Ackermann v. Wyeth Pharmaceuticals

IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT United States Court of Appeals
Fifth Circuit

FILED
April 24, 2008

No. 06-41774 Charles R. Fulbruge III
Clerk

ROZLYN ACKERMANN,
Individually and as Personal Representative of
Martin Lindsey Ackermann, Deceased

Plaintiff-Appellant
v.

WYETH PHARMACEUTICALS

Defendant-Appellee

Appeal from the United States District Court
for the Eastern District of Texas

Before JONES, Chief Judge, and WIENER and CLEMENT, Circuit Judges.
EDITH H. JONES, Chief Judge:
Appellant Rozlyn Ackermann (“Ackermann”) challenges the district court’s
grant of summary judgment dismissing her claim that Wyeth Pharmaceuticals
(“Wyeth”) failed adequately to warn about the drug-induced risk of suicide from
its drug Effexor, and this deficiency led to her husband’s suicide. Because
Ackermann has failed to demonstrate causation under the learned-intermediary
doctrine, we affirm.
I. BACKGROUND
In November 2001, Martin Ackermann (“Martin”), a 53-year-old
businessman, suffered from clinical depression brought on by severe business
 No. 06-41774

and family problems. Martin initially sought treatment from his personal
physicians and began taking the prescription antidepressant drug Celexa.
Acting on a friend’s advice, Martin sought treatment from psychiatrist
Dr. Thomas Sonn on January 4, 2002. Martin saw Dr. Sonn four times in the
following eight days. During that time, Dr. Sonn changed Martin’s medication
and gave him a sample trial pack1 of another antidepressant, Effexor XR.2 Sonn
instructed Martin to take one low-dose 37.5-milligram pill each day as he
monitored him. Martin took one 37.5-milligram pill for three days, then took one
therapeutic-dose 75-milligram pill each day from January 9 to January 12.
On January 12, Martin complained to Dr. Sonn of various side effects he
attributed to Effexor, including akathisia3 and anxiety. Martin announced he
would no longer take the medication and terminated his relationship with
Dr. Sonn. Nevertheless, Dr. Sonn changed Martin’s medication from Effexor to
Celexa because of the side effects. Martin continued to take Celexa for five days
until January 17, 2002, when he committed suicide with a revolver. At the time
of his death, Martin had detectable levels of Celexa, but not Effexor, in his
bloodstream.

1
The sample trial pack, supplied by Wyeth, included seven 37.5-milligram pills, and
seven 75 milligram pills. The range of recommended doses for treating depression with Effexor
is from 75 to 225 milligrams.
2
Effexor is a member of the class of drugs referred to as “selective serotonin and
norepinephrine reuptake inhibitors” (“SNRI”). SNRIs are used to treat major depressive
disorder, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, and
social anxiety disorder. The FDA generally groups Effexor with the selective serotonin
reuptake inhibitor (“SSRI”) class of antidepressants, which includes Celexa, Prozac, Paxil, and
Zoloft. “XR” simply stands for “extended release.”
3
Akathisia, or inability to sit still, is a neurological phenomenon with characteristics
of intense internal restlessness, agitation, and feelings of unease or discomfort.

2
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Rozlyn Ackermann, his widow, sued Wyeth, the manufacturer of Effexor,
in July 2004, pleading causes of action under strict liability, negligence
(including failure to warn), and implied warranty theories under common law
and the TEXAS DECEPTIVE TRADE PRACTICES-CONSUMER PROTECTION ACT
(“DTPA”).4 She also pleaded breach of express warranty, fraud, and
misrepresentation.
Wyeth initially moved for partial summary judgment, arguing that
Ackermann’s failure-to-warn claims conflicted with and were preempted by
federal law. Dr. Sonn then testified at deposition that he believed the package
insert for Effexor as it existed in January 2002 adequately warned him of the
risks of suicide and that he would continue to prescribe the drug to depressed
patients. In June 2006, Wyeth filed a separate motion for summary judgment
on all claims. Regarding the warnings-based claims, Wyeth asserted a defense
based on the learned-intermediary doctrine and, alternatively, on the statutory
presumption of non-liability created by section 82.007(a) of the TEXAS CIVIL
PRACTICE & REMEDIES CODE. Wyeth argued that summary judgment was
appropriate for Ackermann’s implied and express warranty claims under
common law and the DTPA because no sale of the product had occurred, and

