Cole v. Risperdal Manufacturer

Filing 179

ORDER granting 132 Motion for Summary Judgment. (cc: all counsel and via US Mail to Reginald Cole) (Griesbach, William)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF WISCONSIN
REGINALD S. COLE, JR.,
Plaintiff,
v.

Case No. 15-CV-57

JANSSEN PHARMACEUTICALS, INC.,
Defendant.

DECISION AND ORDER GRANTING
DEFENDANT’S MOTION FOR SUMMARY JUDGMENT

The plaintiff, Reginald S. Cole, Jr. (Cole), is a Wisconsin state prisoner representing himself.
He is proceeding on a products liability claim against the defendant, Janssen Pharmaceuticals, Inc.
(Janssen). The Court has jurisdiction of this action under 28 U.S.C. § 1332. This matter is before
the Court on Janssen’s motion for summary judgment.
FACTS1
Cole is an inmate housed at Waupun Correctional Institution (Waupun) in Wisconsin. He
has been incarcerated since April 2007. Cole alleges that his ingestion of the prescription drug
Risperdal caused him adverse side effects including migraines, swollen and sore chest, cramping,
throwing up blood, stomach pains, dizziness, weakness, nausea, and an elevated prolactin level. He
also alleges that Risperdal caused him to develop gynecomastia, a condition in which a male
experiences an enlargement of breast tissue.

1

This section is taken from Janssen’s Statement of Proposed Material Facts and from Cole’s
Statement of Proposed Material Facts. ECF Nos. 134, 172. Relevant facts that comply with Federal
Rule of Civil Procedure 56(c) are included in this section.

Risperdal is a prescription antipsychotic medication manufactured and distributed by Janssen.
It was first approved for sale in the United States by the FDA in 1993 to treat adult schizophrenia
patients. Risperdal is generically known as Risperidone. Since its approval and until the present day,
Risperdal’s FDA-approved label has always disclosed that Risperdal, like other medicines in its class,
has been associated with endocrine-related side effects, including reported cases of gynecomastia.
The FDA-approved label has also included the following adverse side effects: vomiting, abdominal
pain, and nausea.
Janssen lost its patent protection for Risperdal in June 2008. In July 2008, generic
Risperidone that was produced, marketed, and sold by many manufacturers (including Janssen)
became widely available. Janssen stopped marketing brand-name Risperdal in 2008. By the end of
2009, Janssen’s Risperdal sales had declined by 95.5%.
Risperdal, or its generic equivalent, was prescribed for Cole and discontinued at various times
between May 2007 and October 2013. Cole’s use of Risperdal in particular appears to have been
for relatively short periods of time. Risperdal was prescribed to Cole in May 2007. It was
discontinued in July 2007 due to Cole’s refusal to take it. Risperdal was again prescribed for Cole
in September 2007 but again discontinued in December 2007 because Cole refused to take it.
Risperdal by name was last prescribed to Cole in February 2008 but discontinued in April 2008.
Risperidone was prescribed to Cole in December 2012. In the fall of 2013, Cole saw a
plaintiff’s personal injury law firm’s ad on television stating that persons who took Risperdal and
developed gynecomastia might be entitled to substantial compensation. After watching the ad, Cole
suggested to his health-care professionals that he might suffer from gynecomastia.

