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Cole v. Janssen Pharmaceuticals Inc.

United States District Court, E.D. Wisconsin

December 12, 2017

REGINALD S. COLE, JR., Plaintiff,


          William C. Griesbach, United States District Court Chief Judge

         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.


         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.

         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.

         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.

         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 ...

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