Court Opinion

ID: 4576118
Source: CourtListenerOpinion
Date Created: 2020-10-13 18:02:17.524202+00
Date Added: 2024-06-11T13:31:28.320917
License: Public Domain

Filed 10/13/20 Mills v. Janssen Pharmaceuticals CA2/7
   NOT TO BE PUBLISHED IN THE OFFICIAL REPORTS

California Rules of Court, rule 8.1115(a), prohibits courts and parties from citing or relying on opinions
not certified for publication or ordered published, except as specified by rule 8.1115(b). This opinion
has not been certified for publication or ordered published for purposes of rule 8.1115.

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

                         SECOND APPELLATE DISTRICT

                                      DIVISION SEVEN

 THOMAS K. MILLS,                                                B300508

           Plaintiff and Appellant,                              (Los Angeles County
                                                                 Super. Ct. No. BC652652)
           v.

 JANSSEN PHARMACEUTICALS,
 INC.,

           Defendant and Respondent.

      APPEAL from a judgment of the Superior Court of Los
Angeles County, Daniel J. Buckley, Judge. Affirmed.
      Thomas K. Mills, in pro. per., for Plaintiff and Appellant.
      Faegre Drinker Biddle & Reath, Rodney M. Hudson, and
William A. Hanssen, for Defendant and Respondent.

                             ____________________________
                        INTRODUCTION

       Thomas K. Mills appeals from the judgment entered in his
products liability action against Janssen Pharmaceuticals, Inc.
after the trial court denied Mills’s motion for summary judgment
and granted Janssen’s motion for summary judgment.
Representing himself on appeal, as he did in the trial court, Mills
contends the trial court erred in denying his motion and granting
Janssen’s. We affirm.

      FACTUAL AND PROCEDURAL BACKGROUND

      In March 2017 Mills filed this action for products liability,
personal injury, and “intentional tort” against Janssen, which
makes and markets the antipsychotic drug Risperdal, the brand
name for risperidone, “an antipsychotic medication that was first
approved by the FDA in 1993 for managing manifestations of
psychotic disorders in adults.” (Risperdal & Invega Cases (2020)
49 Cal.App.5th 942, 947.) Mills alleged the drug, which doctors
prescribed him while he was incarcerated for periods in 2014 and
2016, caused him to develop gynecomastia.1 He alleged Janssen

1      Gynecomastia is “a condition characterized by the
enlargement of male breast tissue.” (Risperdal & Invega Cases,
supra, 49 Cal.App.5th at p. 946.) “Risperidone elevates blood
levels of prolactin, a hormone produced by the pituitary gland.
Elevated levels of prolactin (hyperprolactinemia) are associated
with gynecomastia.” (Id. at p. 947, fn. omitted.) “‘Prolactin . . . is
a protein that is best known for its role in enabling mammals,
usually females, to produce milk.’” (W.C. v. Janssen
Pharmaceuticals, Inc. (In re Risperdal Litig.) (Pa. Super.Ct. 2017)
174 A.3d 1110, 1121, fn. 6; see State ex rel. Wilson v.

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knew gynecomastia was a common side effect of the drug but did
not “place any warning about the side effect” on the product.
       In January 2019 Mills filed a motion for summary
judgment, which is not in the record. In June 2019 Janssen
moved for summary judgment on the grounds, among others, that
at all relevant times Risperdal’s label disclosed the potential risk
of gynecomastia and that Mills could not establish a different
warning would have altered his treating physicians’ decisions to
prescribe Risperdal.
       In support of its motion Janssen submitted evidence that
during the relevant period the package insert for Risperdal
included, among its “Warnings and Precautions,” statements that
Risperdal “elevates prolactin levels and the elevation persists
during chronic administration,” that Risperdal “is associated with
higher levels of prolactin elevation than other antipsychotic
agents,” and that gynecomastia had “been reported in patients
receiving prolactin-elevating compounds.” In addition, in an
“Adverse Reactions” section, under the subheading “Other
Adverse Reactions Observed During the Clinical Trial Evaluation
of Risperidone,” the insert named gynecomastia and
hyperprolactinemia (i.e., elevated levels of prolactin) in a list of
disorders that followed these statements: “The following adverse
reactions occurred in < 1% of the adult patients and in < 5% of
the pediatric patients treated with RISPERDAL® in the above
double-blind, placebo-controlled clinical trial data sets. In
addition, the following also includes adverse reactions reported in

Ortho-McNeil-Janssen Pharmaceuticals, Inc. (2015) 414 S.C. 33,
51, fn. 7 [“Prolactin is a hormone that causes breasts to grow and
produce milk”].)

