Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

In Re: Yasmin and Yaz (Drospirenone v. Bayer Corp.

December 16, 2011


The opinion of the court was delivered by: David R. Herndon Chief Judge United States District Court



Defendants Bayer HealthCare Pharmaceuticals Inc. and Bayer Pharma AG (Bayer) move to exclude certain opinions of plaintiff's case-specific experts Mitchell Botney, M.D., Anthony Disciullo, M.D., Henry Rinder, M.D., and Mehrdad Sehizadeh, M.D. Bayer also moves for summary judgment on plaintiff's failure to warn and defective manufacture and construction strict products liability claims (Doc. 81).*fn1 Further, in Bayer's reply (Doc. 171) to plaintiff's response (Doc. 87), it moves for summary judgment as to plaintiff's negligence per se claim brought for the first time in her third amended complaint (Doc. 165). For the following reasons, Bayer's motion to exclude certain opinions of plaintiff's case-specific experts and for summary judgment as to plaintiff's failure to warn claim is DENIED (Doc. 81). Bayer's motion for summary judgment as to plaintiff's negligence per se claim is also DENIED as untimely (Doc. 187).


a. MDL Generally*fn2

This multidistrict litigation (MDL) relates to the manufacture, marketing, and sale of the prescription pharmaceuticals known as YAZ and Yasmin.*fn3 YAZ and Yasmin, which are manufactured, marketed, and sold by Bayer, are members of a class of prescription medicines known as combined hormonal oral contraceptives (COCs), which contain an estrogen and a progestin component (Doc. 2090, p. 6). The vast majority of COC's, including YAZ and Yasmin, contain the same type of estrogen -- ethinyl estradiol (EE) (Doc. 2090, p. 6).*fn4 In contrast to estrogen, the progestins in COCs are of many types. The progestin in YAZ and Yasmin is a newer type of progestin known as drospirenone (DRSP) (Doc. 2090, p. 6).

DRSP-containing COCs are known as "fourth-generation" COCs (classified by the type of progestin used) (Doc. 2090, pp. 5-6). COCs containing earlier developed progestins are categorized as "first-generation," "second-generation," and "third-generation" (Doc. 2090, p. 6). First-generation COCs contain the progestin norethynodrel (Doc. 2090, p. 6). Second-generation COCs contain the progestin Levonorgestrel (LNG) and third-generation COCs contain several progestins, including desogestrel, gestodene, and norgestimate (Doc. 2090, p. 6)

It is generally accepted that there is an increased risk of venous thromboembolic (VTE) disease (disease relating to blood clotting in the veins) in COC users (Doc. 2102-14, p. 5; Doc. 2090-2, p. 2). It is also generally accepted that second-generation COCs (LNG-containing COCs) are considered to have a low risk for VTE disease (Doc. 2102-14, p. 6). Because the VTE risk associated with second-generation COCs is relatively low, LNG-containing COCs are often selected as a reference treatment in comparative studies evaluating whether there is an association between third-generation COCs and an increased risk of VTE disease (See e.g., Doc. 2102-4) and in comparative studies evaluating whether there is an association between DRSP-containing COCs and an increased risk of VTE disease (See e.g., Doc. 2102-14 pp. 5-6). In the mid-1990s, various reports indicated that users of third-generation COCs were at higher risk of VTE disease than users of second-generation COCs (Doc. 2090-2, p. 2).

At issue in this litigation, is the safety of DRSP-containing COCs and whether DRSP use is associated with a higher risk of VTE disease. Specifically, plaintiffs, including plaintiff Sims currently in issue, contend that Bayer misrepresented or omitted facts pertaining to the safety and efficacy of YAZ and Yasmin. With regard to the safety of YAZ and Yasmin, plaintiffs contend that the DRSP component of the drugs is associated with an increased risk of VTE disease and of potentially life threatening thrombosis complications, including deep vein thrombosis (DVT) (a blood clot formation in one of the body's deep veins) and pulmonary embolism (a clot formation that travels to the lungs).

