JOHNSON & JOHNSON, INC. AND ORTHO-McNEIL-JANSSEN PHARMACEUTICALS, INC.
BRENDA FORTENBERRY, AS THE CONSERVATOR OF THE ESTATE OF PERSON OF LOUISE TAYLOR
OF JUDGMENT: 01/27/2015
COUNTY CIRCUIT COURT TRIAL, HON. LAMAR PICKARD JUDGE.
ATTORNEYS FOR APPELLANTS: KATHLEEN ELIZABETH CARRINGTON DONNA
BROWN JACOBS PAUL V. CASSISA, JR. ADAM JULIUS SPICER CHRISTY
ATTORNEYS FOR APPELLEE: DAVID NEIL McCARTY TIMOTHY W. PORTER
JOHN TIMOTHY GIVENS PATRICK MALOUF.
COURT ATTORNEYS: TIMOTHY W. PORTER PATRICK MALOUF JOHN
TIMOTHY GIVENS DANIEL J. McGLYNN PAUL V. CASSISA, JR. ADAM
JULIUS SPICER DONNA BROWN JACOBS JENNIFER A. HAWKS-BLAND
KIMBERLY NELSON HOWLAND DAVID LOREN STRANGE, JR. CHRISTY D.
JONES CHAD ROBERTS HUTCHINSON.
RANDOLPH, P.J., COLEMAN AND MAXWELL, JJ.
The subject of the present products liability lawsuit is
Risperdal, an antipsychotic medication approved by the
Federal Food and Drug Administration on December 29, 1993, as
a safe and effective prescription drug for the management of
the manifestation of psychotic disorders. We hold that, as a
matter of law, the Risperdal in question contained an
adequate warning; we reverse and render the statutory
inadequate warning judgment. We further hold that, as more
fully set forth below, various errors in the jury
instructions require reversal of the plaintiff's verdict
that sounded in negligent misrepresentation, and we reverse
and remand the negligent misrepresentation claim. We also
address other, nondispositive issues that might arise again
Louise Taylor began suffering psychotic episodes when she was
seventy-one years old, in early 1998. From March 1998 to
January 2001, Psychiatrist Richard Rhoden prescribed
Risperdal to Taylor for the treatment of her recurrent
psychotic manifestations. In February 2001, Taylor developed
tardive dyskinesia, a movement disorder caused by
antipsychotic medications. Tardive dyskinesia is a syndrome
of potentially irreversible, involuntary, dyskinetic
movements in patients treated with antipsychotic drugs.
Tardive dyskinesia is a type or subcategory of extrapyramidal
symptoms, which is a general category of movement disorders
that may result from neuroleptic exposure to antipsychotics.
On August 6, 2002, Taylor filed a complaint against Ortho-McNeil
Janssen Pharmaceuticals, the manufacturer, seller, and
distributer of Risperdal, and its parent company Johnson
& Johnson (collectively "Janssen"), claiming
that Risperdal caused her to develop tardive dyskinesia.
Taylor also named her treating physician, Dr. Richard Rhoden,
as a defendant in her complaint. Taylor settled her claims
against Dr. Rhoden prior to trial. The case went to trial on
November 7, 2014. On November 14, 2014, the jury, in a nine
to three decision, found that Taylor was harmed by Risperdal
due to: (1) Janssen's "failure to provide adequate
warnings/instructions" and (2) Janssen's
"negligent marketing/misrepresentation." The jury
awarded Taylor $650, 000 in actual economic damages and $1.3
million in noneconomic damages, for a total damages award of
$1, 950, 000.
Janssen appeals, raising the following issues:
I. Is Janssen entitled to judgment as a matter of law on
Taylor's failure-to-warn claim because there was no
evidence of any alleged inadequacy in the Risperdal warning
because Janssen warned of the risk of Tardive Dyskinesia; and
there was no evidence that any alleged inadequacy in the
Risperdal warning proximately caused Taylor's Tardive
II. Is Janssen entitled to judgment as a matter of law on
Taylor's negligent misrepresentation claim because Taylor
failed to offer proof that Taylor's prescribing
physician, Dr. Rhoden, received any specific
misrepresentation from Janssen, much less that Dr. Rhoden
relied on any alleged misrepresentation in prescribing
Risperdal to Taylor?
