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Drake v. Ortho McNeil Janssen Pharmaceuticals Inc.

United States District Court, N.D. Alabama, Northeastern Division

March 22, 2018

KEVIN DRAKE, and DOROTHY DRAKE, as Guardian for Kevin Drake, Plaintiffs,
ORTHO-McNEIL-JANSSEN PHARMACEUTICALS, INC., a Pennsylvania Corporation f/k/a JANSSEN PHARMACEUTICA INC.; and JOHNSON & JOHNSON, a New Jersey Corporation, Defendants.



         Plaintiff Kevin Drake and his mother and legal guardian, Dorothy Drake, bring this products liability action based on injuries that Mr. Drake allegedly incurred because he took Risperdal, a prescription drug manufactured by defendant Ortho-McNeil-Janssen Pharmaceuticals, Inc. f/k/a Janssen Pharmaceutica, Inc. (“Janssen”). The plaintiffs contend that Janssen and its parent company, defendant Johnson & Johnson, knew that Risperdal was unreasonably dangerous and failed to adequately warn about the dangers of the drug. The defendants argue that the plaintiffs' claims fail as a matter of law because the plaintiffs cannot establish causation. The Court agrees. Because the plaintiffs have not identified a disputed question of material fact regarding causation, the Court finds that the defendants are entitled to judgment as a matter of law and grants the defendants' motion for summary judgment.


         “The court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). To demonstrate that there is a genuine dispute as to a material fact that precludes summary judgment, a party opposing a motion for summary judgment must cite “to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials.” Fed.R.Civ.P. 56(c)(1)(A). “The court need consider only the cited materials, but it may consider other materials in the record.” Fed.R.Civ.P. 56(c)(3). When considering a summary judgment motion, the Court must view the evidence in the record in the light most favorable to the non-moving party and draw reasonable inferences in favor of the non-moving party. White v. Beltram Edge Tool Supply, Inc., 789 F.3d 1188, 1191 (11th Cir. 2015).


         A. Risperdal and Gynecomastia

         Janssen manufactures and distributes Risperdal, an antipsychotic medication used to treat schizophrenia. (Doc. 40-10, p. 2; Doc. 40-11, p. 2).[1] Risperdal comes in two forms: a Risperdal pill and a long-acting injection called Risperdal Consta. (See Doc. 44-3, p. 20). In 1993, the United States Food and Drug Administration, better known as the FDA, approved Risperdal for the treatment of psychosis in adults. (See Doc. 40-10, p. 2; Doc. 40-11, p. 2). In 2007, the FDA approved Risperdal for the treatment of schizophrenia in adolescents from ages thirteen to seventeen years old. (Doc. 40-11, p. 2).

         Antipsychotic medications like Risperdal have been associated with gynecomastia. (Doc. 40-13, pp. 5, 7, 10-11; Doc. 40-17, p. 2; see also Doc. 40-10, p. 9; Doc. 40-11, p. 33; Doc. 40-12, p. 25). Gynecomastia is the benign enlargement of breast tissue in males. (Doc. 40-13, p. 3). Gynecomastia may occur during normal physiological development in puberty, and in some cases, it may persist after puberty. (Doc. 40-13, p. 3). In a study of adult males seeking treatment for gynecomastia, 25% of patients had “persistent gynecomastia due to puberty, ” another 25% had idiopathic gynecomastia, meaning that no cause for the condition could be identified, 10-20% of patients had gynecomastia “related to drugs or medication, ” and the remaining patients had gynecomastia caused by various diseases and disorders. (Doc. 40-13, p. 3). Gynecomastia is distinct from pseudo-gynecomastia, which is breast enlargement due to fat deposits in overweight males. The two conditions may be differentiated only with a physical exam. (Doc. 40-13, pp. 4-5; Doc. 44-7, pp. 7, 10; Doc. 44-8, p. 4).

         B. Mr. Drake's Risperdal Use

         Mr. Drake suffers from schizophrenia. (Doc. 44-2, p. 4; Doc. 44-3, p. 9). Dr. Steven Taylor diagnosed schizophrenia in Mr. Drake in 1999 when Mr. Drake was seventeen years old. (See Doc. 44-3, pp. 13, 24). Dr. Taylor prescribed Risperdal in 1999 to treat Mr. Drake's schizophrenia. (Doc. 44-3, p. 24). That same year, Dr. Trevor Lindsay, a psychiatrist in Huntsville, began treating Mr. Drake, and he continued to treat Mr. Drake until 2011. (Doc. 44-3, pp. 4, 11).

         Dr. Lindsay confirmed Mr. Drake's diagnosis of schizophrenia, but switched Mr. Drake's medication from Risperdal to Clozaril in September 1999. (Doc. 44-3, pp. 13, 24-25, 27).[2] Weight gain and hyperprolactinemia are known side effects of Clozaril. (Doc. 44-3, p. 24). Dr. Lindsay also prescribed Haldol and Zyprexa to treat Mr. Drake's schizophrenia. (Doc. 44-3, p. 27). Weight gain and hyperprolactinemia are known side effects of Zyprexa. (Doc. 44-3, p. 28). In 2001, when Mr. Drake was nineteen years old, Dr. Lindsay switched Mr. Drake's medication back to Risperdal. (Doc. 44-3, p. 30). When Dr. Lindsay prescribed Risperdal for Mr. Drake, Dr. Lindsay took into account the fact that Risperdal may elevate prolactin levels. (Doc. 44-3, p. 18). Prolactin is a hormone that induces lactation, but it “does not have a direct growth-stimulating effect on the breast glandular tissue.” (Doc. 40-13, pp. 7-8). “Adult men with high levels of prolactin [] may exhibit gynecomastia, ” (Doc. 40-13, p. 8), but elevated prolactin levels do not necessarily lead to gynecomastia, and there are multiple potential causes for prolactin elevation. (Doc. 44-8, p. 5). Dr. Lindsay maintained Mr. Drake's treatment with Risperdal through 2011. (Doc. 44-3, p. 41).[3]

         Mr. Drake changed psychiatrists in 2011 and began seeing Dr. Rachel Pope. (See Doc. 44-3, p. 11; Doc. 44-5, pp. 20-26). Mr. Drake continued taking Risperdal through September 2014. (See Doc. 44-5, pp. 20-26). Sometime between September and December 2014, Dr. Pope discontinued Mr. Drake's Risperdal prescription and instead prescribed Abilify and Zyprexa to treat Mr. Drake's schizophrenia. (See Doc. 44-5, pp. 16-26; Doc. 44-2, p. 34).

         Ms. Drake does not remember Dr. Lindsay discussing the risks and benefits of Risperdal, but she relied on Dr. Lindsay and other psychiatrists to prescribe the medication that would provide the best treatment for Mr. Drake's symptoms. (Doc. 44-2, pp. 23-24). Ms. Drake testified that her son's behavior improved when he was on Risperdal, and the medication helped control his symptoms of schizophrenia. (Doc. 44-2, pp. 27, 30).

         C. Mr. ...

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