4
Notably, she declined to name Forest Laboratories, Inc., the manufacturer of Celexa,
as a party to this lawsuit or in a separate lawsuit. The Complaint indicates that “[p]ursuant
to a presuit agreement between the parties, limitations was contractually tolled to explore
settlement possibilities,” and that the suit against Wyeth was timely filed within the extended
limitations period. Only an incomplete explanation is given by Ackermann regarding the
omission of Forest Laboratories as a party:

[B]ecause this claim was initiated on the eve of limitations, and further because
Wyeth chose not to name Forest Laboratories, Inc., the manufacturer of Celexa
as a “responsible third party” within the meaning of § 33.004(a), TEX. CIV. PRAC.
& REM. CODE, Forest Laboratories could not be joined and the jury would not be
permitted to allocate fault or causation to Celexa.

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because she had failed to identify an express warranty that had been breached.
Finally, Wyeth argued that summary judgment was appropriate regarding her
fraud and misrepresentation claims because she had failed to identify specific
misrepresentations.
The magistrate judge first recommended that the district court grant
Wyeth’s motion for partial summary judgment based on preemption.
Subsequently, the magistrate judge recommended that the district court grant
Wyeth’s June 2006 motion for summary judgment on all claims, adopting, inter
alia, Wyeth’s learned-intermediary doctrine theory for the failure-to-warn
claims. Ackermann filed various objections. The district court overruled her
objections, adopted the magistrate judge’s recommendation to grant summary
judgment for all claims — including the failure-to-warn claims based on the
learned-intermediary doctrine — and dismissed the lawsuit. The magistrate
judge, in turn, vacated as moot his report recommending partial summary
judgment based on preemption.
Ackermann timely appealed. The only issue before this court is whether
the learned-intermediary doctrine bars her strict-liability and failure-to-warn
claims. She does not challenge the district court’s conclusions regarding her
express and implied warranty, fraud, and misrepresentation claims. Wyeth
responds that the district court correctly applied the learned-intermediary
doctrine, but it alternatively requests that this court affirm the district court on
preemption grounds, should we hold that the learned-intermediary doctrine is
inapplicable.
II. DISCUSSION
We review a grant of summary judgment de novo. Ford Motor Co. v. Tex.

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Dep’t of Transp., 264 F.3d 493, 498 (5th Cir. 2001). “Summary judgment is
proper ‘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 FED.
R. CIV. P. 56(c)). “The evidence and inferences from the summary judgment
record are viewed in the light most favorable to the nonmovant.” Minter v. Great
Am. Ins. Co. of N.Y., 423 F.3d 460, 465 (5th Cir. 2005). But “[w]here 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.” Whiting v. Univ. of S. Miss., 451 F.3d
339, 344 (5th Cir. 2006) (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 322
(1986)).
The learned-intermediary doctrine states that, in some situations, a
warning to an intermediary fulfills a supplier’s duty to warn consumers. See
Alm v. Aluminum Co. of Am., 717 S.W.2d 588, 591–92 (Tex. 1986). “In Texas,
the most common use of this doctrine is in prescription drug cases.” Wyeth-
Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87, 91 (Tex. App.-Texarkana 2000, no
writ) (citations omitted). Under the doctrine, a patient-purchaser’s doctor stands
between the patient and the manufacturer, professionally evaluating the
patient’s needs, assessing the risks and benefits of available drugs, prescribing
one, and supervising its use. Id. If the doctor is properly warned of the
possibility of a side effect and is advised of the symptoms normally
accompanying the side effect, it is anticipated that injury to the patient will be
avoided. Accordingly, the doctrine excuses a drug manufacturer “from warning

