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In Re: Yasmin and Yaz v. Bayer Healthcare Pharmaceuticals Inc.

December 16, 2011

IN RE: YASMIN AND YAZ (DROSPIRENONE) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION THIS DOCUMENT RELATES TO: BRADISH
v.
BAYER HEALTHCARE PHARMACEUTICALS INC., ET AL.,



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

MEMORANDUM AND ORDER

I. Introduction and Background

Now before the Court is defendants' motion to exclude plaintiffs' case specific expert testimony and for partial summary judgment (Doc. 46). Plaintiff opposes the motion (Doc. 58). Familiarity with the underlying proceedings is presumed. Although the motion is fully briefed, the Court holds in abeyance the portion of the motion regarding summary judgment until after the resolution of the trial in Sims v. Bayer Healthcare Pharmaceuticals Inc., et al., 09-10012-DRH-PMF. Based on the pleadings, the applicable law and the following, the Court denies the motion to exclude plaintiff's expert.

This multidistrict litigation "(MDL") relates to the manufacture, marketing, and sale of the prescription pharmaceuticals known as YAZ and Yasmin.*fn1 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. The vast majority of COC's, including YAZ and Yasmin, contain the same type of estrogen -- ethinyl estradiol ("EE"). Id.*fn2 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"). Id.

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

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. It is also generally accepted that second-generation COCs (LNG-containing COCs) are considered to have a low risk for VTE disease. 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 and in comparative studies evaluating whether there is an association between DRSP-containing COCs and an increased risk of VTE disease . 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.

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 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 ("PE") (a clot formation that travels to the lungs).

In the case at bar, plaintiff, Patti Bradish, was given a sample pack of YAZ in February of 2007. At some point between February and May 2007 Mrs. Bradish used the sample pack of YAZ. In May 2007, Mrs. Bradish received a prescription for YAZ and began using YAZ as her method of birth control. Six months later Mrs. Bradish visited her primary care physician's office complainint of pain in her left leg. Laboratory and diagnostic testing was ordered, and she was instructed to discontinue her use of YAZ. The laboratory results showed significantly elevated D-diver levels, which can indicate a blood clot. Mrs. Bradish was eventually diagnosed with bilateral pulmonary emboli and "probable acute bilateral" DVT.

Bayer moves to exclude the opinions of plaintiffs' expert, Dr. Henry Rinder. Bayer contends that Dr. Rinder's opinions fail to meet the requirements for admissible expert testimony under Federal Rule of Evidence 702 and Daubert v. Merrill Dow Pharms., 509-UC 579 1993 (Daubert). Specifically, Bayer seeks to preclude testimony by Dr. Rinder regarding Mrs. Bradish's alleged damages and prognosis as speculative and unfairly prejudicial.

II. Legal Standard

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).*fn3 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). ...


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