Ebel v. Eli Lilly & Co. ( 2009 )

IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT United States Court of Appeals
Fifth Circuit
FILED
March 30, 2009
No. 08-40170 Charles R. Fulbruge III
Clerk
BEATRIZ E EBEL, Individually and as Personal Representative of the Estate
of Philip Wayne Ebel, Deceased, and as Next Friend of Eric Fernando Ebel
and Gabriela Nicole Ebel, Minors
Plaintiff - Appellant
v.
ELI LILLY & CO
Defendant - Appellee
Appeal from the United States District Court for the
Southern District of Texas, Brownsville
USDC No. 1:04-CV-194
Before KING, BENAVIDES, and CLEMENT, Circuit Judges.
PER CURIAM:*
Plaintiff–Appellant Beatriz Ebel brings this suit against Eli Lilly &
Company on behalf of herself, her late husband’s estate, and her two children.
She claims that Eli Lilly & Company failed to warn that its drug, Zyprexa, can
cause akathisia—a feeling of severe restlessness—and suicide and that, as a
result, her husband, Philip Ebel, committed suicide on November 11, 2002. The
*
Pursuant to 5TH CIR . R. 47.5, the court has determined that this opinion should not
be published and is not precedent except under the limited circumstances set forth in 5TH CIR .
R. 47.5.4.
district court dismissed her claim on summary judgment, concluding both that
Zyprexa’s warning was adequate as a matter of law and that Beatriz Ebel failed
to present evidence that the warning was the producing cause of Philip’s death.
We agree that Beatriz Ebel has failed to point to evidence demonstrating that
Zyprexa’s warning was the producing cause of Philip’s death; therefore, we
affirm the district court’s judgment.
I. FACTUAL AND PROCEDURAL BACKGROUND
Philip Ebel battled chronic and severe headaches that significantly
interfered with both his professional and personal life. Over the course of that
battle, he tried roughly forty-seven different medications, the last of which were
Zyprexa and Paxil. 1 After taking Zyprexa for nearly four months, Philip
tragically ended his own life on November 11, 2002, by a self-inflicted gunshot
wound. He left behind his two children and wife, Beatriz Ebel (“Ebel”). Ebel
now brings this suit against Eli Lilly & Company (“Lilly”) on behalf of herself,
her children, and Philip’s estate; she alleges Zyprexa’s label did not warn that
the drug may cause akathisia and suicide and that the drug caused Philip’s
suicide.
Beginning in February 2001, Philip sought treatment from Dr. Robert
Nett, who is located in San Antonio, Texas, and is board-certified in pain
management. After trying numerous combinations of prescription drugs that
only marginally increased Philip’s quality of life, Dr. Nett recommended that
Philip obtain an appointment at Dr. Joel Saper’s Michigan Headache &
Neurological Institute, a clinic specializing in the treatment of severe headaches.
1
This suit addresses only those claims concerning Zyprexa; an additional suit was
brought against GlaxoSmithKline, the maker of Paxil, but the parties have since settled those
claims.
2
Philip took this advice and attended the Michigan clinic for three weeks in
December 2001. Unfortunately, he returned no better off than when he left.
Back in Dr. Nett’s care, Philip was present when Dr. Nett conferred over the
telephone with Dr. David Gordon from the Michigan clinic in order to ascertain
additional treatment options available to Philip. Dr. Gordon suggested
prescribing one of two possible drugs: Pamelor or Zyprexa. Dr. Nett described
the decision to prescribe Zyprexa in his deposition:
[B]asically, [Philip] was saying that [Nardil, the current drug,] was
not working, side effects were becoming intrusive and, you know,
that’s when it was like he was on no medication. So it was, okay,
let’s call Ann Arbor, Joe [sic] Saper’s practice, get someone on the
phone to say, okay, look, I’m—I have a fellow here that now is
declaring himself that he realizes he’s at the end of his rope. What
else can we try?