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each patient who receives the product when the manufacturer properly warns
the prescribing physician of the product’s dangers.” Porterfield v. Ethicon, Inc.,
183 F.3d 464, 467–68 (5th Cir. 1999).
The learned-intermediary doctrine is not an affirmative defense. Under
Texas law, it delineates to whom a defendant — usually a prescription drug
manufacturer — owes the duty to warn, but it is not used to show that the
plaintiff has no valid case. Medrano, 28 S.W.3d at 94; see also Harrison v. Am.
Home Prods. Corp. (In re Norplant Contraceptive Prods. Liab. Litig.), 165 F.3d
374, 378 (5th Cir. 1999) (making an Erie guess that the Texas Supreme Court
would hold that the learned-intermediary doctrine is a common-law doctrine
rather than a common-law defense). Thus, “when the warning to the
intermediary is inadequate or misleading, the manufacturer remains liable for
injuries sustained by the ultimate user.” Alm, 717 S.W.2d at 592.
To recover for failure to warn under this doctrine, a plaintiff must show
that (1) the warning was defective, and (2) the failure to warn was a producing
cause of the injury. Porterfield, 183 F.3d at 468.5 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.” McNeil, 462 F.3d at 372 (internal quotations omitted). If,
however, “the physician was aware of the possible risks involved in the use of the

5
The Complaint alleges both strict-liability and negligence claims. “Negligence requires
a showing of proximate cause, while producing cause is the test in strict liability.” Union
Pump Co. v. Allbritton, 898 S.W.2d 773, 775 (Tex. 1995). But “[c]ommon to both proximate
and producing cause is causation in fact, including the requirement that the defendant’s
conduct or product be a substantial factor in bringing about the plaintiff’s injuries.” Id. The
learned-intermediary doctrine applies to both strict-liability and negligence claims. Burton v.
Am. Home Prods. Corp. (In re Norplant Contraceptive Prods. Liab. Litig.), 955 F. Supp. 700,
709 (E.D. Tex. 1997), aff’d 165 F.3d 374 (5th Cir. 1999).

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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.
Porterfield, 183 F.3d at 468. “Even if the physician is not aware of a risk, ‘the
plaintiff must show that a proper warning would have changed the decision of
the treating physician, i.e., that but for the inadequate warning, the treating
physician would have not used or prescribed the product.’” Dyer v. Danek Med.,
Inc., 115 F. Supp. 2d 732, 741 (N.D. Tex. 2000) (quoting Willett v. Baxter Int’l,
Inc., 929 F.2d 1094, 1099 (5th Cir. 1991)); see also Burton v. Am. Home Prods.
Corp. (In re Norplant Contraceptive Prods. Liab. Litig.), 955 F. Supp. 700,
710–11 (E.D. Tex. 1997) (applying the Willett standard to Texas law); Medrano,
28 S.W.3d at 95.
“In prescription drug cases involving the learned intermediary doctrine,
. . . when ‘a warning specifically mentions the circumstances complained of, the
warning is adequate as a matter of law.’” McNeil, 462 F.3d at 368 (quoting
Rolen v. Burroughs Wellcome Co., 856 S.W.2d 607, 609 (Tex. App.-Waco 1993,
writ denied)). Here, the January 2002 package insert warning mentions the risk
for suicide twice.6 The first instance states that suicide risk is “inherent in
depression and may persist until significant remission occurs,” and cautions that
“[c]lose supervision of high-risk patients should accompany initial drug therapy.”
More importantly, the second instance identifies the frequencies of suicidal
behavior observed in patients taking Effexor and lists “suicide attempt” as
occurring “infrequent[ly].” “Infrequent” occurrences are defined as those
“occurring in 1/100 to 1/1000 patients” in Wyeth’s premarketing assessment.

6
It should be noted that Wyeth did change the warning label for Effexor in 2003 and
2004, the latter requested by the FDA, but both changes occurred after Martin’s death.

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Suicide ideation or attempts were not listed as adverse events documented in
postmarketing reports.7
Ackermann nonetheless contends that “there was nothing in the Effexor
label to suggest that Effexor ‘may produce’ suicidality or any of its known
precursors,” and characterizes this as a “no warnings” case. She is incorrect.
The package insert identified the possible risk for suicide twice, including listing
suicide attempt as infrequent and quantifying the risk according to its pre-
marketing research. Taken together, the insert’s discussions of suicide establish
that at least some risk of suicide exists when a patient takes Effexor. But “if the
manufacturer decides to label a risk as ‘comparatively rare’ and also to provide
a numerical quantification of that risk, that number must be within a certain
degree of accuracy. . . . The issue is therefore whether there is a genuine issue
of material fact as to whether the label was misleading.” McNeil, 462 F.3d at
368–69.
An issue of fact may exist regarding whether there were significant
differences between the disclosed risk and the actual risk of suicide known by
Wyeth in January 2002. We need not determine, however, whether the warning
for risk level of suicide was misleading, because, as Wyeth contends, this appeal
is resolved on the second prong of the analysis, namely, whether any defect in
the Effexor warning was a substantial cause of Martin’s death. Porterfield,
183 F.3d at 468.
The learned-intermediary doctrine bars Ackermann’s claims if she cannot
show that the allegedly inadequate warning was a producing cause of her

7
The 2002 version of the Physician’s Desk Reference upon which Dr. Sonn relied
reiterated the same general and specific warnings given in the Effexor package insert.

