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Baldonado v. Wyeth

August 6, 2012


Order Form (01/2005)

Name of Assigned Judge Amy J. St. Eve Sitting Judge if Other or Magistrate Judge than Assigned Judge



The Court denies the remainder of Defendant's motion to exclude the expert opinions of Dr. Suzanne Parisian [94]. The parties should carefully review the enclosed order together with the Court's prior order on the admissibility of Dr. Parisian's anticipated testimony [239].

O[ For further details see text below.] Notices mailed by Judicial staff.


In advance of trial, Defendant Wyeth moves to exclude the expert opinions of Dr. Suzanne Parisian, M.D. pursuant to Rule 702 and the Supreme Court's decision in Daubert v. Merrell Dow Pharma., Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993). The Court previously ruled in part on the motion. (R. 239.) As explained below, the remainder of the motion is denied.

I. Background

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 Prempro caused her breast cancer, Plaintiff filed the present civil action against Defendant. In her Complaint, Plaintiff alleges, among other things, that Defendant breached its duty to adequately test and study the relationship between Prempro and breast cancer, particularly in light of certain safety signals, and that this breach resulted in Defendant's failure to discover and thus adequately warn about the link between Prempro and breast cancer.

The parties agree that to prevail on this claim, Plaintiff must prove that Defendant breached the applicable standard of care. See, e.g., Carrizales v. Rheem Mfg. Co., Inc., 226 Ill. App. 3d 20, 44-45, 168 Ill. Dec. 169, 89 N.E.2d 569 (Ill. App. Ct. 1991) (standard of care must be "relevant in terms of time and conduct"); accord Ennenga v. Starns, 677 F.3d 766, 777-78 (7th Cir. 2012) (discussing elements of negligence under Illinois law). This necessarily requires Plaintiff to establish what the applicable standard of care was in the industry at the relevant time. In an attempt to do so, Plaintiff has proffered the expert testimony of Dr. Suzanne Parisian, a medical doctor and former medical officer with the Food and Drug Administration ("FDA").

Dr. Parisian holds a medical degree from the University of South Florida and both a bachelor's and master's degree in biology from the University of Central Florida. (Tr.*fn1 at 6.) At the FDA, Dr. Parisian began as a medical officer in the Office of Health Affairs. (Id.) She later served as a medical officer and then chief medical officer in the Office of Device Evaluation. (Id. at 7.) While at the FDA, Dr. Parisian received training on FDA regulations and the concept of pharmacovigilence, which refers to a drug maker's obligation to monitor and update information relating to its drugs. (Id.; see also id. at 77.) In 2001, Dr. Parisian published a book entitled "FDA: Inside and Out," which she testified provides "guidance for manufacturers and for situations like this. It's just a reference book about the FDA." (Id. at 8.) After leaving the FDA, Dr. Parisian founded a consulting company through which she advises drug companies on matters relating to the FDA. (Id. at 9-10.) Dr. Parisian has testified as an expert witness in numerous trials, including numerous times in trials involving hormone therapy.

If permitted to testify, Dr. Parisian would opine that Defendant "breached the standard of care by failing to act as a reasonable drug company [would] in the same or similar circumstances including by failing to follow up on safety signals with breast cancer studies." (R. 318, Pl.'s Post-Hr'g Br. at 6.) Specifically, Dr. Parisian would testify that "Wyeth could have and should have done additional studies on E because (a) there were sufficient safety signals or red flags to justify such studies being done and (b) a reasonable drug company should respond to such signals with studies." (Id. at 9.) As a result of Defendant's alleged failure to undertake adequate study and/or testing, Dr. Parisian would conclude that "Wyeth's warnings were inadequate." (Id. at 10.)

On February 21, 2012, Defendant moved in limine to exclude Dr. Parisian's testimony under Rule 702 and Daubert. The Court subsequently granted the motion in part, denied the motion in part, and took one issue under advisement pending a Daubert hearing -- namely, whether Dr. Parisian has a reliable basis to opine on the applicable standard of care for her "failure to test" opinions. (R. 239.) The present order is limited to that issue. The Court held the Daubert hearing on June ...

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