Fields v. Eli Lilly & Company
MEMORANDUM OPINION AND ORDER DENYING Lilly's 90 MOTION for Summary Judgment, as further set out in order. Signed by Chief Judge William Keith Watkins on 7/20/15. (Attachments: # 1 civil appeals checklist)(djy, )
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF ALABAMA
DANA FIELDS, individually and as
Natural Parent of D.F., a minor,
ELI LILLY AND COMPANY,
CASE NO. 2:13-CV-35-WKW
MEMORANDUM OPINION AND ORDER
In this pharmaceutical products liability action, Plaintiff Dana Fields alleges
that her use of Prozac® during her pregnancy in the mid-1990s caused her son,
D.F., to be born with a congenital heart defect.
She brings this action both
individually and as the natural parent of D.F., seeking monetary recovery on
various state-law claims from the drug’s manufacturer, Eli Lilly and Company
(“Lilly”). Before the court is Lilly’s motion for summary judgment. (Doc. # 90.)
Lilly argues that Mrs. Fields cannot establish a genuine dispute of material fact that
she took Prozac® during her pregnancy with D.F. or that, under the learnedintermediary doctrine, Lilly’s warnings about Prozac®, even if inadequate, were
the factual causation of Mrs. Fields’s ingesting Prozac®.1 The parties have fully
There are other pending motions for summary judgment and to exclude expert
testimony that are not addressed in this opinion.
briefed the motion and have submitted evidence in support of their opposing
positions. (Docs. # 91–92, 99, 100, 102.) After careful consideration of the
arguments of counsel, the relevant law, and the submissions of the parties, the
court finds that Lilly’s motion is due to be denied.
I. JURISDICTION AND VENUE
Subject-matter jurisdiction is proper pursuant to 28 U.S.C. § 1332. Personal
jurisdiction and venue are uncontested.
II. STANDARD OF REVIEW
To succeed on summary judgment, the movant must demonstrate “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). The court must view the evidence and
the inferences from that evidence in the light most favorable to the nonmovant.
Jean-Baptiste v. Gutierrez, 627 F.3d 816, 820 (11th Cir. 2010).
The party moving for summary judgment “always bears the initial
responsibility of informing the district court of the basis for its motion.” Celotex
Corp. v. Catrett, 477 U.S. 317, 323 (1986).
This responsibility includes
identifying the portions of the record illustrating the absence of a genuine dispute
of material fact. Id. Or a movant who does not have a trial burden of production
can assert, without citing the record, that the nonmoving party “cannot produce
admissible evidence to support” a material fact. Fed. R. Civ. P. 56(c)(1)(B); see
also Fed. R. Civ. P. 56 advisory committee’s note (“Subdivision (c)(1)(B)
recognizes that a party need not always point to specific record materials. . . . [A]
party who does not have the trial burden of production may rely on a showing that
a party who does have the trial burden cannot produce admissible evidence to carry
its burden as to the fact.”). If the movant meets its burden, the burden shifts to the
nonmoving party to establish – with evidence beyond the pleadings – that a
genuine dispute material to each of its claims for relief exists. Celotex, 477 U.S.
A genuine dispute of material fact exists when the nonmoving party
produces evidence allowing a reasonable fact finder to return a verdict in its favor.
Waddell v. Valley Forge Dental Assocs., 276 F.3d 1275, 1279 (11th Cir. 2001).
On the other hand, “[i]f the evidence is merely colorable or is not significantly
probative, summary judgment may be granted.” Anderson v. Liberty Lobby, Inc.,
477 U.S. 242, 249–50 (1986).
On January 29, 1997, Mrs. Fields gave birth to a son, D.F. The birth of a
child is generally a time of immense joy, but there was little time for celebration
for Mrs. Fields and her husband. Their son, D.F., was born with tetralogy of Fallot
and moderate pulmonary valve insufficiency. Mrs. Fields contends that her son’s
congenital heart defect was caused by her ingestion of the prescription drug
Prozac® during the first eight months of her pregnancy. Mrs. Fields brings an
assortment of state-law claims against Lilly for its alleged tortious conduct in
connection with its manufacturing and marketing of Prozac®. The facts, viewed in
the light most favorable to Mrs. Fields, are as follows.
Prozac® and Its Warning Label
This action focuses on Lilly’s alleged failure to provide adequate warnings
in 1996 about the risks of Prozac® to cause birth defects if used during pregnancy.
Prozac® is a well-known, widely prescribed antidepressant medication
manufactured by Lilly. Also known by its generic name, fluoxetine, Prozac® is in
the class of drugs referred to as selective serotonin reuptake inhibitors, or “SSRIs.”
The U.S. Food and Drug Administration (“FDA”) approved Lilly’s marketing of
the drug in 1987.
During the time frame that Mrs. Fields took Prozac®, the warning label
Pregnancy – Teratogenic Effects – Pregnancy Category B;
Reproduction studies have been performed in rats and rabbits at doses
9 and 11 times the maximum daily human dose (80 mg) respectively
and have revealed no evidence of harm to the fetus due to Prozac.
There are, however, no adequate and well-controlled studies in
pregnant women. Because animal reproduction studies are not always
predictive of human response, this drug should be used during
pregnancy only if clearly needed.
(Doc. # 100-6, at 11; see also Doc. # 99-1, at 24; Doc. # 102, at 5 n.2.)
Mrs. Fields’s Prozac® Use During Her Pregnancy with D.F.
Beginning in 1987, Mrs. Fields’s primary care physician was Jimmy D.
Durden, M.D., who practiced in her hometown of Tallassee, Alabama. Dr. Durden
served as Mrs. Fields’s primary care physician until his death in 2009.