And that’s when Gordon took time, reviewed the case, and he
said, look, Bob, you know, Zyprexa is worth a trial, and for
completeness, Pamelor. I didn’t think Pamelor would be a real
viable option, because [Philip] had been on Tofranil for so long, and
amitryptyline in the past, that the similarities of those compounds,
I would go with Zyprexa. . . .
Zyprexa, which is the trade name for olanzapine, is an atypical
antipsychotic drug produced by defendant Lilly and approved by the Food and
Drug Administration (the “FDA”) for the treatment of schizophrenia and bipolar
disorder. The drug has the additional effect of reducing the severity of
headaches in some patients, and it is for this off-label use that Dr. Nett
prescribed it to Philip. However, Zyprexa is not without its side effects: under
the heading “Precautions,” the drug’s 2002 label states:
Suicide—The possibility of a suicide attempt is inherent in
schizophrenia and in bipolar disorder, and close supervision of high-
risk patients should accompany drug therapy.
3
Under the same heading and the subheading “Other Adverse Events Observed
During the Clinical Trial Evaluation of Olanzapine,” suicide attempt is identified
as a “frequent” event—an event that occurs “in at least 1/100 patients.” With
regard to akathisia, in the section entitled “Adverse Reactions,” four of six tables
delineate akathisia as a side effect that occurs more often in clinical-trial
participants taking olanzapine than in those taking the placebo.
Dr. Nett demonstrated his awareness of these side effects in his deposition.
Questions from Lilly’s attorney revealed the doctor’s knowledge that Zyprexa
may cause akathisia:
Q [D]o you remember this class of antipsychotic medications can
cause some restlessness, or what’s sometimes called akathisia?
[Dr. Nett] Yes.
Q And at the time you prescribed that for [Philip], you were
aware of that?
A Yes. Akathisia is fairly rare as far as, you know, fullblown.
But it’s the irritability that it’s kind of like a ca—I described it as
you might get irritable as though you had two extra cups of coffee
and you’re kind of jumpy a little bit. And I wanted him to report
that.
Dr. Nett’s understanding that using Zyprexa entailed a risk of suicide was
demonstrated during the examination by Ebel’s attorney:
Q In July of 2002 when you prescribed it, what did you know
about the side effect profile of Zyprexa? And if you’d give me some
specifics, you know, what it caused—
[Dr. Nett] It can cause—
Q —frequency of cause—of what it caused. Those types of
things is what I’m getting at.
A I mean, I would have to get a [Physicians’ Desk Reference] to
be exact—
4
Q Sure.
A —to the amount of sedation. But sedation, lightheadedness,
dizziness, moodiness, irritability, agitation, can be easily observed
with this product. They tend to be mild to moderate. They tend to
be transient. . . . And he was to report any rage, violent anger,
intrusive thoughts.
* * *
Q Had anyone from Eli Lilly ever discussed with you the
potential for Zyprexa induced suicides, or suicidality?
A I believe that’s been brought up, specially in the context of the
adolescent data with antidepressants and new warnings of
heightened suicide likelihood in younger—in younger patients. So
I think that’s been on the forefront of detailing.
Q [W]e really need to focus on July 2002. . . .
A Yeah, I mean, I am reasonably sure that such dialogue had
occurred. And I would say that because of this heightened
awareness by all companies when they are detailing
antidepressants and atypicals, that the enhanced rate of suicide . . .
needs to be of a concern in prescribing the product.
So, you know, specifically in 2001 and 2002, and 2003, I mean,
I’m reasonably sure that those dialogues have occurred. To try to
look back five years ago and cite specifically without reservation,
that becomes more difficult, Fred.
And, again when questioned by Ebel’s attorney, Dr. Nett further indicated that
he communicated the risks of akathisia and suicide to Philip and that, given
Philip’s circumstances and Dr. Nett’s self-described awareness of the drug’s
risks, the risk–benefit analysis favored prescribing Zyprexa:
Q [I]s it accurate to state that you are aware of the suicide issue
and the akathisia issue?
[Dr. Nett] I’m aware of akathisia enhanced suicides if I’m going to
prescribe a product. There’s been heightened awareness over the
5
last several—several years in that regard. And I am certainly using
a product that has that potential last, or i.e., Nardil, and atypicals.
