Drake et al v. Allergan, Inc.
Filing
212
OPINION AND ORDER granting 206 Motion for Judgment on Verdict; denying 207 Post-trial Motion for Judgment as a Matter of Law or, in the alternative, MOTION for New Trial. Signed by Judge William K. Sessions III on 5/22/2015. (law)
UNITED STATES DISTRICT COURT
FOR THE
DISTRICT OF VERMONT
KEVIN DRAKE and LORI DRAKE,
individually and as next friend
of J.D.
Plaintiffs,
v.
ALLERGAN, INC.
Defendant.
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Case No. 2:13-cv-234
Opinion and Order
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.
(jury verdict form).
should be awarded.
ECF No. 201
The jury also found that punitive damages
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.
for judgment incorporating the jury’s verdict.
Plaintiffs move
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 offlabel uses in the years 2000 to 2005.
Technically Allergan was
charged with misbranding, which is how off-label promotion can
2
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
3
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.
No. 1.
ECF
Although they initially alleged claims for strict
liability failure to warn, negligence, strict liability design
4
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.
found that punitive damages were warranted.
5
It also
The jury awarded
$2,778,881.35 in total compensatory damages and $4,000,000.00 in
punitive damages.1
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
1
The jury awarded compensatory damages as follows: J.D. was
entitled to $2,500,000.00 in compensatory damages, Lori Drake
and Kevin Drake were entitled to $28,881.35 in compensatory
damages, and Lori Drake and Kevin Drake were entitled
$250,000.00 in mental anguish damages.
6
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)).
B. Discussion
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.
1. Causation
The Court charged the jury, without objection, to consider
whether Allergan’s “act or omission played a substantial part in
7
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,2 was
discredited during cross-examination.
The Court initially noted that the Albavera-Hernández study
was an important piece of epidemiological evidence in its
2
Tr. Ex. 108, Cidronio Albavera-Hernández et al., Safety of
Botulinum Toxin Type A among Children with Spasticity Secondary
to Cerebral Palsy: A Systematic Review of Randomized Clinical
Trials, 23 Clinical Rehabilitation 394 (2009).
8
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.
Hollander court observed:
9
The
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 evidence that
may have been insufficient to support a finding of causation in
isolation could be sufficient when considered together.
The First Circuit reversed a trial court’s decision to
exclude testimony from an expert under similar circumstances.
The trial court failed to appreciate that the expert inferred
causality “from the accumulation of multiple scientifically
acceptable inferences from different bodies of evidence.”
Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11,
10
26 (1st Cir. 2011).
It is valid for an expert to infer
causation based on the totality of evidence when combined it
supports such an inference.
Id. at 23.
Plaintiffs 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.
As
described below, the Plaintiffs’ evidence included: the seizure
rates in Allergan’s clinical trials; 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
J.D.’s seizures.
Although no single piece of evidence
necessarily may have been conclusive in isolation, together it
paints a picture sufficient to support the jury’s finding on
medical causation.
i. Seizure Rates in Clinical Trials
First, Plaintiffs presented evidence suggesting that the
overall rate of seizures in Allergan’s clinical trials was
higher in Botox groups than in placebo groups and that Allergan
may have selected favorable data to make this fact less obvious
in its reports to the FDA.
Exhibit 112 is a series of internal
Allergan emails from February of 2009.
In one of these emails,
an Allergan employee states that the number of seizures reported
11
in double blind placebo controlled studies was 0.61% for Botox
groups and 0.37% for placebo groups, or in his words, “[a]lmost
twice the rate” for participants receiving Botox.
Tr. Ex. 112
at AGN2164348.
However, in Allergan’s 2012 report to the FDA titled
Seizure Disorder Safety Analysis Allergan reported that the
“convulsion” rates for clinical trials were 0.7% for Botox and
0.6% for placebo.
Tr. Ex. 143 at AGN1735510.
The report
explains that “upper limb spasticity appeared imbalanced” so
“the raw adverse event frequencies from the pooled data were not
used for statistical comparisons.”
Id.
The jury could have
reasonably inferred that Allergan reported the data in a way
that made the disparity in seizure rates across groups less
obvious.
The jury also reasonably may have inferred that Allergan
changed the way it reported its data to obscure the total number
of positive rechallenges.
A positive rechallenge means that the
seizures ceased when Botox was withheld but then reoccurred when
Botox was reintroduced.
The number of positive rechallenges was
included in the 2004 report but is absent from the 2012 report.
Compare Tr. Ex. 40 with Tr. Ex. 143.
12
ii.
The Graham Study
Next, Dr. Hristova relied on the Graham study.3
Participants in this study received either Botox and hip bracing
or no injections and no bracing.
The jury could have reasonably
given this study significant weight because participants in the
treatment group received an average dose of 13.9 u/kg of Botox.
This dose was higher than the highest dose of 8 u/kg Allergan
had studied in its clinical trials and was more consistent with
the dose J.D. received.