On May 23, 1996, when she was twenty-two years old, Mrs. Fields had an
appointment with Dr. Durden. The medical records document that she complained
of malaise, fatigue, tiredness, and generally of not “feeling good.” Dr. Durden
rendered diagnoses of “anemia and malaise.”2 In the plan section of the record, he
wrote: “I’m going to go ahead and put her on some Chromagen but I’m going to
wait to see her thyroid and chemistry. If they are normal[,] I’m going to start her
on some Prozac, one daily.” (Doc. # 100-2.) This is the only mention of Prozac®
in the medical records produced during discovery. Dr. Durden’s records do not
include the laboratory test results on Ms. Fields’s “thyroid and chemistry” or any
notation by Dr. Durden that he prescribed Prozac® to Mrs. Fields at any time after
the May 23 appointment.
When deposed, however, Mrs. Fields provided additional information about
her May 23 appointment and Prozac® use.
She testified that, during this
appointment, Dr. Durden recommended Prozac® and gave her a starter blister pack
Mrs. Fields testified that, around this time frame, Dr. Durden knew that she was trying
to get pregnant and knew that she had had a miscarriage in 1995, although Mrs. Fields’s
testimony does not indicate whether she discussed her pregnancy plans with Dr. Durden during
the May 23, 1996 appointment. (Pl.’s Dep., at 134, 305–06.)
of Prozac®, as well as a prescription with three refills. (Pl.’s Dep., at 160–64, 220,
225–29 (Doc. # 92-3).) Dr. Durden knew that she was trying to conceive a child
but did not inform her that ingestion of Prozac® during pregnancy posed an
increased risk of birth defects. (Pl.’s Dep. at 306–07.) Mrs. Fields completed her
laboratory tests the same day, but she does not recall learning the results of those
tests. She “just assumed” that the tests were normal – in other words that no news
was good news – and started taking Prozac® shortly after the May 23 appointment.
(Pl.’s Dep., at 220.)
Eleven days later, on June 3, 1996, Mrs. Fields had another appointment
with Dr. Durden and reported a positive pregnancy test. (Doc. # 100-2, at 2; Pl.’s
Dep., at 222–24.) During that appointment, Dr. Durden did not discuss with her
any medications, including her use of Prozac®. (Pl.’s Dep. at 224–25.) Rather, in
accordance with his general practice, that same day, Dr. Durden referred Mrs.
Fields to Ralph Garrard, M.D., an obstetrician and gynecologist in Montgomery,
Alabama, for treatment during her pregnancy with D.F. (Doc. # 100-2, at 2.)
Beginning on June 10, 1996, and throughout her pregnancy, Mrs. Fields remained
under the care of Dr. Garrard.
Mrs. Fields does not recall whether she told Dr. Garrard that she was taking
Prozac®, but she confirms that Dr. Garrard did not prescribe it for her. (Pl.’s Dep.,
at 210–11, 229, 242–43, 248, 252.) Dr. Garrard likewise has no independent
recollection of Ms. Fields’s having informed him that Dr. Durden had prescribed
her Prozac®, and the medical records covering Dr. Garrard’s treatment of her
contain no indication – one way or the other – of Prozac® use by Mrs. Fields.
Additionally, Mrs. Fields had no consultations with Dr. Durden about her
Prozac® use during the time that she was under Dr. Garrard’s care. (Pl.’s Dep.,
at 209–111, 226–27, 229.) Nonetheless, although some of the testimony about the
dosages and number of prescription refills Dr. Durden prescribed is difficult to
follow, Mrs. Fields testified that the starter pack, prescriptions, and refills provided
ample Prozac® to last throughout her pregnancy with D.F., and that she continued
to use Prozac® until approximately her eighth month of pregnancy. She ceased
using Prozac® at that time, not on a physician’s advice, but based on her own
decision because of nausea she experienced during her third trimester. (See Pl.’s
Dep., at 165, 201–07, 210, 226–34.)
Mrs. Fields’s husband, Scott Fields, also has submitted a declaration. He
verifies Mrs. Fields’s use of Prozac® from approximately May 1996 to December
1996 and confirms that, during this time frame, he saw the prescription bottles
labeled “Prozac®.” (Scott Fields’s Decl., at 1 (Doc. # 92-13).)
The Birth of D.F.
Mrs. Fields delivered her son, D.F., on January 29, 1997. (Pl.’s Dep.,
A congenital heart defect was suspected, and D.F. was airlifted to
Children’s Hospital in Birmingham, Alabama. (Pl.’s Dep., at 266.) On January
30, 1997, D.F. was diagnosed with tetralogy of Fallot with moderate pulmonary
valve deficiency. D.F. had his first open-heart surgery when he was six weeks old
and a second open-heart surgery to repair damaged valves when he was around
five years old. He remains under specialized cardiac care and has undergone
multiple heart catheterizations and other procedures to monitor and correct his
congenital heart defect. (Pl.’s Dep., at 267–69, 280; Pl.’s Suppl. Resp. to Interrog.
No. 10 (Doc. # 92-2, at 10).)
It is undisputed that cardiac development occurs during the first trimester of
pregnancy. Mrs. Fields’s first trimester of pregnancy with D.F. occurred from
approximately May 1996 to August 1996, a time period during which Mrs. Fields
says she took Prozac®.
The Absence of Documentary or Other Physical Evidence of Mrs.
Fields’s Prozac® Use
As mentioned, there is a stark absence of documentary or other physical
evidence of Mrs. Fields’s Prozac® use. There are no medical or pharmaceutical
records that indicate that Mrs. Fields ever was prescribed Prozac® or provided
samples of Prozac® at any time before, during, or after her pregnancy with D.F.
There is only a single notation in Dr. Durden’s medical chart on May 23, 1996,
that indicated he would “start [Ms. Fields] on some Prozac, one daily,” if he was
satisfied with the pending laboratory tests as to “her thyroid and chemistry.” (Doc.
# 100-2.) There also are no pharmaceutical records because, according to Mrs.
Fields, the pharmacy in Tallassee where she filled the prescriptions no longer has
those records. (Pl.’s Dep., at 15–16, 209.) Furthermore, Mrs. Fields is unable to
produce “a written doctor’s order or pharmacy record reflecting a prescription for
Prozac.” (Pl.’s Resp. to Req. for Admis., No. 5 (Doc. # 92-11, at 3).) She also has
not produced any bank statement, receipts, or other financial documents reflecting
a purchase of Prozac®.