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husband’s death. There must be a genuine issue of material fact whether
Dr. Sonn would have prescribed Effexor had the warning been “adequate.” To
carry her burden in defeating summary judgment, Ackermann first argues that
Dr. Sonn’s testimony about the certainty of his decision to prescribe Effexor even
with a more complete warning was inconsistent. Alternatively, she contends
that a Texas “read-and-heed” presumption overcomes the doctor’s testimony by
presuming that when an adequate warning is given by the manufacturer, it is
heeded by the learned intermediary. We address each argument in turn.
A. Dr. Sonn’s Testimony
In her opposition to Wyeth’s summary judgment motion, Ackermann
proposed a specific warning for suicide risk that she contended Wyeth should
have provided in January 2002.8 Because Dr. Sonn had not been examined by
either party regarding that proposed warning in his December 2005 deposition,
Wyeth obtained permission from Ackermann to ask Dr. Sonn ex parte to review
the postulated warning.9 Dr. Sonn then executed a sworn declaration stating

8
The proposed warning was framed in a hypothetical question directed to Dr. Sonn to
determine whether he would have acted differently had he been given a different warning
regarding Effexor’s risk for suicide, which is a key element in evaluating a learned-
intermediary defense. The pleading proposed this question:

“Dr. Sonn, if my client had issued a prominent warning to caution you that, in
a ‘small vulnerable sub-population’ of patients, Effexor can trigger suicide, and
had ‘brought home’ that warning to you via (i) bold faced or ‘black boxed’
wording in the package insert, (ii) a ‘Dear Doctor’ letter, and/or (iii) visits from
your Wyeth sales representative, would you have (a) heeded that warning, or (b)
ignored it?”
9
Ackermann insinuates throughout her briefs that this ex parte contact taints the
relevance and trustworthiness of the statement. But she does not challenge the district court’s
consideration of this evidence on summary judgment. In particular, Ackermann did not move
under Rule 56(f) to depose Dr. Sonn again. Therefore, any issue related to the ex parte
communications between Wyeth and Dr. Sonn is waived. See Askanase v. Fatjo, 130 F.3d 657,

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that he had reviewed the proposed warning and concluded:
If the [proposed] warning . . . had been communicated to me
effectively and in a prominent manner before I prescribed Effexor
XR to Martin Ackermann in January 2002, I would have considered
or heeded it just as I consider or heed any warning, but it would not
have changed my decision to prescribe Effexor XR to Martin
Ackermann to treat his depression, beginning with low-dose pills.
It also would have not changed my decision to monitor and observe
Martin Ackermann closely for suicide-related risks as I did by,
among other things, (a) seeing him in person four times in the eight
days he was my patient, and (b) providing contact information and
asking that I be informed immediately of any changes in his
behavior.
Dr. Sonn continued:
If there were a legal requirement that I communicate the
[proposed] warning . . . directly to a patient, I would comply with
that requirement. Otherwise, and as I did with Martin Ackermann,
I would address the suicide-related risks reflected in that warning
by close monitoring and observation, rather than through
discussions with the patient expressly mentioning the risk of suicide
or drug-triggered suicide.
Ackermann relies on this court’s reasoning in McNeil to suggest that these
statements are in conflict and create an issue of fact regarding causation. In
McNeil, the prescribing doctor gave conflicting testimony regarding whether he
would have prescribed Reglan had he known of significant risks associated with
the drug. 462 F.3d at 372. He said he would have prescribed the drug and
alerted the patient to “significant” risks had he been aware of them, but he also
stated that he would not have prescribed the drug had the label stated that the

668 (5th Cir. 1997) (“All issues not briefed are waived.”); see also Edwards v. Johnson, 209 F.3d
772, 776 n.1 (5th Cir. 2000) (if petitioner does not assign error to certain findings of the district
court in its initial brief on appeal, then “any challenge to these findings has been abandoned
on appeal”).

