Tyrieke Chandler, Plaintiffv.Janssen Pharmaceuticals, Inc., Johnson & Johnson, and Janssen Research & Development, LLC, Defendants
MEMORANDUM & ORDERPlaintiff Tyrieke Chandler (“Plaintiff” or “Chandler”) brings this matter alleging that Defendants Janssen Pharmaceuticals, Inc., Johnson & Johnson, and Janssen Research & Development, LLC (collectively “Defendants”), the manufacturers of antipsychotic prescription drug Risperdal®, failed to warn Plaintiff of the injurious side effects of the drug, including gynecomastia, a medical condition that causes the enlargement of breast tissue. The parties allege jurisdiction under 28 U.S.C. §§1332, 1441, and 1446 because the parties are of diverse citizenship and the amount in controversy exceeds $75,000. Before the Court is Defendants’ motion for summary judgment. For the reasons set forth herein, the Court grants Defendants’ motion for summary judgment in its entirety and all claims against Defendants are dismissed.BACKGROUNDI. Relevant FactsA. Risperdal®Risperdal®1 is a prescription antipsychotic medication that was first approved by the United States Food and Drug Administration (“FDA”) in 1993 for use in adults. (Defendants’ Rule 56.1 Statement (“Defs’. 56.1″), Dkt 46-2, at1.)2 Risperdal is generically known as risperidone. (Id. at2.) Since 1993, Risperdal’s FDA-approved labeling has contained the following language regarding the risk of gynecomastia and galactorrhea, a medical condition involving the excessive or inappropriate production of breast milk, in the “PRECAUTIONS” section:Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with previously detected breast cancer. 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. As is common with compounds which increase prolactin release, an increase in pituitary gland, mammary gland, and pancreatic islet cell hyperplasia and/or neoplasia was observed in the risperidone carcinogenicity studies conducted in mice and rats (See CARCINOGENESIS). However, neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time.(Id. at3 (emphasis in original).) The 1993 Label also stated that the “safety and effectiveness [of Risperdal] in children have not been established.” (Id. at4.)Risperdal was first approved for pediatric use — for irritability associated with autistic disorder — on October 6, 2006. (Id. at5.) A subsection entitled “Pediatric Use” was added to the “PRECAUTIONS” section of Risperdal’s label at that time. It states, in relevant part:The safety and effectiveness of RISPERDAL® in pediatric patients with schizophrenia or bipolar mania have not been established.The efficacy and safety of RISPERDAL® in the treatment of irritability associated with autistic disorder were established in two 8-week, placebo-controlled trials in 156 children and adolescent patients, aged 5 to 16 years (see CLINICAL PHARMACOLOGY-Clinical Trials, INDICATIONS AND USAGE, and ADVERSE REACTIONS). Additional safety information was also assessed in a long-term study in patients with autistic disorder, or in short-and long-term studies in more than 1200 pediatric patients with other psychiatric disorders who were of similar age and weight, and who received similar dosages of RISPERDAL® as patients who were treated for irritability associated with autistic disorder.…Hyperprolactinemia, Growth, and Sexual MaturationRisperidone has been shown to elevate prolactin levels in children and adolescents as well as in adults (see PRECAUTIONS-Hyperprolactinemia). In double-blind, placebo-controlled studies of up to 8 weeks duration in children and adolescents (aged 5 to 17 years) 49 percent of patients who received risperidone had elevated prolactin levels compared to 2 percent of patients who received placebo.In clinical trials in 1885 children and adolescents with autistic disorder or other psychiatric disorders treated with risperidone, galactorrhea was reported in 0.8 percent of risperidone-treated patients and gynecomastia was reported in 2.3 percent of risperidone-treated patients.The long-term effects of risperidone on growth and sexual maturation have not been fully evaluated.(Id. (emphasis in original).)In 2007, the label was changed, and the “WARNINGS” and “PRECAUTIONS” sections were merged. The label included the following language:WARNINGS AND PRECAUTIONSHyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, RISPERDAL® elevates prolactin levels and the elevation persists during chronic administration. RISPERDAL® 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.(Risperdal Label 2007, Dkt. 52-18, at 1, 12.) The 2007 label contained the same information as the 2006 label about the clinical trial of 1885 children and adolescents, and the gynecomastia incidence rate of 2.3 percent. (Id. at 33.)B. Plaintiff’s Psychiatric HistoryPlaintiff was born in 1996. (Defs’. 56.1 at6.) Plaintiff has a long history of psychological issues that began when he was six years old. (Id. at8.) In June 2002, the Administration for Children’s Services (“ACS”) removed Plaintiff from his mother’s home when his infant brother tested positive for marijuana at birth. (Id. at9.) Plaintiff was housed in seven different foster homes over the next month and showed aggressive behavior toward adults and other children during this period. (Id. at10.) In August 2002, Plaintiff was brought to the emergency room at Lincoln Medical and Mental Health Center (“Lincoln”) because he was showing “uncontrollable behavior” toward his foster mother. (Id. at11.) Plaintiff was released to the care of a new foster mother, but returned to Lincoln two days later for behavioral issues. (Id. at