Mrs. Fields filed this diversity action against Lilly on January 16, 2013,
contending that her use of Prozac® during her pregnancy caused her son’s
congenital heart defect. The dominant theme underlying Mrs. Fields’s state-law
claims is that, during the time frame that she was pregnant with D.F., Lilly failed to
warn adequately of the risks of birth defects associated with the use of Prozac®
during pregnancy. The Complaint alleges multiple claims, some of which Mrs.
Fields now has decided not to “further pursue.” (Doc. # 163-4, at 25 n.65.) The
following claims remain: (1) failure to warn under the Alabama Extended
Manufacturer’s Liability Doctrine (“AEMLD”) (2) negligence; (3) negligent
failure to warn; (4) breach of express warranty; (5) fraud; (6) negligent
misrepresentation; (7) negligence per se; and (8) unfair and deceptive trade
practices. Lilly has filed this summary judgment motion as to these claims.
Lilly’s summary judgment motion is predicated on two grounds. First, Lilly
contends that Mrs. Fields fails to establish a genuine dispute of material fact that
she took Prozac® during her pregnancy with D.F. Second, Lilly argues that, under
Alabama’s learned-intermediary doctrine, Mrs. Fields cannot establish factual
causation on her failure-to-warn claims because there is no testimony from the
prescribing physician – who died four years prior to the commencement of this suit
– that he would not have prescribed Mrs. Fields Prozac® had Lilly warned about
an increased risk of birth defects associated with the use of Prozac® during
Whether There Is a Genuine Dispute of Material Fact that Mrs. Fields
Took Prozac® During Her Pregnancy
Lilly insists that Mrs. Fields’s claims cannot survive summary judgment
based upon her own self-serving testimony, supported only by the equally selfserving testimony of her husband, that Dr. Durden prescribed her Prozac® and that
she took it during her pregnancy with D.F. Lilly argues that Mrs. Fields has no
“hard evidence” to support her and her husband’s testimony that she took Prozac®
during her pregnancy with D.F. (Doc. # 91-1, at 11 (citation and internal quotation
marks omitted).) Lilly highlights the absence of any medical or pharmaceutical
records documenting a prescription for Prozac® or of any physical evidence, such
as even a leftover pill bottle. Lilly sums up the state of the summary judgment
record by emphasizing that, “in all of [Mrs. Fields’s] medical records from the last
twenty-four years, the only reference to Prozac is Dr. Durden’s statement from
May 23, 1996[,] that he was ‘going to wait’ for some test results before he
determined whether or not to prescribe Prozac.” (Doc. # 91-1, at 13.) Based upon
the lack of physical evidence, Lilly argues that the self-serving testimony offered
by Mrs. Fields and her husband is insufficient to raise a genuine dispute of material
fact on an essential element of her causes of action, namely, “proof of use of the
product at issue.” (Doc. # 91-1, at 14.) Mrs. Fields contends, on the other hand,
that the fact that her and her husband’s testimony is self-serving does not
disqualify its consideration on summary judgment. The law supports Mrs. Fields’s
The summary judgment process is not about judging credibility or weighing
the evidence, or even about the certainty of the evidence. The inquiry on summary
judgment is “whether the evidence presents a sufficient disagreement to require
submission to a jury or whether it is so one-sided that one party must prevail as a
matter of law.” Anderson, 477 U.S. at 251–52. Evidence is not so one-sided
merely because it is self-serving. As the Eleventh Circuit has recognized, “[c]ourts
routinely and properly deny summary judgment on the basis of a party’s sworn
testimony even though it is self-serving.” Price v. Time, Inc., 416 F.3d 1327, 1345
(11th Cir.) (collecting cases), as modified on denial of reh’g, 425 F.3d 1292 (11th
Cir. 2005); see also United States v. Davis, 809 F.2d 1509, 1512–13 (11th Cir.
1987) (explaining that “self-serving testimony, by itself” can create a genuine
dispute of material fact). The self-serving nature of testimony is not a bar to its
consideration on summary judgment where the testimony comes from personal
knowledge and sets forth facts that would be admissible in evidence. See Berry v.
Chi. Transit Auth., 618 F.3d 688, 691 (7th Cir. 2010) (“[W]e long ago buried – or
at least tried to bury – the misconception that uncorroborated testimony from the
non-movant cannot prevent summary judgment because it is ‘self-serving.’ If
based on personal knowledge or firsthand experience, such testimony can be
evidence of disputed material facts.” (internal citation and quotation marks
omitted); Santiago-Ramos v. Centennial P.R. Wireless Corp., 217 F.3d 46, 53 (1st
Cir. 2000) (A “party’s own affidavit, containing relevant information of which he
has first-hand knowledge, may be self-serving, but it is nonetheless competent to
support or defeat summary judgment.” (citation and internal quotation marks
Not surprisingly, the Federal Rules of Civil Procedure are in harmony with
the case law. With respect to summary judgment affidavits or declarations, the
federal rules require that they “be made on personal knowledge, set out facts that
would be admissible in evidence, and show that the affiant or declarant is
competent to testify on the matters stated.” Fed. R. Civ. P. 56(c)(1)(4). There is
no prohibition against self-serving testimony. The Rule 56(c)(1)(4) criteria also
are appropriate for gauging whether deposition testimony is admissible on
summary judgment. See Macuba v. Deboer, 193 F.3d 1316, 1323 (11th Cir. 1999)
(holding that Rule 56(e), now Rule 56(c)(1)(4), “also applies to testimony given on
deposition”). Admissibility is not foolproof, however. If the deposition testimony
is “so fantastic, so internally inconsistent, or so speculative that it ha[s] no
probative value,” then the summary judgment standard does not permit its
consideration. Davis, 809 F.2d at 1513.
