United States District Court, M.D. Alabama, Northern Division
PATRICIA WEST, as legal guardian of LAQUINTON K. WEST, Plaintiff,
JANSSEN PHARMACEUTICALS, INC., Defendant.
REPORT AND RECOMMENDATION
A. BAKER UNITED STATES MAGISTRATE JUDGE.
pharmaceutical products liability case, Plaintiff Patricia
West, as legal guardian of LaQuinton K. West,  sues Defendant
Janssen Pharmaceuticals, Inc.,  alleging her son's ingestion
of Risperdal and generic risperidone caused her son to
develop gynecomastia, an abnormal development of breasts in
males. Pending before the court are the Motion for Summary
Judgment by Janssen (Doc. 184), Plaintiff's Motion to
Exclude Certain Testimony by Janet Arrowsmith, M.D., (Doc.
175), Plaintiff's Motion to Exclude Certain Testimony by
Elias G. Chalhub, M.D. (Doc. 177), Defendant's Motion to
Preclude Expert Testimony by Michael D. Freeman, MedDr, MPH,
FAAFS (Doc. 186), Defendant's Motion to Preclude Expert
Testimony of Elizabeth Z. Naftalis, M.D. (Doc. 188), and
Defendant's Motion to Preclude Expert Testimony of Laura
M. Plunkett, PhD, DABT (Doc. 190). The parties filed sealed
and unsealed joint exhibits in support, see Doc.
206, and have had the opportunity to fully brief the motions.
See Docs. 176, 178, 185, 187, 189, 191,
192-205. The court requested additional briefing on
the Eleventh Circuit's recent opinion in Small v.
Amgen, Inc., et al., No. 17-11440, 2018 WL 501354 (11th
Cir. Jan. 22, 2018). (Docs. 207-09). For the reasons that
follow, it is recommended that the Motion for Summary
Judgment by Janssen (Doc. 184) be granted
and the Daubert motions (Docs. 175, 177, 186, 188,
190) be denied as moot.
Pharmaceuticals, Inc. (“Janssen”) removed the case
to this court pursuant to 28 U.S.C. § 1332 on the basis
of diversity of citizenship and an amount in controversy in
excess of seventy-five thousand dollars. (Doc. 1).
Plaintiff dismissed the individual Defendants, some of whom
were non-diverse. (Doc. 13). The only remaining Defendant is
Janssen Pharmaceuticals, Inc. The parties do not contest
personal jurisdiction or venue, and the court finds
sufficient information of record to support both.
See 28 U.S.C. § 1391. On January 5, 2017, the
above-styled matter was referred to the undersigned for
recommendation on all pretrial matters. (Doc. 62); see
also 28 U.S.C. § 636(b); Rule 72, Fed. R. Civ. P.;
United States v. Raddatz, 447 U.S. 667 (1980);
Jeffrey S. v. State Bd. of Educ. of State of Ga.,
896 F.2d 507 (11th Cir. 1990).
court shall grant summary judgment if the movant shows that
there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law.”
Fed.R.Civ.P. 56(a). In ruling on a motion for summary
judgment, the Court construes the facts and all reasonable
inferences therefrom in the light most favorable to the
nonmoving party. Reeves v. Sanderson Plumbing Prods.,
Inc., 530 U.S. 133, 150 (2000). However, when faced with
a “properly supported motion for summary judgment, [the
nonmoving party] must come forward with specific factual
evidence, presenting more than mere allegations.”
Gargiulo v. G.M. Sales, Inc., 131 F.3d 995, 999
(11th Cir. 1997).
judgment is mandated “against a party who fails to make
a showing sufficient to establish the existence of an element
essential to that party's case, and on which that party
will bear the burden of proof at trial.” Celotex
Corp. v. Catrett, 477 U.S. 317, 322 (1986).
“Summary judgment may be granted if the non-moving
party's evidence is merely colorable or is not
significantly probative.” Sawyer v. Southwest
Airlines Co., 243 F.Supp.2d 1257, 1262 (D. Kan. 2003)
(citing Anderson v. Liberty Lobby, Inc., 477 U.S.
242, 250-51 (1986)).
the summary judgment stage the judge's function is not
himself to weigh the evidence and determine the truth of the
matter but to determine whether there is a genuine issue for
trial.” Anderson, 477 U.S. at 249.