The Graham study reported that two
children in the Botox group died.
died.
None in the control group
The authors reported that the autopsy findings suggested
that the deaths resulted from “asphyxiation related to
epilepsy.”
Tr. Ex. 752 at 29.
The authors claimed that the two
deaths were not thought to be injection-related but provided no
further analysis.
Id.
Dr. Hristova testified that these two deaths were
statistically significant according to her calculations and that
the study was sponsored by Allergan.
ECF No. 172 at 76.
She
also testified that other studies show that when drug
manufacturers sponsor research, the experiments conducted tend
to have poorer controls and tend to favor the drug.
3
Dr.
Tr. Ex 752, H. Kerr Graham et al., Does Botulinum Toxin A
Combined with Bracing Prevent Hip Displacement in Children with
Cerebral Palsy and “Hips at Risk”?, 90 J. Bone Joint Surg. Am.
23 (2008).
13
Hristova concluded that the number of deaths from epilepsy in
the Graham study is much higher than would be expected in the
background population.
Id.
Thus the jury could have found that
the Graham study supported Dr. Hristova’s conclusions.
iii. Adverse Event and Anecdotal Reports
Next, Dr. Hristova relied on adverse event reports
submitted to the FDA.
She explained that people typically take
the time to submit adverse event reports only when they believe
that there is some relationship between a particular drug and an
event, especially busy doctors.
ECF No. 172 at 80.
The fact
that many of the reports Dr. Hristova analyzed were medically
confirmed gave her greater confidence in inferring that Botox
was the potential cause.
See ECF No. 172 at 85.
Dr. Hristova
also analyzed individual seizure reports including, for example,
one pediatric report in which a child experienced seizures
immediately after receiving Botox and was subsequently diagnosed
with epilepsy based on positive EEG and MRI findings.
Tr. Ex.
198; ECF No. 176 at 12-13.
At least one doctor, Dr. Mark Gormley, a frequent Botox
injector, also directly raised some concerns to Allergan
employees about the connection between Botox and seizures when
eight of his patents experienced seizures after Botox.
21.
One patient experienced a positive rechallenge.
Tr. Ex.
Id.
Allergan may have declined to investigate these reports because
14
one employee could “not see a good outcome from poking around in
this subject.”
Id. at AGNRVB0384912.
Dr. Gormley later
reported yet another first time seizure that he admitted could
be coincidental but “certainly seem[ed] related” in his view.
Tr. Ex. 24 at AGNRBV038374.
The jury could have inferred that the medically confirmed
reports and positive rechallenges should be given greater weight
than other adverse event and anecdotal reports.
See Glastetter
v. Novartis Pharm. Corp., 252 F.3d 986, 990 (8th Cir. 2001)
(noting that positive rechallenge data is “substantially more
valuable than run-of-the-mill case reports because a patient’s
reactions are measured against his own prior reactions”).
While
caution may be advised when attributing causation solely on the
basis of these kinds of reports, the jury could properly
consider them to be a relevant factor.
iv.
Biological Plausibility and Theoretical
Mechanism of Action
Next, the Plaintiffs presented evidence from which a jury
reasonably could have inferred that it is biologically plausible
that Botox can cause seizures.
Plaintiffs also presented
evidence describing theories about how it might do so.
Biological plausibility takes on greater significance when
epidemiological evidence is lacking or inconclusive.
Fosamax, 645 F. Supp. 2d at 181.
15
See
Dr. Roger Aoki, before retiring, was Allergan’s Vice
President of Neurotoxin Research Program and had many years of
experience studying Botox.
In 2001 Dr. Brin received Dr.
Gormley’s reports described above and asked Dr. Aoki for the
first time whether there is a mechanism by which Botox can cause
seizures.
ECF No. 176 at 97.
In his deposition many years
later, Dr. Aoki testified that injections like the ones J.D.
received could plausibly cause seizures.
(Q
Aoki Dep. Tr. 32:20-23
“[M]y question is is triggering of seizures due to
peripheral BOTOX injections biologically plausible? A
Yes.”).
At trial, however, Dr. Aoki qualified the statement in his
deposition and stated that after examining whether it is
possible he “would have to reject that hypothesis and say it
can’t trigger –- a peripheral administrative botulinum toxin
would not trigger a seizure.”
ECF No. 176 at 76.
The jury
could have credited his statement in his deposition rather than
his testimony at trial.
Dr. Hristova’s testimony and article4 describing potential
mechanisms of how Botox might spread, including to the brain
4
Tr. Ex. 140, Anna H. Hristova et al., Severe Nervous System
Complications after Botulinum Type A Therapy: Three Case Reports
with Reviews of FDA-Reported Nervous System Effects, 4 PM&R 613
(Aug. 2012).
16
further, support an inference of biologic plausibility.5
No. 172 at 33-38, Tr. Ex. 140.
See ECF
Dr. Hristova testified about
research by Flavia Antonucci6 and Matteo Caleo7 and others
suggesting that Botox may travel by retrograde axonal transport.