There is no question that Mr. and Mrs. Fields’s deposition and declaration
testimony is self-serving. But based upon the foregoing principles, the testimony’s
self-serving nature will not bar its consideration at the summary-judgment stage so
long as the deponent (Mrs. Fields) and the declarant (Mr. Fields) are competent,
the testimony is based on personal knowledge, and the testimony contains facts
that would be admissible at trial. These three prerequisites are met.
A Competent Witness
The court need not tarry long on the requirement of a competent witness.
The summary judgment record contains no evidence and no argument has been
made that Mr. and Mrs. Fields are not competent to testify.
Mr. and Mrs. Fields’s testimony is based upon their personal knowledge of
Mrs. Fields’s Prozac® use.
Mrs. Fields provides specific, non-conclusory
testimony about the time frame during which she took Prozac®, who prescribed
her Prozac®, how the pills were packaged, what the pills looked like, the number
of refills permitted for each prescription, the dosage prescribed, and the pharmacy
where she filled the prescriptions. Also, Mr. Fields provides particularized insight
as to the time frame during which Mrs. Fields took Prozac® and gives personal
observations from that time frame, including that he saw the Prozac® pill bottles in
their home and saw Mrs. Fields take the pills.
Admissibility of Testimony
Lilly argues that, even if the self-serving nature of the testimony is not an
impediment to its consideration, the testimony of the Fields contains three other
flaws that preclude its admissibility.
First, Lilly points out that there are internal inconsistencies in Mrs. Fields’s
own testimony (whether she used Prozac® just during her pregnancy with D.F. or
for a longer overlapping time period), as well as inconsistencies between Mrs.
Fields’s testimony and that of her husband’s (including, for example, where in
their home Mrs. Fields stored her prescription medication bottles, what time of day
Mrs. Fields took her Prozac® pills, and how many pills were in the starter blister
Based upon careful review, there lies ample fodder in the summary
judgment record for attacking the credibility of the testimony that Mrs. Fields took
Prozac® during her pregnancy with D.F.
These inconsistencies are not so
contradicting, however, that no reasonable jury could believe the core of the
testimony that Mrs. Fields, in fact, took Prozac® during her pregnancy with D.F.
The inconsistencies in the testimony go to its weight but do not undermine it
sufficiently to preclude a reasonable jury from believing and finding in favor of
Mrs. Fields. The court would be required to reach this conclusion even if it were
inclined to find the testimony suspect. See Miller v. Harget, 458 F.3d 1251, 1256
(11th Cir. 2006) (“Even if the district court believes that the evidence presented by
one side is of doubtful veracity, it is not proper to grant summary judgment on the
basis of credibility choices.”).
Second, Lilly argues that the testimony of Mr. and Mrs. Fields contradicts
the medical and pharmaceutical records such that the testimony is wholly
discredited and fantastical. Lilly relies upon the Supreme Court’s holding in Scott
v. Harris, 550 U.S. 372 (2007), that, “[w]hen opposing parties tell two different
stories, one of which is blatantly contradicted by the record, such that no
reasonable jury could believe it, a court should not adopt that version of the facts
for purposes of ruling on a motion for summary judgment.” Id. at 380. In Scott, a
video recording of law enforcement officers’ pursuit of a fleeing suspect, whose
aggressive maneuvering of his vehicle posed a great danger to other motorists and
pedestrians, “clearly contradict[ed]” the testimony of the criminal suspect (turned
civil plaintiff) that he was abiding by all rules of the road and driving in a
controlled and careful manner. See id. at 378–79. Because the objective video
recording of the police chase so “utterly discredited” the plaintiff’s story to the
degree that “no reasonable jury could have believed him,” the summary judgment
facts were those shown in the video recording, and not those insisted upon by the
plaintiff. Id. at 380–81.
This case is not like Scott. Here, there is an absence of any documentation
in the medical and pharmaceutical records that Dr. Durden prescribed Prozac® to
Mrs. Fields, either during or after the May 23, 1996 appointment. However, the
absence of physical evidence to support a fact is not the same thing as the presence
of physical evidence that directly contradicts a fact.
There is no direct
contradiction in the medical and pharmaceutical records to justify rejecting the
testimony of Mr. and Mrs. Fields.3
The testimony, taken together with Dr.
Durden’s notation in the May 23, 1996 medical record that he would prescribe
Prozac® to Mrs. Fields if the pending laboratory tests for her “thyroid and
chemistry” returned normal results (Doc. # 110-2), supports an inference from
which a reasonable jury could find that Mrs. Fields took Prozac® during her
pregnancy with D.F. The general rule on summary judgment is that “facts must be
viewed in the light most favorable to the nonmoving party.” Scott, 550 U.S.
at 380. Ms. Fields’s version of the facts is not “blatantly contradicted by the
record” so as to warrant an exception to the general rule. Id.
Third, Lilly suggests that a different rule should apply in pharmaceutical
cases where the plaintiff cannot produce medical or prescription records to
substantiate a self-serving affidavit or declaration that he or she actually used the
drug at issue. But the court is unfamiliar with any binding precedent, and none is
cited that sets forth the rule Lilly urges. The few out-of-circuit unpublished district
court cases upon which Lilly relies stand in a different posture from this case, and
none concluded that a plaintiff’s declaration or sworn testimony about his or her
product use was insufficient evidence to defeat summary judgment. In sum, Lilly
There is then no need to decide whether an affirmative notation in a medical or
pharmaceutical record of a physician’s refusal to prescribe Prozac® to the patient would be
analogous to the objective video recording in Scott.
advances no persuasive argument that the testimony of Mr. and Mrs. Fields would
not be admissible at trial.4
Mr. and Mrs. Fields’s testimony, even though self-serving, satisfies the
criteria for consideration on summary judgment. That testimony creates a genuine
dispute of material fact on the issue of product use. Accordingly, Lilly’s motion
for summary judgment on this ground is due to be denied.
