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Fields v. Eli Lilly & Co.

United States District Court, M.D. Alabama, Northern Division

July 20, 2015

DANA FIELDS, individually and as Natural Parent of D.F., a minor, Plaintiff,

For Dana Fields, Individually and as Natural Parent of D. F., a minor, Plaintiff: Christopher L. Schnieders, LEAD ATTORNEY, PRO HAC VICE, Wagstaff & Cartmell, LLP, Kansas City, MO; Gregory D Bentley, LEAD ATTORNEY, PRO HAC VICE, Reilly Pozner, LLP, Denver, CO; Joseph J Zonies, LEAD ATTORNEY, Reilly Pozner, Denver, CO; Mark William Premo-Hopkins, LEAD ATTORNEY, PRO HAC VICE, Reilly Pozner LLP, Denver, CO; Richard A. Freese, LEAD ATTORNEY, Freese & Goss, PLLC, Birmingham, AL; Thomas P Cartmell, LEAD ATTORNEY, PRO HAC VICE, Wagstaff & Cartmell LLP, Kansas City, MO.

For Eli Lilly & Company, Defendant: Alan Daniel Mathis, James Clifton Barton, Jr., LEAD ATTORNEYS, BUTLER SNOW LLP, Birmingham, AL; Andrew E. Kantra, Nina M. Gussack, LEAD ATTORNEY, PRO HAC VICE, Pepper Hamilton LLP, Philadelphia, PA; Anthony Charles Howard Vale, Barry H. Boise, Christopher W. Wasson, Eric Rothschild, Francis X. Lane, Hyung Steele, LEAD ATTORNEYS, Pepper Hamilton LLP, Philadelphia, PA; John F. Brenner, Ronni E. Fuchs, LEAD ATTORNEYS, Pepper Hamilton LLP, Princeton, NJ.

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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® .[1] The parties have fully briefed the motion and have submitted evidence in support of

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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.


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. 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.

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."

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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.)

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 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,

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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 ...

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