Virginia Federal Jury Says Woman Didn't Prove Prempro Warnings Were Inadequate

ALEXANDRIA, Va. - (Mealey's) A Virginia federal jury on Dec. 3 found that a woman who claimed to have developed breast cancer from taking Wyeth's Prempro hormone replacement therapy drug did not prove that warnings provided to her doctor were inadequate (Georgia Torkie-Tork v. Wyeth, No. 04-945, E.D. Va.).

Georgia Torkie-Tork took Prempro to treat menopausal symptoms between May 1999 and June 2002.  Prempro is a combination of estrogen and progestin. 

Torkie-Tork alleged that Wyeth knew about the drug's risk of breast cancer but failed to warn doctors or to conduct clinical studies about the risk.

Wyeth argued that the warnings on Prempro's label in 1999 warned that some studies found a risk of breast cancer. 

The jury in U.S. District Court for the Eastern District of Virginia answered "no" to the first question on the verdict form about whether Torkie-Tork proved by the greater weight of evidence that Prempro's warnings were inadequate.  The jury did not have to reach questions about whether an adequate warning would have changed Torkie-Tork's doctor's decision to prescribe Prempro and whether a decision not to prescribe the drug would have meant that Torkie-Tork would not have developed breast cancer or that her breast cancer would not have been aggravated.

The jury also did not have to determine compensatory damages.  Judge T.S. Ellis III deferred a decision on whether to have the jury rule on punitive damages. 

Trial began Nov. 16, and the case went to the jury Dec. 2.

[Editor's Note:  Full coverage will be in the Dec. 16 issue of Mealey's Emerging Drugs & Devices.  In the meantime, the verdict form is available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844.  Document #28-101216-006V.  For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]

Download the document now:

Mealeysonline.com - Document #28-101216-006V 

For more information, call editor Tom Moylan at 215-988.7739, or e-mail him at tom.moylan@lexisnexis.com.