Failure-to-Warn Claims and the Learned-Intermediary Doctrine
Lilly next argues that Mrs. Fields’s failure-to-warn claims fail under
Alabama’s learned-intermediary doctrine. Where a plaintiff asserts a claim based
upon a manufacturer’s failure to warn adequately of a drug’s side effects, Alabama
has adopted the learned-intermediary doctrine.5 See Toole v. Baxter Healthcare
Corp., 235 F.3d 1307, 1313–14 (11th Cir. 2000) (observing that Alabama courts
apply the learned-intermediary doctrine “[i]n cases involving complex products,
such as those in which pharmaceutical companies are selling prescription drugs”);
Based upon these findings, it is not necessary to address the opposing arguments
concerning whether the testimony from Mrs. Fields’s sister, concerning a conversation she had
with Mrs. Fields about her (Mrs. Fields’s) Prozac® use, constitutes hearsay or falls within an
exception to the hearsay rule.
The parties do not dispute that Alabama law controls. This court, which sits in
diversity, must adhere to the substantive law of the forum state. See Towne Realty, Inc. v. Safeco
Ins. Co. of Am., 854 F.2d 1264, 1269 n.5 (11th Cir. 1988) (“[W]hen considering a diversity case
under state law, we are bound to decide the case the way it appears the state’s highest court
would . . . .”).
Stone v. Smith, Kline & French Labs., 447 So. 2d 1301, 1304–05 (Ala. 1984)
(adopting the learned-intermediary doctrine in pharmaceutical products liability
Under the learned-intermediary doctrine, “[a] prescription-drug
manufacturer fulfills its duty to warn the ultimate users of the risks of its product
by providing adequate warnings to the learned intermediaries who prescribe the
Wyeth, Inc. v. Weeks, 159 So. 3d 649, 673 (Ala. 2014).
manufacturer has no duty to ensure, therefore, that the adequate warning reaches
the patients to whom the physician prescribes the drug. “The principle behind the
learned-intermediary doctrine is that prescribing physicians act as learned
intermediaries between a manufacturer and the consumer/patient and, therefore, the
physician stands in the best position to evaluate a patient’s needs and assess the
risks and benefits of a particular course of treatment.”
Nail v. Publix Super
Markets, Inc., 72 So. 3d 608, 614 (Ala. 2011).
For purposes of its summary judgment motion only, Lilly assumes that its
warning on the Prozac® label in May 1996 was inadequate and should “have
warned of an increased risk of birth defects” from ingestion of Prozac® during
pregnancy.6 (Doc. # 102-1, at 5 n.2.) The same assumption as to the inadequacy
of the warning will be made for purposes of this opinion.7
Lilly denies that a warning stronger than the one it provided in 1996 was required. If
Lilly ultimately proves that the warning was adequate, then it will prevail under the learnedintermediary doctrine. See Wyeth, 159 So. 3d at 673 (“A prescription-drug manufacturer fulfills
An inadequate warning does not end the inquiry, however. Even when the
warning to the prescribing physician is “inadequate or misrepresents the risk,” the
patient still must prove that the inadequacy of the warning “was the actual and
proximate cause of the patient’s injury.” Wyeth, 159 So. 3d at 673. The focus here
is on factual causation. The court refers to the causation inquiry as “factual
causation” to distinguish the inquiry from “legal causation.”8 “Factual causation,
or ‘but for’ causation, is that part of causation analysis that asks if the complainedof injury or damage would have occurred but for the act or omission of the
defendant.” Springer v. Jefferson Cnty., 595 So. 2d 1381, 1383 (Ala. 1992). On
the other hand, “[p]roximate or legal causation is that part of causation analysis
that asks if ‘the act for which the [defendant] is responsible [is] of such a nature
that courts of law will recognize it as the [cause] of the injury.’” Id. (citation and
internal quotation marks omitted).
its duty to warn the ultimate users of the risks of its product by providing adequate warnings to
the learned intermediaries who prescribe the drug.”). This Memorandum Opinion and Order
expresses no opinion on the adequacy of the warning.
Other courts applying Alabama law have made the same assumption and focused on
causation. See, e.g., Bodie v. Purdue Pharma Co., 236 F. App’x at 511, 519 (11th Cir. 2007)
(“Even were we to assume that Purdue’s warnings and accompanying literature about OxyContin
were, in fact, inadequate and deceptive, . . . Bodie has failed to satisfy his burden of providing
proximate causation between these allegedly flawed warnings and his injury of addiction.”);
Trasylol Prod. Liab. Litig. MDL-1928, No. 08-MD1928, 2011 WL 2117257, at *4 (S.D. Fla.
May 23, 2011) (“[a]ssuming, only for the sake of argument, that Bayer’s warning was inadequate
. . . .” (applying Alabama law)).
Lilly uses the terminology “warning causation.” (Doc. # 136-1.)
While there is a dispute whether Mrs. Fields ever was prescribed Prozac®, it
is undisputed that, if she was, it was Dr. Durden who did so. Thus, under the
learned-intermediary doctrine, the success of Mrs. Fields’s failure-to-warn claims
is contingent upon whether she can show that an adequate warning would have
altered Dr. Durden’s prescribing practices. Lilly contends that, under Alabama’s
learned-intermediary doctrine, Mrs. Fields cannot make that showing. It argues
that the effect of the warnings on Mrs. Fields’s decision of whether to refuse to
take Prozac® is not relevant to the causation equation because, under the learnedintermediary doctrine, the focus is on the warning’s effect on the physician, not on
the patient. (Doc. # 102-1, at 9 n.6.) Lilly says, therefore, that Mrs. Fields fails to
demonstrate that the allegedly inadequate warning caused her to ingest Prozac®.
The culmination of Lilly’s argument is that Dr. Durden is “[t]he only witness
capable of providing testimony necessary to help [Mrs. Fields] meet her burden” of
proving that a different warning would have prevented her ingestion of Prozac®,
but that, prior to his death, “his testimony was never preserved.” (Doc. # 91-1,
To be sure, Alabama law underscores the importance of the prescribing
physician’s perspective in a failure-to-warn case where the learned-intermediary
doctrine is in play, and persuasive federal court authority confirms it. See Bodie v.