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On September 26, 2013, upon physical examination for gynecomastia, the nurse noted that
Cole’s exam was “unremarkable,” there was “no nipple dimpling or discharge” and “no palpable
lumps.” Cole’s nurse documented that he was a “questionable historian.” Cole’s nurse concluded
that there was no “objective evidence of gynecomastia or breast abnormality.” ECF No. 137-1 at
33.
On October 2, 2013, Cole’s psychiatrist, Dr. Ralph Froelich, discontinued Cole’s Risperidone
prescription based on Cole’s subjective complaints. Dr. Froelich’s Psychiatric Report from the
appointment states that Cole complained of breast tenderness and that Cole “is informed that the
risperidone he has been on of [sic] several years may be causing the problem and I informed him that
I would stop the medication and do some lab work so we can explain it on the basis of increased
prolactin.” Id. at 170.
On October 16, 2013, Cole saw Dr. Froelich and the doctor’s Psychiatric Report from that
appointment states in relevant part that Cole is “less worried about his breast enlargement” and that
the “tenderness is gone.” The report also states that Cole “reports no difficulties since [Dr. Froelich]
stopped the risperidone.” Additionally, the report states that, “[r]ecent laboratory values revealed
a prolactin level of 26.8, with a reference range of 4.0 to 15.2. This was ordered because of his
complaint of breast tenderness. Although there was no breast enlargment felt on exam, the elevated
prolactin could be an explanation for the complaint.” Id. at 168.
Dr. Froelich’s Psychiatric Report from a December 11, 2013, appointment with Cole states
in relevant part that Cole “has also had a problem with breast tenderness which may have been
related to elevated prolactin and has been discontinued from potential medications causing that which
was risperidone.” The report also stated that Cole “has managed well without risperidone.” Id. at
166.
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As noted above, a lab test taken in October 2013 revealed Cole had elevated prolactin. The
follow-up lab test taken in January 2014 revealed that Cole’s prolactin levels had returned to normal.
Cole continued to complain about chest pain and “gynecomastia” but subsequent physical exams
revealed that Cole’s chest continued to be within normal limits.
The word “gynecomastia” appears approximately six times in Cole’s medical records. Each
time it appears, Cole’s health care professionals were either describing Cole’s subjective complaints
about the same or reporting that there was no objective evidence of the same. He was never
diagnosed with gynecomastia. Cole has no medical training and is not licensed to practice medicine.
No expert has opined that Risperdal caused Cole’s purported injuries.
Throughout Cole’s incarceration, he complained about the symptoms he now attributes to
Risperdal, even when he was not taking Risperdal. For instance, Cole complained of chest pain
during his incarceration numerous times when he was not taking Risperdal. He complained that
contaminated milk caused him migraines, chest cramping, throwing up blood, and stomach pains in
another case he filed in the Eastern District of Wisconsin. See Cole v. Thurman, et al., E.D. Wis.
Case No. 08-C-0695, ECF No. 1 at 4. Cole once reported having breast reduction surgery, though
a physical exam and chart review revealed no evidence of breast reduction surgery. During his
deposition, Cole denied having had breast reduction surgery.
Cole’s medical records reveal that in April 2010, he agreed that his self-report psychotic
behaviors were less than genuine. After purportedly attempting to commit suicide by overdosing on
Citalopram in May 2010, Cole’s medical records note that he acknowledged that he was never
suicidal and was simply “having some fun you know how it is.” ECF No. 139-1 at 191. Cole’s
medical history is also replete with complaints about hearing voices, seeing ghosts, trouble sleeping,
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chest pain, vomiting, migraines, nausea and various other complaints. Cole admits that he pretended
to suffer from mental illness hoping to be transferred from Waupun to the Wisconsin Resource
Center, which is a mental health treatment facility within the Wisconsin Department of Corrections.
Cole filed his amended complaint in this matter, naming Janssen as a defendant on May 16,
2015, seeking billions of dollars in damages for his alleged injuries. Cole’s sole theory that Risperdal
is defective is its potential to cause adverse side effects. No expert has opined that Risperdal is
defective as it relates to Cole’s ingestion thereof or that it is a cause of any of the symptoms alleged.
SUMMARY JUDGMENT STANDARD OF REVIEW
Under the Federal Rules of Civil Procedure, summary judgment “is properly regarded not
as a disfavored procedural shortcut, but rather as an integral part of the Federal Rules as a whole,
which are designed to ‘secure the just, speedy and inexpensive determination of every action.’”
Celotex Corp. v. Catrett, 477 U.S. 317, 327 (1986) (quoting Fed. R. Civ. P. 1). Summary judgment
is proper if the pleadings, depositions, answers to interrogatories, and admissions on file, together
with any affidavits, show that there is no genuine issue of material fact and the moving party is
entitled to judgment as a matter of law. Fed. R. Civ. P. 56(c). “[T]he plain language of Rule 56(c)
mandates the entry of summary judgment, after adequate time for discovery and upon motion,
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,
477 U.S. at 322.
As Celotex makes clear, the burden that each party carries with respect to a motion for
summary judgment under the federal rules varies significantly depending upon which party bears the
burden of proof at trial on the issue upon which summary judgment is sought. Where the party
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seeking summary judgment does not bear the burden of proof at trial on any element of the claim,
it is enough that it inform the court of “the basis of its motion and identif[y] those portions of ‘the
pleadings, depositions, answers to interrogatories, and admissions on file, together with affidavits,
if any,’ which it believes demonstrates the absence of a genuine issue of material fact.” Id. at 323.
There is no requirement that a moving party who does not bear the burden of proof establish that
the element does not exist. In other words, a moving party who does not have the burden of proof
at trial, (usually the defendant), is not required to prove a negative in order to make a prima facie
showing for summary judgment. Id.
Once such a showing is made, however, the nonmoving party who does have the burden of
proof at trial, (usually the plaintiff), must respond. In the face of a properly supported motion for
summary judgment by the defendant, the plaintiff must designate specific facts to support or defend
each element of the cause of action, showing that there is a genuine issue for trial. Id. at 322–24.
Moreover, the party that bears the burden of proof at trial must show that it has admissible evidence
to support its claim:
When as in the present case a defendant moves for summary judgment on the ground
that the plaintiff lacks evidence of an essential element of his claim, the plaintiff is
required by Fed.R.Civ.P. 56, if he wants to ward off the grant of the motion, to
present evidence of evidentiary quality—either admissible documents or attested
testimony, such as that found in depositions or in affidavits—demonstrating the
existence of a genuine issue of material fact. The evidence need not be in admissible
form; affidavits are ordinarily not admissible evidence at a trial. But it must be
admissible in content, in the sense that a change in form but not in content, for
example a substitution of oral testimony for a summary of that testimony in an
affidavit, would make the evidence admissible at trial.
Winskunas v. Birnbaum, 23 F.3d 1264, 1267–68 (7th Cir. 1994) (internal citations omitted). It is
for this reason that summary judgment is referred to in federal courts as the “put up or shut up

