Drake et al v. Ortho McNeil Janssen Pharmaceuticals Inc et al
Filing
58
MEMORANDUM OPINION AND ORDER - For the reasons discussed above, the Court GRANTS the defendants motion for summary judgment. (Doc. 38). The plaintiffs claims against the defendants are DISMISSED WITH PREJUDICE. Signed by Judge Madeline Hughes Haikala on 3/22/2018. (KEK)
FILED
2018 Mar-22 PM 02:01
U.S. DISTRICT COURT
N.D. OF ALABAMA
UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ALABAMA
NORTHEASTERN DIVISION
KEVIN DRAKE, and DOROTHY )
DRAKE, as Guardian for Kevin )
)
Drake,
)
)
Plaintiffs,
)
)
v.
)
)
ORTHO-McNEIL-JANSSEN
PHARMACEUTICALS, INC., a )
Pennsylvania
Corporation
f/k/a )
JANSSEN
PHARMACEUTICA )
INC.; and JOHNSON & JOHNSON, )
)
a New Jersey Corporation,
)
)
Defendants.
Case No.: 5:15-CV-01507-MHH
MEMORANDUM OPINION AND ORDER
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.
I.
SUMMARY JUDGMENT STANDARD
“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).
2
II.
RELEVANT FACTUAL AND PROCEDURAL BACKGROUND
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
1
The generic form of Risperdal is risperidone. (See Doc. 40-10, p. 2). At times, Mr.
Drake took risperidone rather than Risperdal. (See Doc. 44-6). For purposes of this
memorandum opinion, the Court does not distinguish between Risperdal and risperidone.
3
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. 443, 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
2
Dr. Lindsay switched Mr. Drake’s medication in September 1999 because the
Risperdal “didn’t seem to be working right . . . .” (Doc. 44-3, p. 27).
4
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).
Risperdal through September 2014.
Mr. Drake continued taking
(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).
3
At times, Mr. Drake refused to take medication by mouth. (Doc. 44-2, p. 15). When
that happened, Dr. Lindsay would prescribe Risperdal Consta, the injectable form of Risperdal.
(Doc. 44-3, p. 38; see also Doc. 44-2, p. 15).
5
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. Drake’s Injuries
According to the plaintiffs, because Mr. Drake took Risperdal, he developed
enlarged breasts and experienced excessive weight gain. (Doc. 44-1, p. 9).4 In
August 2006, more than five years after he first prescribed Risperdal for Mr.
Drake, Dr. Lindsay noted in Mr. Drake’s records that Mr. Drake had “large
breasts.”
(Doc. 53-6).
Still, Dr. Lindsay did not diagnose Mr. Drake with
gynecomastia, and no other physician has formally diagnosed him with the
condition. (Doc. 44-1, p. 10; Doc. 44-2, p. 12; Doc. 44-3, pp. 24, 39). Ms. Drake
has acknowledged that she “is unaware of a physician who has diagnosed Kevin
Drake with gynecomastia.” (Doc. 44-1, p. 10, #12). No doctor and no other health
4
The plaintiffs also contend that Risperdal caused Mr. Drake to suffer urinary
incontinence and fecal incontinence. (Doc. 44-1, p. 9). In response to the defendants’ motion
for summary judgment, the plaintiffs did not raise arguments or cite evidence regarding those
alleged injuries. (See Doc. 49; Doc. 53-9). Accordingly, the plaintiffs have abandoned their
claims based on Mr. Drake’s alleged urinary and fecal incontinence, and the defendants are
entitled to summary judgment as to those claims. See Resolution Trust Corp. v. Dunmar Corp.,
43 F.3d 587, 599 (11th Cir. 1995), cert denied, 516 U.S. 817 (1995) (“[G]rounds alleged in the
complaint but not relied upon in summary judgment are deemed abandoned.”).
6
care provider has told Ms. Drake that Risperdal caused Mr. Drake to experience
excessive weight gain. (Doc. 44-2, p. 14).
In the summer of 2014, a social worker noticed that Mr. Drake had large
breasts and told Ms. Drake that her son should be tested for gynecomastia. (See
Doc. 44-1, p. 9; Doc. 44-2, pp. 8-9). The social worker stated that Risperdal could
be the cause of Mr. Drake’s large breasts. (See Doc. 44-1, p. 9). Medical staff at
Wellstone Behavioral Care and Dr. Chimata, Mr. Drake’s family care doctor,
ordered lab work to test Mr. Drake’s hormone levels. (Doc. 44-2, pp. 8-9, 11, 20).