Purdue Pharma Co., 236 F. App’x 511, 522 n.12 (11th Cir. 2007) (“The question,
for purposes of [the plaintiff’s] negligent failure to warn action, is whether [the
doctor’s] decision to prescribe OxyContin to [the plaintiff] ultimately hinged on
the information (accurate or inaccurate) that he obtained from Purdue.”); Tatum v.
Schering Corp., 795 F.2d 925, 927 (11th Cir. 1986) (applying Alabama law in a
failure-to-warn action and observing that “[i]t all returns . . . to the critical inquiry
of what Dr. Karst knew” for purposes of causation). Mrs. Fields does not dispute
the law and admits she lacks evidence – either testimonial or documentary –
directly from her prescribing physician who died four years prior to the
commencement of this suit. Recognizing these evidentiary shortcomings, as well
as the dearth of Alabama case law addressing causation on a failure-to-warn claim
where the prescribing physician has died prior to suit, Mrs. Fields argues that the
Alabama Supreme Court, if asked to rule, would align with the Fifth Circuit’s
pronouncements in Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 812 (5th Cir.
Thomas, which involved an interpretation of Mississippi law, is factually
distinct in that the prescribing physician testified at trial.
See id. at 811.
Nonetheless, Mrs. Fields relies upon Thomas because it offered an alternative
method for proving causation, apart from the treating physician’s testimony. The
Fifth Circuit held that a plaintiff can demonstrate causation by introducing “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.” Id. at 812. First, Mrs. Fields points to the testimony of other doctors
concerning the standard of medical practice in the locality during the relevant time
frame as objective evidence “of how a reasonable physician would have responded
to an adequate warning.” Id. Second, she relies upon the deposition testimony of
Dr. Durden’s nurse of twelve years, concerning Dr. Durden’s customs and
practices, as subjective evidence of how Dr. Durden would have responded to an
adequate warning. She argues that this subjective evidence proves that had Lilly
warned Dr. Durden of an increased risk of birth defects posed by Prozac® use
during pregnancy, he would have passed along those warnings to Mrs. Fields, who
he knew was trying to conceive a child, and she would have declined to take
Hence, under either method of proof, Mrs. Fields argues that the
allegedly inadequate warnings are the factual cause of her ingestion of Prozac®.
Alabama courts have not had the occasion to sanction or reject the objectiveevidence standard, and Lilly cites persuasive authority that the objective-evidence
standard in Thomas represents the minority position among courts. See Sauls v.
Wyeth Pharm., Inc., 846 F. Supp. 2d 499, 503 (D.S.C. 2012) (observing that “[n]o
other jurisdiction that adheres to the learned intermediary doctrine has followed the
approach taken by the Fifth Circuit” in Thomas) (citing, among other cases, Schilf
v. Eli Lilly & Co., No. CIV 07–4015, 2010 WL 4024922, at *4 n.3 (D.S.D. Oct. 13,
2010) (“It appears that only the Fifth Circuit has indicated that a plaintiff in some
circumstances might be allowed to supplement the treating physician’s testimony
with objective evidence of how a reasonable physician would have responded to an
adequate warning.”)). Ultimately, the court need not decide whether Alabama’s
highest court would adopt Thomas’s objective-evidence standard in a prescription
drug case involving the learned-intermediary doctrine because the court finds that
Mrs. Fields can proceed under the subjective-evidence standard. But the path to
that finding is a rocky one.
The subjective-evidence standard of how the treating physician would have
responded to an adequate warning finds ample support in Alabama law because,
under Alabama’s “‘learned intermediary doctrine,’ the adequacy of [the drug
manufacturer’s] warning is measured by its effect on the physician . . . to whom it
owed a duty to warn, and not by its effect on [the patient].” Toole v. McClintock,
999 F.2d 1430, 1433 (11th Cir. 1993) (citing Stone, 447 So. 2d at 1304–05).
Nonetheless, the subjective-evidence path that Mrs. Fields trudges brings to the
forefront two other issues under Alabama law. The first is whether Alabama
courts would recognize the theory that Mrs. Fields advances, namely, that had Dr.
Durden received a stronger warning from Lilly about the increased risk of birth
defects from the ingestion of Prozac® during pregnancy, he would have passed
along that warning to Mrs. Fields and, in turn, Mrs. Fields would have declined to
take Prozac®, even if Dr. Durden still had recommended it. The second issue is
whether subjective evidence of how the treating physician would have responded
to an adequate warning can be established with evidence other than the prescribing
physician’s testimony. Lilly says both issues must be answered in the negative. It
contends, first, that, under Alabama law for purposes of the learned-intermediary
doctrine, Plaintiff must show that Dr. Durden would not have prescribed Prozac®
had he been warned adequately and, second, that the evidence to prove this theory
must come from the Dr. Durden himself.
Mrs. Fields’s Theory
Mrs. Fields does not rely upon the Eleventh Circuit’s interpretation of
Alabama’s learned-intermediary doctrine in Toole v. McClintock to argue that she
has a viable theory for proving her failure-to-warn claims. Nor does Lilly mention
Toole in the present briefing.9 The court does not have the benefit, therefore, of
vigorous exchange between adversaries as to Toole’s principles and its
applicability here. Nonetheless, although Toole is not on all fours, the court finds
that there is sufficient reasoning in Toole to permit Mrs. Fields to go forward on
her failure-to warn claims.
In Toole, the plaintiff developed scar tissue around her silicone breast
implants and underwent a closed capsulotomy, a procedure where a surgeon
In a subsequently filed summary-judgment motion in this case, Lilly cites Toole
favorably. (Doc. # 136-1, at 16–17.)
manually compresses the affected breast to rupture the scar tissue. This procedure
ruptured her breast implants, causing serious injuries.
The plaintiff sued the
manufacturer of her breast implants, alleging that it had failed to warn her doctor
of the risk of ruptures during a closed capsulotomy. 999 F.2d at 1431. The jury
returned a verdict in the plaintiff’s favor, and the Eleventh Circuit affirmed the
district court’s denial of the manufacturer’s motion for a directed verdict, rejecting
the manufacturer’s argument that there was “no evidence that a different warning
from [the manufacturer] would have caused [the plaintiff’s physician] to behave
differently.” Id. at 1433.