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moment in a lawsuit.” Johnson v. Cambridge Indus., Inc., 325 F.3d 892, 901 (7th Cir. 2003)
(internal quotes omitted).
DISCUSSION
Janssen contends that the Court should grant its motion for summary judgment because Cole
cannot prove that Risperdal caused any of his alleged injuries and because Cole cannot show that
Risperdal is defective. Janssen also contends that the statute of limitations bars Cole’s claims of
injuries from Risperdal in 2007 and 2008, and that Cole cannot show that he took Risperdal in 2012
and 2013. Cole filed a response in which he contends that he can demonstrate a causal link between
his injuries and the ingestion of Risperdal. He also contends that Janssen’s product is defective.
In product liability claims in Wisconsin, whether under a strict liability theory or a negligence
theory, a plaintiff is required to prove that the allegedly defective product caused his injuries. See
Morden v. Continental AG, 2000 WI 51, ¶ 45, 235 Wis. 2d 325, 611 N.W.2d 659 (negligence); Wis.
Stat. § 895.047(1)(e) (strict product liability); Peters v. AstraZeneca LP, 224 Fed. Appx. 503, 506
(7th Cir. 2007). To prove causation in a products liability case, a plaintiff ordinarily must provide
expert testimony because of the specialized knowledge required. Peters, 224 Fed. Appx. at 506.
Expert testimony is required if the issue to be decided is outside the common knowledge of a layman.
Johnson v. Mylan Inc., 107 F. Supp. 3d 967, 972 (E.D. Wis. 2015) (citing City of Cedarburg Light
& Water Comm’n v. Allis-Chalmers Mfg. Co., 33 Wis. 2d 560, 568, 149 N.W.2d 661, 662 (1967)).
Cole’s claim that the ingestion of a prescription drug injured him is the type of claim where an expert
witness is required. See City of Cedarburg, 33 Wis. 2d at 568; Johnson, 107 F. Supp. 3d at 975;
Peters, 224 Fed. Appx. at 506–07.