“Essentially, the inquiry is ‘whether the
evidence presents a sufficient disagreement to require
submission to the jury or whether it is so one-sided that one
party must prevail as a matter of law.'”
Sawyer, 243 F.Supp.2d at 1263 (quoting
Anderson, 477 U.S. at 251- 52).
K. West (“Plaintiff”) is the mother and legal
guardian for her son, LaQuinton K. West (“West”).
(Doc. 1-13, ¶ 4). Plaintiff filed this lawsuit against
Janssen related to the design, manufacture, sale, marketing,
advertising, promotion, and distribution of Risperdal and
generic risperidone. Id., ¶ 1. She alleges that
West ingested Risperdal and suffered injuries as a result,
including a condition called gynecomastia,  abnormal
development of breasts in males. Id., ¶ 2- 3.
Plaintiff asserts claims against Janssen for failure to warn
under the Alabama Extended Manufacturer's Liability
Doctrine (“AEMLD”) (Count I), negligence (Count
II), wanton misconduct (Count III), failure to warn (Count
IV), breach of implied warranty of merchantability (Count V),
fraud (Count VIII), and negligent misrepresentation (Count
(Doc. 1-13). The facts, viewed in a light most favorable to
Plaintiff as the non-moving party, are as follows:
West's Risperdal and Risperidone Use
was born January 19, 1983. (Doc. 206-82 at 35:2). He was 32
years old when this lawsuit was filed in 2015. He was
diagnosed with autism at an early age. (Doc. 206-82 at 34:18-
24). Plaintiff testified her son was first
prescribed Risperdal by Dr. Love at the Vaughn
Clinic.(Doc. 206-82 at 47:14-48:14). West first
saw Dr. Jan Mathisen in 1995 when he was 12 years old; Dr.
Mathisen did not prescribe Risperdal at that time. (Doc.
206-83 at 81:7-16). He first prescribed Risperdal for West in
October 2000, which was approximately three months prior to
West turning 18 years old. Id. at 81:7-16;
90:15-92:23. In the October 11, 2000 visit, Plaintiff
indicated to Dr. Mathisen that her son's behavior was
getting worse and he was not sleeping well. Id. at
90:15-91:5. Dr. Mathisen prescribed Risperdal for West's
autism and obsessive compulsiveness. Id. at
90:15-92:23. West was 17 years old. Id. Dr. Mathisen
testified that West was physically fully developed, at Tanner
Stage V, at that time. (Doc. 206-103 at 367:3- 369:9). In
West's follow-up visit with Dr. Mathisen on April 26,
2001, it was noted that West had no side effects from the
Risperdal and “Mom is very pleased with his
progress”; the plan was to continue him on Risperdal
and to follow up in six months. (Docs. 206-112 at 2, 206-83
at 94:7- 95:2). Dr. Mathisen saw West in October 2001, and he
was doing quite well with no reported new problems; Risperdal
was continued. Id. at 96:12-21. When West was next
seen in April 2002, his mother reported concerns with her
son's increasing libido. Id. at 98:2-10. Because
he knew that Risperdal can reduce libido at certain doses,
Dr. Mathisen increased West's Risperdal prescription to
three milligrams per day. Id. at 98:11-100:9. The
doctor had a conversation with Plaintiff about alternatively
using first-generation antipsychotics, Haldol or Prolixin,
but the Plaintiff did not want to pursue those medications
because of their side effects. Id. at 100:10-20.
There are no records of visits with Dr. Mathisen between the
April 10, 2002 visit and January 19, 2006. Id. at
101. There are pharmacy records of Risperdal prescription
refills, however, during this period between
visits. See (Docs. 206-83 at 106-20,
206-84 at 4). The last time Dr. Mathisen saw West was January
19, 2006. (Doc. 206-83 at 101:19-103:9). At the January 2006
visit, West was 23 years old, and it was reported he
wasn't taking his medications and he had an increased
libido. Id. at 101-02. Dr. Mathisen offered the
option of taking intermittent doses of Risperdal in a melt
version. Id. at 102:15-23. Although January 2006 was
the last office visit, the last risperidone prescription
where Mathisen was the prescribing doctor was filled by West
in April 2007. Id. at 120:6-11.