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benefits decrease while the risks increase with prolonged use. Id. On this basis,
the court held there was a genuine issue concerning whether the doctor would
have prescribed Reglan if given a proper warning.
Dr. Sonn gave no such contradictory testimony; his testimony was
unequivocal. In his deposition and in his later declaration, Dr. Sonn affirmed
that he would have prescribed Effexor to Martin and adhered to the treatment
regimen he used regardless whether he had received the proposed stronger
warning.10 In December 2005, he testified that he would not have warned
Martin about the possibility of an increased risk of suicide primarily based on
his belief that the suggestion would either plant seeds in the patient’s mind that
suicide was an option or would discourage the patient from pursuing
pharmacological treatment. He testified that his medical training regarding
clinical depression and his experience from treating other patients with Effexor
made him aware of the need to monitor depressed patients for suicide ideation,
but that he also read the warnings regarding the risk of suicide and believed
they were adequate and did not provide him with new information. Other than
some possible future legal requirement mandating that he tell patients about
potential increased risk for suicide, Dr. Sonn stated that he would continue his
normal practice of balancing the risks and benefits of the drug with the
treatment needs of the patient when deciding what to disclose to patients.11

10
This was established so many times during the deposition that when counsel for
Wyeth asked Dr. Sonn toward the end of the deposition whether, given everything he knew in
December 2005, would he still have prescribed Effexor to Martin, Ackermann’s counsel
objected on the grounds that the question was “hopelessly, hopelessly repetitive.”
11
Dr. Sonn knew about ongoing discussions regarding the possible suicide-inducing
effects of drugs such as Effexor, and that some patients on Effexor had exhibited suicide
ideation when he prescribed Effexor to Martin. But based on his analysis of Martin, and the

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Dr. Sonn was asked to review the warning label accompanying Effexor
that was in effect at the time of his deposition in December 2005, which included
a “black box” warning for potential increased suicide in children and
adolescents.12 When asked if the black box warning would change his practice
with adults, he responded that he “wouldn’t feel medically that [providing
specific suicide warnings] was indicated.” When asked a follow-up question in
August 2006 about a proposed similar warning for adults, Dr. Sonn reiterated
his prior testimony and confirmed that “it would not have changed [his] decision
to prescribe Effexor XR to Martin Ackermann to treat his depression.”
Ackermann argues that Dr. Sonn’s testimony, like the doctor’s testimony
in McNeil, is conflicting. She points to his comment: “If there were a legal
requirement that I communicate the warning set forth . . . . directly to a patient,
I would comply with that requirement.” She contends that a legal requirement

normally accepted medical procedure for monitoring such patients and slowly building their
exposure to drugs such as Effexor, he stated additional warnings would not have changed his
decision to prescribe the drug. Dr. Sonn’s testimony is unwavering that whatever the warning,
short of a legally mandated warning, he would have adhered to the accepted medical practice
of refraining from mentioning suicide ideation to a depressed patient, prescribing the drug, and
monitoring the patient’s condition and dosage amounts.
The record is also clear that Dr. Sonn only gave Martin extremely low dosage, non-
therapeutic amounts of Effexor in order to first monitor his reaction to the drug. Dr. Sonn also
acknowledged that Effexor had a much better professional reputation vis-a-vis other similar
drugs, and he took the drug himself. Thus, Ackermann’s argument that Dr. Sonn’s testimony
is unclear whether he would have prescribed the same low dosage Effexor if it carried a
different warning is unsupported by the record.
12
A “black box” warning is the strongest warning that the U.S. Food and Drug
Administration requires. Black-box warnings reveal “[c]ertain contraindications or serious
warnings, particularly those that may lead to death or serious injury” and “ordinarily must be
based on clinical data.” 21 C.F.R. § 201.57(c)(1). In January 2002, Wyeth was forbidden from
providing a “black box” warning because “[t]o ensure the significance of boxed warnings in drug
labeling, they are permitted in labeling only when specifically required by the FDA.” Labeling
and Prescription Drug Advertising; Content for Format for Labeling for Human Prescription
Drugs, 44 FED. REG. 37,434 at 37,448 (June 26, 1979) (codified at 21 C.F.R. pts. 201–02).

