MINNEAPOLIS (CN) – A federal class action claims that Solvay Pharmaceutical deceived doctors and patients for 45 years by selling a menopause drug that the FDA had not approved. Doctors have written 35 million prescriptions for Estratest since 1997, and Solvay made $178 million a year from it, according to the complaint.
The four named plaintiffs say they took Estratest for periods ranging from a couple of months to more than a dozen years. They say that until early this year, Solvay illegally pushed the estrogen-androgen drug as a safe way to treat moderate-to-severe menopause symptoms in cases where estrogen therapy alone was unsuccessful.
The class claims: “Since 1964, the defendant promoted the misperception that Estratest is FDA-approved when in fact it is not.”
In 2003 the FDA found that estrogen-androgen drug combinations were no more effective than estrogen alone in reducing hot flashes, but Solvay continued push Estratest and Estratest Half Strength for the complaint, the class claims. They say the U.S. Food, Drug and Cosmetic Act demands that drug manufacturers receive FDA approval that their drug is safe and effective before they push the product for “indicated” uses.
Solvay not only deceived “thousands” of unwitting patients, the class claims, it deceived leading researchers of estrogen-androgen therapies through the Physicians’ Desk Reference, a standard medical guide.
The PDR, which is meant to direct doctors to FDA-approved drugs, includes Estratest because Solvay sent the publishers the same misinformation that appears on Solvay’s Web site, the class claims.
Solvay also claimed to have FDA approval in a form it filled out to sell Estratest to the Defense Department, the class claims, citing a March 20, 2003 Wall Street Journal article.
The class seeks punitive damages, disgorgement and an injunction. It is represented by Daniel Gustafson with Gustafson Gluek and Elizabeth Alexander of Lieff Cabraser of San Francisco.