The lab results showed that Mr. Drake had three times the normal level of the
hormone prolactin in his blood. (Doc. 44-2, pp. 9, 11). 5 After receiving the
results, a nurse from Wellstone told Ms. Drake that Dr. Pope said: “We’ve got to
stop this. The drug is what’s causing that.” (Doc. 44-2, p. 11). Dr. Pope then took
Mr. Drake off of Risperdal. (See Doc. 44-2, p. 11; see also Doc. 44-5, pp. 16-26).6
Wellstone tested Mr. Drake’s hormone level again six to seven months after he
stopped taking Risperdal, and his prolactin levels were lower. (Doc. 44-2, p. 11).
5
Ms. Drake did not identify the hormone tested in Mr. Drake’s blood, (see Doc. 44-2, pp.
9, 11), and the plaintiffs did not cite medical records showing the results of Mr. Drake’s blood
tests. (See Doc. 49; Doc. 53-9). Viewing the evidence in the light most favorable to the
plaintiffs, the Court infers that the hormone that Ms. Drake described is prolactin, a hormone that
may become elevated with Risperdal use and that has been associated with gynecomastia. (See
Doc. 40-13, p. 8).
6
Mr. Drake currently takes Abilify to treat his schizophrenia. (Doc. 44-2, p. 4).
7
Ms. Drake testified that she noticed that her son had developed larger breasts
several years before the social worker raised a concern, but Ms. Drake attributed
Mr. Drake’s enlarged breasts to “weight gain.” (Doc. 44-2, p. 9). The plaintiffs
attribute Mr. Drake’s weight gain to his Risperdal use, (see Doc. 44-1, p. 9), but no
physician has told Ms. Drake that her son gained weight because he took
Risperdal, (Doc. 44-2, p. 14). Ms. Drake testified that she can’t say that Risperdal
“was the sole reason that [Mr. Drake] gained weight.” (Doc. 44-2, p. 31).
Mr. Drake was overweight before Dr. Lindsay prescribed Risperdal to treat
Mr. Drake’s schizophrenia. (Doc. 44-3, p. 28, 30). Mr. Drake gained weight
between August and December 2000 while he was taking Zyprexa. (Doc. 44-3, p.
29). Accordingly, Dr. Lindsay encouraged him to eat less and lose weight. (Doc.
44-3, p. 29).
Mr. Drake continued to gain weight after Dr. Lindsay prescribed Risperdal
for him in 2001. Between August 22, 2001 and March 27, 2002, Mr. Drake’s
weight increased from 260 to 300 pounds. (Doc. 44-3, p. 30, 32). Mr. Drake then
lost weight between 2002 and 2006 while taking Risperdal, and he weighed 270
pounds on August 23, 2005, and 264 pounds on May 9, 2006. (Doc. 44-3, p. 34).
Mr. Drake gained weight again after 2006 while still on Risperdal, and he weighed
286 pounds on August 12, 2013. (Doc. 44-7, p. 9). Mr. Drake gained weight after
8
he stopped taking Risperdal in 2014. On December 30, 2014, Dr. Pope noted that
Mr. Drake had gained significant weight. (Doc. 44-5, p. 18).
D.
Risperdal’s Label
Risperdal’s and Risperdal Consta’s FDA-approved labels warn that the drug
“elevates prolactin levels,” that “the elevation persists during chronic
administration,” and that gynecomastia has “been reported in patients receiving
prolactin-elevating compounds.” (Doc. 40-10, p. 4; Doc. 40-11, p. 12; Doc. 40-12,
pp. 13, 68). Risperdal’s label also states that “the clinical significance of elevated
serum prolactin levels is unknown for most patients.” (Doc. 40-10, p. 4). The
labels identify gynecomastia as a rare adverse event associated with the drug.
(Doc. 40-10, p. 9; Doc. 40-11, p. 24; Doc. 40-12, pp. 25, 80). Risperdal’s 2007
label states that in clinical trials involving 1,885 children and adolescents,
“gynecomastia was reported in 2.3% of Risperdal-treated patients.” (Doc. 40-11,
p. 33). The 2007 label warns that “Risperdal is associated with higher levels of
prolactin elevation that other antipsychotic agents.”
(Doc. 40-11, p. 12).
Risperdal’s and Risperdal Consta’s labels identify weight gain and increased
appetite as commonly observed adverse events in clinical trials of the drug. (Doc.
40-20, p. 6; Doc. 40-11, pp. 2, 18, 21, 27; Doc. 40-12, pp. 2, 28, 51, 73, 81).
