Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

For years, Mrs. Smith* chose not to take hormone replacement therapy (HRT) to treat bothersome symptoms of menopause. During menopause, some women become “estrogen deficient” – their estrogen level drops so low that they experience symptoms such as hot flashes, night sweats and vaginal dryness that can be so severe it interferes with a woman’s quality of life.

Mrs. Smith talked to her doctor, who recommended Prempro, a pill made by Wyeth that contains a mixture of estrogen and synthetic progestin hormones. The pills were also marketed to doctors and women as a miracle drug that tamed not only menopausal symptoms but also had the added benefit of protecting women against heart disease and osteoporosis. HRT became widely prescribed, and Wyeth racked in billions in profits.

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In July 2000, Cynthia L. Waldrep was a territory specialist with Wyeth-Ayerst’s female healthcare division, promoting the company’s pharmaceuticals to doctors throughout Alabama and Georgia, when her conscience led her to write a letter to Wyeth’s executives and to the company’s Office of Ethics and Business Conduct.

“Instruction from my management for promotion of products … has included information outside of labeling. In other words, core presentations for promotion contain information that the FDA has not granted approval for use with these drugs. Specifically, the use of Premarin for the prevention/treatment of cardiovascular disease, Alzheimer’s disease, and colorectal cancer. Additionally, the issue of potential side effects has been minimized, such as the risk of breast cancer,” she wrote.

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Thousands of women who claim their hormone replacement therapy (HRT) caused them to develop breast cancer and other deadly diseases and conditions may finally have some resolution, now that Pfizer Inc. has announced it expects to shell out an additional $300 million to settle the last of more than 10,000 product liability lawsuits. The drug giant has already paid $472 million to settle with plaintiffs.

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U.S. District Judge Bill Wilson Jr. has ordered scientific data collected by the Cancer Research Center since August 2005 as a follow up to a study on the effects of hormone replacement therapy (HRT) on postmenopausal women should be released to Wyeth Pharmaceuticals as it defends itself against numerous lawsuits over the safety of its HRT meds.

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According to the World Health Organization, breast cancer is the most common cancer worldwide among women. It is the fifth most deadly cancer, killing about 502,000 people per year. All of us know a family who has had to deal with this most serious problem.

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The U.S. Supreme Court will hear arguments today in the first of two cases this term that consumer advocates fear could shut courthouse doors to patients injured by FDA-approved drugs or medical devices.

Legal experts say the cases could also affect lawsuits already filed by tens of thousands of Americans challenging the safety of blockbuster drugs such as Celebrex and Prempro and a host of medical devices.

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The Reno trial involving three breast cancer survivors who are suing Wyeth is now nearing the end of its fourth week. The Nevada plaintiffs are suing Wyeth, the manufacturer of Prempro and Premarin, after they each developed breast cancer attributed to their long-term use of combination hormone replacement drugs.

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