In 1991, many years before he became an Allergan employee, Dr.
Brin co-wrote a paper stating that “after peripheral
administration [botulinum toxin] can enter the central nervous
system.”
Tr. Ex. 3, Joseph Jankovic & Mitchell F. Brin,
Therapeutic Uses of Botulinum Toxin, 324 New England J. of Med.
118 (1991); see also Tr. Ex. 5 at AGN210341 (“Animal studies
have clearly demonstrated that BTX can reach the central nervous
system from inoculations of muscles.”).
this position.
Dr. Brin later recanted
Tr. Ex. 190, Brin Dep. 120:18-121:2; 123:3-10.
Even Dr. Aoki admitted that retrograde axonal transport may
“possibly” occur and that it is a “valid theory.”
ECF No. 176
5
Dr. Hristova’s peer-reviewed article reflects her theories of
how Botox may spread beyond the site of injection, including in
the bloodstream or by retrograde axonal transport. While it
does not specifically focus on how botulinum toxin A might
spread to the brain and then cause a seizure, little is
understood about the mechanism of action for any seizure. Dr.
Hristova’s theories about how Botox spreads are relevant because
it is more likely that Botox can seizures if there is a
plausible theory as to how it might reach the brain.
6
Tr. Ex. 78, Flavia Antonucci et al, Long-Distance Retrograde
Effects of Botulinum Neurotoxin A, 28(14) J. of Neuroscience
3689 (April 2, 2008).
7
Tr. Ex. 107, Matteo Caleo et al, A Reappraisal of the Central
Effects of Botulinum Neurotoxin Type A: By What Mechanism?, 109
J. of Neurochemistry 15 (2009).
17
at 85-86.
The Plaintiffs’ evidence thus included both a
statement from an Allergan scientist about biological
plausibility and a theoretical mechanism of action the jury
could have reasonably relied on.
v.
FDA Guidance and the Botox Label
Next, the FDA’s own guidance supports an inference that
there is some relationship between Botox and seizures.
In 2010
Allergan put a warning regarding seizures in the Post-Marketing
Experience section of the Botox label.
Tr. Ex. 133 at 6.3 (“New
onset or recurrent seizures have also been reported, typically
in patients who are predisposed to experiencing these events.”).
Although the label states that the exact relationship of these
events to the botulinum toxin has not been established, adverse
reactions are selected for inclusion on the label when “there is
some basis to believe there is a causal relationship between
occurrence of an adverse event and the use of a drug.”
199 at 8.
Tr. Ex.
While this guidance is not binding on drug companies,
it is an additional factor supporting the jury’s finding.
vi.
Temporality and Lack of Alternative
Explanations
Finally, the temporality and lack of alternative
explanations for J.D.’s seizures support an inference that the
Botox injections he received were the cause of J.D.’s seizures.
Dr. Benjamin testified that he thought that whatever had
18
happened to J.D. was the result of the Botox because of timing
of the events.
ECF No. 170 at 15.
As of the date of trial Dr.
Benjamin still thought it was possible that Botox caused J.D.’s
seizures and stated that he would not give J.D. any more Botox.
ECF No. 170 at 16.
The Second Circuit affirmed an expert’s opinion that relied
in part on the progression and timing of the development of a
disease to support an inference of causality.
Zuchowicz v.
United States, 140 F.3d 381, 390 (2d Cir. 1998); see also
Westberry v. Gislaved Gummi AB, 178 F.3d 257, 265 (4th Cir.
1999) (explaining that under some circumstances “a temporal
relationship between exposure to a substance and the onset of a
disease or a worsening of symptoms can provide compelling
evidence of causation”);
Heller v. Shaw Indus., Inc., 167 F.3d
146, 154 (3d Cir. 1999) (noting courts “have looked favorably on
medical testimony that relies heavily on a temporal relationship
between an illness and a causal event”).
The defense’s theory at trial was that J.D.’s seizures
developed simply by chance because he is at greater risk for
seizures in general due to his cerebral palsy.
However, Dr.
Hristova’s testimony suggested this would be an extremely
unlikely coincidence.
She testified that only 21% of
individuals with spastic diplegia, a milder form of cerebral
palsy, develop seizures.
ECF No. 172 at 49-51.
19
Other evidence
suggested that of cerebral palsy patients who experience a
seizure in their lives, over two thirds of them experience their
first seizure by age two.
Tr. Ex. 208.
Thus Dr. Hristova
testified that the odds of developing a seizure disorder for the
first time after the age of 5 with a relatively mild form
cerebral palsy was very small.
Moreover, she testified that
J.D.’s seizures are autonomic, a much rarer kind of seizure, and
that other features of his experience were unusual.
at 69-70, ECF No. 173 at 87-93.
ECF No. 172
This suggests that J.D.’s
unusual seizure was not a natural occurrence but rather caused
by the Botox.