III. Is Janssen alternatively entitled to a new trial because
the trial court's substantive jury instructions were
IV. Is Janssen alternatively entitled to a new trial because
economic damages should not have gone to the jury, as there
was no proof connecting Taylor's Tardive Dyskinesia, the
only condition allegedly caused by Risperdal, to the need for
twenty-four-hour attendant care - the only economic damages
V. Is Janssen alternatively entitled to a remittitur of the
economic damage award because it is not supported by
VI. Is Janssen alternatively entitled to a new trial because
Taylor's counsel used inflammatory, highly offensive, and
improper argument during closing?
Taylor cross appeals, raising the following issue:
VII. Did the evidence warrant a punitive damages proceeding?
AND PROCEDURAL HISTORY
In early 1998, Taylor began suffering psychotic episodes
featured by paranoia, delusions, and hallucinations. One
morning, Taylor prevented her daughter Fortenberry from
leaving their house to go to work by physically blocking the
door because she believed there were people outside her house
trying to do Fortenberry harm. Taylor believed what she saw
and heard really was there despite Fortenberry's
assurances otherwise. Due to the episode, Fortenberry took
Taylor to a local physician, who referred Taylor to Charter
Hospital, an inpatient behavioral health facility. Taylor was
admitted to Charter Hospital and diagnosed with "severe
depression with a single psychotic episode." While a
patient at Charter Hospital, caregivers prescribed Taylor
Haldol (generic: Haloperidol), a "first generation"
or "typical" antipsychotic medication. Taylor
received treatment for a number of weeks at Charter Hospital,
and on March 3, 1998, she was discharged and was referred to
Dr. Rhoden for further treatment.
On March 23, 1998, Taylor first saw Dr. Rhoden. Dr. Rhoden
continued Taylor's Haldol prescription for her previously
existing psychosis. Dr. Rhoden did not observe Taylor
exhibiting extrapyramidal symptoms during the visit. At the
next visit, on June 4, 1998, Dr. Rhoden discontinued Haldol
and prescribed Seroquel (generic: quetiapine), a "second
generation" or "atypical" antipsychotic
medication. Dr. Rhoden explained that he changed medications
because he believed Seroquel would help Taylor's
insomnia. Dr. Rhoden also explained that Seroquel was
"one of the newer types of [antipsychotics, ]" and
he "was trying to change people from the older type
antipsychotics to the newer atypical type." Dr. Rhoden
provided Taylor and Fortenberry with the material side
effects of Seroquel. Dr. Rhoden testified that the material
side effects he believed he would have discussed included
"the different types of EPS which could be either
temporary, or in some cases long term movement or pulling or
different kinds of muscle abnormalities that could
At the next visit on July 20, 1998, Dr. Rhoden continued the
prescription for Seroquel and noted that Taylor "has a
mouth twitch some since stopping Haldol[.]" On September
17, 1998, Dr. Rhoden noted that Taylor's "mouth
twitching is better[.]" Dr. Rhoden also noted that
Taylor was doing well with the current treatment and
continued the prescription for Seroquel.
On November 19, 1998, Taylor was hospitalized at Hardy Wilson
Memorial Hospital following an suicide attempt by taking
sixty Seroquel pills and some Prozac pills, which also had
been prescribed for her. Taylor was diagnosed with
"major depression, recurrent with psychosis[.]" On
December 10, 1998, Taylor was discharged with the need for
constant supervision until her next appointment scheduled for
December 15, 1998, with Region 8 Mental Health. Following the
discharge, Fortenberry left her job to care for Taylor
twenty-four hours a day because of Taylor's severe
depression and psychosis.
