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Courthouse News Service Courthouse News Service

Experts to Testify on Menopause Drug Ads

CHICAGO (CN) - Wyeth Pharmaceuticals cannot bar experts from testifying about how the company markets the hormone therapy drug Prempro, which a woman claims caused her breast cancer.

Jo Baldonado was diagnosed with breast cancer while she was taking Prempro, a hormone-replacement drug for menopausal women made by Wyeth, which is now owned by Pfizer.

A federal trial slated for October 2012 will determine whether Prempro use caused Baldonado's breast cancer.

Baldonado has tapped experts to testify about Prempro marketing practices, but

Wyeth claimed that their testimony should be barred as irrelevant and unreliable.

Baldonado argued that her experts, Dr. Matthew Hollon and Dr. Adriane Fugh-Berman, "will serve to educate the jury on the nature and purpose of the marketing materials seen by Mrs. Baldonado and her physicians ... provid[ing] context for Wyeth's breach of its duty to the physicians and patients."

U.S. District Judge Amy St. Eve agreed last week that the experts should not offer narrative histories about Wyeth's promotion of hormone therapy over the last 60 years.

"Even if the expert may have relied upon his or her expertise to 'wade through the multitude of possibly relevant documents,' the 'vast majority' of the experts' proffered narratives amount to a summary and statement of the experts' 'advocacy-based interpretation of documents in the record concerning' HT marketing practices," St. Eve wrote, quoting precedent.

She also barred Hollon from testifying about the Wyeth's state of mind.

"Nothing in plaintiff's brief or the record suggests that Dr. Hollon has personal knowledge of the internal motivation for any of defendant's actions, and furthermore, the jury is fully capable of considering the issue of intent based on the evidence presented at trial," she wrote.

Since Hollon conducted their own investigation of Wyeth's marketing practices, and did not just rely on Baldonado's attorneys for documentation, however, the court declined to take issue with his reliability.

"Although the pre-trial record contains some evidence of reliance on marketing materials, a ruling on the relevance of the proffered testimony to the negligence or punitive damages claims is premature," St. Eve wrote.

"If plaintiff seeks to offer expert testimony on defendant's marketing practices, plaintiff must first introduce evidence that is 'sufficient to support a finding' that the testimony relates to the underlying facts of this case," she added.

Baldonado must submit a statement of the specific expert opinions she intends to present at trial by the end of May.

Hollon, a physician at the University of Washington in Seattle, has published extensively about pharmaceutical marketing, and consulted on the topic for the Canadian government.

Fugh-Berman teaches physiology and biophysics at Georgetown University Medical Center. She describes her publishing history as having focused on "on the culture of gynecology and the effect of drug company promotion on prescribing habits."

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