Finally, that J.D. and other children with cerebral palsy
may be more prone to seizures is not conclusive.
The jury
needed only to find that Botox was a substantial factor in
bringing about the injury.
The jury was appropriately
instructed that a pre-existing condition that makes the
plaintiff more susceptible to the event does not destroy
causation.
ECF No. 191 at 11.
Dr. Hristova testified that it
is possible J.D.’s cerebral palsy made him more susceptible to
having a Botox-induced seizure.
ECF No. 172 at 71.
The jury
could have reasonably concluded that the Botox either caused the
seizure outright or lowered J.D.’s seizure threshold
sufficiently to cause the seizure.
20
In sum the Plaintiffs presented sufficient evidence to
support the jury’s finding that Botox caused J.D.’s seizures.
b. Negligent Promotion and Proximate Cause
The jury was also required to find that Allergan’s
promotional activities were the proximate cause of J.D.’s
injuries.
Allergan argues that proximate cause can only be
proven if Allergan caused or played a substantial part in
causing Dr. Benjamin to treat J.D. with Botox in May of 2012 and
to select a dose above 12 u/kg.
As the Court instructed the jury, without objection, the
law “recognizes that there may be more than one proximate cause
of an injury” and that “[m]ultiple factors may operate at the
same time, or independently, to cause the injury and each may be
a proximate cause.”
ECF No. 191 at 11.
Under Vermont law,
“‘[d]etermination of proximate cause requires a finding by the
trier of fact except in rare circumstances.’”
Betz v. Highlands
Fuel Delivery, LLC, No. 5:10-CV-102, 2013 WL 392480, at *8 (D.
Vt. Jan. 31, 2013) (quoting Bloomer v. Gibson, 2006 VT 104, ¶
49, 180 Vt. 397, 416, 912 A.2d 424, 437).
Here the Plaintiffs
presented evidence from which a jury could have reasonably found
proximate cause sufficient to find in the Plaintiffs’ favor.
Allergan argues that Dr. Benjamin began and continued using
Botox to treat juvenile cerebral palsy patients with high doses
of Botox because of his training and clinical experience, not
21
because of anything Allergan said or did or failed to say or do.
While this is one possibility, it is not the only reasonable
conclusion that the jury could have reached.
Even if the jurors
credited Allergan’s theory that Dr. Benjamin relied primarily on
his training and experience, they could have nevertheless relied
on a variety of evidence to conclude that Allergan’s promotional
efforts over the years also played a substantial part in Dr.
Benjamin’s choice to treat J.D. with Botox and to select the
dose he administered.
First, the Plaintiffs presented evidence that Allergan
employees had direct contact with Dr. Benjamin during two
separate time periods.
An Allergan sales representative, Larry
Jackson, called on Dr. Benjamin nineteen times between 2000 and
2002 while Dr. Benjamin was completing his pediatric fellowship
at the Kennedy Krieger Institute at Johns Hopkins.
Tr. Ex. 20.
Dr. Benjamin testified that during his residency and then
fellowship there he first learned to inject Botox.
at 6-7.
ECF No. 170
The jury could have reasonably inferred that Mr.
Jackson promoted off-label use of Botox during these calls based
on Mr. Jackson’s call notes.
See Tr. Ex. 20.
Next, in 2005 Scott Traub of Allergan called on Dr.
Benjamin several times and “renewed [Dr. Benjamin’s] interest”
in injecting Botox for pediatric cerebral palsy.
AGN_DRAKE_00001068.
Tr. Ex. 44 at
Mr. Traub also apparently talked to Dr.
22
Benjamin about high dose Botox.
Id.
Dr. Benjamin did not
recall the specifics of these conversations.
ECF No. 170 at 50.
From these interactions with Mr. Jackson and Mr. Traub, the jury
could have inferred that Allergan influenced Dr. Benjamin’s
decisions to treat pediatric spasticity patients with Botox.
The jury also could have reasonably inferred that doctors
may be influenced by drug promotion but may not be consciously
aware of how the promotion has influenced their behavior.
Dr.
Benjamin agreed that many doctors might say that they think that
drug company promotion influences other doctors but not them.
ECF No. 170 at 65.
Dr. David Kessler also described a study by
the World Health Organization and Health Action International
finding promotion influences attitudes more than doctors
realize.
ECF No. 165 at 46-47
The Plaintiffs elicited testimony suggesting that Dr.
Benjamin may have been influenced by medical literature that
Allergan had some hand in editing, shaping, directing, or even
ghost writing.
Tr. Ex. 44; see also ECF No. 165 at 50-51, 54-55
(Dr. Kessler describing Allergan’s influence over the
literature).
Dr. Benjamin could not say for sure if he read any
item in particular on a list of articles that Allergan was
involved with in some way.
However, given the sheer number and
Dr. Benjamin’s testimony that some looked “familiar” and that it
is “likely [he] reviewed some of them,” it would be reasonable
23
for the jury to conclude that Allergan’s influence reached Dr.