On March 18, 1999, Taylor returned to Dr. Rhoden for her next
visit. Dr. Rhoden recognized that Taylor "was on
Seroquel and at some point, she was worse and had to be
hospitalized[, ]" so he discontinued the Seroquel. In an
effort to "try something different[, ]" Dr. Rhoden
prescribed Risperdal (generic: risperidone), a "second
generation" or "atypical" antipsychotic, to
Taylor. Dr. Rhoden first started Taylor on Risperdal at one
to two milligrams at nine p.m. as directed. Dr. Rhoden's
record confirmed that "side effects [were] given
inc[luding] T.D. [and] EPS." Dr. Rhoden testified that
he informed both Taylor and Fortenberry of the risk of
tardive dyskinesia and extrapyramidal symptoms during the
visit. Dr. Rhoden explained that he would have told Taylor
and Fortenberry: "[R]emember that this medicine, as in
all medicines in this class, can produce certain movement
problems or pulling or muscle problems that can develop that
can be short term. It can be treated, but sometimes they
can't be; they can be long term."
Risperdal, along with all other antipsychotic medications on
the market, were required to carry the Food and Drug
Administration approved class label warning for tardive
dyskinesia. The Food and Drug Administration utilizes a class
label for the purpose of informing the physician that the
medication carries the potential risk for the same particular
adverse events as all the other medications in the same
class. The pertinent portions of the Food and Drug
Administration approved class label included in the Risperdal
label during the time period that Dr. Rhoden prescribed
Risperdal to Taylor provided:
RISPERDAL ™ (risperidone) is an antipsychotic agent
belonging to a new chemical class, the benzisoxazole
derivatives. . . . .
RISPERDAL ™ (risperidone) is indicated for the
management of the manifestations of psychotic disorders.
. . . .
A syndrome of potentially irreversible, involuntary,
dyskinetic movements may develop in patients treated with
antipsychotic drugs. Although the prevalence of the syndrome
appears to be highest among the elderly, especially elderly
women, it is impossible to rely upon prevalence estimates to
predict, at the inception of antipsychotic treatment, which
patients are likely to develop the syndrome. Whether
antipsychotic drug products differ in their potential to
cause Tardive Dyskinesia is unknown.
The risk of developing Tardive Dyskinesia and the likelihood
that it will become irreversible are believed to increase as
the duration of treatment and the total cumulative dose of
antipsychotic drugs administered to the patient increase.
However, the syndrome can develop, although much less
commonly, after relatively brief treatment periods at low
There is no known treatment for established cases of Tardive
Dyskinesia, although the syndrome may remit, partially or
completely, if antipsychotic treatment is withdrawn.
Antipsychotic treatment, itself, however, may suppress (or
partially suppress) the signs and symptoms of the syndrome
and thereby may possibly mask the underlying process. The
effect that symptomatic suppression has upon the long-term
course of the syndrome is unknown.
Given these considerations, RISPERDAL ™ (risperidone)
should be prescribed in a manner that is most likely to
minimize the occurrence of Tardive Dyskinesia. Chronic
antipsychotic treatment should generally be reserved for
patients who suffer from a chronic illness that (1) is known
to respond to antipsychotic drugs, and (2) for whom
alternative, equally effective, but potentially less harmful
treatments are not available or appropriate. In patients who
do require chronic treatment, the smallest dose and the
shortest duration of treatment producing a satisfactory
clinical response should be sought. The need for continued
treatment should be reassessed periodically.
If signs and symptoms of Tardive Dyskinesia appear in a
patient on RISPERDAL ™, drug discontinuation should be
considered. However, some patients may require treatment with
RISPERDAL ™ despite the presence of the syndrome.
Dr. Rhoden was aware that all antipsychotics, including
Risperdal, had been associated with tardive dyskinesia. Dr.
Rhoden, who had prescribed Risperdal since the early 1990s,
had familiarized himself with the Risperdal label before
prescribing it. Dr. Rhoden verified that the label's
language regarding tardive dyskinesia was consistent with his
understanding of tardive dyskinesia and its association with
Dr. Rhoden continued to treat Taylor with Risperdal and on
May 6, 1999, Dr. Rhoden increased Taylor's dosage to
three milligrams per day. On November 10, 1999, Dr. Rhoden
noted that, "psychiatrically [Taylor] is more bright and
stable than ever." On January 10, 2000, Dr. Rhoden
noted: "reviewed again side effects of Rx esp.