Dr. Lindsay reviewed the information in Risperdal’s label before prescribing
the medication. (Doc. 44-3, p. 16). Dr. Lindsay was familiar with and relied upon
9
the information contained in the label when he prescribed Risperdal for Mr. Drake.
(Doc. 44-3, pp. 16, 18-19). Considering the information available to him, Dr.
Lindsay prescribed Risperdal for Mr. Drake because he believed that the drug’s
benefits outweighed the risks for Mr. Drake. (Doc. 44-3, pp. 16, 17, 19).
III.
ANALYSIS
The plaintiffs assert claims against the defendants under Alabama law for
negligence, breach of express warranty, strict product liability, fraudulent
concealment, failure to warn, and negligent misrepresentation. (Doc. 1).
To
prevail on each of those claims, the plaintiffs must prove that Risperdal caused Mr.
Drake’s injuries. See Univ. of Texas Southwestern Med. Ctr. v. Nassar, 570 U.S.
338, 346 (2013) (“Causation . . . is a standard requirement of any tort claim. . . .”)
(citations omitted); Lemley v. Wilson, 178 So. 3d 834, 842 (Ala. 2015)
(“‘Proximate cause is an essential element of [] negligence claims . . . .’”)
(quotation omitted); Wyeth, Inc. v. Weeks, 159 So. 3d 649, 656 (Ala. 2014)
(identifying causation as an element of fraudulent misrepresentation and products
liability claims); Ala. Pattern Jury Instr. Civ. §§ 18.05, 28.00, 32.06-07, 32.15,
32.17-18 (3d ed. 2017) (identifying causation as an element of negligence, breach
10
of express warranty, products liability, failure to warn, fraudulent concealment,
and fraudulent misrepresentation claims). 7
In a pharmaceutical products liability case such as this one, a plaintiff must
prove both general and specific causation. See Kilpatrick v. Breg, Inc., 613 F.3d
1329, 1334 n.4 (11th Cir. 2010); see also McClain v. Metabolife Int’l, Inc., 401
F.3d 1233, 1237 (11th Cir. 2005) (“Plaintiffs must prove the toxicity of the
ephedrine/caffeine combination and that it had a toxic effect on them causing the
injuries that they suffered . . . .”) (applying Alabama law). General causation
requires proof that the drug at issue is capable of causing the type of injuries the
plaintiff suffered.
Chapman v. Procter & Gamble Distributing, LLC, 766 F.3d
1296, 1303 (11th Cir. 2014); McClain, 401 F.3d at 1239. Specific causation
requires proof that the drug caused the plaintiff’s specific injuries. Chapman, 766
F.3d at 1303; McClain, 401 F.3d at 1239.
Due to the complex nature of the claims, expert testimony generally is
required to establish general and specific causation in product liability cases.
McClain, 401 F.3d at 1237 (“This type of proof requires expert testimony . . . .”);
see also Garrison v. Novartis Pharma. Corp, 30 F. Supp. 3d 1325, 1339 (M.D.
Ala. 2014) (granting summary judgment in favor of the defendant in an AEMLD
7
Because this action is before the Court on the basis of diversity jurisdiction, (see 28
U.S.C. § 1332; see also Doc. 1, p. 3), Alabama substantive law applies. See, e.g., Erie Railroad
Co. v. Tompkins, 304 U.S. 64 (1938).
11
case because the plaintiff “lacks admissible expert testimony to show specific
causation”); Sutherland v. Matrixx Initiatives, Inc., 2006 WL 6617000, * 14 (N.D.
Ala. 2006) (“[W]ithout an expert to connect a toxin to an injury, there is no toxic
tort.”).
To support their claims, the plaintiffs rely on expert reports by and testimony
from Dr. David A. Kessler, the former commissioner of the FDA, who has testified
in other cases involving Risperdal. (See Docs. 49 & 53-9). In those cases, Dr.
Kessler opined that the defendants misrepresented the risk of gynecomastia for
children and adolescents taking Risperdal. (Doc. 44-3, p. 39).8 Dr. Kessler’s
report and deposition testimony from other cases might be sufficient to raise a
question of fact regarding general causation, (see Doc. 53-3, p. 7, ¶ 17), but his
report and testimony contain no evidence regarding the cause of Mr. Drake’s
alleged injuries. Dr. Kessler has not examined Mr. Drake.