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to communicate warnings is implicit within the learned-intermediary doctrine.
While the manufacturer can rely upon an intermediary to fulfill the
manufacturer’s duty to warn, “this reliance seems less reasonable where the
learned intermediary fails to pass necessary information to the patient because
the manufacturer has understated the degree of risk.” McNeil, 462 F.3d at 373
n.6. Because she construes this as a “no warnings” case, she argues that Wyeth
“completely sabotaged” the intermediary, who, in turn, failed to warn Martin of
the risk of suicide. For this reason, she views Dr. Sonn’s testimony that he
would have given a required warning to mean, “if Wyeth had given me a
warning, I would have warned.”13 This interpretation, however, is incompatible
with Dr. Sonn’s testimony that his treatment protocol would not have changed
and he still would have prescribed Effexor regardless of the warning given by the
manufacturer. Ackermann’s interpretation fails because (1) the warnings for
Effexor did include warnings of the risk of suicide, and (2) Dr. Sonn was aware
of the risk for suicide, not just from reading the warning label for Effexor, which
mentioned the risk for suicide twice, but also from his training and experience
as a psychiatrist treating depressed patients. Under McNeil, no genuine issue
of material fact exists regarding whether the inadequacy of the warning was a
producing cause of her husband’s death. Dr. Sonn would have prescribed Effexor
even had the warning been stronger.
B. “Read-and-Heed” Presumption
Appellant also contends that, regardless of Dr. Sonn’s testimony, Texas

13
If there is any conflict in Dr. Sonn’s testimony, it may be attributable to the fact that
during his deposition, he appears to have been under the impression that he was required to
dispense “black box” warnings to patients. But in 2002, Wyeth was forbidden by the FDA from
providing a black box warning. Further, the FDA has to date required “black box” warnings
for Effexor only when prescribed to pediatric patients.

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law creates a presumption of supporting a causal link between Wyeth’s
inadequate warning and her husband’s death.14 Texas law creates no such
presumption.
In general, “when a manufacturer fails to give adequate warnings or
instructions, a rebuttable presumption arises that the product user would have
read and heeded such warnings or instructions (the ‘read and heed
presumption’).” Koenig v. Purdue Pharma Co., 435 F. Supp. 2d 551, 556 (N.D.
Tex. 2006) (quoting Magro v. Ragsdale Bros., 721 S.W. 2d 832, 834 (Tex. 1987));
see also RESTATEMENT (Second) OF TORTS § 402A cmt. j (1977). The read-and-
heed presumption’s effect “is to shift the burden of producing evidence to the
party against whom it operates.” Gen. Motors Corp. v. Saenz ex rel. Saenz,
873 S.W.2d 353, 359 (Tex. 1993).15
But neither Texas nor federal courts applying Texas law have applied the
read-and-heed presumption to pharmaceutical cases involving learned
intermediaries. In fact, Texas has explicitly rejected the RESTATEMENT (SECOND)

14
Specifically, she argues that the learned intermediary is substituted as the end
product user in prescription drug cases and, therefore, the read-and-heed presumption helps
her fulfill her burden of establishing Wyeth’s inadequate warning as the producing cause of
her husband’s death. The cases cited by Ackermann do not apply Texas law.
15
Ackermann argues that a corollary to the “read-and-heed” presumption is that a
defendant can rebut the presumption by offering evidence that a reasonably prudent physician
would ignore the adequate warning and still prescribe the drug. In Thomas v. Hoffman-
LaRoche, Inc., 949 F.2d 806, 812 (5th Cir. 1992), this court stated that under the learned-
intermediary doctrine, a plaintiff may satisfy the burden of demonstrating warning causation
by producing either objective evidence of how a reasonable physician would have responded
to an adequate warning, or subjective evidence of how the treating physician would have
responded. Thomas, however, applied Mississippi law. Even if Ackermann had argued here
for the objective standard to show causation, she failed to produce any objective evidence that
a reasonably prudent physician would not have prescribed Effexor had that doctor been
adequately warned. And in any event, as we explain, Texas has not adopted the heeding
presumption to which this corollary might allegedly apply.