Daniel Mejer first saw West on July 6, 2006. (Doc. 206-86 at
31:20-25). West was present with his parents who expressed
concerns of insomnia and exhibitionist behavior. Id.
at 33. Current medication included Risperdal, but the notes
reflect he was non-adherent to his medication. Id.
at 33-34. Dr. Mejer did not recall West's autism
diagnosis. Id. at 36. Dr. Mejer next saw West
November 16, 2006, and he was doing well behaviorally and
denied adverse events. Id. at 39:23-40:23. In his
next visit of February 1, 2007, West was doing well with no
reports of sexually inappropriate behavior. Id. at
42:19-20. On May 3, 2007, West was reportedly tired in the
mornings and not taking his medication at school. In
response, Dr. Mejer changed the time for his medication
administration. Id. at 43-44. In his next visit of
July 5, 2007, his weight was at 176 and he still had some
exhibitionist behavior, albeit less frequent. Id. at
45. In December 2007, his weight was 174 and in March 2008
his weight was 165. Id. at 45-46. Dr. Mejer ordered
labs to check for a metabolic issue which is a known side
effect of second-generation antipsychotics. Id. at
50. In the May 2008 visit, his weight was stable at 165,
there was no concern with his medication, but his symptoms
worsened with non-adherence. Id. at 51:19-52:9. Up
to this point in Dr. Mejer's treatment of West, he
observed that West did better when compliant with his
medication, and that West did not experience side effects
from Risperdal. Id. at 58:11-23, 60:8- 16. Dr. Mejer
prescribed Risperdal and generic risperidone for West
starting in July 2006 and continuing into October 2015.
(Docs. 206-86 at 97:10-16; 206-85 at 6-13). Dr. David
Schaffer took over West's care for a period starting in
September 2008. Id. at 54.
Shaffer saw West from approximately September 2008 to June
2011. (Doc. 206-87 at 31:21-32:1). West was physiologically
an adult the entire time he was treated by Dr. Schaffer.
Id. at 82:9-83:17. Notes from the September 4, 2008
visit, show West's weight was 168 pounds, he was having
problems with inappropriate sexual behavior, and part of his
problem was due to noncompliance with his medication.
Id. at 76:12-16. Dr. Schaffer continued West on the
Risperdal that he was previously prescribed. Id. at
76:17-78:2. He was next seen by Dr. Schaffer on December 4,
2008, his behavior had improved, with room for further
improvement, and there were no side effects of the
medication. Id. at 92:9-15. He was continued on
Risperdal. Dr. Schaffer saw West again on March 5 and then
June 4, 2009. Id. at 95-96. Overall, he was doing
well, and he was continued on the Risperdal M. Id.
West was next seen January 7, 2010. Id. at 101. His
behavior was stable, and his prescription for Risperdal M was
renewed. Id. In his July 1, 2010 visit, West
reported he was fine. Id. at 102. Dr. Schaffer noted
a diagnosis of ADHD and prescribed Adderal, in addition to
the Risperdal. Id. at 102-03. In his January 6, 2011
visit, West's parents requested his Risperdal dosage be
increased to help with his walking outside at nighttime.
Id. at 109. From September 2008 until January 2011,
West's weight went from 168 to 164 pounds. Id.
at 110:6-111:7. During his time treating West, Dr. Schaffer
did not note any side effects of the Risperdal, nor did the
parents report any. Id. at 110-112. It was Dr.
Schaffer's opinion that the benefits of Risperdal
outweighed any side effects or negative effects. Id.
records show West was prescribed generic risperidone not
manufactured by Janssen from October 2012 through October
2015. (Docs. 206-85 at 6-8; 93-2 at 2-11). Dr. Bernard Hale
saw West January 15, 2016 for a physical and prescription
refill. (Doc. 206-88 at 24:9-13). West weighed 185 pounds on
that date. Id. at 70. There is no mention of
gynecomastia in Dr. Hale's notes. Id. at 76.
Pharmacy records show West was prescribed risperidone by Dr.