Because of enhanced concerns for side effects, including suicide, risk
benefit in Philip at that time was valuable to try.
Q I understand. But—
A He would have been told, as illustrated in chart notes,
concerns for irritability and agitation that go beyond that. He was
asked specifically for depression, suicidal thoughts, intrusive
thoughts—
Philip began taking Zyprexa in July 2002. He additionally obtained a
prescription for Paxil from a different physician on November 9, 2002. Two days
later, on November 11, 2002, Philip ended his life.
Ebel subsequently filed the current complaint, arguing that, under
theories of strict liability, negligence, and breach of warranty, Lilly was liable
for Philip’s death because its warning that Zyprexa may cause akathisia and
suicide was defective. Lilly filed a motion for summary judgment alleging that,
under the learned intermediary doctrine, (1) Zyprexa’s warning was adequate
as a matter of law and (2) Ebel failed to present evidence that Zyprexa’s label
was the producing cause of the harm. The district court agreed with Lilly on
both grounds. Applying Texas law and the learned intermediary doctrine, the
court first determined that Zyprexa’s warning was adequate as a matter of law
under Texas Civil Practice and Remedies Code Annotated § 82.007(a) and that
§ 82.007(b)’s overpromotion exception did not apply. Second, the district court
concluded that Ebel had failed to present evidence establishing that Zyprexa’s
warning was the producing cause of the harm and that the read-and-heed
presumption did not apply so as to put the burden of negating causation on Lilly.
6
Consequently, the district court granted Lilly’s motion for summary judgment
in its January 29, 2008 order. Ebel timely appealed.
II. STANDARD OF REVIEW
We review de novo a grant of summary judgment. Ackermann v. Wyeth
Pharm., 526 F.3d 203, 207 (5th Cir. 2008). Summary judgment is appropriate
“‘if the pleadings, depositions, answers to interrogatories, and admissions on file,
together with the affidavits, if any, show that there is no genuine issue as to any
material fact and that the moving party is entitled to a judgment as a matter of
law.’” McNeil v. Wyeth, 462 F.3d 364, 367 (5th Cir. 2006) (quoting
F ED. R. C IV. P. 56(c)). We view the evidence in the light most favorable to the
nonmovant, but no genuine issue of material fact exists where “the non-moving
party fails to establish the existence of an element essential to that party’s case,
and on which that party will bear the burden of proof at trial.” Ackermann, 526
F.3d at 207 (internal quotation marks omitted); see also Stahl v. Novartis
Pharm. Corp., 283 F.3d 254, 263 (5th Cir. 2002) (“[I]f the non-moving party can
point to nothing in the record supporting its claim, summary judgment is
appropriate.”).
III. DISCUSSION
Summary judgment is proper in this case. Where the learned
intermediary doctrine applies, a plaintiff must show both that the drug’s
warning was defective and that the warning was the producing cause of the
injury. Ebel has failed to present evidence in support of the latter requirement,
and because this alone is sufficient to support the grant of summary judgment
favoring Lilly, we need not address Ebel’s arguments concerning whether Lilly’s
warning was defective.
7
The learned intermediary doctrine applies to Texas products-liability suits
involving prescription drugs. See Harrison v. Am. Home Prods. Corp. (In re
Norplant Contraceptive Prods. Liab. Litig.), 165 F.3d 374, 379 (5th Cir. 1999)
(“Two of our cases applying Texas law in [the prescription drug] area have
concluded that, as long as a physician–patient relationship exists, the learned
intermediary doctrine applies.”); Porterfield v. Ethicon, Inc., 183 F.3d 464, 468
(5th Cir. 1999) (“The learned intermediary doctrine applies in medical products
liability actions in Texas.”); cf. Humble Sand & Gravel, Inc. v. Gomez, 146
S.W.3d 170, 185 (Tex. 2004) (“In Alm v. Aluminum Co. of America, [717 S.W.2d
588, 591 (Tex. 1986),] we recognized that ‘a manufacturer or supplier may, in
certain situations, depend on an intermediary to communicate a warning to the
ultimate user of a product.’”). This doctrine dictates whom a manufacturer must
warn—the learned intermediary as opposed to the final user—and “is not an
affirmative defense.” Ackermann, 526 F.3d at 207; see also Hurley v. Lederle
Labs. Div. of Am. Cyanamid Co., 863 F.2d 1173, 1178 (5th Cir. 1988) (“[T]he
learned intermediary doctrine relates only to the issue of whom the
manufacturer warned.”).
