraged to report it to the FDA, whether or not they or their doctors believe that it is related to the drug or caused by the drug. Anyone can submit an adverse event report, including drug manufacturers, doctors, and individual patients. Dr. Benjamin reported J.D.'s reaction.
Plaintiffs filed their Complaint on September 3, 2013. ECF No. 1. Although they initially alleged claims for strict liability failure to warn, negligence, strict liability design defect, breach of implied warranties, and violation of the Vermont Consumer Fraud Act ("VCFA"), Plaintiffs dropped their design defect and implied warranty claims shortly before the trial began.
The first day of trial was November 3, 2014. Plaintiffs finished their case-in-chief on November 12, 2014. On the same day, Allergan moved to strike the testimony of Dr. Anna Hristova, the Plaintiffs' medical causation expert, ECF No. 177, and moved for judgment as a matter of law, ECF No. 178. The Court denied both motions and Allergan proceeded with its case. Allergan renewed its motion for judgment as a matter of law on November 16, 2014, which the Court again denied. ECF No. 187. Plaintiffs dropped their strict liability failure to warn claim during the charge conference. The Court charged the jury only on Plaintiffs' claims for negligence and violation of the VCFA. ECF No. 191.
After deliberating for several days the jury returned its verdict in favor of the Plaintiffs on their negligence claim and in favor of Allergan on the Plaintiffs' VCFA claim. It also found that punitive damages were warranted. The jury awarded $2, 778, 881.35 in total compensatory damages and $4, 000, 000.00 in punitive damages.
II. Allergan's Motion for Judgment as a Matter of Law
A. Legal Standard
Allergan renews its motion for judgment as a matter of law pursuant to Federal Rule of Civil Procedure 50. To succeed on a Rule 50 motion, the moving party must show that, after a full hearing on an issue at trial, "there is no legally sufficient evidentiary basis for a reasonable jury' to resolve the issue in favor of the non-moving party." Cross v. New York City Transit Authority, 417 F.3d 241, 247 (2d Cir. 2005) (quoting Fed.R.Civ.P. 50(a)(1)). In reviewing a Rule 50 motion, a court must "draw all reasonable inferences in favor of the nonmoving party'" and "may not make credibility determinations or weigh the evidence.'" Id. (quoting Reeves. v. Sanderson Plumbing Products, Inc., 530 U.S. 133, 150 (2000)).
A movant's burden in securing Rule 50 relief is "particularly heavy" after a jury has deliberated and returned its verdict. Id. at 248. The motion must be denied unless "the evidence is such that, without weighing the credibility of the witnesses or otherwise considering the weight of the evidence, there can be but one conclusion as to the verdict that reasonable [persons] could have reached.'" Id. (quoting Samuels v. Air Transp. Local 504, 992 F.2d 12, 14 (2d Cir. 1993)). In other words the court may only grant a Rule 50 motion in this posture if there is "such a complete absence of evidence supporting the verdict that the jury's finding could only have been the result of sheer surmise or conjecture'" or there is "such an overwhelming amount of evidence in favor of the movant that reasonable and fair minded men [and women] could not arrive at a verdict against him.'" Id. (quoting Song v. Ives Labs., Inc., 957 F.2d 1041, 1046 (2d Cir. 1992)).
Allergan argues that the Court should enter judgment as a matter of law in its favor on the Plaintiffs' negligence claim because the Plaintiffs failed to provide sufficient evidence to support a finding of causation. Allergan also argues that the jury could not have reasonably found that the evidence demonstrated the culpability required to impose punitive damages. The Court examines each of these arguments, with Allergan's "heavy" burden in mind below. Cross, 417 F.3d at 248.
The Court charged the jury, without objection, to consider whether Allergan's "act or omission played a substantial part in bringing about or actually causing the injury" when evaluating causation. ECF No. 191 at 11. To meet their burden, the Plaintiffs had to prove 1) that Botox was the cause of J.D.'s seizure disorder and 2) that negligence by Allergan caused Dr. Benjamin to prescribe Botox to J.D. in the dose selected. The Plaintiffs presented sufficient evidence for a reasonable jury to find in their favor on both aspects of causation.
a. Medical Causation
Dr. Anna Hristova was the Plaintiffs' medical causation expert. Prior to trial Allergan moved to exclude her testimony under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). ECF No. 93. The Court denied that motion, ECF No. 134, as well as Allergan's subsequent motion to strike her testimony after it was completed, ECF Nos. 177, 183. Allergan now argues that no reasonable jury could have found that Botox caused J.D.'s seizure disorder, primarily because one piece of evidence on which Dr. Hristova relied, the Albavera-Hernández study,  was discredited during cross-examination.
The Court initially noted that the Albavera-Hernández study was an important piece of epidemiological evidence in its Opinion and Order denying Allergan's pretrial motion to exclude Dr. Hristova's testimony. ECF No. 134. Although Allergan effectively discredited the study during cross-examination, that does mean that no reasonable jury could have found that Botox caused J.D.'s seizures or that Dr. Hristova's opinions were too unreliable to be presented to the jury. In its initial Opinion and Order, the Court explicitly noted that an expert is not required to back her opinion with published studies that unequivocally support her position. ECF No. 134 at 15 (citing Amorgianos v. Nat'l Railroad Passenger Corp., 303 F.3d 256 (2d Cir. 2002)). And, importantly, another court had found that case reports, prevalence studies, adverse event reports, animal studies, and a hypothesis about a potential mechanism through which the drug supposedly caused the alleged injury were sufficiently reliable to permit an expert to testify. Id. (citing In re Fosamax Products Liability Litig., 645 F.Supp.2d 164 (S.D.N.Y. 2009)).
The Court denied Allergan's motion to strike Dr. Hristova's testimony because she relied on the "totality of circumstances." ECF No. 184 at 5. Allergan argues that according to Hollander v. Sandoz Pharms. Corp., 289 F.3d 1193, 1216 n.21 (10th Cir. 2002) this is not a sufficiently reliable approach. The Hollander court observed:
The Hollanders also suggest that a totality of the circumstances approach establishes that there are controverted issues of material fact. In essence they maintain that even though each individual category of evidence may be insufficient, all of the evidence considered as a whole raises factual questions as to whether Parlodel caused her stroke. The Hollanders cite no legal authority in support of this approach, and in our view, this argument is inconsistent with Daubert. To suggest that those individual categories of evidence deemed unreliable by the district court may be added to form a reliable theory would be to abandon "the level of intellectual rigor" of the expert in the field.
Id. (emphasis added) (citation omitted). Dr. Hristova's testimony is distinguishable because the district court in Hollander found that the individual categories of evidence related to the particular drug and injuries at issue were unreliable. Here the Court did not find the individual categories of evidence to be unreliable, nor did they present "too great an analytical gap between the data and the opinion proffered." Id. at 1205 (quoting General Elec. Co. v. Joiner, 522 U.S. 136, 146 (2002)). Rather, some pieces of ...