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Cole does not have an expert witness. Instead, he points to his medical records and contends
that the psychiatric reports from Dr. Froelich as well as the nurse evaluation support his claim that
Risperdal caused his injuries. However, Cole’s medical records do not support his contention that
Risperdal caused him gynecomastia or any other injury. As an initial matter, Cole was never
diagnosed with gynecomastia. In September 2013, a nurse examined Cole for gynecomastia and
determined that he did not have it. No medical professional opined that Risperdal caused Cole any
adverse side effects in 2007 and 2008, when he took Risperdal. And while Dr. Froelich stated in his
psychiatric report that the ingestion of Risperidone might explain Cole’s breast sensitivity due to an
elevated prolactin level, there is no evidence in the record to support a finding that Risperidone or
Risperdal caused any breast sensitivity. See C.W. ex rel. Wood v. Textron, Inc., 807 F.3d 827, 832
(7th Cir. 2015); Valente v. Sofamore, S.N.C., 48 F. Supp. 2d 862, 870 (E.D. Wis. 1999).
“[I]t is the plaintiffs’ burden to introduce ‘evidence which affords a reasonable basis for the
conclusion that it was more likely than not that conduct of the defendant manufacturer was a
substantial factor in the injury.’” Johnson, 107 F. Supp. 3d at 975 (quoting Jagmin v. Simonds
Abrasive Co., 61 Wis. 2d 60, 74, 211 N.W.2d 810, 817 (1973)). Cole has not introduced evidence
to show that Risperdal caused him any injury. Nor has he provided any evidence in support of his
contention that Risperdal is defective.
Janssen also contends that even if Cole could prove that Risperdal was defective and caused
him injury, the statute of limitations would bar the claim because Cole has not shown that he took
Risperdal after 2008. The Wisconsin statute of limitations applicable to personal injury claims, such
as this, is three years. See Wis. Stat. § 893.54. Under Wisconsin law, however, the statute does not
begin to run until the plaintiff “discovers, or in the exercise of reasonable diligence should have
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discovered, not only the fact of injury but also that the injury was probably caused by the defendant’s
conduct or product.” Forst v. SmithKline Beechem Corp., 602 F. Supp. 2d 960, 964 (E.D. Wis.
2009) (quoting Nierengarten v. Lutheran Soc. Servs., 219 Wis. 2d 686, 580 N.W.2d 320, 324–25
(1998)). Here, the undisputed evidence is not so clear as to allow a determination as to when Cole
discovered or should have discovered his claim against Janssen. Accordingly, summary judgment
will not be granted on Janssen’s statute of limitations defense. But on the merits, as explained above,
Cole has failed to demonstrate that he has any evidence on which a properly instructed jury could
find that Risperdal is unreasonably defective or that it was a cause of any injury he sustained.
Janssen is entitled to summary judgment.
ORDER
IT IS THEREFORE ORDERED that the defendant’s motion for summary judgment (ECF
No. 132) is GRANTED. The Clerk is directed to enter judgment of dismissal.
Dated at Green Bay, Wisconsin this 12th day of December, 2017.
s/ William C. Griesbach
William C. Griesbach, Chief Judge
United States District Court

This order and the judgment to follow are final. The plaintiff may appeal this court’s decision to the Court
of Appeals for the Seventh Circuit by filing in this court a notice of appeal within 30 days of the entry of
judgment. See Fed. R. App. P. 3, 4. This court may extend this deadline if a party timely requests an
extension and shows good cause or excusable neglect for not being able to meet the 30-day deadline. See
Fed. R. App. P. 4(a)(5)(A). If the plaintiff appeals, he will be liable for the $505.00 appellate filing fee
regardless of the appeal’s outcome. If the plaintiff seeks leave to proceed in forma pauperis on appeal, he
must file a motion for leave to proceed in forma pauperis with this court. See Fed. R. App. P. 24(a)(1).
A party is expected to closely review all applicable rules and determine, what, if any, further action is
appropriate in a case.

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