Hale and nurse practitioner Jodie Shedd in early 2016 after
this lawsuit was filed. (Doc. 206-85 at 13-14). Additionally,
Plaintiff testified in July 2016 that West was still taking
generic risperidone at that time. (Doc. 206-82 at
testified the first time she observed her son's symptom
of swelling of the chest was in July 2013. (Doc. 206-82 at
184:16-20). Dr. Chigozie Obiaka diagnosed West with
gynecomastia on September 19, 2013, at the age of
thirty. (Docs. 206-93 at 3-4; 206-59). Plaintiff
filed a declaration stating she would not have allowed West
to take Risperdal if Dr. Mathisen had advised her that
Risperdal could cause gynecomastia. (Doc. 206-59). It is
undisputed that Risperdal improved West's behavior and
provided a benefit. (Doc. 206-82 at 135-36, 151- 52, 155-56,
1993 and 2006 Risperdal Labels
1993 Risperdal label contained the following information in
the “precautions” section:
Hyperprolactinemia: As with other drugs that antagonize
dopamine D2 receptors, risperidone elevates prolactin levels
and the elevation persists during chronic administration.
… Although disturbances such as galactorrhea,
amenorrhea, gynecomastia, and impotence have been reported
with prolactin-elevating compounds, the clinical significance
of elevated serum prolactin levels is unknown for most
(Doc. 209-90 at 3). The 1993 label additionally noted that
gynecomastia had been reported in pre-marketing clinical
Other Events Observed During the Pre-marketing Evaluation of
Endocrine Disorders: Rare: gynecomastia, male breast
pain, antidiuretic hormone disorder.
(Doc. 206-90 at 6). The above language from the 1993
Risperdal label continued to be contained in the Risperdal
labels until October 2006. See Docs. 206-45-206-58,
206-90. During these years, as it relates to pediatric use,
the Risperdal label stated that “Safety and
effectiveness in children have not been established.”
1996, Janssen added a section to the label concerning adverse
events since market introduction which were temporally (but
not necessarily causally) related to Risperdal. Up until
October 2006, the section never included a reference to
gynecomastia being an adverse event. See Docs.
October 2006 Risperdal label added and deleted certain
language as it relates to hyperprolactinemia. Specifically,
the reference to the “clinical significance of elevated
serum prolactin levels is unknown for most patients”
was deleted in the October 2006 version. Compare
Doc. 206-45 at 4 with Doc. 206-90 at 3. The revised
language contained in the “precautions” section
Hyperprolactinemia As with other drugs that antagonize
dopamine D2 receptors, risperidone elevates prolactin levels
and the elevation persists during chronic administration.
Risperidone is associated with higher levels of prolactin
elevation than other antipsychotic agents. …
Galactorrhea, amenorrhea, gynecomastia and impotence have
been reported in patients receiving prolactin-elevating
(Doc. 206-90 at 4). The October 2006 Risperdal label included
the following language regarding pediatric use and the risk
of gynecomastia for children/adolescents:
The efficacy and safety of RISPERDAL in the treatment of
irritability associated with autistic disorder were
established in two 8-week, placebo-controlled trials in 156
children and adolescent patients, aged 5 to 16 years.
Hyperprolactinemia, Growth, and Sexual Maturation Risperidone
has been shown to elevate prolactin levels in children and
adolescents as well as in adults.
In clinical trials in 1885 children and adolescents with
autistic disorder or other psychiatric disorders treated with
risperidone, galactorrhea was reported in 0.8% of
risperidone-treated patients and gynecomastia was reported in
2.3% of risperidone-treated patients.
(Doc. 206-90 at 5).
Janssen Studies and Knowledge of Risks Prior to 2006 Label
December 1994, Janssen conducted a Risperdal taskforce
examining the strengths and weaknesses of Risperdal versus
competitors' drugs. (Doc. 206-121). High prolactin
increase was listed as a Risperdal weakness, id. at
8, compared to Sertindole which had a strength of no
prolactin increase, id. at 6, Seroquel had low
prolactin increase, id. at 5, and Olanzapine had
limited prolactin increase, id. at 4. In July 1997,
Janssen conducted a “Risperdal National Advisory
Board” meeting in which Janssen recognized
Ziprasidone's “prolactin increase is less than
observed with Risperdal, ” and “prolactin
increase does produce related-side effects regardless of what
Integrated Safety Base data shows.” (Doc. 206-122 at
3). In August 1997, Janssen prepared a 1998 Business Plan
recognizing that Olanzapine, Quetiapine, and Sertindole had
“low prolactin, ” and that “prolactin
elevation” was a weakness for Risperdal. (Doc. 206-123
at 3-4). In December 1998, Janssen presented a comparison of
risperidone and olanzapine to the American College of
Neuropsychopharmacology in which it was acknowledged that
gynecomastia is an adverse event “definitely causally
related to serum prolactin.” (Doc. 206-125 at 2-3).