8
When, as here, the learned intermediary doctrine applies,2 “a plaintiff
must show that (1) the warning was defective, and (2) the failure to warn was
a producing cause of the injury.” Ackermann, 526 F.3d at 208 (citing Porterfield,
183 F.3d at 468). Regarding the first requirement, Lilly asserts that Zyprexa’s
warning is not defective and is, instead, adequate as a matter of law under
T EXAS C IVIL Practice and Remedies Code Annotated § 82.007(a) because the
FDA approved the drug’s label.3 Ebel counters that the statute should not apply,
arguing that Lilly altogether failed to provide a warning that the drug may
cause akathisia or suicide because it tied such indications of akathisia and
2
Ebel contests that an overpromotion exception to the learned intermediary doctrine
should apply because Lilly allegedly promoted off-label uses of Zyprexa to doctors. As support,
Ebel points to an internal presentation of Lilly’s that purportedly planned to market Zyprexa
by increasing primary-care physicians’ awareness of the drug. Ebel, however, does not point
to any Texas case law adopting an overpromotion exception to the learned intermediary
doctrine, nor can we find a Texas case doing so. Additionally, though we are skeptical that a
Texas court would adopt such an exception in the first place, see Harrison, 165 F.3d at 379
(refusing to apply the different, but similar direct-to-consumer-marketing exception to Texas’s
learned intermediary doctrine because “as long as a physician–patient relationship exists, the
learned intermediary doctrine applies”), we need not decide the issue because, as the district
court indicated, Ebel has failed to produce evidence demonstrating that the alleged marketing
plan in fact resulted in overpromoting Zyprexa’s off-label uses and that Dr. Nett ever received
any such marketing material overpromoting Zyprexa, see id. (stating that the argument to
apply a direct-to-consumer-marketing exception “is critically weakened by the absence of any
evidence on the record that any of the five plaintiffs actually saw, yet alone relied[] on[,] any
marketing materials issued to them by [defendant]”). Besides arguing that this exception
should apply, Ebel does not challenge the application of the learned intermediary doctrine.
3
Section 82.007(a) states:
In a products liability action alleging that an injury was caused by a failure to
provide adequate warnings or information with regard to a pharmaceutical
product, there is a rebuttable presumption that the defendant . . . [is] not liable
with respect to the allegations involving failure to provide adequate warnings
or information if:
(1) the warnings or information that accompanied the product in its
distribution were those approved by the [FDA] for a product approved under the
Federal Food, Drug, and Cosmetic Act, as amended . . . .
9
suicide to the conditions of schizophrenia and bipolar disorder and because it
failed to list these side effects under the label’s “Warnings” section as required
by 21 C.F.R. § 201.80(e) (formerly 21 C.F.R. § 201.57(e)).4 Failing that, Ebel
contends that the statute’s overpromotion exception applies; that exception
states that § 82.007(a)’s presumption of no liability no longer applies when “the
defendant recommended, promoted, or advertised the pharmaceutical product
for an indication not approved by the [FDA].” See T EX. C IV. P RAC. & R EM. C ODE
A NN. § 82.007(b)(3)(A). However, we need not address these arguments because
Ebel failed to present any evidence establishing the existence of the second
requirement under the learned intermediary doctrine—that Zyprexa’s 2002 label
was the producing cause of Philip’s death.
The failure to warn is a producing cause of the injury if “‘the alleged
inadequacy caused [the] doctor to prescribe the drug for [the patient].’”
