Smith (ID 47310) v. Janssen Pharmaceuticals, Inc. et al
MEMORANDUM AND ORDER granting 67 Motion for Summary Judgment; denying as moot 65 Motion to Strike ; denying as moot 83 Motion to Strike ; denying as moot 85 Motion to Consolidate Cases. Signed by District Judge Julie A. Robinson on 2/27/17. Mailed to pro se party Bernard L. Smith by regular and certified mail ; Certified Tracking Number: 7012 3460 0000 8262 5941. (kao)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF KANSAS
BERNARD L. SMITH,
Case No. 15-9085-JAR
JANSSEN PHARMACEUTICALS, INC., ET
MEMORANDUM AND ORDER
Pro se plaintiff Bernard L. Smith brings product liability claims against defendants Janssen
Pharmaceuticals, Inc., Johnson & Johnson Company, and Janssen Research & Development, LLC,
alleging the prescription drug Risperdal caused him to develop gynecomastia and galactorrhea.
Janssen Pharmaceuticals is the manufacturer/distributor of Risperdal, an anti-psychotic medication,
and Johnson & Johnson is the parent company of Janssen. Before the Court is Defendants’ collective
Motion for Summary Judgment (Doc. 67). Defendants argue Plaintiff has failed to present evidence on
causation, a necessary element for his claim. For the following reasons, the Court grants Defendants’
Plaintiff has been incarcerated in Kansas since May 16, 2005. While incarcerated, Plaintiff was
treated for various mental health issues, including bipolar disorder and auditory and visual
hallucinations. On February 4, 2007, Plaintiff was placed on a trial of Risperdal, which he took until
he was prescribed the generic version, Risperidone, on July 6, 2008. Plaintiff then took Risperidone in
varying doses until February 10, 2014, minus a two-week period he was prescribed a different drug.
Based on medical records provided by Plaintiff and Defendants, Plaintiff first complained of
gynecomastia—a condition in which men experience abnormally enlarged breast tissue—and
galactorrhea—a spontaneous discharge from the nipple on the breast—in a February 8, 2014 “Nursing
Progress Note.” Plaintiff told the reporting nurse that “he had talked to his lawyer and with the advice
of his lawyer that his medical records needed to have information about the galactorrhea and
gyneromastia [sic] on his inmate medical records.” (SEALED Doc. 73-1 at 2.) Plaintiff complained of
pain in his breast and sore and leaking nipples. Id. On February 10, 2014, Plaintiff had a psychiatric
evaluation in which he complained of swelling and leaking breasts. (SEALED Doc. 73-2 at 2.) He
told the physician “[m]y attorney said I need to get it in writing what is going on with the medication.”
The reporting physician noted she recommended that Plaintiff discontinue the Risperdal
prescription as it can cause galactorrhea and gynecomastia. Id. There is no evidence to suggest
Plaintiff took Risperdal or Risperidone at any time after February 10, 2014.
According to a February 11, 2014 Nursing Progress Note, Plaintiff again reported that he was
on Risperdal and developed swollen breasts and sore nipples. He told the reporting nurse “[m]y doctor
on the street says I have gynecomastia and galactorrhea. I need to see someone so it can be logged. I
need something, for the pain. I need you to log that this is what it is. Why come you just cant this is
what going on with my body.” (SEALED Doc. 73-3 at 2.) The reporting nurse noted that Plaintiff
said his lawyer told him he needed a doctor to diagnose him with the condition. Id.
referred to a doctor for his alleged condition. Id.
Approximately two weeks after Plaintiff’s Risperidone prescription was discontinued, Plaintiff
again visited the prison health facilities complaining of sore and leaking breasts. (SEALED Doc. 73-5
at 2). The treating APRN noted on Plaintiff’s Chart Note there was “no discharge from either breasts,
no inflammation, c/o tenderness with palpation. No abnormal enlargement noted.” Id. at 3. Under the
“Assessment Plan” the APRN noted “Inflammatory Disease of Breast (611.0), Acute.” Id.