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OF TORTS § 402A, Comment j’s “read-and-heed” presumption for policy reasons
and because it has been superseded by RESTATEMENT (THIRD) OF TORTS:
PRODUCTS LIABILITY § 2. See Uniroyal Goodrich Tire Co. v. Martinez, 977
S.W.2d 328, 336–37 (Tex. 1998). Additionally, the relevant cases show the
plaintiff bore the burden of showing that the inadequacy of the warning was a
producing cause of injury. See Porterfield, 183 F.3d at 468; Skotak v. Tenneco
Resins, Inc., 953 F.2d 909, 912–13 (5th Cir. 1992); Koenig, 435 F. Supp. 2d at
556–57 (stating expressly that the read-and-heed presumption does not apply in
cases involving learned intermediaries); Gerber v. Hoffmann-La Roche Inc., 392
F. Supp. 2d 907, 921–22 (S.D. Tex. 2005); Dyer, 115 F. Supp. 2d at 741; Medrano,
28 S.W.3d at 95; Stewart v. Janssen Pharmaceutica, Inc., 780 S.W.2d 910, 911
(Tex. App.-El Paso 1989, writ denied).16
Further, we doubt the Texas Supreme Court would apply such a
presumption here, when it would not serve its intended purposes. The read-and-
heed presumption has been justified because
[i]t excuses plaintiff from the necessity of making self-serving
assertions that he would have followed adequate instructions,
simply to put the issue of causation in sufficient dispute to avoid
summary judgment or directed verdict, and it assists plaintiffs in
cases where the person injured has died and evidence of what he
would have done is unavailable for that reason.
Saenz, 873 S.W.2d at 359. In the learned-intermediary context, however, it is

16
But cf. Anderson v. Sandoz Pharm. Corp., 77 F.Supp. 2d 804, 809 (S.D. Tex. 1999)
(stating that Texas law supplies a “read-and-heed” presumption). To support this conclusion,
Sandoz cites Technical Chemical Co. v. Jacobs, 480 S.W.2d 602 (Tex. 1972). But Jacobs does
not state explicitly whether Texas adopted the presumption, only stating in dicta that some
have suggested it should. Id. at 606. Moreover, Jacobs was not a pharmaceuticals case
involving learned intermediaries. For these reasons, Sandoz is not a reliable guide to Texas
law.

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Dr. Sonn, not Ackermann or her husband, who had to testify about his decision
to prescribe Effexor. One federal court speculated that the Texas Supreme Court
would agree with other courts, including this court, that have held “to ‘read and
heed,’ in the context of a learned intermediary, means only that the physician
would have incorporated the additional risk into his decisional calculus.”
Koenig, 435 F.Supp. 2d at 557.17
Further, even if the presumption applied, it would not change the result
here. No genuine issue of material fact exists regarding whether the inadequacy
of the warning was a producing cause of her husband’s death because Dr. Sonn’s
testimony rebuts the read-and-heed presumption.18 Dr. Sonn has remained firm
in stating that even if Ackermann’s proposed “black box” warning had been given
to him, he “would have considered or heeded it just as [he] consider[s] or heed[s]
any warning, but it would not have changed [his] decision to prescribe Effexor
XR to Martin Ackermann to treat his depression.” But as we note, the read-and-
heed presumption does not apply to Texas cases involving learned
intermediaries.
For these reasons, we conclude the district court properly granted

17
Commenting on various cited federal cases, Koenig further stated: “In these cases, the
plaintiffs bore the burden of production on causation. Though not stated specifically in the
Texas cases . . . this is the likely analysis applied by Texas courts as well. See [Medrano],
28 S.W.3d at 95 (“In a failure to warn case that is governed by the learned intermediary
doctrine . . . the plaintiff must still prove causation.”). 435 F. Supp. 2d at 557 (emphasis in
original; citation omitted).
18
Appellant points to statements in Dr. Sonn’s deposition testimony that he heeds other
warnings even when he has no experience of patients exhibiting those side effects. For
instance, Dr. Sonn heeds the warning that Ritalin may induce psychosis, even though Dr. Sonn
has never had a patient demonstrate that symptom after taking Ritalin. But Ritalin would
seem to be different from an antidepressant drug where patient suicide is always a risk, and
where, according to Dr. Sonn, there is a specific, accepted practice of monitoring dosage and
patient behavior while the drug is prescribed.

16
 No. 06-41774

summary judgment to Wyeth on appellant’s failure-to-warn and strict-liability
claims because she failed to show that an inadequate warning was a producing
cause of her husband’s death. We pretermit discussion of Wyeth’s Texas
statutory and federal preemption arguments.
The judgment of the district court is AFFIRMED.

17