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Adeghe v. Janssen Pharmaceuticals, Inc.

United States District Court, S.D. New York

August 30, 2017

JAMAL ADEGHE, Plaintiff,
v.
JANSSEN PHARMACEUTICALS, INC., Defendant.

          OPINION AND ORDER

          LORNA G. SCHOFIELD UNITED STATES DISTRICT JUDGE

         Plaintiff Jamal Adeghe brings this products liability action under New York law based on his ingestion of Risperdal, a medication manufactured by Defendant Janssen Pharmaceuticals Inc. (“Janssen”). Defendant moves to preclude the testimony of Plaintiff s medical expert, Dr. Barry Bercu, and moves for summary judgment. For the following reasons, Janssen's motion to preclude is denied and its motion for summary judgment is granted in part and denied in part.

         I. BACKGROUND

         The following facts are taken from the parties' statements pursuant to Local Civil Rule 56.1 and submissions on this motion, and construed in Plaintiffs favor. See Wright v. N.Y. State Dep't of Corr., 831 F.3d 64, 71-72 (2d Cir. 2016).

         A. Plaintiff's Medical History

         Around November 2003, when Plaintiff was ten years old, he was first prescribed Risperdal and lithium to treat his depressive symptoms, impulse control and aggression. Defendant manufactures Risperdal, an antipsychotic medication generally known as risperidone. In September 2004, Plaintiffs prescription for Risperdal and lithium was discontinued.

         At some point in 2004, and no later than October 2004, Plaintiff was diagnosed with gynecomastia -- the development of glandular breast tissue in males. Plaintiff estimates that each of his breasts grew to be larger than a tennis ball. Plaintiff's doctor informed him that surgery was the only treatment.

         In October 2004, Plaintiff was 65 inches tall and weighed 166 pounds, which his medical record describes as overweight. A contemporaneous test of Plaintiff found that his prolactin levels were normal. Between March 2005 and the Fall of 2005, he was again prescribed Risperdal for his behavioral issues. A physical examination of Plaintiff in June 2005 found that he was 68 inches tall, weighed 187 pounds and had gynecomastia.

         During high school and for a year thereafter, Plaintiff used marijuana. In either 2013 or 2014, a court ordered Plaintiff to receive “assisted outpatient treatment.” As part of the treatment, Plaintiff was prescribed Risperdal among other drugs. In June 2016, Plaintiff was 72 inches tall, weighed 189 pounds and had gynecomastia. Even though he had lost twenty pounds since 2006, his breasts were the same size they were when he first developed gynecomastia in 2004.

         B. Risperdal's Labeling

         In 1993, the FDA approved Risperdal for adult use. Risperdal's label contained the following in its “PRECAUTIONS” section:

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. . . . Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients.

         The 1993 label also stated that the “[s]afety and effectiveness in children have not been established.” In October 2006, Defendant revised the “PRECAUTIONS” section of the Risperdal label. The new label stated:

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents. . . . Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.
. . .
Pediatric Use: The safety and effectiveness of [Risperdal] in pediatric patients with schizophrenia or bipolar mania have ...

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