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Tsao v. Ferring Pharmaceuticals, Inc.

United States District Court, S.D. Texas, Houston Division

March 26, 2018

Anne S. Tsao, M.D., Plaintiff,
Ferring Pharmaceuticals, Inc. Defendant.



         This case was referred by District Judge Vanessa Gilmore pursuant to 28 U.S.C. § 636(b)(1)(A) for the determination of all non-dispositive pretrial matters. (Dkt. 61). Pending before the court are Defendant Ferring Pharmaceuticals, Inc.'s (“Defendant's” or “Ferring's”) motions to exclude the expert testimony of Plaintiff Anne Tsao (“Plaintiff” or “Tsao”) and Dr. Laura M. Plunkett (“Dr. Plunkett”). (Dkt. 42 and 45). Plaintiff has responded to each motion and Defendant has replied. (Dkt. 58, 59, 62, 63).

         A ruling on a motion to exclude the testimony of an expert witness is non-dispositive and may be reversed if the factual findings are clearly erroneous or the legal conclusions are contrary to law. See Garcia v. BRK Brands, Inc., 266 F.Supp.2d 566, 569 (S.D. Tex. 2003) (citing 28 U.S.C. § 636(b)(1)(A)). After considering the pleadings, the record, and the applicable law, it is ORDERED that Defendant's motion to exclude the expert testimony of Plaintiff is GRANTED, and Defendant's motion to exclude the expert testimony of Laura M. Plunkett is GRANTED, in part, and DENIED, in part.

         I. Background

         A. Nature of Plaintiff's claims

         Plaintiff has sued Ferring for breach of express warranty, breach of implied warranty, and violations of the Texas Deceptive Trade Practices Act (“DTPA”) resulting from her purchase and use of allegedly “defective, adulterated, and misbranded Bravelle, ” a medication prescribed as part of in vitro fertilization (“IVF”) treatment. (Dkt. 34 at ¶¶ 1, 3). Ferring voluntarily recalled various lots of the medication in October of 2015 because routine stability testing indicated that certain batches of Bravelle “did not meet potency specifications through the entire shelf life and were out of specification (“OOS”) at the time of testing (twelve months or more into their shelf life).” (Dkt. 44 at 5).

         Plaintiff seeks recovery of economic damages including costs incurred to purchase the Bravelle, the costs of the medications used in conjunction with Bravelle as part of her IVF treatment, and the cost of all IVF treatments that were “associated with administration of the defective, adulterated, and misbranded Bravelle.” (Dkt. 34 at ¶ 2). She complains that Ferring failed to inform her that the Bravelle she purchased lacked the potency described in the drug's “Prescribing Information, ” and that she would not have purchased and used Bravelle had she known it did not meet those product specifications. (Dkt. 34 at ¶¶ 56, 61).

         B. Use of Bravelle in connection with an in vitro fertilization cycle

         In vitro fertilization is a procedure in which eggs, or oocytes, are extracted from an ovary, artificially inseminated, and implanted in a woman. (Expert Report of Eve Feinberg, M.D., Dkt 42-3 at 6). Before a woman begins IVF she undergoes various diagnostic tests designed to assess the “ovarian reserve” or functional capacity of the ovaries. (Dkt. 42-3 at 4). Ovarian reserve testing attempts to measure the number of eggs that can be harvested in a single month as well as the overall egg supply within the ovary. (Id.). One of the diagnostic tests performed as part of the ovarian reserve testing is an Antral Follicle Count (“AFC”). (Id.). The AFC is “one of the most important tools a [r]eproductive [e]ndocrinologist can use to predict how many eggs can potentially be retrieved in a single month with the use of fertility drugs.” (Id. at 4-5).

         Oocytes or eggs grow inside the antral follicles and every month a woman has a group of antral follicles that she “uses or loses.” (Id. at 5). During a normal menstrual cycle, a woman's hormones cause only one follicle to become the dominant follicle in a cohort and each month at ovulation, a single egg is released from that dominant follicle and the other follicles are unused or lost. (Id. at 6). During an ovarian stimulation cycle for IVF, the combination of follicle stimulating hormone (“FSH”) and other hormones allows many antral follicles, rather than just the dominant follicle, to grow and develop in a single month, which allows multiple eggs to be retrieved from the woman's body. (Id. at 6). Bravelle, which contains FSH, is one of the drugs used during the ovarian stimulation phase of IVF to induce the development of more than one follicle and, ultimately, the harvesting of multiple oocytes or eggs. (Id.).