Risperdal" including, "T.D." and
"EPS[.]" Dr. Rhoden also noted "no significant
problems" of the side effects, tardive dyskinesia and
extrapyramidal symptoms. On May 1, 2000, Dr. Rhoden noted
"no EPS[, ]" and increased Risperdal to four
milligrams. On November 6, 2000, Dr. Rhoden noted "no
EPS[.]" On January 24, 2001, Dr. Rhoden noted that
Taylor had "developed an oral dyskinesia which I had
previously warned her and her daughter about." In
response, Dr. Rhoden decreased the dosage of Risperdal and
restarted Taylor on Seroquel.
On February 21, 2001, Taylor visited with Dr. Rhoden for the
last time. Dr. Rhoden noted that since the previous
month's visit, Taylor "has been having trouble w[ith
her] tongue moving around inside and darting outside of her
mouth since changing from the Risperdal to the new medication
- Seroquel- to the point of being unable to wear
dentures." Dr. Rhoden noted that Taylor's chief
concern was the cause of the involuntary movement of her
tongue. Dr. Rhoden noted that Taylor was "clearer
psychiatrically, not dizzy - is pleased [with] this even
though her oral dyskinesia has increased as above - most
likely rebound effect after Risperdal [decreased] - I again
reminded her and her daughter of T.D. and [associated] risk
factors (age, gender . . .) - [t]hey want to continue
[prescription] and try to [treat] side effects[.]" It
was apparent to Dr. Rhoden that Taylor had developed tardive
dyskinesia as of the February 21, 2001, visit.
Taylor has since been treated by dozens of other physicians
and has continuously needed an antipsychotic medication for
the treatment of her severe psychosis. At the time of trial,
Taylor was on Seroquel.
Dr. Richard Trosch, a neurologist specializing in movement
disorders, testified for Taylor. Dr. Trosch explained that
all tardive dyskinesia is caused by antipsychotic medications
or neuroleptics by definition. Dr. Trosch opined that
Taylor's exposure to Risperdal over a period of nearly
three years had caused her tardive dyskinesia. Dr. Trosch
opined that, with regard to extrapyramidal symptoms and
tardive dyskinesia, the safest antipsychotics are Seroquel
and Clozaril (generic: Clozapine). Dr. Trosch opined that had
Taylor been prescribed Seroquel or Clozaril, rather than
Risperdal, it would be "very unlikely" that she
would have developed tardive dyskinesia.
Whether Janssen is entitled to judgment as matter of
law on Taylor's failure to warn claim.
Janssen argues that the trial court erred by denying its
motion for a judgment notwithstanding the verdict.
Specifically, Janssen argues that Taylor's failure to
warn claim fails as a matter of law because she failed to
present evidence of any inadequacy in the Risperdal warning.
Alternatively, Janssen argues that there was no evidence that
any inadequacy in the Risperdal warning caused Taylor's
"The standard of review for the denial of a motion for a
judgment notwithstanding the verdict (JNOV) is de novo."
United Servs. Auto. Ass'n (USSA) v. Lisanby, 47
So.3d 1172, 1176 (¶ 8) (Miss. 2010). "A motion for
JNOV is a challenge to the legal sufficiency of the evidence,
and this Court will affirm the denial of a JNOV if there is
substantial evidence to support the verdict."
Id. The Court considers the evidence in the light
most favorable to the appellee, giving that party the benefit
of all favorable inferences that may be reasonably drawn from
the evidence. Id. "In essence, judgments as a
matter of law present both the trial court and the appellate
court with the same question - whether the evidence, as
applied to the elements of a party's case, is either so
indisputable, or so deficient, that the necessity of a trier
of fact has been obviated." Id.
Under the Mississippi Products Liability Act, "[a]
manufacturer is liable under a failure-to-warn theory if the
product 'failed to contain adequate warnings, ' the
inadequate warnings 'rendered the product unreasonably
dangerous to the user or consumer, ' and the inadequate
warning 'proximately caused the damages for which
recovery is sought.'" Union Carbide
Corp. v. Nix, Jr., 142 So.3d 374, 385 (¶ 18) (Miss.
2014) (quoting Miss. Code Ann § 11-1-63(a)(i)-(iii)).
A drug manufacturer has a duty adequately to warn the
prescribing physician of any known adverse effects which
might result from the use of its prescription drugs.
Wyeth Labs., Inc. v. Fortenberry, 530 So.2d
688, 691 (Miss. 1988) (citing Swayze v. McNeil
Laboratories, Inc., 807 F.2d 464 (5th Cir. 1987).