Janssen conducted a study between 1996 and 2000 comparing
risperidone and haloperidol in adult patients. (Doc.
206-126). The results of the study issued in a July 2003
report demonstrated prolactin-related adverse events were
seen in a higher number of risperidone subjects than
haloperidol subjects. Id. at 3.
November 1997 until May 1998, Janssen conducted a study
comparing Risperdal and olanzapine in adults aged 18 to 64.
(Doc. 206-129). The results of the study published in June
2000 revealed gynecomastia and lactation nonpuerperal were
adverse events attributable to prolactin disorder and that
prolactin-related adverse events occurred in four risperidone
subjects and in two olanzapine subjects. Id. at 6.
In September 1999, Janssen reported on a study comparing
risperidone and olanzapine which demonstrated a
hyperprolactinemia rate of 7.1% for risperidone users
compared to 0.0% for olanzapine subjects. (Doc. 206-130 at
May 1997 until October 1998, Janssen conducted a study of
risperidone use in children aged 5 to 12 years. (Doc.
206-127). The November 2000 report on the study showed a
12.7% rate for hyperprolactinemia in the children treated
with risperidone. Id. at 3. In a risperidone study
conducted September 18, 1997 until July 1, 1999 in children
aged 5 to 12 years, Janssen reported in November 2000 that
the study revealed an 11.3% rate for hyperprolactinemia in
the children and adolescents treated with
risperidone. (Doc. 206-128 at 2-5). In a September
2003 report, Janssen admitted that “[e]levated
prolactin plasma levels can directly induce galactorrhea and
gynecomastia, ” and in long-term phase III trials, 3.7
% of males reported gynecomastia. (Doc. 206-131 at 3).
2003 article titled Prolactin Levels During Long-Term
Risperidone Treatment in Children and Adolescents,
see Doc. 206-133, the authors noted “[n]o
correlation was found between SHAP [side effects
hypothetically attributable to prolactin] and prolactin
levels, even when male gynecomastia during puberty was
included.” Id. at 8. Plaintiff has proffered
communications between the authors and Janssen
representatives, prior trial testimony of the authors, and
drafts of the manuscript to demonstrate Janssen was aware of
a statistically significant relationship at usage for 8 to 12
weeks between SHAP and prolactin levels, which directly
contradicts the article's statement of no correlation.
(Doc. 199 at 21-22). A white paper from Janssen Medical
Affairs, LLC, dated August 2004 and titled Prolactin: From
Mechanisms to Sequelae, stated: “Current evidence
suggests that risperidone leads increases in prolactin levels
when other atypicals have comparative weak to neutral effects
on prolactin.” (Doc. 206-83 at 183).
Knowledge of Prescribing Physicians
Mathisen started prescribing antipsychotics early in his
practice in approximately 1988. (Doc. 206-83 at 66:5-15). He
prescribed first-generation antipsychotics such as Haldol and
Mellaril. Id. In the 1996-1997 time frame, he began
prescribing Risperdal, a second-generation antipsychotic, to
his patients. Id. at 68. This was considered an
off-label use because an indication for Risperdal
in autistic children and adolescents was not approved until
2006. Id. at 69:7-12. He was aware that
hyperprolactinemia was a side effect of the first-generation
antipsychotics and because Risperdal was a drug that
similarly blocked the dopamine receptor, “it made sense
that it would have a similar response, that it would cause
some elevation of prolactin.” Id. at
72:17-73:7. His understanding, however, was that there were
no specific long-term issues. Id. at 73:7-10. He was
aware that prolactin elevation can cause side effects of
galactorhhea, breast enlargement, and osteoporosis.
October 2006, Dr. Mathisen had treated over one thousand
patients with Risperdal without any patient experiencing
gynecomastia as a side effect. (Doc. 206-103 at
517:18-518:7). If he had seen something unusual, he would
have spent more time looking at the package insert regarding
it. Id. at 518:7-13. Dr. Mathisen was aware that
gynecomastia was a potential side effect of
prolactin-elevating compounds independent of what was
contained in the label.
Q. And with respect to the information in the label, without
a doubt it was there; and had you read it, you would have
seen it, and you could have taken it into account in your
prescribing decisions, correct? …
A. That's true.
Id. at 518:18-519:3