On June 11, 2015, Plaintiff was seen by Dr. Gordon Harrod. Dr. Harrod noted Plaintiff wanted
“some documentation of gynecomastia from Risperdal therapy. . . . He tells me he has breast leaking
‘constantly.’ The fluid is thin white/yellow. It was worse while on the Risperdal. He is very adamant
about something being in his chart about gynecomastia.” (SEALED Doc. 73-4 at 2.) After his
evaluation, however, Dr. Harrod rejected any diagnosis of gynecomastia:
“Regarding is [sic] ‘gynecomastia,’ I see no reason to tack on that diagnosis. He speaks
of a lawyer wanting something saying in the chart that he has gynecomastia. I cannot in
good conscious [sic] say he has true gynecomastia. He has some muscular pectoralis
muscles but I can’t see any discharge or any irregularity in his breast exam.”
Id. at 3.
On August 28, 2015, Plaintiff sent correspondence to “Dr. Wade” of Corizon Health
requesting “Dr. Wade” sign a sworn affidavit stating “on June, 2015, I diagnosed Mr. Bernard Smith of
having a continuous prolonged physical damage called gynacomastia [sic] which was caused by taking
a Drug called Respidal [sic].” (SEALED Doc. 73-6 at 2.) Mr. Wade, an APRN, returned the
correspondence to Plaintiff noting “Wade, APRN, did not diagnose you with gynecomastia, nor does
he feel you suffer from this condition.” Id.
Neither party has provided any evidence showing Plaintiff was ever diagnosed with
gynecomastia or galactorrhea. Nor is there any expert evidence in the record linking any symptoms
Plaintiff may have suffered to either Risperdal or Risperidone.
On April 13, 2015, Plaintiff filed a petition for personal injury in the District Court of Labette
County, Kansas. (Doc.1-1 at 1.) Plaintiff alleged he was injured after taking Risperdal, which caused
extreme weight gain and gynecomastia. (Doc. 1-1 at 2.) Defendants removed the case to this Court
based on diversity jurisdiction.
Summary judgment is appropriate if the moving party demonstrates that there is “no genuine
issue as to any material fact” and that it is “entitled to judgment as a matter of law.” Fed. R. Civ. P.
56(c). A “genuine” factual dispute requires more than a mere scintilla of evidence. Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 247 (1986). The party seeking summary judgment bears the initial
burden of showing the absence of any genuine issue of material fact. Celotex Corp. v. Catrett, 477
U.S. 317, 323 (1986). Once the moving party demonstrates an absence of evidence in support of an
element of the case, the burden then shifts to the nonmoving party who “must set forth specific facts
showing that there is a genuine issue for trial.” Anderson, 477 U.S. at 248. The nonmoving party
“may not rest upon the mere allegations or denials of his pleading.” Id.
In making the summary judgment determination, the court must view the evidence and
reasonable inferences in the light most favorable to the nonmoving party. Adler v. Wal-Mart Stores,
Inc., 144 F.3d 664, 670 (10th Cir. 1998) (citing Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475
U.S. 574, 587 (1986)). Ultimately, the court evaluates “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.” Liberty Lobby, 477 U.S. at 252.
Plaintiff asserts a product liability claim under Kansas law, arguing he developed gynecomastia
and galactorrhea after taking Risperdal. Product liability claims in Kansas are governed by the Kansas
Product Liabilities Act, K.S.A. §§ 60–3301 et seq. (“KPLA”). The KPLA “applies to all product
liability claims regardless of the substantive theory of recovery.” Danaher v. Wild Oats Markets, Inc.,
779 F. Supp. 2d 1198, 1209 (D. Kan. 2011). To prevail on a claim under the KPLA, a plaintiff must
demonstrate that: “(1) his injury resulted from a condition of the product; (2) the condition was
unreasonably dangerous; and (3) the condition existed at the time the product left defendant’s control.”
