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HORMONE THERAPY LITIGATION Battling for Breast Cancer Survivors Zoe Littlepage Littlepage Booth 2043 A West Main Street Houston, Texas 77098 (713) 529-8000 [email protected] Hormone Therapy Litigation The Hormone Therapy Litigation includes more than 11,000 plaintiffs who took combination hormone drugs (E+P or estrogen and progestin) and developed breast cancer. The MDL is pending in Little Rock, Arkansas before Judge William Wilson. There are also pockets of state court litigation: more than a thousand cases in Philadelphia, PA; less than 200 in New Jersey; less than 100 in New York and then a scattering of single cases across the country. While there are also cases pending for other injuries including ovarian cancer, stroke, blood clots and heart problems, there are currently no trial settings involving these injuries. The focus of the Bellwether trials to date have been for women who developed breast cancer cases following ingestion of E+P whether in two pills (Premarin and Provera) or in one combination tablet, Prempro. The chief defendants in the litigation are Wyeth (makers of Premarin and Prempro) and the Pfizer/ Pharmacia/Upjohn defendants (maker of Provera). Indeed, these two drug companies owned more than 85% of the hormone therapy market. However, hundreds of women also took estrogen or progestin made by other named defendants including Bristol Myers, Solvay, Barr, Novartis etc. To date, there have been numerous trials and en women have settled their claims with the following results: HRT Trials Name Location Outcome Reeves v. Wyeth Nelson v. Wyeth McCreary v. Wyeth Daniel v. Wyeth Little Rock, AR Philadelphia, PA Reno, Nevada Philadelphia, PA Nelson v. Wyeth (retrial) Rush v. Wyeth Simon v. Wyeth & Pfizer Deutsch v. Wyeth Rowatt et al v. Wyeth Philadelphia, PA Defense verdict $1.5 million verdict Settled $1.5 million verdict Punitive damage award sealed $3 million verdict Scroggin v. Wyeth & Pfizer Little Rock, AR Philadelphia, PA New Brunswick, NJ Reno, Nevada Little Rock, AR Defense verdict $1.5 million verdict Settled $134 million verdict Pfizer settled pre-trial $2.75 million + $19.3 million in punitives Background of Hormone Therapy Drugs Premarin (estrogen) was first marketed to alleviate menopausal symptoms in 1942. However, its use did not become popular until 1966 when a bestselling book, Feminine Forever, hit the market and strongly recommend estrogen as a fountain of youth drug. Sales took off – until 1975 – when bad news hit. In 1975, two published medical articles established that estrogen was causing an endometrial cancer epidemic in this country. For the first time, doctors and women knew that estrogen alone caused cancer below the waist. Premarin sales plummeted. The manufacturers’ solution was to recommend the use of two drugs together: estrogen to help with hot flashes and synthetic progestin or MPA (Provera) to protect the endometrium from the cancercausing potential of estrogen. Unfortunately, even though the drug companies started promoting this combination of drugs for long-term use, not a single company did any long-term studies to look at the carcinogenic potential of this combination in a woman’s body. Despite internal memorandum confirming that the companies knew that breast cancer was an open and unresolved issue with the combination drugs, no studies were conducted. One has to wonder if the endometrial cancer crisis had taught drug companies one thing: don’t test for cancer because cancer warnings kill sales. The combination E+P sold well. Indeed, so well, that in 1994 Wyeth got a new drug approved (Prempro) which was a single tablet containing both E+P. Prempro allowed women to get just one prescription, pay one co-pay and take only one pill each morning. Prempro quickly dominated the E+P market. At its height, Wyeth sold more than $2 Billion per year of its hormone therapy drugs. For years, Wyeth spent more than $200 million each year in marketing the drugs while, at the same time, ignoring numerous red flags that the drugs were not safe. Wyeth chose to protect its bottom dollar instead of protecting the patients. It was not until July of 2002, when the government’s Women’s Health Initiative (WHI) study stopped early because of the breast cancer problems, that doctors and the public finally learned the truth. When the WHI results were released, hormone drug prescriptions tanked. Importantly, in lock-step with this fall in sales, came a fall in breast cancer rates in this country. Studies now show that 17,500 fewer breast cancers per year occurred when women stopped taking these drugs, the greatest decline in breast cancers in the history of this country. And the only thing that changed was that the prescriptions for hormone therapy drugs dropped.