Wyeth, Inc. (now owned by Pfizer, Inc.) manufactures the hormone replacement therapy (HRT) drugs Premarin, Prempro, and Premphase. HRT is approved for the prevention of postmenopausal osteoporosis and to treat vasomotor symptoms associated with menopause (e.g., hot flashes, night sweats) and vaginal atrophy. Wyeth marketed HRT not only for the approved purposes but for non-approved, off-label uses, including the prevention of cardiovascular disease, dementia, and Alzheimer’s disease. Wyeth also systematically used marketing efforts to assure physicians and patients that HRT did not increase the risk of breast cancer. In truth, HRT increased the risk of breast cancer as well as the risk of cardiovascular disease, dementia, and Alzheimer’s disease.
A class action on behalf of all California purchasers was filed against Wyeth for falsely advertising and deceptively marketing the HRT drugs in violation of California’s Consumer Legal Remedies Act and California’s Unfair Competition Law. In March 2011, the United States District Court of the Southern District of California certified a class of California women who purchased HRT between January 1995 and January 2003 who were exposed to a representation from Wyeth, or health care providers, that HRT lowered cardiovascular, Alzheimer’s and/or dementia risk, or did not increase breast cancer risk.
After considerable discovery, Wyeth moved the District Court to decertify the class. Wyeth contended that members of the class were not sufficiently ascertainable and that there were not prevailing issues of fact or law. On Oct. 7, 2015, the District Court denied Wyeth’s motion finding that the Plaintiff class was sufficiently identifiable through objective evidence (prescription records, insurance records, etc.) as well as self-identification through affidavits.
Moreover, the court found that the Plaintiffs submitted substantial evidence that Wyeth misrepresented that HRT products lower a woman’s risk of cardiovascular disease, dementia, and Alzheimer’s disease, without increasing breast cancer risk, through the drugs’ packaging, letters to doctors, and sales representatives. The Court found that “HRT users and physicians were systematically exposed to Defendants’ material misrepresentations during the class period through Defendants’ massive advertising campaign, which included, among others:
• sales calls designed to mislead and/or omit crucial health risk information;
• funding of various media advertisements and press releases;
• funding and publication of newsletters, brochures, medical studies, and other written media that downplayed, among others, breast cancer risks and promoted fictitious health benefits;
• funding and creation of physician and patient outreach and informational programs; and
• funding, publication, and dissemination of “Dear Doctor” letters.
The Court also agreed with the Plaintiff that every California woman who purchased HRT drugs during the class period was exposed to Defendants’ material misrepresentations through Defendants’ drug labels originating from Defendants. The Court denied Wyeth’s motion to decertify the class and adopted Plaintiffs’ suggested class definition:
All California consumers who purchased Wyeth’s Hormone Replacement Therapy products, Premarin, Prempro, and/or Premphase, for personal consumption between January 1995 and January 2003, and who do not seek personal injury damages resulting therefrom.
The class is represented by Leigh O’Dell, Andy Birchfield and David Byrne, all lawyers in our firm’s Mass Torts Section, Eileen McGeever, and Gary Holt. Leigh O’Dell had this to say:
We are very pleased with the Court’s ruling and believe that it brings us one step closer to vindicating the rights of women in California who purchased Wyeth’s hormone replacement therapy drugs (HRT) during the 1995 to 2003 timeframe. We look forward to presenting all of the evidence of Wyeth’s fraudulent marketing campaign at trial.
I have always felt that the persons who are responsible for the problems caused by the HRT drugs would be held fully accountable. I am now convinced that will happen.
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