Benjamin through the literature.
ECF No. 170 at 68.
Dr. Benjamin himself conceded that Allergan’s activities
affected his practice but could not quantify how much influence
Allergan might have had.
ECF No. 170 at 65.
However, he did
testify that Allergan has been a part of all the experiences,
influence, and training he has had and that all of that together
“would have had some influence in general over the practice.”
ECF No. 170 at 59.
The jury also could have inferred that Allergan’s
promotional activities influenced Dr. Benjamin’s dosing choices,
whether consciously or unconsciously, including the dose he
chose for J.D.
Dr. Benjamin testified that when he first
started injecting he was using a maximum dose of 10 to 12 u/kg.
ECF No. 170 at 7-8.
While attending the American Academy of
Cerebral Palsy and Developmental Medicine there was a breakout
session in which doctors discussed the various dosing ranges.
Dr. Benjamin testified that pharmaceutical companies, including
Allergan, are involved in such conferences and that session
influenced his dosing.
ECF No. 170 at 9.
Dr. Benjamin also testified that he gave a talk using a
slide set put together by WE MOVE.
ECF No. 170 at 33-34, 53.
WE MOVE is a non-profit organization that Dr. Mitchell Brin
founded and used to run before he moved to Allergan.
24
Tr. Ex.
190, Brin Dep. 61:2-24.
Allergan pled guilty to “controll[ing]
and fund[ing]” WE MOVE.
Tr. Ex. 126 at 13.
Allergan
influenced the content of the dosing guidelines WE MOVE
published.
ECF No. 165 at 33-34; Tr. Ex. 32 (email from Dr.
Brin concerning language regarding dosing in WE MOVE chapters).
The dosing guidelines from 2005 list the lesser of 16 u/kg or
400 units as the maximum dose.
Tr. Ex. 52.
The guidelines
previously listed 12 u/kg as the maximum dose.
139.
Tr. Ex. 24 at
Dr. Benjamin testified that he used WE MOVE and its
website as a resource and that he had seen the WE MOVE
guidelines before.
ECF No. 170 at 33-34, 112.
WE MOVE’s high
dosing guidelines could have influenced his dosing decisions.
Although Dr. Benjamin could not remember the time frame
with precision, he testified that he increased his dosing around
eight to ten years ago, which a jury could have inferred was
around the time he was talking with Scott Traub in 2005 about
high dose Botox.
See ECF No. 170 at 9-10.
Dr. Benjamin
explained that any discussion about high dose Botox in the
“gestalt of conferences and information and training, et cetera,
getting information about higher-dose Botox being used safely
would influence my ability to use higher doses.”
58-59.
15 u/kg is now his maximum dose.
ECF No. 170 at
ECF No. 170 at 8.
Thus the jury could have inferred that Allergan’s influences led
25
him to move to selecting doses above 12 u/kg, as was the dose he
gave J.D.
For the reasons described above the jury could have
reasonably concluded that Allergan’s promotional activities were
a substantial factor influencing Dr. Benjamin’s practice.
The
jury also could have reasonably concluded that Allergan’s
influence was a substantial factor in Dr. Benjamin’s choice to
move from doses above 10-12 u/kg to 15 u/kg.
Therefore there is
no reason to disturb any of the jury’s findings on causation.
2. Punitive Damages
Allergan argues that is entitled to judgment as a matter of
law on the issue of punitive damages because the evidence was
insufficient to support the jury’s verdict.
The Court
disagrees.
The Vermont Supreme Court’s jurisprudence on punitive
damages, by its own concession, “has not been a model of
clarity.”
Fly Fish Vermont Inc. v. Chapin Hill Estates, 2010 VT
33, ¶ 18, 187 Vt. 541, 996 A.2d 1167.
However, it is clear that
the purpose of punitive damages is to “punish conduct that is
morally culpable to the degree of outrage frequently associated
with crime.”
Id. ¶ 19.
Plaintiffs seeking punitive damages
must prove two elements: 1) “wrongful conduct that is
outrageously reprehensible” and 2) malice, “defined variously as
bad motive, ill will, personal spite or hatred, reckless
26
disregard, and the like.”
Id. ¶ 18.
When evaluating punitive
damages, juries may only consider evidence that has “a nexus to
the specific harm suffered by the plaintiff.”
State Farm. Mut.
Auto. Ins. Co. v. Campbell, 538 U.S. 408, 422 (2003).
Thus, the Plaintiffs were required to prove that Allergan’s
conduct was outrageously reprehensible and that Allergan acted
with malice.
It is clear that in this case the Plaintiffs do
not allege - nor could they prove – that Allergan had any ill
will, personal spite, or hatred towards the Drakes individually.
The question then is whether the Plaintiffs 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.
Defining the contours of a standard for reckless disregard
sufficient to warrant a finding of malice proved to be somewhat
slippery for the Vermont Supreme Court.
On the one hand, the
court had held that in order to qualify for punitive damages the
conduct at issue must be more than simply wrongful or unlawful.