b. Facts Pertaining to Plaintiff Sims' Claims

In June 2008, plaintiff requested that her gynecologist switch her current COC prescription to YAZ. Plaintiff cites to advertisements promoting YAZ's ability to treat moderate acne as motivating her request. Plaintiff's physician then prescribed YAZ. Plaintiff used YAZ continuously from June 2008 to July 2008. In July 2008, plaintiff was diagnosed with a pulmonary embolism (PE) while taking YAZ (Doc. 87, pp. 2-3). Relevant to the instant dispute, plaintiff contends Bayer knew or should have known by 2003 that DRSP COCs carry a higher risk for VTE than other commonly used COCs. Plaintiff cites to numerous reports, studies, and FDA actions as the basis for this contention (Doc. 87, pp. 5-6). Based on Bayer's alleged knowledge, plaintiff claims Bayer's YAZ label is misleading and does not adequately warn of YAZ's increased risk of thrombotic events, including PE (Doc. 87, pp. 7-8). The Court refers to Bayer's motion (Doc. 81) and plaintiff's statement of material facts in response (Doc. 87) for the remainder of the disputed factual allegations.


a. Legal Standard

i. Generally

FEDERAL RULE OF EVIDENCE 702, and Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993), govern the admissibility of expert testimony. The Daubert standard applies to all expert testimony, whether based on scientific competence or other specialized or technical expertise. Smith v. Ford Motor Co., 215 F.3d 713, 719 (7th Cir. 2000) (citing Kumho Tire Co., Ltd. v. Carmichael, 526 U.S.137, 141 (1999)). Rule 702 provides:

If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.

Fed. R. Evid. 702. Daubert clarified Rule 702 charges the district court with the task of ensuring expert testimony is both relevant and reliable. Daubert, 509 U.S. at 589.

Courts in the Seventh Circuit conduct a three-step analysis under Daubert. Ervin v. Johnson & Johnson, Inc., 492 F.3d 901, 904 (7th Cir. 2007).*fn5 First, the district court must determine whether the person whose testimony is offered is in fact an expert, as codified in Rule 702 through "knowledge, skill, experience, training, or education." Id. (citing Fed. R. Evid. 702). Notably, although "extensive academic and practical expertise" sufficiently qualify a potential witness as an expert, Bryant v. City of Chicago, 200 F.3d 1092, 1098 (7th Cir. 2000), "Rule 702 specifically contemplates the admission of testimony by experts whose knowledge is based on experience," Walker v. Soo Line R.R. Co., 208 F.3d 581, 591 (7th Cir. 2000). Smith, 215 F.3d at 718 (citing Kumho, 526 U.S. at 156 ("[N]o one denies that an expert might draw a conclusion from a set of observations based on extensive and specialized experience.")).

Secondly, the district court must determine the expert's reasoning or methodology is reliable. Ervin, 492 F.3d at 904; see Mihailovich v. Laatsch, 359 F.3d 892, 918 (7th Cir. 2004) (citing Kumho, 526 U.S. at 147). Specifically, the testimony must have a reliable basis in the knowledge and experience of the relevant discipline, Kumho, 526 U.S. at 149 (internal quotations removed), consisting in more than subjective belief or unsupported speculation. Chapman v. Maytag Corp., 297 F.3d 682, 687 (7th Cir. 2002); Daubert, 509 U.S. at 590. Further, as to reliability, Daubert provided the following non-exhaustive list of relevant factors: "(1) whether the scientific theory can be or has been tested; (2) whether the theory has been subjected to peer review and publication; (3) whether the theory has been generally accepted in the scientific community." Ervin, 492 F.3d 901, 904 (7th Cir. 2007) (citing Daubert, 509 U.S. at 593-94). However, there is no requirement that courts rely on each factor, as the gatekeeping inquiry is flexible and must be "tied to the facts" of the particular case. Kumho, 526 U.S. at 150 (quoting Daubert, 509 U.S. at 591); see also Chapman, 297 F.3d at 687. Thus, "the role of the court is to determine whether the expert is qualified in the relevant field and to examine the methodology the expert has used in reaching his [or her] conclusions." Smith, 215 F.3d at 718 (citing Kumho, 526 U.S. at 153).

The district court possesses "great latitude in determining not only how to measure the reliability of the proposed expert testimony but also whether the testimony is, in fact, reliable." United States v. Pansier, 576 F.3d 726, 737 (7th Cir. 2009) (citing Jenkins v. Bartlett, 487 F.3d 482, 489 (7th Cir. 2007)). Accordingly, the court's gatekeeping function requires focus on the expert's methodology; "[s]oundness of the factual underpinnings of the expert's analysis and the correctness of the expert's conclusions based on that analysis are factual matters to be determined by the trier of fact." Smith, 215 F.3d at 718 (citing Daubert, 509 U.S. at 595; Walker, 208 F.3d at 587).