Ackermann, 526 F.3d at 208 (quoting McNeil, 462 F.3d at 372). “If, however, ‘the
physician was aware of the possible risks involved in the use of the product but
decided to use it anyway, the adequacy of the warning is not a producing cause
of the injury’ and the plaintiff’s recovery must be denied.” Id. (quoting
Porterfield, 183 F.3d at 468). “Even if the physician is not aware of a risk, the
plaintiff must show that proper warning would have changed the decision of the
treating physician, i.e., that but for the inadequate warning, the treating
4
That regulation states, in pertinent part:
Warnings. Under this section heading, the labeling shall describe serious
adverse reactions and potential safety hazards . . . . The labeling shall be
revised to include a warning as soon as there is reasonable evidence of an
association of a serious hazard with a drug; a causal relationship need not have
been proved.
We do not express any opinion as to whether this regulation actually requires what Ebel
asserts that it does.
10
physician would have not used or prescribed the product.” Id. (internal
quotation marks omitted).
Ebel has presented no evidence to suggest that Dr. Nett was unaware of
the risks engendered by Zyprexa’s use at the time he prescribed the drug or that
an alternative warning would have changed Dr. Nett’s decision to prescribe
Zyprexa. Dr. Nett’s deposition demonstrates that he was aware of Zyprexa’s
akathisia and suicide risks and that he communicated these risks to Philip. Dr.
Nett did not indicate that, had he been made aware of additional information
regarding the drug, his risk–benefit analysis of whether to use Zyprexa would
have changed. Instead of pointing to evidence that Dr. Nett was uninformed or
would have changed his prescription, Ebel argues that Lilly bears the burden of
establishing that Dr. Nett was fully aware of Zyprexa’s risks and that Dr. Nett’s
testimony was too equivocal to meet that burden. Ebel compares Dr. Nett’s
testimony to that of the doctor in McNeil, where a panel of this court reversed
the grant of summary judgment that favored a pharmaceutical company.
Ebel’s arguments fail, however, because she, as the plaintiff, bears the
burden of establishing that the allegedly inadequate warning is the producing
cause of the harm and because Dr. Nett’s testimony does not resemble that of the
doctor in McNeil. First, Ebel’s argument is based on the erroneous premise that
the learned intermediary doctrine is an affirmative defense, contrary to this
court’s statement in Ackermann that “[t]he learned-intermediary doctrine is not
an affirmative defense.” 526 F.3d at 207. Instead, under this doctrine, the
“plaintiff must show that . . . the failure to warn was a producing cause of the
11
injury.” Id. at 208 (emphasis added).5 Lilly’s motion for summary judgment
alleged, among other things, that evidence demonstrating that Zyprexa’s
warning was the producing cause of the injury was lacking, and the district court
agreed. We, too, agree, and despite Ebel’s assertion to the contrary, determining
that a party has failed to establish an essential element of the claim is a proper
consideration on summary judgment and is not a finding of fact to be left to the
jury. See Ackermann, 526 F.3d at 207 (“But where the non-moving party fails
to establish the existence of an element essential to that party’s case, and on
which that party will bear the burden of proof at trial, no genuine issue of
material fact can exist.” (internal quotation marks omitted)). Furthermore,
placing the burden on the plaintiff to produce evidence of causation is not, as
Ebel avers, “completely inimical to Texas products liability law”; indeed, it is
required by Texas law. See id. at 208 (“In other words, ‘[u]nder Texas law, a
plaintiff who complains that a prescription drug warning is inadequate must
also show that the alleged inadequacy caused her doctor to prescribe the drug
for her.’” (quoting McNeil, 462 F.3d at 372)).
5
In her argument, Ebel points to Garside v. Osco Drug, Inc., 976 F.2d 77 (1st Cir.
1992), as support for the requirement that the defendant drugmaker bears the burden of
disproving causation by providing evidence that the prescribing doctor was aware of all the
information that a sufficient warning would include. In that case, the First Circuit first
determined that the read-and-heed presumption—“a rebuttable presumption in favor of the
plaintiff that a physician would have heeded an adequate warning”—applied and, for that
reason, the burden shifted to the defendant to show that the doctor would not have heeded the
warning because he was already fully aware of the drug’s risks. See id. at 80–83. Such a
presumption, however, has not been applied by this court to Texas products-liability cases
involving the application of the learned intermediary doctrine. See Ackermann, 526 F.3d at
214 (“[T]he read-and-heed presumption does not apply to Texas cases involving learned
intermediaries.”).