Fly Fish, 2010 VT 33, ¶ 19.
And conduct evincing a “mere
reckless disregard of the plaintiff’s rights” or “a reckless
disregard of the right of others” is likewise insufficient.
Id.
¶¶ 19-20 (discussing Brueckner v. Norwich University, 730 A.2d
1086 (Vt. 1999) and Bolsta v. Johnson, 848 A.2d 306 (Vt. 2004)
(internal quotation omitted)).
The court noted that there must
27
be some kind of bad motive on top of the tort because a
threshold of reckless disregard, without more, would be so
flexible it could become virtually unlimited in its application.
Fly Fish, 2010 VT 33, ¶¶ 20-21.
On the other hand, the Vermont Supreme Court had longrecognized the notion of malice arising from acting with a
wanton disregard for great harm.
Id. ¶ 23.
When defining the
line between “reckless, wanton, or heedless misconduct”
sufficient to warrant punitive damages and “mere reckless
disregard” the Vermont Supreme Court held:
the culpability necessary for an award of punitive damages
based on reckless or wanton misconduct requires evidence
that the defendant acted, or failed to act, 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.
Id. ¶¶ 19, 21, 25.
This is the measure by which reckless
misconduct reaches the point of actual malice sufficient to
support an award of punitive damages.
Id. ¶ 25.
There are some circumstances, however, in which no reckless
disregard analysis was necessary to find malice when there was
either an element of bad motive by definition or otherwise
demonstrable malice present.
For example, the Vermont Supreme
Court explained that an attorney who intentionally
misappropriated money from a widowed plaintiff and lied about it
in DeYoung v. Ruggiero, 2009 VT 9, ¶ 27, 185 Vt. 267, 971 A.2d
28
627, was egregious enough that malice could be inferred.
Fish, 2010 VT 33, ¶ 29.
Fly
In DeYoung the court noted that “malice
may arise from deliberate and outrageous conduct aimed at
securing financial gain or some other advantage at another’s
expense, even if the motivation underlying the conduct is to
benefit oneself rather than harm another.”
¶ 27.
DeYoung, 2009 VT 9,
The defendant’s admitted motive in DeYoung was to enrich
himself and promote the interests of his company, which the
court found “in and of itself demonstrates a bad motive.”
29.
Id. ¶
It is not necessary to find an intention to do harm to find
malice.
Id.
The court also included dicta suggesting that
punitive damages should be available against companies that
“knowingly [place] dangerous products into the market, hoping
that people [will] not get hurt” while ignoring a great risk of
harm to increase profits.
Id.
The other cases in which the court described finding
demonstrable malice involved, for example, fraud, Follo v.
Florindo, 2009 VT 11, 185 Vt. 390, 970 A.2d 1230, a campaign of
terror motivated by sectarian and racial bias, Shahi v. Madden,
2008 VT 25, 183 Vt. 320, 949 A.2d 1022, and filing a false
mechanic’s lien on property in an effort to extort right-of-way
concessions from owners who had no prior business with the
company and owed nothing, Wharton v. Tri–State Drilling &
Boring, 2003 VT 19, 175 Vt. 494, 824 A.2d 531.
29
The Due Process Clause of the United States Constitution
limits the scope of evidence juries may properly to consider to
conduct with a “nexus” to the specific harm suffered.
Farm, 538 U.S. at 422.
State
Therefore the jury could only consider
promotional activities that reached Dr. Benjamin in some way.
a. Wrongful and Outrageously Reprehensible Conduct
Allergan pled guilty to a criminal prosecution by the
United States government in 2010 for promoting Botox for offlabel uses, including pediatric spasticity, from 2000 to 2005.
Tr. Ex. 128.
The Plaintiffs introduced evidence demonstrating
Allergan’s promotional activities were aimed at pediatric
spasticity and pediatric specialists during this time.
e.g., Tr. Exs. 27, 28, 34, 86.
See,
Sales of Botox for off-label use
in pediatric spasticity more than doubled between 2002 and 2007.
Tr. Exs. 27, 65.
The Plaintiffs also introduced evidence supporting an
inference that doses above 8 u/kg are less safe but Allergan
nevertheless promoted higher doses.
First, Dr. Brin testified
by video deposition that 8 u/kg is the maximum pediatric dose
studied and is the dose listed in the Company Core Data Sheet.
Tr. Ex. 190, Brin Dep. 12:10-12:20.
Of the countries that have
approved Botox for pediatric spasticity, 8 u/kg is the maximum
dose in every single country.
21:1; ECF No. 186 at 78-79.
Tr. Ex. 190, Brin Dep. 20:21-
Allergan also defined “overdose” in
30
the context of pediatric use as doses greater than 8 u/kg.
Ex. 190, Brin Dep. at 15:20-16:19; Tr. Ex. 77.
Tr.
Finally, Dr.