Applying Alabama’s learned-intermediary doctrine, the Eleventh Circuit
held that a reasonable jury could have found that the manufacturer’s warning
“understated the risks of implant rupture from closed capsulotomies” and that the
jury heard evidence that “a different warning would have caused [the physician] to
warn [the plaintiff] before her augmentation surgery.” Id. (emphasis added).
Hence, the physician would have behaved differently had the manufacturer issued
a stronger warning because he testified that he would have warned the plaintiff of
the risk of implant rupture prior to performing the augmentation surgery. See id.
at 1433 n.6. The further implication in Toole was that had the plaintiff received a
stronger warning from the physician, she would not have consented to breastaugmentation surgery. See id. at 1432–33; see also Barnhill v. Teva Pharm. USA,
Inc., 819 F. Supp. 2d 1254, 1261 (S.D. Ala. 2011) (recognizing that, under
Alabama law, “[t]heoretically,” proof of proximate cause could take the form of
evidence that, “although [the physician] still would have prescribed [the drug], [the
physician] would have changed her behavior or treatment in some way that would
have resulted in a different outcome for the [p]laintiff”); cf. McNeil v. Wyeth, 462
F.3d 364, 373 (5th Cir. 2006) (“Where the physician would have adequately
informed a plaintiff of the risks of a disease, had the label been sufficient, but fails
to do so on that account, and where the plaintiff would have rejected the drug if
informed, the inadequate labeling could be a ‘producing’ cause of the injury,
because it effectively sabotages the function of the intermediary.” (applying Texas
Although Toole involved a failure-to-warn claim in the context of a
physician-provided product, rather than a physician-provided prescription drug,
both Toole and this case involve complex products to which Alabama’s learnedintermediary doctrine applies. This court is bound by Toole, see United States v.
Chubbuck, 252 F.3d 1300, 1305 n.7 (11th Cir. 2001) (noting that the prior
precedent rule applies to the circuit’s interpretation of state law), unless Alabama’s
highest court or an intermediate appellate court has “specifically contradict[ed]” its
holding. Roboserve, Ltd. v. Tom’s Foods, Inc., 940 F.2d 1441, 1451 (11th Cir.
1991); see also Provau v. State Farm Mut. Auto. Ins. Co., 772 F.2d 817, 820 (11th
Cir. 1985) (In a diversity case, where “the state supreme court has not addressed
the issue, a federal court applying state law is bound to adhere to decisions of the
state’s intermediate appellate courts absent some persuasive indication that the
state’s highest court would decide the issue otherwise.” (alterations, citation, and
internal quotation marks omitted)).
Lilly does not cite an Alabama appellate
decision that undermines Toole’s holding with respect to its interpretation of
Alabama’s learned-intermediary doctrine.
Lilly does rely on Wyeth, Inc. v. Weeks, 159 So. 3d 649 (Ala. 2014),
elsewhere in its briefing. In Wyeth, the Alabama Supreme Court summed up the
learned-intermediary doctrine by stating, “[i]n short, the patient must show that,
but for the false representation made in the warning, the prescribing physician
would not have prescribed the medication to his patient.” Id. at 673–74. But
Wyeth addressed an issue very different from the present one. It tackled as a
matter of first impression on a certified question the sustainability of a fraudulent
suppression claim against a brand-name-drug company for injuries suffered by a
generic drug consumer.
Wyeth did not address whether, in a pharmaceutical
failure-to-warn case, evidence that, had the warnings been adequate, the
prescribing physician would have altered his risks discussion with the patient and,
resultantly, the patient would not have taken the drug. That issue simply was not
before the court in Wyeth, and Wyeth does not undermine Toole.
The court finds that, in accordance with Toole, under Alabama’s learnedintermediary doctrine, Mrs. Fields can demonstrate factual causation by proving
that had Lilly given Dr. Durden a stronger warning about the association between
the ingestion of Prozac® during pregnancy and an increased risk of birth defects,
Dr. Durden would have informed Mrs. Fields of the risk and his warning would
have resulted in a different outcome for Mrs. Fields in that she would not have
taken Prozac®. This theory is not predicated on the effect an adequate warning
would have had on Mrs. Fields, but rather upon the effect an adequate warning
would have had on Dr. Durden’s prescribing practices.10
Toole is contrary,
therefore, to Lilly’s argument that the sole method by which to measure a
Florida law also applies the learned-intermediary doctrine for failure-to-warn claims
brought against a drug manufacturer. It is notable that, in cases applying Florida law where there
is evidence that the physician would have conveyed drug warnings to the plaintiff if the drug
manufacturer had provided them, courts have denied summary judgment based upon the
plaintiff’s testimony that he would not have taken the drug if he had been adequately warned.
See Kirchman v. Novartis Pharm. Corp., No. 8:06cv1787-T-24-TBM, 2014 WL 2158519, at *19
(M.D. Fla. May 23, 2014) (collecting cases). In Kirchman, the drug manufacturer argued that
the plaintiff could not establish proximate cause on a failure-to-warn claim because the physician
testified that he still would have prescribed Aredia or Zometa, even if the warnings had been
adequate. The court agreed with the plaintiff’s counterargument that the physician’s decision of
whether to prescribe the drugs “does not control the proximate cause issue.” Id. at *5. It denied
summary judgment on the issue of proximate cause because there was evidence from which “a
reasonable juror could find that [the prescribing physician], had he been adequately warned,
would have changed his prescribing practices by giving different warnings or instructions to [the
plaintiff]” and that the plaintiff, “had he been given different warnings or instructions, would
have declined Aredia and/or Zometa.” Id. Notably, Kirchman cited Toole as persuasive
authority for its holding. See id. at *5 (citing Toole, 999 F.2d at 1433); see also Levine v. Wyeth,
Inc., No. 8:09-cv-854-T-33AEP, 2010 WL 5137424, at *6 n.2 (M.D. Fla. Dec. 10, 2010) (finding
Toole instructive for interpreting Florida law because “both Florida and Alabama apply the
learned intermediary doctrine when analyzing a failure to warn claim against a manufacturer of a
prescription drug or device”).
warning’s effect on the physician is through evidence that the prescribing
physician would not have prescribed the drug had the warnings been adequate.
