Filed 10/13/20 Mills v. Janssen Pharmaceuticals CA2/7

NOT TO BE PUBLISHED IN THE OFFICIAL REPORTS

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IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

SECOND APPELLATE DISTRICT

DIVISION SEVEN

THOMAS K. MILLS,

Plaintiff and Appellant,

v.

JANSSEN PHARMACEUTICALS, 

INC.,

Defendant and Respondent.

 B300508

 (Los Angeles County

 Super. Ct. No. BC652652)

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.

____________________________
2

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.
3

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”].)
4

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. 
5

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 
6

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 
7

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 
8

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.
9

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.