Brin agreed that “the risk [of possible distant spread of toxin]
is higher at doses greater than 8 units per kilogram” and that
Allergan considers seizures to be an important potential risk.
Tr. Ex. 190, Brin Dep. 95:22-96:3; 118:7-13.
Allergan’s animal toxicology data confirms that systemic
adverse effects begin to appear at doses of 8 u/kg and higher.
Tr. Ex. 145 at AGN4928938.
A Botox employee refused to provide
free Botox to a researcher who hoped to conduct a clinical trial
at higher doses in 2005 because Allergan’s “toxicology and
safety data (both in house and on file at FDA) cannot not
support doses >6-8 units of Botox per Kilo.”
RVB0150261.
Tr. Ex. 58 at AGN
A scatterplot that was repeatedly introduced with
witnesses and discussed at length at trial plotted the dose that
post-marketing pediatric “possible distant spread of toxin”
cases received.
Tr. Ex. 145 at AGN928944.
The scatterplot
includes a line labeled “CCDS Maximum Dose” at 8 u/kg and
reveals that all of the pediatric cases, save one with special
circumstances, occurred above 8 u/kg.
Id.
The Maximum Dose
Consideration Review determined that Allergan would keep the
pediatric dose at 8 u/kg.
Tr. Ex. 201.
From this evidence the
jury could have reasonably inferred that Allergan had
31
significant evidence in its possession suggesting that doses
above 8 u/kg were more dangerous.
The jury could also have reasonably found that Allergan
promoted doses above 8 u/kg.
Plaintiffs’ evidence suggested
that Allergan’s marketing personnel and executives sought to
increase sales by encouraging doctors to inject patients with
higher doses.
See Tr. Ex. 28 (2001 business planning memorandum
identifying “[i]ncreased dosing for pediatric spasticity (from
4-6 units/kg several years ago to 10-20 units/kg now)” as an
important factor underlying growth in volume of use by pediatric
physiatrists); Tr. Ex 34 (marketing plan reflecting goal of
moving the maximum dose to a higher acceptable limit); Tr. Ex.
45 (slide deck prepared by Dr. Edward Goldstein but financed and
edited by Allergan stating “20 Units per ‘Ki’ . . . Is OK by
Me!”); Tr. Ex. 50 (email from Allergan CEO David Pyott inquiring
whether Allergan was doing any work in the area of dosing as
high as 30-35 u/kg).
The jury also could have concluded that Allergan promoted
higher doses through its control and influence of WE MOVE.
See
Tr. Ex. 26 at 139 (WE MOVE dosing schedule recommending up to 12
u/kg for total maximum dose per body visit); Tr. Ex. 22 (email
to Drake Barborka describing WE MOVE budget proposals for the
year); Tr. Ex. 194, Barborka Dep. 54:12-55:16 (Mr. Barborka
testified that Allergan paid indirectly for the publication and
32
dissemination of pediatric dosing charts); Tr. Ex. 192, Traub
Dep. 21:6-27:36, 54:5-22 (Mr. Traub testified that he
distributed WE MOVE dosing guidelines at conferences, meetings,
and talks he gave to doctors).
Finally, Allergan CEO David
Pyott gave a presentation in which potential reduction of
pediatric dose due to FDA safety concerns was a reason why the
rate of sales growth of Botox might slow.
Tr. Ex. 110.
The jury could also have inferred Allergan’s promotional
efforts reached Dr. Benjamin.
As described above, Larry Jackson
called on Dr. Benjamin around the time Allergan’s 2001 business
planning memorandum was circulated.
“dosing trend” with Dr. Benjamin.
Mr. Jackson discussed the
The jury could have inferred
the “dosing trend” was to move from 4-6 u/kg to 10-20 u/kg as
described in materials from the marketing department.
Exs. 20, 28.
See Tr.
Additionally, around the time that Scott Traub
called on Dr. Benjamin and discussed high dose Botox, Mr. Traub
had circulated a slide deck by Dr. Goldstein stating 20 u/kg was
an acceptable maximum.
Tr. Exs. 44, 45.
This was about the
time that Dr. Benjamin may have increased his maximum dose to
15.
The jury also could have inferred Dr. Benjamin was
influenced by WE MOVE because he testified that he referred to
their website in his practice and had seen the dosing schedule
before.
ECF No. 170 at 33, 54.
33
The evidence described above was sufficient to support the
jury’s conclusion that Allergan’s promotional activities were
outrageously reprehensible, especially in light of the
Plaintiffs’ evidence regarding the promotion of higher doses.
To begin with, it may have been fair to infer that Allergan’s
off-label promotion deserved a “degree of outrage frequently
associated with crime” because Allergan actually pled guilty to
a crime.
Fly Fish, 2010 VT 33, ¶ 18.
Allergan cites United States v. Caronia 703 F.3d 149 (2d
Cir. 2012) and argues that its promotional activities may have
been legal under federal law.
