Hormone Replacement Therapy
Prempro is a combination hormone replacement therapy drug manufactured by Wyeth that is prescribed to postmenopausal women to alleviate the effects of menopause, and reduce the health consequences associated with low hormone levels such as osteoporosis or loss of bone density. Wyeth promoted Prempro as being safe and effective without conducting any long-term clinical trials to determine the drug’s safety and efficacy.
Beginning at puberty, a woman's ovaries produce natural hormones estrogen and progesterone. The hypothalamus and pituitary glands send messages to the follicle (eggs encased in their sacs) to produce hormones.
The production of hormones slows over time. By age 35, a woman's hormone production has dropped considerably. Progesterone, often called the "feel good" hormone, is the first hormone to decline and drops 120 times more rapidly than estrogen.
Menopause is a life phase through which all women pass. It is the body's process of phasing out the reproductive cycle by reducing natural estrogen. During menopause, a woman's estrogen level drops sharply. Hot flashes are a common condition of menopause. For some women, hot flashes are just a vague feeling of warmth. For others, the skin suddenly flushes and beads with sweat, while the pulse races. When estrogen levels decline, so does calcium in the skeleton. As a result, the risk of osteoporosis and spine, hip and other fractures increases.
Combination hormone therapy is a prescription, two-drug drug regimen designed to replace female hormones estrogen and progesterone. Wyeth brought two drugs to market in the 1940s and 1950s: (1) Premarin, a form of estrogen manufactured from horse urine, and (2) Provera, a synthetic progestin, which is chemically similar to progesterone. At the time that Premarin and Provera were brought to market in the 1940s and 1950s, the FDA did not have authority to evaluate their safety and efficacy. Thus, both drugs were “grandfathered” in and never met the current FDA standards.
In the early years, Wyeth had difficulty selling Premarin. That all changed when, in 1966, a book funded by Wyeth, Feminine Forever, encouraged women to take estrogen to eliminate the symptoms of menopause. The book became a bestseller and the sales of Premarin soared. The surge in sales of Premarin was unfortunately accompanied by a surge in cases of endometrial cancer. Once the association between Premarin and endometrial cancer became widely known, predictably, sales plummeted.
In response to the decrease in sales of Wyeth’s Premarin, Wyeth’s sales representatives promoted a two-drug combination by adding Provera, a progestin, to counterbalance the carcinogenic effects of Premarin. The combination was not FDA approved and the FDA repeatedly told Wyeth that the marketing and promotion of this combination violated the law. Despite the FDA’s warnings, Wyeth continued to sell the two-drug combination drug and did so without conducting any studies to determine the risk that the combination presented to women across the country. Since both drugs were grandfathered into the market, the FDA lacked any authority to require Wyeth to conduct the necessary safety studies. Yet, despite the FDA’s request for Wyeth to conduct such studies, Wyeth refused and continued to market the drugs as been safe and effective for menopausal relief. Moreover, Wyeth marketed the two-drug combination as having cardiovascular benefits and preventing Alzheimer’s disease and osteoporosis.
In the mid-1990s, Wyeth combined the two pills into a single pill called Prempro. The study Wyeth submitted to the FDA with its New Drug Application for Prempro was a short term clinical study, not long enough to quantify the breast cancer risk. Nevertheless, five of the women who participated in the experimental trial developed breast cancer.
In 2002, the National Institutes of Health prematurely discontinued the largest clinical trial ever conducted of women’s health after it was revealed that the risks of Prempro far outweighed the benefits. The study, known as the Women’s Health Initiative, indicated that the breast cancer risk associated with Prempro was unacceptably high, and that Prempro presented other serious health risks including blood clot formation and heart attacks.
As a result of Wyeth’s failure to warn the healthcare profession and public about the increased risk of breast cancer associated with long term use of Prempro, women have developed and suffered from breast cancer, and sadly, there have been some deaths as a result. Our law firm represents these women and their families all over the country in their lawsuits against Wyeth for the devastating and life changing injury they have sustained as a result of Wyeth’s failure to test Prempro and Wyeth’s failure to warn the public of the potential risk of developing breast cancer as a result of long term use of its drug.
The drug litigation group at Cohen & Malad, LLP works tirelessly to protect the rights of women who have been harmed as a result of taking hormone therapy. Our group works with lawyers across the country in order to obtain the best results for our clients. We have tried cases across the country resulting in significant jury verdicts for women who developed breast cancer as a result of ingesting hormone therapy. The chart below represents the jury verdicts in the hormone therapy cases:
|Singleton, Audrey||Philadelphia, PA||$9.45 Million|
|Kendall, Donna||Philadelphia, PA||$6.3 Million|
$28 million Punitive Damages
|Barton, Connie||Philadelphia, PA||$3.7 Million|
$75 million Punitive Damages
|Scroggin, Donna||Little Rock, AR||$2.7 Million|
$27 Million in Punitive Damages
|Scofield, Jeraldine||Reno, NV||$10.5 Million + 33 million in Punitive Damages|
|Forrester, Pamela||Reno, NV||$12.5 Million + 35 million in Punitive Damages|
|Rowatt, Arlene||Reno, NV||$12 Million + 31 million in Punitive Damages|
|Simon, Merle||Philadelphia, PA||$1.5 Million|
|Nelson, Jennie||Philadelphia, PA||$3 Million|
|Daniel, Mary||Philadelphia, PA||$1.5 Million + Punitive Damages|
|Nelson, Jennie||Philadelphia, PA||$1.5 Million|
If you or a loved one has suffered an injury as a result of ingesting hormone therapy, please contact Cohen & Malad, LLP to speak with one of our experienced products liability/personal injury attorneys to discuss your legal options and help you seek the compensation you deserve.