Resolution of an expert's credibility or the correctness of his or her theories is left to the jury's determination after opposing counsel has cross-examined the expert at issue. Id. (citing Walker, 208 F.3d at 589-90). Thus, "[i]t is not the trial court's role to decide whether an expert's opinion is correct. The trial court is limited to determining whether expert testimony is pertinent to an issue in the case and whether the methodology underlying that testimony is sound." Id. (citing Kumho, 526 U.S. at 159 (Scalia, J., concurring) (stating that the trial court's function under Daubert is to exercise its discretion "to choose among reasonable means of excluding expertise that is fausse and science that is junky")). However, as an expert must explain the methodologies and principles that support his or her opinion, he or she cannot simply assert a "bottom line" or ipse dixit conclusion. Metavante Corp. v. Emigrant Sav. Bank, 619 F.3d 748, 761 (7th Cir. 2010) (quoting Minix v. Canarecci, 597 F.3d 824, 835 (7th Cir. 2010)).

Lastly, the district court must consider whether the proposed testimony will assist the trier of fact in its analysis of any issue relevant to the dispute. See Smith, 215 F.3d at 718; Chapman, 297 F.3d at 687; Daubert, 509 U.S. at 592. It is crucial that the expert "testify to something more than what is 'obvious to the layperson' in order to be of any particular assistance to the jury.'" Dhillon v. Crown Controls Corp., 269 F.3d 865, 871 (7th Cir. 2001) (quoting Ancho v. Pentek Corp., 157 F.3d 512, 519 (7th Cir. 1998)). However, the expert need not have an opinion as to the ultimate issue requiring resolution to satisfy this condition. Smith, 215 F.3d at 718 (citing Walker, 208 F.3d at 587).

ii. Physician Testimony

Indisputably, a medical degree does not qualify a doctor to opine on all medical subjects. Gayton v. McCoy, 593 F.3d 610, 617 (7th Cir. 2010) (citing Carroll v. Otis Elevator Co., 896 F.2d 210, 212 (7th Cir. 1990)). However, the Seventh Circuit recognizes that often a "physician in general practice is competent to testify about problems that a medical specialist typically treats." Id. (citing 29 Wright & Gold, Federal Practice and Procedure, § 6265 (1997); Doe v. Cutter Biological, Inc., 971 F.2d 375, 385 (9th Cir. 1992) ("The fact that the experts were not licensed hematologists does not mean that they were testifying beyond their area of expertise. Ordinarily, courts impose no requirement that an expert be a specialist in a given field, although there may be a requirement that he or she be of a certain profession, such as a doctor."); Dickenson v. Cardiac & Thoracic Surgery of E. Tenn., 388 F.3d 976, 978-79 (6th Cir. 2004); United States v. Viglia, 549 F.2d 335, 336 (5th Cir. 1977) (holding that a pediatrician who had degrees in medicine and pharmacology but no experience in treating patients in obesity had sufficient knowledge, training, and education to testify regarding drug's effect on obese persons)). Thus, courts must individually evaluate each conclusion drawn to determine whether the purported expert "has the adequate education, skill, and training to reach them." Id.

b. Arguments and Analysis

1. Daubert Analysis Generally

The following qualifications and statements concerning the reliability of the experts' opinions are applicable to all statements for which Bayer seeks exclusion. As to the third prong under Fed. R. Evid. 702 and Daubert, whether the proposed testimony will offer assistance to the trier of fact, the Court finds all of the experts' opinions as stated in their reports are helpful to the trier of fact's analysis of issues relevant to the dispute. All of the at-issue experts opine from the perspective of medical doctors. Accordingly, they testify as to something more than what is obvious to a layperson. Thus, the Court will only independently analyze the qualifications of the relevant expert and the reliability of their opinions.

a. Dr. Mitchell Botney

i. Qualifications

Plaintiff offers Dr. Botney to opine, from a pulmonary perspective, as to plaintiff's future damages and prognosis resulting from her PE (Doc. 90, p. 2).

Dr. Botney received his Bachelor of Science from the University of Michigan in 1974. In 1984, he received a Doctorate of Medicine from the Ohio State University College of Medicine. He completed a fellowship in Respiratory and Critical Care at the Washington University School of Medicine in 1988. Thus, he has over twenty years of clinical experience as a pulmonologist. Further, he has authored numerous articles pertaining to thrombotic events (See Doc. 90-2).

ii. Reliability

In forming his opinions, Dr. Botney consulted numerous publications concerning acute pulmonary embolism, the relation of recurrent VTE and pregnancy, the risk of VTE in relation to DRSP COC users, and other related subjects. Further, he consulted the depositions of plaintiff and Dr. Mark Erwin. Finally, he consulted all of plaintiff's relevant medical records (See Doc. 90-4).

b. Dr. Henry ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.