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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. These advertisements and product descriptions falsely indicate that the Estratest is FDA-approved and proven effective.
PAL Member Litigation
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.
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. The Court ruled that the PAL coalition organizations that were plaintiffs in that case, Congress of California Seniors and CALPIRG, did not have standing to be plaintiffs in the wake of the state referendum. However, the Court granted permission for the other plaintiffs to file an amended complaint, which they did on March 30, 2005. Based on the 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. In December 2005, the plaintiffs submitted the Fifth Amended Complaint.
Update: The parties have completed the class certification briefing. A hearing on class certification was to be held on December 20, 2007. The court stayed all proceedings until at least January 31, 2008, as a result of a global
Court: Superior Court of California, County of Los Angeles (Judge Mohr)