W. KEITH WATKINS, Chief Judge.
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 learned-intermediary doctrine, Lilly's warnings about Prozac®, even if inadequate, were the factual causation of Mrs. Fields's ingesting Prozac®.
Subject-matter jurisdiction is proper pursuant to 28 U.S.C. § 1332. Personal jurisdiction and venue are uncontested.
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, 106 S.Ct. 2548, 91 L.Ed.2d 265 (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. at 324, 106 S.Ct. 2548. 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, 106 S.Ct. 2505, 91 L.Ed.2d 202 (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.
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."
During the time frame that Mrs. Fields took Prozac®, the warning label read:
(Doc. # 100-6, at 11; see also Doc. # 99-1, at 24; Doc. # 102, at 5 n. 2.)
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."
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 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,
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).)
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 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®.
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
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 pregnancy.
Lilly insists that Mrs. Fields's claims cannot survive summary judgment based upon her own self-serving testimony, supported only by the equally self-serving 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 position.
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.
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.
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 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, 127 S.Ct. 1769, 167 L.Ed.2d 686 (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, 127 S.Ct. 1769. 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, 127 S.Ct. 1769. 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, 127 S.Ct. 1769.
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,
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 advances no persuasive argument that the testimony of Mr. and Mrs. Fields would not be admissible at trial.
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.
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.
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.
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."
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
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 Fed.Appx. 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. 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 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®.
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 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.
In Toole, the plaintiff developed scar tissue around her silicone breast implants
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 breast-augmentation 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 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 learned-intermediary 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
The court finds that, in accordance with Toole, under Alabama's learned-intermediary 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.
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 products-liability context.
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.
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 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 Fed.Appx. 979, 990 (11th Cir.2010) (citation and internal quotation marks omitted). Mrs. Ledbetter's testimony
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.
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.