United States District Court, N.D. Alabama, Northeastern Division
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.
MEMORANDUM OPINION AND ORDER
MADELINE HUGHES HAIKALA, UNITED STATES DISTRICT JUDGE.
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.
SUMMARY JUDGMENT STANDARD
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).
RELEVANT FACTUAL AND PROCEDURAL BACKGROUND
Risperdal and Gynecomastia
manufactures and distributes Risperdal, an antipsychotic
medication used to treat schizophrenia. (Doc. 40-10, p. 2;
Doc. 40-11, p. 2). 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).
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).
Mr. Drake's Risperdal Use
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,
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,
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).
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).
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).