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RISPERDAL®-treated patients who participated in other studies,
including double-blind, active-controlled and open-label studies in
schizophrenia and bipolar mania studies in pediatric patients
with psychiatric disorders other than schizophrenia, bipolar
mania, or autistic disorder, and studies in elderly patients with
dementia.”2
      Janssen also submitted deposition testimony from the three
doctors who prescribed Risperdal for Mills in 2014 and 2016.
Dr. Maya Kumar, who in 2014 diagnosed Mills with
schizophrenic disorder bipolar type and prescribed Risperdal for a
time to help treat it, stated in her deposition that when she
prescribed Mills the drug she knew from its package insert and
other sources about the risk of elevated prolactin levels and
gynecomastia. She stated she considered these risks when she
prescribed Mills the drug, decided the drug’s benefit to him
outweighed these risks, and although aware he shortly afterward
claimed he developed gynecomastia, would make the same
prescribing decision today. Dr. Arastou Aminzadeh, who
prescribed Mills Risperdal in 2016 to help treat auditory
hallucinations, and Dr. David Gellman, who renewed that
prescription, made similar statements in their depositions.3

2     Janssen asserts, without citing the record, the “FDA
approved these warnings in 2007 to conform to FDA’s newly
revised labeling requirements.”

3     In his deposition Mills stated that, at the time
Dr. Aminzadeh prescribed him Risperdal, Mills knew
gynecomastia was a potential side effect of the drug, believed he
had already experienced gynecomastia as a result of his earlier
use of the drug, and agreed to take the drug because he believed
the benefit outweighed the risk.

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       The trial court denied Mills’s motion, ruling he did not
establish he was entitled to judgment as a matter of law because
he merely asserted the court should grant summary judgment in
his favor based on “the evidence on file, and the videotaped
deposition,” and provided “no legal citation or argument from
that evidence.” The court granted Janssen’s motion. The court
stated that, “at their core, all of Plaintiff’s claims arise under a
failure to warn theory” and that a prescription drug
manufacturer “discharges its duty to warn if it provides adequate
warnings to the physician about any known or reasonably
knowable risks, regardless of whether the warning reaches the
patient.” Citing Janssen’s evidence that “Risperdal has been
clearly labelled, since its FDA approval in 1993, to warn of the
risks of gynecomastia associated with its use” and that, in
response, Mills merely stated the warnings on the Risperdal label
at the time he was prescribed the drug “were not adequate as a
matter of law,” the court ruled Mills failed to raise a triable issue
of fact on whether Janssen breached its duty to warn. The court
entered judgment in favor of Janssen, and Mills timely appealed.

                           DISCUSSION

       A.     Standard of Review
       “Summary judgment is appropriate only ‘where no triable
issue of material fact exists and the moving party is entitled to
judgment as a matter of law.’” (Regents of University of
California v. Superior Court (2018) 4 Cal.5th 607, 618; see Valdez
v. Seidner-Miller, Inc. (2019) 33 Cal.App.5th 600, 607.) “To meet
its initial burden in moving for summary judgment, a defendant
must present evidence that either ‘conclusively negate[s] an
element of [each of] the plaintiff’s cause of action’ or ‘show[s] that

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the plaintiff does not possess, and cannot reasonably obtain,’
evidence necessary to establish at least one element of [each]
cause of action.” (Henderson v. Equilon Enterprises, LLC (2019)
40 Cal.App.5th 1111, 1116; see Aguilar v. Atlantic Richfield Co.
(2001) 25 Cal.4th 826, 853-854.) “Once the defendant satisfies its
initial burden, ‘the burden shifts to the plaintiff . . . to show that
a triable issue of one or more material facts exists as to the cause
of action or a defense thereto.’” (Henderson, at p. 1116; see
Aguilar, at p. 849.)
       We review a trial court’s ruling on a motion for summary
judgment de novo. (Samara v. Matar (2018) 5 Cal.5th 322, 338.)
We consider “‘“‘“all the evidence set forth in the moving and
opposing papers except that to which objections were made and
sustained.”’ [Citation.] We liberally construe the evidence in
support of the party opposing summary judgment and resolve
doubts concerning the evidence in favor of that party.”’”
(Hampton v. County of San Diego (2015) 62 Cal.4th 340, 347; see
Hartford Casualty Ins. Co. v. Swift Distribution, Inc. (2014) 59
Cal.4th 277, 286.) “‘We affirm the trial court’s decision if it is
correct on any ground the parties had an adequate opportunity to
address in the trial court, regardless of the reasons the trial court
gave.’” (Wolf v. Weber (2020) 52 Cal.App.5th 406, 410.)