The Court has explained:
The general rule is that where prescription drugs are
concerned, a manufacturer's duty to warn only extends to
physicians and not to laymen. If the language of the warning
is adequate then the drug manufacturer ordinarily is freed
from liability. The learned intermediary doctrine is the
basis for this rule.
Janssen Pharmaceutica, Inc. v. Bailey, 878 So.2d 31,
57 (¶ 122) (Miss. 2004) (quoting Fortenberry,
530 So.2d at 691 (internal quotations and citations
Under the learned intermediary doctrine, "the
manufacturer's failure to warn the patient of the
product's risks does not render the product defective or
unreasonably dangerous so long as the manufacturer adequately
warns the learned intermediary." Bailey, 878
So.2d at 58 (¶ 124). "If there is no physician in
the role of 'learned intermediary' then the drug
manufacturer has a duty to adequately warn the
consumer." Fortenberry, 530 So.2d 688 at 692.
"By law, the labeling of every prescription drug must
include a package insert listing known side effects."
Bailey, 878 So.2d at 36 (¶ 7) (citing 21 C.F.R.
§§ 201.56-201.57). "The [Food and Drug
Administration] must approve the content of such inserts,
which communicate to prescribing physicians the essential
information about the medication's benefits and
risks." Id. "An adequate warning is one
reasonable under the circumstances." Id. at 55
(¶ 109). "To be reasonable, the warning should
neither understate nor overstate the known risks associated
with the use of a particular product." Id. In
some cases, a package insert may be sufficient for the
warning to be adequate as a matter of law. Id. at 55
The Court also has held that "[t]he issue of a
warning's adequacy is factual and usually will be
resolved by the trier of fact." Fortenberry,
530 So.2d at 692. The adequacy of a warning addressed to the
medical community may fall into the category of issues
requiring expert testimony because prescription drugs are
likely to be complex medicines, esoteric in formula and
varied in effect. Id. "Where the adequacy of
the warning is not obvious to the ordinary layperson it is
necessary to have expert testimony[.]" Id.
In Fortenberry, Billy Joe Fortenberry suffered
paralysis after receiving a flu vaccine manufactured by Wyeth
Laboratories and administered by his local physician, Dr.
T.L. Moore. Id. at 689. Fortenberry eventually was
diagnosed with transverse myelitis, which is closely related,
in etiology and pathology, to Guillain-Barre syndrome.
Id. Fortenberry filed a complaint against Wyeth and
Dr. Moore for failure to warn. Id. The vaccine
package contained an insert for the prescribing physician
warning of possible adverse reactions, including
Guillain-Barre syndrome. Id. Dr. Moore testified
that he had received and read the package insert and kept
abreast of recent medical literature. Id. Dr. Moore
also testified that he believed the risk to be minimal and
remote. Id. Therefore, Dr. Moore believed a warning
to his patients would scare them and was not required.
The Court determined it was clear from the record that
Fortenberry was in the group of "healthy adults"
for whom the vaccine was not recommended. Id. at
692. The vaccine was recommended for those "who are at
increased risk of adverse consequences from infections of the
lower respiratory tract." Id. at 692-93. The
package insert went on to warn physicians that, although the
connection between the vaccine and Guillain-Barre syndrome
was not clear, persons considering the vaccine "should
be made aware of the benefits and possible risks, including
[Guillain-Barre syndrome], of administration."
Id. at 693. Dr. Moore testified that he kept abreast
of the medical literature and did not believe there was a
sufficient connection between the vaccine and Guillain-Barre
syndrome to warrant a warning. Id. Therefore, Dr.
Moore decided to give no warning to Fortenberry. Id.
The Court held that the warning on the package insert was
adequate as a matter of law and reversed and rendered
judgment in favor of Wyeth. Id. at 691, 693.
Here, the Risperdal label unequivocally communicated the risk
of tardive dyskinesia associated with the use of all
antipsychotic drugs, including Risperdal. The label provided
that tardive dyskinesia "may develop in patients treated
with antipsychotic drugs." The label also provided:
"[w]hether antipsychotic drug products differ in their
potential to cause Tardive Dyskinesia is unknown." Dr.
