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Jo Belle Baldonado v. Wyeth and Its Division

May 17, 2012


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


Defendant Wyeth moves in limine to exclude the anticipated expert testimony of two of Plaintiff's designated marketing experts -- Dr. Matthew F. Hollon and Dr. Adriane J. Fugh-Berman. See Fed. R. Evid. 702; Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993). As explained below, Defendant's motion is granted in part, and denied in part.


Plaintiff Jo Belle Baldonado was diagnosed with breast cancer while she was taking Prempro, a prescription hormone therapy ("HT") medication that Defendant Wyeth designed, manufactured, and marketed. Plaintiff's prescribing physicians were Dr. Teresita D. Avila, M.D. and Dr. Mani Akkineni, M.D. Alleging that Prempro caused her breast cancer, Plaintiff filed the present civil action against Defendant and others. Trial is scheduled for October 9, 2012.

In advance of trial, Defendant moves to exclude the testimony of Dr. Matthew Hollon and Dr. Adriane Fugh-Berman, both of whom Plaintiff has designated as experts on Wyeth's marketing practices for its hormone therapy medications. The witnesses are "general liability experts" who have not filed case-specific expert reports. (R. 131, Pl's Resp. at 1.)

I. Expert Qualifications

Defendant does not challenge the qualifications of either Dr. Hollon or Dr. Fugh-Berman to offer expert opinions on Defendant's marketing practices. See Fed. R. Evid. 702(a) (stating that an expert may by qualified by "knowledge, skill, experience, training, or education"). For purposes of context, however, the Court briefly summarizes each expert's professional background.

A. Dr. Matthew F. Hollon, M.D., MPH

Dr. Hollon is a Board-certified physician of Internal Medicine at the University of Washington in Seattle ("UW"). (R. 131, Ex. 13, Expert Report of Dr. Hollon ("Hollon Report"), at 1.) He graduated from the UW School of Medicine in 1994, and thereafter completed a medical residency and fellowship in Internal Medicine at UW. (Id.) During his fellowship, Dr. Hollon attended classes at the UW School of Public Health and Community Medicine and received a Masters of Public Health. (Id.) Currently, Dr. Hollon is the Director of Evidence-Based Medicine for the Internal Medicine Residency Program at the UW Department of Medicine and an Assistant Professor in the Division of General Internal Medicine. (Id.) Dr. Hollon has been an active member in numerous professional organizations, and has published extensively in the area of pharmaceutical marketing. (Id. at 1-2.) He has also consulted on this topic for the Canadian government. (Id.)

B. Dr. Adriane J. Fugh-Berman, M.D.

Dr. Fugh-Berman is an associate professor in the Department of Physiology and Biophysics at Georgetown University Medical Center, where she teaches "graduate courses in the history of medicine and critical assessment of medical literature, including a module on clinical trial methodology and assessment of adverse events." (R. 131, Ex. 15, Expert Report of Dr. Fugh-Berman ("Fugh-Berman Report"), at 1.) She also lectures about "pharmaceutical company influence on physician prescribing practices." (Id.) For more than twenty-five years, Dr. Fugh-Berman has "worked in the field of women's health and corporate influence on healthcare," and has published numerous articles in that regard, including articles "on the culture of gynecology and the effect of drug company promotion on prescribing habits." (Id.) Dr. Fugh-Berman previously practiced general medicine with a focus on women's health. (Id.) After leaving clinical practice in 2001, Dr. Fugh-Berman has, among other professional pursuits, "been a consultant, scientific reviewer, working group member, or speaker on women's health issues for the National Institutes of Health, the Federal Trade Commission, the Centers for Disease Control, the Agency for Health Care Research and Quality, the Department of Defense, the National Security Agency, and the Institute of Medicine." (Id. at 1-2.)

II. Anticipated Expert Testimony

Plaintiff seeks to call either Dr. Hollon or Dr. Fugh-Berman as a general liability expert on Defendant's marketing practices.*fn1 If permitted to testify, according to Plaintiff, the experts would opine that Defendant's marketing of HT products including Prempro fell below the standard of care that a pharmaceutical company should exercise. (R. 131, Pl.'s Resp. at 5-6, 8.) The experts in their respective reports offer extensive detail about Defendant's marketing practices and opine on the impact of those practices on patients and physicians. (Id.)

Plaintiff offers the experts to establish "key elements in Plaintiff's negligence and punitive damages claims." (R. 131, Pl.'s Resp. at 3.) Plaintiff contends that the experts "will serve to educate the jury on the nature and purpose of the marketing materials seen by Mrs. Baldonado and her physicians" (id. at 8), thereby "provid[ing] context for Wyeth's breach of its duty to the physicians and patients . . . ." (Id. at 3.)


"The admissibility of expert testimony is governed by Federal Rule of Evidence 702 and the Supreme Court's opinion in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993)." Lewis v. CITGO Petroleum Corp., 561 F.3d 698, 705 (7th Cir. 2009). "The district court functions as a gatekeeper with respect to testimony proffered under Rule 702 to ensure that the testimony is sufficiently reliable to qualify for admission." Mihailovich v. Laatsch, 359 F.3d 892, 918 (7th Cir. 2004) (citing Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147, 119 S. Ct. 1167, 143 L. Ed. 2d 238 (1999)); see also Bielskis v. Louisville Ladder, Inc., 663 F.3d 887, 893 (7th Cir. 2011) ("It is the district courts' role to ensure that expert testimony is both relevant and reliable."). Whether to admit expert testimony rests within the discretion of the district court. See Gen. Elec. Co. v. Joiner, 522 U.S. 136, 118 S. Ct. 512, 139 L. Ed. 2d 508 (1997). Indeed, a district court has "wide latitude in performing its gatekeeping function and determining both how to measure the reliability of expert testimony and whether the testimony itself is reliable." Bielskis, 663 F.3d at 894.

Under Rule 702, "[a] witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case." Fed. R. Evid. 702; see also Ortiz v. City of Chicago, 656 F.3d 523, 526 (7th Cir. 2011). The inquiry under Rule 702 is "flexible." Bielskis, 663 F.3d at 894.

District courts employ a three-part analysis before admitting expert testimony: (1) the expert must be qualified as an expert by knowledge, skill, experience, training, or education; (2) the expert's reasoning or methodology underlying his testimony must be scientifically reliable; and (3) the expert's testimony must assist the trier of fact in understanding the evidence or to determine a factual issue. See Myers v. Ill. Cent. R.R. Co., 629 F.3d 639, 644 (7th Cir. 2010). "The goal of Daubert is to assure that experts employ the same 'intellectual rigor' in their courtroom testimony as ...

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