Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-almd-2_13-cv-00035/USCOURTS-almd-2_13-cv-00035-0/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 28:1332 Diversity-Product Liability

---

IN THE UNITED STATES DISTRICT COURT

FOR THE MIDDLE DISTRICT OF ALABAMA

NORTHERN DIVISION

DANA FIELDS, individually and as )

Natural Parent of D.F., a minor, )

 )

Plaintiff, )

 )

v. ) CASE NO. 2:13-CV-35-WKW

 ) [WO]

ELI LILLY AND COMPANY, )

 )

Defendant. )

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 

 

1

There are other pending motions for summary judgment and to exclude expert 

testimony that are not addressed in this opinion. 

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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 

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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. 

at 324. 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).

III. BACKGROUND

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 

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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.

A. 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 

read:

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.) 

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B. 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 

 

2 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.) 

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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 

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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).)

C. The Birth of D.F.

Mrs. Fields delivered her son, D.F., on January 29, 1997. (Pl.’s Dep.,

at 247.) A congenital heart defect was suspected, and D.F. was airlifted to 

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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®. 

D. 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 

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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®. 

E. This Lawsuit

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 

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misrepresentation; (7) negligence per se; and (8) unfair and deceptive trade 

practices. Lilly has filed this summary judgment motion as to these claims.

IV. DISCUSSION

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 

pregnancy. 

A. 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 

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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 

position. 

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 

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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 

omitted)). 

Not surprisingly, the Federal Rules of Civil Procedure are in harmony with 

the case law. With respect to summary judgment affidavits or declarations, the 

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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.

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1. 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.

2. Personal Knowledge

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. 

3. 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 

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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 

pack). 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 

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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 

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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 

 

3

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. 

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advances no persuasive argument that the testimony of Mr. and Mrs. Fields would 

not be admissible at trial.4

4. Summary

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. 

B. 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”); 

 

4 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.

5

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 . . . .”). 

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Stone v. Smith, Kline & French Labs., 447 So. 2d 1301, 1304–05 (Ala. 1984) 

(adopting the learned-intermediary doctrine in pharmaceutical products liability 

cases). 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 

drug.” Wyeth, Inc. v. Weeks, 159 So. 3d 649, 673 (Ala. 2014). A drug 

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 

 

6

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 

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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.

7 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)).

8

Lilly uses the terminology “warning causation.” (Doc. # 136-1.) 

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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, 

at 19.) 

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, 

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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. 

1992). 

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 

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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 

Prozac®. 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, 

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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 

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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.

1. 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 

 

9

In a subsequently filed summary-judgment motion in this case, Lilly cites Toole

favorably. (Doc. # 136-1, at 16–17.)

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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, 

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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 

law)). 

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 

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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.

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 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 

 

10 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”).

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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 

 

11 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. 

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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. 

2. 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 

 

12 Lilly does not dispute, as a general matter, that Ms. Ledbetter is a “disinterested” and 

“unbiased” witness. (Doc. # 91-1, at 15.) 

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Evidence 406. 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.

3. Summary

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 

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the drug’s risks to Mrs. Fields and she would have not taken the drug. 

Accordingly, Lilly is not entitled to summary judgment. 

V. CONCLUSION

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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