Rhoden, who was not designated as an expert, specifically
testified that he considered the language of the Risperdal
label adequate to warn him of the risk of tardive dyskinesia
in Rispderal users at the time he prescribed it to Taylor.
Dr. Rhoden testified that he became familiar with
Risperdal's package insert before prescribing the
medication to his patients. Dr. Rhoden's records and
testimony confirm that he understood and appreciated the risk
of tardive dyskinesia associated with Risperdal. Dr.
Rhoden's awareness also was evident from the medical
records in which he repeatedly noted that he specifically had
warned Taylor and Fortenberry about the risk of
extrapyramidal symptoms and tardive dyskinesia associated
with Risperdal. Dr. Rhoden prescribed Risperdal after
performing a risk/benefit analysis. Dr. Rhoden testified:
Q. Doctor, despite th[e label's] language and despite
your knowledge about tardive dyskinesia and Risperdal, you
made the medical judgment that Risperdal was an appropriate
medication for Ms. Taylor?
Q. And that is even with the knowledge of the risk
A. Correct. Because the benefit was much greater than and the
loss of that benefit would be much worse than the risk of the
Q. . . . . What was your understanding of the benefits of
Risperdal for a patient like Ms. Taylor?
A. The benefits would be to decrease or put into remission
the psychotic symptoms which are terrible and unremitting and
lead to very bad outcomes. And those are much more certain
than the risks of possible side effects.
Q. And despite that, you did, nonetheless, warn Ms. Taylor
and her daughter, Brenda Fortenberry, of the risk of tardive
dyskinesia with Risperdal?
Taylor sought to prove that the warning was inadequate by way
of Janssen's promotional materials, internal documents,
and expert testimony. Dr. William Edwin Fann, an academic
psychiatrist and academic physician, testified for Taylor.
Dr. Fann testified that the Food and Drug Administration
Risperdal class warning label was cookie cutter information
and meaningless because it was marketed as
"atypical." Dr. Fann testified:
[Y]ou could go through the PDR, Physicians' Desk
Reference, or go through the U.S. Pharmaceutical and Drug
Information, and that same information is there on every
anti-psychotic. It was required. That doesn't mean as
much as it sounds like it means. Because all of this has been
gained, that is, not erased but balanced, counter-balanced by
saying it's an atypical. To say this drug is as likely to
cause tardive dyskinesia as any of the others, but it's a
-- you know, those that's what some people would call
cookie-cutter information. That's something you're
saying about every drug.
Taylor's attempt to prove her failure to warn claim
through Janssen's marketing materials and internal
documents expanded the claim beyond the statutory scope of
the Products Liability Act. Based on the terms of the Act,
enacted in 1993, the only pertinent question is whether the
prescription drug label contained adequate warnings or
instructions. See Miss. Code Ann. §
11-1-63(c)(i)-(ii) (Rev. 2014).
Although the statutory scope of a failure to warn claim is
limited to actual warnings or instructions for a product, the
Court has mentioned marketing materials in the prescription
drug context. In a pre Products Liability Act case, the Court
stated: "Notwithstanding the government regulations in
this field, the package insert is a marketing or
merchandising procedure to promote sales." Thompson
v. Carter, 518 So.2d 609, 612 (Miss. 1987) (holding that
a package insert was admissible in a medical malpractice
case). Moreover, the Court stated, "[d]rug manufacturers
have had to answer for alleged dilution of warnings by
over-promotion in sales programs." Id.
In Bailey, a post-Act case, the Court alluded to the
association of prescription drug marketing materials in the
context of a failure to warn claim. There, the Court reversed
and remanded for severance and new trial of the claims of ten
plaintiffs based on improper joinder, and the Court discussed
pertinent principles of an inadequate warning case against a
prescription drug manufacturer. Bailey, 878 So.2d at
49 (¶ 88). The plaintiffs contended that they had
offered sufficient proof to show that, through aggressive
marketing and over promotion, the drug manufacturer had
nullified the effectiveness of the warnings that it did
issue. Id. at 55 (¶ 109). The Court concluded
that the issue of whether the Food and Drug Administration
approved labeling was adequate, was a question of fact which
should be determined by ...