Kernke v. The Menninger Clinic, Inc., 173 F. Supp. 2d 1117, 1122 (D. Kan. 2001).
The elements of a product liability claim under the KPLA “may be proven inferentially, by
either direct or circumstantial evidence.” Samarah v. Danek Med., Inc., 70 F. Supp. 2d 1196, 1202 (D.
Kan. 1999) (quoting Mays v. Ciba–Geigy Corp., 233 Kan. 38, 54 (1983)). If circumstantial evidence is
used, it “must tend to negate other reasonable causes, or there must be an expert opinion that the
product was defective.” Id. Thus, because product liability must be based on more than mere
speculation, guess, or conjecture, “the circumstances shown must justify an inference of probability as
distinguished from mere possibility.” Id.
The threshold issue in a products liability case is whether the allegedly defective product
caused the injuries asserted by plaintiff. See id. at 1206. “The mere fact that a person suffered injury
while using a product is insufficient in itself to satisfy the requirement of proof that a defect in the
product was a proximate cause of the injury.” Id. Thus, in order to prove his case, Plaintiff must come
forward with “sufficient evidence to establish that there exists a causal nexus between the injury
alleged and the defect charged.” Id.
Here, however, the Court need not even consider the issue of whether the drug Risperdal
caused Plaintiff’s alleged injuries. Plaintiff has failed to establish he has even suffered an injury.
Based on the medical files in the record, no health care professional has diagnosed Plaintiff with
gynecomastia or galactorrhea. In fact, a doctor concluded Plaintiff did not have either condition.
Plaintiff has not come forward with any evidence to meet his burden to overcome summary judgment,
as he has no proof—besides his subjective opinion—that he has gynecomastia or galactorrhea.
Plaintiff’s self-diagnosis alone is not sufficient to overcome summary judgment. See Fry v. AlAbduljalil, No. 05-1179, 2006 WL 226025 at *3 (10th Cir. Jan. 31, 2006) (noting “Mr. Fry’s personal
conclusions regarding his stomach problems are insufficient to demonstrate a triable issue of fact for
the purpose of overcoming summary judgment.”). Rather, expert opinion as to a medical diagnosis is
required because “the diagnosis, care, and treatment of a patient are typically issues outside the
knowledge of an average person who has not received specialized training.” Hubbard v. Mellion, 302
P.3d 1084, 1092 (Kan. Ct. App. 2013).
Beyond the absence of an established injury, Plaintiff has also failed to establish a nexus
between his complained of symptoms and his ingestion of Risperdal. Because Plaintiff has no expert
opinion as to causation, any circumstantial evidence must tend to negate other reasonable causes for
the alleged injury. See Samarah, 70 F. Supp. 2d at 1202. The record demonstrates Plaintiff was
prescribed a number of other medications during his incarceration, including a generic version of
Risperdal and other anti-psychotic drugs. Plaintiff provides no evidence that would exclude other
medications as the cause of his alleged injury. Further, Defendants note that medical records show that
Plaintiff was listed as “morbidly obese” when he saw his physician in June 2015 regarding his
gynecomastia symptoms. (Doc. 63 at 4.) Defendants argue Plaintiff is unable to rule out his obesity as
a cause of his symptoms. Because Plaintiff has presented no scientific evidence that would suggest his
symptoms were caused by his ingestion of Risperdal, the Court finds he has not met his burden to
overcome summary judgment and therefore grants Defendants’ motion.
IT IS THEREFORE ORDERED that Defendants’ Motion for Summary Judgment (Doc. 67)
IT IS FURTHER ORDERED that Defendants’ Motions to Strike (Doc. 65) and (Doc. 83) and
Plaintiff’s Motion to Consolidate Cases and Add Defendants (Doc. 85) are denied as moot.
This case is closed.
IT IS SO ORDERED.
Dated: February 27, 2017
S/ Julie A. Robinson
JULIE A. ROBINSON
UNITED STATES DISTRICT JUDGE
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