The plaintiffs’ evidence concerning specific causation is threadbare. There
is no evidence that Mr. Drake has been diagnosed with gynecomastia. Ms. Drake
admits that she is not aware of such a diagnosis. (Doc. 44-1, p. 10, #12). Dr.
Lindsay testified that he did not make such a diagnosis. (Doc. 44-3, p. 39).
The plaintiffs’ evidence that Mr. Drake had three-times the normal level of
the hormone prolactin in his blood is a start, but the association between elevated
8
The defendants object to the plaintiffs’ reliance on Dr. Kessler’s reports and testimony.
(Doc. 56, pp. 8-12). These objections are moot.
12
levels of prolactin and gynecomastia falls short of proof of specific causation. (See
Doc. 44-2, pp. 9, 11). Association does not establish causation. (Doc. 40-13, p. 5);
see also Kilpatrick v. Breg, Inc., 613 F.3d 1329, 1338 (11th Cir. 2010) (“‘Showing
an association is far removed from proving causation.’”) (quotation, alteration, and
emphasis in original omitted). The plaintiffs have not introduced evidence that
contradicts the defendants’ expert’s testimony that elevated prolactin levels do not
necessarily lead to gynecomastia. (Doc. 44-8, p. 5; see also Doc. 49; Doc. 53-9).
Rather, the plaintiffs argue that if Mr. Drake’s elevated prolactin level caused
“testosterone level drops leading to estrogen expression[, then] the drug could
theoretically cause gynecomastia.” (Doc. 49, p. 26) (citing 44-8, p. 9) (emphasis
added). But there is no evidence in the record regarding Mr. Drake’s testosterone
or estrogen levels, and evidence that Risperdal could theoretically cause
gynecomastia is not sufficient to raise a disputed question of material fact
concerning specific causation. See Tidwell v. Upjohn Co., 626 So. 2d 1297, 1301
(Ala. 1993) (“On issues of medical causation a showing of probably cause, rather
than possible cause, must be made.”).
In the absence of medical or expert
evidence, a fact finder must speculate about the cause of Mr. Drake’s enlarged
breasts, and a verdict may not rest on speculation.
The plaintiffs argue that they can carry their burden of proof because they
can establish that Risperdal may cause weight gain, which can lead to pseudo13
gynecomastia. (Doc. 49, p. 2). The argument is unavailing for a number of
reasons.
First, evidence indicates that Mr. Drake was overweight before Dr.
Lindsay prescribed Risperdal in February 2001, and there is no medical or expert
evidence to suggest that Risperdal caused Mr. Drake’s weight gain. (See Doc. 443, pp. 28, 30). In fact, evidence in the record suggests that other medications
potentially could have caused Mr. Drake’s weight gain: Dr. Lindsay testified that
Mr. Drake gained excessive weight while taking Zyprexa in 2000, and Mr. Drake
gained weight in 2014 after he stopped taking Risperdal. (Doc. 44-3, p. 29; Doc.
44-5, p. 18). Besides, proof that a drug may cause weight gain still is proof of
general causation; the evidence does not bridge the specific causation gap.
Ms. Drake’s testimony that a nurse at Wellstone told her that Dr. Pope said
Risperdal “is what’s causing that” does not allow her to avoid summary judgment.
(See Doc. 44-2, p. 11). Dr. Pope’s alleged statement, which is hearsay within
hearsay, is ambiguous. It is not clear from Ms. Drake’s testimony whether Dr.
Pope’s purported statement means that Dr. Pope believed that the drug was causing
Mr. Drake’s enlarged breasts or his elevated prolactin levels. Because Dr. Pope
allegedly made the statement after receiving the results of the lab tests on Mr.
Drake’s hormone levels, the Court cannot infer from the hearsay statement that Dr.
Pope believed that Risperdal caused Mr. Drake’s enlarged breasts as opposed to his
elevated prolactin levels.
14
Based on the record before the Court, there is no evidence from which a
factfinder could reasonably infer that Mr. Drake’s use of Risperdal caused his
enlarged breasts or weight gain.
Because the plaintiffs have not identified
sufficient evidence to raise a genuine issue of material fact regarding specific
causation, the Court will grant the defendants’ motion for summary judgment.
IV.
CONCLUSION
For the reasons discussed above, the Court GRANTS the defendants’
motion for summary judgment. (Doc. 38). The plaintiffs’ claims against the
defendants are DISMISSED WITH PREJUDICE.
DONE and ORDERED this March 22, 2018.
_________________________________
MADELINE HUGHES HAIKALA
UNITED STATES DISTRICT JUDGE
15
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