12
Second, Dr. Nett’s deposition testimony does not resemble that of the
doctor in McNeil. There, the drug’s warning was allegedly inadequate because
it under-represented the frequency with which a side effect occurred when the
drug was used for more than twelve weeks. See McNeil, 462 F.3d at 370. The
prescribing doctor, Dr. Wilkinson, indicated both that “he still would have
prescribed the drug had he known that the risk was ‘significant’” and that “he
would not have prescribed the drug had its label stated that use for longer than
twelve weeks is contraindicated because the risks are significant and the
benefits have not been proven.” Id. at 372. Further, the doctor “testified that
he was never informed of the significant risk” associated with the long-term use
of the drug “and that such information certainly would have changed the
‘risk/benefit analysis’ and the conversation he would have had with [the patient]
about the risks.” Id. Those statements created a genuine issue of material fact
as to whether Dr. Wilkinson would have changed his prescription had he been
accurately informed of the risks associated with the particular drug—that is,
whether the drug’s warning was the producing cause of the harm. Id. at 372–73.
But no such genuine issue of material fact exists here because Dr. Nett clearly
indicated that he was aware of the risks of akathisia and suicide that Zyprexa
engendered.6
6
Ebel attempts to undermine the certainty of Dr. Nett’s statements by implying that
Dr. Nett was confused as to whether the risks of akathisia and suicide were attributable to
“antidepressants” as opposed to “atypical antipsychotics” by pointing to Dr. Nett’s statement
that “I believe [the risk of akathisia and suicide has] been brought up, specially in the context
of the adolescent data with antidepressants and new warnings.” (Emphasis added.) However,
in response to the very next question, Dr. Nett indicated that his awareness of these risks
additionally applied to “atypicals,” which include Zyprexa: “because of the heightened
awareness by all companies when they are detailing antidepressants and atypicals, that the
enhanced rate of suicide . . . needs to be of a concern in prescribing the product.”
13
Further, Ebel presented no evidence to suggest that Dr. Nett would have
changed either his decision to prescribe Zyprexa or his risk–benefit analysis had
he received some alternative warning concerning Zyprexa. Indeed, the record
indicates that Zyprexa was perceived to be the last remaining treatment option
available to Philip after he had tried upwards of forty-five other medications to
no avail. When Dr. Nett conferred with Dr. Gordon to ask “[w]hat else can we
try,” Dr. Gordon suggested prescribing either Zyprexa or Pamelor. Because
Philip had found no relief with medicine similar to Pamelor, Dr. Nett prescribed
Zyprexa. Zyprexa was, effectively, Philip’s last resort, and Ebel has produced no
evidence demonstrating that Dr. Nett would have prescribed anything other
than Zyprexa at that time. For these reasons, Ebel has failed to show that a
genuine issue of material fact exists as to whether Lilly’s warning was the
producing cause of Philip’s death.
Alternatively, Ebel argues that the read-and-heed presumption should
apply and that this presumption would satisfy her burden of showing causation.
The read-and-heed presumption presumes that, were an adequate warning
provided, the consumer would heed that warning; therefore, it places the burden
on the manufacturer to disprove that the consumer would have heeded the
warning. This detour around demonstrating causation has been made
unavailable, however, by our ruling in Ackermann that “the read-and-heed
presumption does not apply to Texas cases involving learned intermediaries.”
526 F.3d at 214. Thus, Ebel’s argument fails.
After considering the summary judgment record, we agree with the district
court’s conclusion that Ebel has failed to point to evidence establishing that
14
Zyprexa’s warning was the producing cause of Philip’s suicide. Summary
judgment is therefore appropriate.
IV. CONCLUSION
For the reasons stated above, we AFFIRM the district court’s judgment.
15