Solvay Pharmaceuticals, Inc. (Solvay) manufactures Estratest, a combination drug that contains esterified estrogen and methyltestosterone (an androgen). Estratest is primarily used by menopausal women who suffer from moderate to severe vasomotor symptoms ("hot flashes") and who have not received relief from their symptoms from estrogen-only therapy. In 2000, Estratest was the 199 th top selling prescription drug in the United States , with sales of $110 million in 2001.
In 1972 the Food and Drug Administration (FDA) approved several other estrogen/androgen combination therapies for the treatment of menopausal symptoms of women not improved by estrogen-only treatment. In 1979, the FDA reminded Reid-Provident Laboratories (subsequently acquired by Solvay), which at the time was already marketing and selling Estratest, that their product was not among those approved in 1972 and, therefore, their marketing and sales of the drug were illegal. In response to that letter and a 1981 Center for Drug Evaluation and Research report that the combination of esterified estrogens and methyltestosterone has similar efficacy to the approved combination drugs, the company filed a New Drug Application seeking approval of Estratest for the treatment of moderate to severe vasomotor symptoms. However, that application was never approved and in an unrelated 1999 patent case, the FDA, along with the Department of Justice and the presiding judge, again reprimanded Solvay for its continued marketing and sales of Estratest.
On April 14, 2003 , the FDA announced that it now believes that there is no substantial evidence proving that estrogen/androgen therapies are effective in treating hot flashes.
Despite its lack of FDA approval and the questions regarding the efficacy of Estratest, Solvay Pharmaceuticals continues to sell Estratest and to market it to doctors as hormone replacement therapy. Solvay develops and provides doctors with literature, advertisements and promotion materials that advocate the use of Estratest with claims that it is "indicated" for managing moderate to severe vasomotor symptoms in women not aided by estrogen-only therapy.
It is alleged that these advertisements and product descriptions falsely indicate that the Estratest is FDA-approved and proven effective.
In August 2003, PAL brought suit against Solvay alleging that it illegally and fraudulently marketed the drug Estratest for uses that have not been approved by the FDA. Specifically, the lawsuit alleges that Solvay has marketed Estratest for the treatment of hot flashes in menopausal women despite the fact that the FDA never approved the use of the drug for this purpose, and in fact, has recently announced that there is no evidence supporting the efficacy of estrogen/androgen combination drugs in treating this condition.
The complaint was brought on behalf of the Congress of California Seniors and CALPIRG under California 's Unfair Competition Law (Business and Professions Code §17200, et seq.), which prohibits unlawful, unfair and fraudulent business acts and practices. The complaint also alleges that Solvay violated California's Untrue and Misleading Advertising Law (Business and Professions Code §17500, et seq.), which prohibits corporations from intentionally using statements that are, or should be, known to be false or misleading to induce the public into making purchases.
On November 5, 2003 , Judge Hess of the Superior Court of California, County of Los Angeles sustained Solvay's Motion to Dismiss the Complaint with leave to amend. On December 5, 2003, Plaintiffs' filed their First Amended Complaint. In response, Defendants filed another Motion to Dismiss.
The Plaintiffs filed their Second Amended Complaint on March 1, 2004, and the Defendants filed another demurrer (similar to a motion to dismiss). Judge Hess overruled their demurrer in May 2004 and the Defendants filed an Answer to the Second Amended Complaint on June 11, 2004. The case is now proceeding with discovery. On September 27, 2004, the parties presented a joint discovery plan to the court at a case management conference.
Update: Following the passage of a state referendum that changed the requirements for bringing a case under California's consemer protection statute, the defendants filed a Motion for Judgment on the Pleadings. On February 18, 2005, the Court granted this motion, ruling that the referendum applies to cases previously filed in California state courts, and dismissing the case. However, the Court granted permission for the plaintiffs to file an amended complaint, which they did on March 30, 2005. Based on the recently enacted Class Action Fairness Act (CAFA), the defendants removed the case to federal court and filed motions to stay and dismiss the case. The plaintiffs filed a motion to remand the case back to state court, which the federal court granted on June 24, 2005. The federal court also dismissed the defendants' motion to dismiss based on the remand ruling. The next status conference is scheduled for October 3, 2005.
Court: Superior Court of California, County of Los Angeles (Judge Hess)
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