      B.    The Trial Court Did Not Err in Its Rulings on the
            Motions for Summary Judgment
      Although Mills suggests “there is evidence in the record
that supports [his] request for judgment,” he offers no
substantive argument on this point and cites no evidence. The
record, moreover, does not include a copy of his motion for
summary judgment or any evidence he may have submitted to

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support it. Mills has therefore failed to demonstrate any error by
the trial court in denying his motion for summary judgment.
(See Abdulkadhim v. Wu (2020) 53 Cal.App.5th 298, 301 [“‘“[I]t is
the appellant’s responsibility to affirmatively demonstrate error
and, therefore, to point out the triable issues the appellant claims
are present by citation to the record and any supporting
authority. In other words, review is limited to issues which have
been adequately raised and briefed.”’”].)
       Nor has he demonstrated the trial court erred in granting
Janssen’s motion for summary judgment. Mills does not dispute
his causes of action rest on a failure-to-warn theory. (See Webb v.
Special Electric Co., Inc. (2016) 63 Cal.4th 167, 179 [“A product
can be defective in its manufacture or design, or because it fails
to include a warning about known risks.”].) “‘Generally speaking,
manufacturers have a duty to warn consumers about the hazards
inherent in their products.’” (Id. at p. 181.) In the case of
prescription drugs, however, California has adopted the “learned
intermediary doctrine,” according to which “‘the duty to warn
runs to the physician, not to the patient.’ [Citation.] ‘“[I]f
adequate warning of potential dangers of a drug has been given
to doctors, there is no duty by the drug manufacturer to insure
that the warning reaches the doctor’s patient for whom the drug
is prescribed.”’” (Bigler-Engler v. Breg, Inc. (2017) 7 Cal.App.5th
276, 318; see Webb, at p. 187, fn. 10; Carlin v. Superior Court
(1996) 13 Cal.4th 1104, 1116; Stevens v. Parke, Davis & Co.
(1973) 9 Cal.3d 51, 65.) “‘“The rationale of the foregoing rule is:
‘(1) The doctor is intended to be an intervening party in the full
sense of the word. Medical ethics as well as medical practice
dictate independent judgment, unaffected by the manufacturer’s
control, on the part of the doctor. (2) Were the patient to be given

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the complete and highly technical information on the adverse
possibility associated with the use of the drug, he would have no
way to evaluate it, and in his limited understanding he might
actually object to the use of the drug, thereby jeopardizing his
life. (3) It would be virtually impossible for a manufacturer to
comply with the duty of direct warning, as there is no sure way to
reach the patient.’”’” (Bigler-Engler, at p. 319.)
        Janssen’s evidence concerning the warnings that appeared
in the Risperdal package insert and the statements by Mills’s
prescribing physicians showed that Janssen adequately warned
those doctors of the risk of gynecomastia when prescribing
Risperdal. And Mills does not dispute his doctors were
adequately warned. Rather, he contends he raised a triable issue
of material fact because “no warning was given to [him,] as a
consumer” of the medicine. He argues (without citing to the
record) that “[t]he consent form [he] was given to sign outlining
the side effects of the medicine[ ] didn’t mention anything about
gynecomastia” and that “gynecomastia wasn’t mentioned to [him]
by any of the doctors.” As stated, however, Janssen did not have
a duty to make sure a warning of the risk of gynecomastia
reached Mills through his doctors. (See Stevens v. Parke, Davis &
Co., supra, 9 Cal.3d at p. 65; Bigler-Engler v. Breg, Inc., supra, 7
Cal.App.5th at p. 318.) Therefore, the trial court did not err in
granting Janssen’s motion for summary judgment.

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                           DISPOSITION

      The judgment is affirmed. The parties are to bear their
costs on appeal.

             SEGAL, Acting P. J.

We concur:

             FEUER, J.

             DILLON, J.*

*     Judge of the Los Angeles Superior Court, assigned by the
Chief Justice pursuant to article VI, section 6 of the California
Constitution.

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