         The goal of the stimulation phase, which comprises only one part of the total IVF cycle, is the development of multiple follicles rather than a single dominant follicle. Bravelle is medically indicated only for the stimulation of multiple follicles and is used only in the stimulation phase. Additional IVF stages follow stimulation, with the ultimate goal being implantation and development of a chromosomally normal embryo that develops into a sustained pregnancy and live birth.

         Following the stimulation and retrieval stages, the harvested eggs are given time to mature prior to fertilization. (Id. at 8). Once fertilization is complete, the egg is considered a zygote, which is one cell with two sets of DNA. (Id. at 9). Ideally, over a period of five to six days, the zygote will develop into a blastocyst, which can then be screened for chromosomal abnormalities. (Id. at 9-10). It is generally accepted that only chromosomally normal blastocysts will be transferred and implanted into the patient. (Id. at 11).

         The number of follicles developed and oocytes retrieved after stimulation generally decreases with a woman's age. For example, the mean number of oocytes retrieved in an IVF cycle for a 41 year old woman is 8.6 plus/minus 6.3, compared to 14.75 plus/minus 6.8 for a woman under 30. (Id. at 20). In addition, egg quality, which refers to several factors including the incidence of chromosomal abnormalities, decreases markedly with the age. (Dkt. 63-1 at 19). The potential for successful implantation of an embryo and a pregnancy that results in a live birth is highest when the egg has not sustained damage due to aging and does not possess any chromosomal abnormalities. (Dkt. 47-14 at 20).

         C. FDA's New Drug Application process and potency specifications for biologic drugs

         A manufacturer seeking approval of a new drug such as Bravelle must submit a detailed New Drug Application (“NDA”) in accordance with the requirements of The United States Federal Food, Drug, and Cosmetic Act (“FDCA”) and other regulations promulgated by the Food and Drug Administration (“FDA”). 21 U.S.C. § 355(a). As part of the NDA, the manufacturer must submit scientific expert reports and other data evaluating the effectiveness of the drug. Id. at § 355(b)(1). The effectiveness, or potency, of a product containing biologically active ingredients, such as Bravelle, is measured by biological activity, which is defined as “the effect or response generated by a given agent upon a living organism.” (Dkt. 65-1 at 11). The biological activity of FSH is measured in International Units (“IUs”). The FDA approved two FSH potency specifications for Bravelle, one potency specification for the release of the product and another potency specification for stability testing to be conducted after release. (Dkt. 65-1 at 6; Dkt. 70 at 10, 11). Each of these specifications permits a range of potency defined as a percentage of 82.5 IUs. Upon release, Bravelle must contain 85% to 125% of the label claim of 82.5 IUs to meet the FDA approved potency specification, and during its post-release shelf life, Bravelle must contain 80% to 125% of 82.5IUs. (Dkt. 65-1 at 6; Dkt. 70 at 10, 11). In other words, the FDA permits an FSH bioactivity level anywhere between 70.1 and 103.1 IUs at the release of the product, and 66 to 103.1 IUs throughout the drug's shelf life. (Dkt. 65-1 at 6; Dkt. 70 at 10, 11). FDA regulations require that the potency of a drug comply with the specification range approved in the NDA, not the precise label claim. (Dkt. 65-1 at 10) (citing U.S. Dept. of Health & Human Services, Food and Drug Administration, ICH, Guidance for Industry, Q1A(R2) Stability Testing of New Drug Substances and Products, Rev. 2 (Nov. 2003), available at, (last visited March 20, 2018). In addition, the Code of Federal Regulations defines potency for biologic products as “…the specific ability or capacity of the product, [as measured by appropriate laboratory tests or clinical data]…to effect a given result.” 21 C.F.R. §600.3(s).

