Chandler v. Janssen Pharm., Inc.

• Decision Date: 29 June 2018
• Docket Number: 15–CV–3106 (PKC) (SJB)
• Citation: 322 F.Supp.3d 314
• Parties: Tyrieke CHANDLER, Plaintiff, v. JANSSEN PHARMACEUTICALS, INC., Johnson & Johnson, and Janssen Research & Development, LLC, Defendants.
• Court: U.S. District Court — Eastern District of New York

322 F.Supp.3d 314

Tyrieke CHANDLER, Plaintiff,

v.JANSSEN PHARMACEUTICALS, INC., Johnson & Johnson, and Janssen Research & Development, LLC, Defendants.

15–CV–3106 (PKC) (SJB)

United States District Court, E.D. New York.

Signed June 29, 2018

Andres F. Alonso, David Bruce Krangle, Alonso Krangle LLP, Melville, NY, Ronald C. Burke, Kelner and Kelner, New York, NY, Plaintiff.

John D. Winter, Rachel Sabrina Schwartz, Thomas Philip Kurland, Patterson Belknap Webb & Tyler LLP, New York, NY, for Defendants.

MEMORANDUM & ORDER

Pamela K. Chen, United States District Judge

Plaintiff 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.

BACKGROUND

I. Relevant Facts

A. 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, at ¶ 1.)² Risperdal is generically known as risperidone. (Id. at ¶ 2.) 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. at ¶ 3 (emphasis in original).) The 1993 Label also stated that the "safety and effectiveness [of Risperdal ] in children have not been established." (Id. at ¶ 4.)

Risperdal was first approved for pediatric use—for irritability associated with autistic disorder—on October 6, 2006. (Id. at ¶ 5.) 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 Maturation

Risperidone 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% of patients who received risperidone had elevated prolactin levels compared to 2% 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% of risperidone-treated patients and gynecomastia was reported in 2.3% 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 PRECAUTIONS

Hyperprolactinemia : 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%. (Id. at 33.)

B. Plaintiff's Psychiatric History

Plaintiff was born in 1996. (Defs'. 56.1 at ¶ 6.) Plaintiff has a long history of psychological issues that began when he was six years old. (Id. at ¶ 8.) 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. at ¶ 9.) 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. at ¶ 10.) 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. at ¶ 11.) Plaintiff was released to the care of a new foster mother, but returned to Lincoln two days later for behavioral issues. (Id. at ¶¶ 15–16.) A subsequent psychiatric consultation diagnosed Plaintiff with Attention Deficit Hyperactive Disorder ("ADHD") and Depressive Disorder, and indicated that he "poses a danger to self and others." (Id. at ¶ 19.) Plaintiff was taking Adderall XR and Zoloft at the time. (Id. at ¶20.)

In February 2003, Plaintiff was hospitalized at St. Vincent's Hospital for a week after becoming "physically aggressive at school." (Id. at ¶ 22.) Plaintiff was diagnosed with ADHD and Oppositional Defiant Disorder. (Id. at ¶ 23.) Plaintiff's doctor discontinued Zoloft, decreased Plaintiff's Adderall dosage, and prescribed Risperdal. (Id. at ¶ 24.) A few months later, in August 2003, Plaintiff was brought to New York Foundling Hospital, where he was placed on Adderall 20 mg and Risperdal 0.75 mg, which was soon thereafter increased to 1.5 mg. (Id. at ¶¶ 26–27.) In September 2003, Plaintiff's social worker noted that Plaintiff had "made a significant improvement in symptoms of hyperactivity, impulsivity and attention span" and noted his "positive response to the combination of psychotropic medication and routine, structure and consistent limit setting." (Id. at ¶ 28.) One of Plaintiff's doctors, Fatima Taylor, recommended that Plaintiff be placed in a residential treatment center and continue on psychotropic medications. (Id. at ¶ 30.)

In October 2003, Plaintiff was placed in The Children's Village in Dobbs Ferry. (Id. at ¶ 31.) The psychiatrists at Children's village continued prescribing Plaintiff Adderall and Risperdal. (Id. at ¶ 32.) In April 2004, Children's Village psychiatrist Dr. Mary Lincoln noted that Plaintiff was prescribed Adderall 30 mg and Risperdal 2 mg to treat his symptoms of ADHD and aggression. (Id. at ¶ 33.) Dr. Lincoln noted that Plaintiff's issues seemed to worsen in the absence of regular contact with his mother, and diagnosed Plaintiff with ADHD and Oppositional Defiant Disorder. (Id. at ¶¶ 33–34.) Between August and October 2004, Plaintiff's aggression appeared to decline, so Plaintiff's doctor decreased Plaintiff's Risperdal dose to 0.5 mg. (Id. at ¶¶ 35–36.) But, in November 2004, Plaintiff's behavior deteriorated; his therapist noted that his behavior was "explosive and unsafe." (Id. at ¶ 38.) In December 2004, Plaintiff was admitted to the Crisis Residence section of Children's Village for behavioral issues at a Thanksgiving dinner after he learned he could not visit his birth mother. (Id. at ¶ 39.) Progress notes from February 2005 state that Plaintiff's noncompliance with his medication was "associated w[ith] dramatic behavioral deterioration" and that Plaintiff's grandmother stated that Plaintiff "kicked her and threw [a] tantrum" on his last home visit. (Id. at ¶ 40.) Less than a year later, in January 2006, Plaintiff's grandmother stated that on a recent home visit, Plaintiff threw chairs, took the hinges off a door, grabbed her by the collar, and threatened to break her glasses. (Id. at ¶ 41.) Children's Village psychiatrists increased Plaintiff's Risperdal dosage to 2 mg per day to...