In Caronia the Second Circuit
held that the misbranding provisions of the Federal Food, Drug
and Cosmetic Act do not prohibit or criminalize the truthful
off-label promotion of FDA-approved prescription drugs because
construing the Act any other way would raise First Amendment
concerns.
Id. at 160, 168.
It appears that, like the defendant
in Caronia, Allergan was prosecuted for its promotional speech.
Thus, under this precedent the mere act of off-label promotion
through speech may not be illegal.
Regardless of the actual legality or illegality of
Allergan’s promotional activities, the jury could have
nevertheless reasonably concluded that Allergan’s conduct was
outrageously reprehensible because Allergan did more than simply
promote an off-label use.
In the light most favorable to the
34
Plaintiffs, Allergan promoted the use of doses that it knew were
risky in order to increase profits.
product sold.
Higher doses meant more
A reasonable jury could have felt morally
outraged by a corporation’s desire to put its bottom line above
children’s health, safety, and even lives.
b. Malice
In DeYoung the Vermont Supreme Court noted that “malice may
arise from deliberate and outrageous conduct aimed at securing
financial gain or some other advantage at another’s expense,
even if the motivation underlying the conduct is to benefit
oneself rather than harm another.”
2009 VT 9, ¶ 27.
The court
later explained that malice could be inferred in situations like
the one DeYoung presented without an analysis of recklessness.
Fly Fish, 2010 VT 33, ¶ 22.
While the court seemed to focus on
the unique concerns related to fraud by attorneys and their
special fiduciary relationship to clients, it also suggested in
dicta that punitive damages should be available in cases in
which companies knowingly place dangerous products in the market
and hope people do not get hurt.
Evidence presented by the
Plaintiffs reasonably suggested that Allergan was motived by
financial gain and knowingly encouraged risky doses despite the
real possibility that children could be injured because the
toxin is more likely to spread above 8 u/kg.
The facts here
appear to present a case in which malice can be inferred.
35
Even if malice cannot be inferred, however, the Plaintiffs
presented sufficient evidence 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.”
Fly Fish, 2010 VT 33, ¶ 25.
The jury could
have reasonably found that promoting doses above 8 u/kg created
a substantial and intolerable risk of harm because doses above 8
u/kg were not proven to be safe and effective and nearly every
incident in which a child was harmed occurred at a dose above 8
u/kg.
While it is a closer question 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
plaintiff that was a reasonable conclusion.
The jury could have
found that Allergan was aware of the risks of high doses but
promoted them anyway in order to reap greater profits.
Thus the Court finds that the Plaintiffs’ evidence was
sufficient to support the jury’s award of punitive damages.
III. Allergan’s Motion for a New Trial
In the alternative to its motion for judgment as a matter
of law, Allergan argues the Court should order a new trial
pursuant to Federal Rule of Civil Procedure 59.
A district
court may grant a motion for a new trial if it concludes that
36
the jury has reached a seriously erroneous result or the verdict
is a miscarriage of justice.
237, 245 (2d Cir. 2003).
Manley v. AmBase Corp., 337 F.3d
A new trial may be granted even if
there is substantial evidence supporting the jury’s verdict.
Id.
Moreover, unlike when deciding whether to grant a Rule 50
motion, courts are free to weigh the evidence and examine it
through their “own eyes.”
Meloff v. New York Life Ins. Co., 240
F.3d 138, 147 (2d Cir. 2001).
The Court also need not view the
evidence in the light most favorable to the verdict winner.
Id.
However, Second Circuit precedent admonishes trial judges
to “exercise their ability to weigh credibility with caution and
great restraint, as a judge should rarely disturb a jury’s
evaluation of a witness’s credibility and may not freely
substitute his or her assessment of the credibility of the
witnesses for that of the jury simply because the judge
disagrees with the jury.”
Raedle v. Credit Agricole Indosuez,
670 F.3d 411, 418 (2d Cir. 2012) (internal citations and
quotations omitted).
great infrequency.
Jury verdicts should be disturbed with
Id.
Moreover, it is “well-settled that Rule
59 is not a vehicle for relitigating old issues, presenting the
case under new theories, securing a rehearing on the merits, or
otherwise taking a ‘second bite at the apple’ . . . .”
Corp. v. GBJ Corp., 156 F.3d 136, 144 (2d Cir. 1998).
37
Sequa
At trial the parties presented conflicting evidence about
all of the questions the jury was asked to answer.
It was up to
the jury therefore to determine which account was credible.
Even when weighing the evidence here, the Court does not
conclude that the jury reached a seriously erroneous result or
that the verdict was a miscarriage of justice.
at 245 (2d Cir. 2003).
Manley, 337 F.3d
The evidence presented was sufficient to
sustain the jury’s verdict and the Court finds no reason to
disturb the jury’s credibility determinations in this case by
ordering a new trial.
Conclusion
For the reasons described above, 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.
DATED at Burlington, in the District of Vermont, this 22nd
day of May, 2015.
/s/ William K. Sessions
William K. Sessions III
District Court Judge
38
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