         As part of the NDA approval process, the manufacturer must submit examples of the proposed drug labeling, including text of the proposed label, as well as references to the technical portions of the NDA that support the inclusion of each statement in the label. 21 U.S.C. §§ 355(b)(1), 314.50 (c)(2)(i). After review of all material facts, the FDA must determine that the proposed label is not “false or misleading in any particular [way].” Id. at § 355 (d)(7). If the FDA finds that the drug meets this standard, it sends an “approvable” letter to the drug manufacturer, which includes the product specific labeling requirements. Id. at § 314.110(a). Approval of the NDA is “conditioned upon the applicant . . . submitting to the FDA a copy of the final printed labeling prior to marketing.” Id. at § 314.105(b).

         D. Opinions from Plaintiff Ann Tsao

         Plaintiff is an oncologist and Director of the Mesothelioma and Thoracic Chemo-Radiation Programs at MD Anderson Cancer Center. Her designation of expert witnesses includes herself as a testifying expert. (Dkt. 25 at 13-17). Plaintiff's expert designation states that she intends to testify to the following facts and opinions, which are outside her personal knowledge of treatment she received as an IVF patient:

• the Bravelle she purchased and used was sub-potent;[1]
• her IVF treatment was likely to fail due to the sub-potency of the Bravelle used and/or using sub-potent Bravelle was sub-optimal therapy;
• the charges for her fertility treatments were fair and reasonable in the locale in which they were made;
• it is well established that a prolonged period of ovarian stimulation adversely affects the quality of the eggs when they are exposed to gonadotropins for a prolonged period;
• the ovarian stimulation period is usually 10-12 days and is defined as the period that you are injected daily with ovarian stimulation drugs;
• ovarian follicles need to be 18-20 mm by ultrasound in order to be deemed mature and ready to harvest, which is the surgery to remove them, and taken for embryo creation;
• she was using the maximum amount of Bravelle and Menopur and it was taking her 14-16 days (longer than the usual 10-12 days) to make ovarian follicles large enough in size to harvest;
• the prolonged period of ovarian stimulation was likely due to receiving inadequate doses of ovarian stimulation drugs given that the Bravelle was sub-potent.

(Dkt. 25 at 13-17). In addition to these opinions identified in her expert designation, Plaintiff also testified in deposition that:

• “in vitro fertilization [requires] a very fine balance . . . [of] FSH and LH” to stimulate ovarian follicles (Dkt. 42-2 at 33:18-20);
• just like chemotherapy drugs, Bravelle and Menopur work in synergy and their combination results in a successful stimulation with “good quality eggs” (Dkt. 42-2 at 33:22-24);
• a physician would never give a suboptimal drug “and expect that the doublet would actually overcome [the other drug's lack of potency]” (Dkt. 42-2 at 33:25-34:2);
• “suboptimal” Bravelle did not help her stimulate follicles (Dkt. 42-2 at 34:10-12);
• the average number of follicles during IVF stimulation is 15-20; (Dkt. 42-2 at 30:9-17);
• if she had been given fully potent Bravelle, she would have had a better stimulation with better egg quality (Dkt. 42-2 at 41:11-19, 67:20-22);
• prolonged stimulation negatively impacts the quality of the eggs that are produced (Dkt. 42-2 at 42:7-25, 67:18-20);
• Ferring intentionally sold subpotent Bravelle and knew Bravelle was subpotent at the time she purchased it (Dkt. 42-2 at 73:20-74:15).

         Defendant contends that Plaintiff is not qualified to testify on these matters because she lacks expertise in the field of reproductive endocrinology. (Dkt. 42 at 11-14). Plaintiff, however, argues that as a medical doctor, she is qualified to give this opinion testimony. (Dkt. 59 at 5-9).

         E. Opinions from Dr. Laura Plunkett

         Plaintiff designated Dr. Plunkett as a specially retained expert to testify on numerous issues relating to causation, as well as Defendant's alleged lack of compliance with FDA regulations regarding drug recall and misbranded or adulterated drugs. (Dkt. 25 at 20-21). Dr. Plunkett issued a written report in this case (Dkt. 45-1) and her opinions, which appear in paragraphs 21 through 25 of the report, include the following:

• less potent Bravelle necessitated administration of a higher dose of the medication to achieve sufficient follicle ...

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