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Jo Belle Baldonado v. Wyeth and Its Division

May 7, 2012


The opinion of the court was delivered by: Amy J. St. Eve, District Court Judge:


Plaintiff Jo Belle Baldonado was diagnosed with breast cancer while she was taking Prempro, a prescription hormone therapy medication that Defendant Wyeth designed, manufactured, and marketed. Alleging that Defendant's hormone therapy products including Prempro caused her breast cancer, Plaintiff filed the present civil action against Defendant and others. This case is one of thousands of similar cases nationwide that individuals have filed against Defendant. The case is set for trial on October 9, 2012.

Before the Court is Defendant's motion in limine to exclude the expert testimony of Dr. Randall Patten, M.D., pursuant to Rule 702 of the Federal Rules of Evidence, and the Supreme Court's decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993). For the reasons explained below, the Court grants Defendant's motion.


I. Menopausal Hormone Therapy Products

This litigation concerns certain "menopausal hormone therapy products" that Defendant Wyeth designed, manufactured, and marketed.*fn1 (Am. Compl.*fn2 ¶ 13.) These hormone therapy products have been "marketed to women who are going through menopause," which is a "time in the natural aging process of a woman when her body's production of the natural hormones estrogen and progesterone is dramatically reduced." (Id. ¶ 11.)

In 1942, Wyeth "received approval for Premarin, which is a conjugated equine estrogen [("CEE")] made from the urine of pregnant mares." (Id. ¶ 12.) Defendant marketed Premarin as a "replace[ment for] the natural female hormone estrogen." (Id.) By the mid-1970s, "more than 30 million prescriptions for Premarin were being written every year." (Id. ¶ 20.) Sales of Premarin, however, soon "plummeted" after two articles in the New England Journal of Medicine "linked estrogen therapy to a significantly increased risk of women developing endometrial cancer." (Id. ¶ 21.)

In 1979, an article in the Journal of the American Geriatrics Society reported that "'estrogen related uterine cancer can be avoided if progesterone is added to the regimen.'" (Id. ¶ 22.) Defendant and others "immediately started promoting" hormone therapy that combined estrogen ("E") and progesterone ("P"). (Id. ¶ 23.) In that regard, Defendant "developed a synthetic hormone product called Medroxyprogesterone Acetate [("MPA")] that was marketed under the brand name Provera." (Id.) From the mid-1980s until 1995, "a common combination prescription was the use of Premarin with Provera." (Id.)

In 1994, Defendant received approval for Prempro, which is "combination hormone therapy in a single pill." (Id. ¶ 31.) Specifically, Prempro is an oral medication that "combines the estrogenic compound CEE with the progestin MPA in a single pull taken one time per day." (Id.) Because Prempro combines estrogen ("E") with progestin ("P"), many refer to the medication as "E." Defendant continues to sell Prempro today. (R. 118 at 9 & Ex. 26.)

II. Plaintiff's Use of Menopausal Hormone Therapy Products

Plaintiff Jo Belle Baldonado is a 65 year old woman. She took Provera from approximately January of 1995 until May of 1996. In May of 1996, Plaintiff switched to Prempro to help alleviate menopausal symptoms, including hot flashes, night sweats, trouble sleeping, and vaginal dryness. Plaintiff's prescribing physicians were Dr. Terestia Avila and Dr. Mani Akkineni. In or about September of 1998, Plaintiff was diagnosed with breast cancer and she stopped taking Prempro at the direction of Dr. Avila. According to Plaintiff, her use of E promoted the development and growth of certain pre-existing cancerous abnormalities in her breast.

III. Procedural History

On May 27, 2003, Plaintiff commenced this action against Defendant and others in the Circuit Court of Cook County, Illinois, alleging that Defendant's hormone therapy products caused Plaintiff to develop breast cancer. In her Amended Complaint, Plaintiff asserts claims that include negligence, strict products liability, failure to warn, breach of express warranty, negligent misrepresentation, fraud, and gross negligence. (Am. Compl. at 15-57.) Defendant removed the action to this Court on June 28, 2004 on the basis of diversity of citizenship. See 28 U.S.C. §§ 1332, 1441, 1446. (R. 1at 1-7, Not. of Removal.) Thereafter, on July 27, 2004, Defendant filed an Answer to the Amended Complaint, denying that Defendant's products caused Plaintiff's breast cancer and contending that the products were appropriately tested, labeled, and marketed. (R. 9, Answer.)

On September 8, 2004, the Judicial Panel for Multidistrict Litigation (the "MDL Panel") conditionally transferred this action to the U.S. District Court for the Eastern District of Arkansas (the "MDL Court"), pursuant to 28 U.S.C. § 1407, for coordinated or consolidated pretrial proceedings with over two hundred similar hormone therapy actions. (R. 13, Conditional Transfer Order, at 1 (citing In re Prempro Prods. Liab. Litig., 254 F. Supp. 2d 1366 (J.P.M.L. 2003) (designating transferee court for individual, class action, and other federal cases arising out of the sale or use of prescription hormone therapy medications)).) Following more than seven years of litigation in the MDL Court, the MDL Panel remanded the action to this District on January 26, 2011, pursuant to 28 U.S.C. § 1407. The case was reassigned to this Court on January 25, 2012. A jury trial is scheduled to begin on October 9, 2012.

IV. Dr. Randall Patten, M.D.

In advance of trial, Defendant moves to exclude the anticipated expert testimony of Dr. Randall Patten, M.D., a diagnostic radiologist who the American Board of Radiology has certified since 1983. (R. 113, Ex. 1, Expert Report of Dr. Randall Patten, M.D. ("Report"), at 1.) Following his fellowship, Dr. Patten taught radiology at the University of Washington and the University of Colorado, in addition to serving on the medical staff of numerous hospitals. (Id.)Dr. Patten is currently "an employee of Tacoma Radiology Associates and Medical Director of TRA Medical Imaging Center-on Lilly." (Id.) His responsibilities are "primarily clinical, performing and interpreting outpatient imaging studies." (Id.) According to Dr. Patten: "I currently review and interpret both screening and diagnostic mammograms, interpreting approximately 4,000 to 5,000 mammograms per year." (Id. at 1-2.)

Plaintiff has designated Dr. Patten as an expert on "mammography; breast cancer causation; density changes and E's impact on density changes." (R. 168, Ex. 25.) Dr. Patten measured Plaintiff's breast density from twenty different mammographic images of Plaintiff, taken between September 27, 1989 and November 1, 2010. If permitted to testify, as explained below, Dr. Patten would opine that his measurements suggest that Plaintiff's use of Prempro caused her breast density to increase, thereby increasing her relative risk of breast cancer.

In his expert report, Dr. Patten explains that the American College of Radiology has developed a Breast Imaging Reporting and Data System ("BI-RADS") to "describe the density of the breast . . . ." (Report at 8.) The system, he ...

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