Moreover, this legal conclusion finds some support in the Alabama Supreme
Court’s treatment of evidence in medical malpractice, informed-consent cases, an
analogy that at least one circuit has found fitting in the pharmaceutical productsliability context.11 In informed-consent cases brought under Alabama law, the
plaintiff’s testimony as to whether he or she would have consented to a procedure
upon full disclosure of the risks is a factor that “may prove helpful to the
factfinder.” Phelps v. Dempsey, 656 So. 2d 377, 381 (Ala. 1995). The rationale of
In Payne v. Novartis Pharmaceuticals Corp., 767 F.3d 526, 532 (6th Cir. 2014), the
Sixth Circuit, applying Tennessee law, addressed whether, in a failure-to-warn case where the
learned-intermediary doctrine applies, the Tennessee Supreme Court would forestall summary
judgment based upon evidence that the plaintiff would have refused to take a drug, where there
was evidence that had the physician known of the drug’s risks, he would have warned the
plaintiff about those risks prior to prescribing the drug. The Sixth Circuit found germane to the
causation analysis that the Tennessee Supreme Court had permitted similar testimony from
plaintiffs in medical malpractice actions where it was alleged that a physician had failed to
obtain the patient’s informed consent prior to performing a procedure.
In informed-consent cases, the Tennessee Supreme Court permits the “‘finder of fact [to]
consider and give weight to the patient’s testimony as to whether the patient would have
consented to the procedure upon full disclosure of the risks.’” Payne, 767 F.3d at 532 (quoting
Ashe v. Radiation Oncology Assocs., 9 S.W. 3d 119, 123–24 (Tenn. 1999)). The Payne court
observed that under Tennessee law, “[c]ausation in both types of cases – informed consent and
failure to warn – ultimately rests with the patient’s decision to take or reject the medication.” Id.
Because “[b]oth types of cases address the same issue,” the Sixth Circuit found “no indication
that the Tennessee Supreme Court would adopt a different standard of proof for essentially the
same link in the causal chain.” Id. Accordingly, the Payne court held that the evidence was
sufficient to send the causation issue to the jury and, as a result, the district court erred by
granting summary judgment in favor of the drug manufacturer.
Phelps fits here as well, and Lilly offers no reason why Alabama’s highest court
would apply a different rationale in pharmaceutical failure-to-warn cases.
The Source of the Evidence to Prove the Theory
The issue turns to whether evidence that the physician would have informed
the patient of the adequate warning, had the manufacturer provided it, must come
directly from the prescribing physician. Mrs. Fields has no testimony from Dr.
Durden, as he is deceased, but instead relies upon the deposition testimony of Ms.
Ledbetter. Ms. Ledbetter worked as a licensed practical nurse for Dr. Durden from
1988 to 2000, participated in the “on-hand care of the patient” in the exam room,
and was familiar with Dr. Durden’s prescribing practices. (Ledbetter’s Dep., at 9–
12 (Doc. # 92-7).) She testified that it was Dr. Durden’s standard practice to
discuss with all of his patients the risks and benefits disclosed on a drug’s package
insert.12 (Ledbetter’s Dep., at 11, 27–28, 34, 86.) Mrs. Fields contends that it is
reasonable to infer from this testimony that had the package insert disclosed that
ingestion of Prozac® during pregnancy increased the risks for birth defects, Dr.
Durden would have disclosed those risks to Mrs. Fields in the course of prescribing
Prozac® to her.
Whether Ms. Ledbetter’s testimony is sufficient to create a jury question on
the theory advanced by Mrs. Fields necessitates a discussion of Federal Rule of
Lilly does not dispute, as a general matter, that Ms. Ledbetter is a “disinterested” and
“unbiased” witness. (Doc. # 91-1, at 15.)
The Rule 406 issue is whether Ms. Ledbetter’s testimony
establishes that Dr. Durden had a habit of conveying to his patients all of the risks
of a prescription drug so as to prove that Dr. Durden would have acted in
accordance with that habit in his course of treating Mrs. Fields in May 1996. See
Fed. R. Evid. 406. “Habit . . . describes one’s regular response to a repeated
specific situation.” United States v. Aguirre, 368 F. App’x 979, 990 (11th Cir.
2010) (citation and internal quotation marks omitted). Mrs. Ledbetter’s testimony
is that, based upon her twelve years of professional employment with Dr. Durden,
she observed that he diligently read the package inserts accompanying prescription
drugs and that he discussed with his patients the risks and benefits of all
medications he prescribed. Lilly has not refuted this evidence as insufficient to
raise a genuine dispute of material fact concerning Dr. Durden’s prescribing habits
for purposes of Rule 406. On this record and in the absence of persuasive legal
arguments by Defendant, the court declines to enter summary judgment.
Mrs. Fields has established a genuine dispute of material fact on factual
causation under Alabama’s learned-intermediary doctrine.
There is sufficient
evidence demonstrating that, if Lilly had provided adequate warnings (and even if
Dr. Durden still would have recommended Prozac® to Mrs. Fields), Dr. Durden
would have changed his treatment practices by passing along adequate warnings of
the drug’s risks to Mrs. Fields and she would have not taken the drug.
Accordingly, Lilly is not entitled to summary judgment.
For the foregoing reasons, Mrs. Fields has raised a genuine dispute of
material fact as to whether she took Prozac® during her pregnancy with D.F. and
as to factual causation under Alabama’s learned-intermediary doctrine.
Accordingly, it is ORDERED that Lilly’s motion for summary judgment (Doc.
# 90) is DENIED.
DONE this 20th day of July, 2015.
/s/ W. Keith Watkins
CHIEF UNITED STATES DISTRICT JUDGE
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