Pfizer Statement On Prempro
Pfizer today announced that subsidiaries Wyeth and Pharmacia & Upjohn will challenge the verdicts against them in two hormone therapy cases - Kendall v. Wyeth et al. and Barton v. Wyeth - before the Philadelphia Court of Common Pleas.On Friday, a Philadelphia jury found Wyeth and Pharmacia & Upjohn liable in the Kendall v. Wyeth case, and decided that punitive damages were warranted. Today, the jury decided the amount of punitive damages. In addition, the punitive damage award in Barton v. Wyeth, a separate case in the same court decided in October, was unsealed.“We are disappointed with the verdicts in these cases. We believe that neither the awards of punitive damages nor the liability verdicts were supported by the evidence or the law. We plan to challenge both decisions in post-trial motions and, if necessary, through an appeal,” said Pfizer spokesman Chris Loder.
Wyeth and Pharmacia & Upjohn have prevailed in the vast majority of hormone therapy cases previously set for trial through a combination of rulings by judges, verdicts by juries, and dismissals by plaintiffs themselves to avoid being put to trial. Indeed, of the 34 trial-set cases to date, there have been only four plaintiffs’ verdicts that have not been set aside - including the verdicts rendered in the Kendall and Barton cases - and all four are being, or will be, challenged as legally deficient.“We stand by our belief that our subsidiaries acted responsibly by providing proper and accurate warnings regarding the hormone therapy medicines’ risks, performing and supporting studies on the known and potential benefits and risks of hormone therapy, and keeping the U.S. Food and Drug Administration (FDA) fully informed,” added Loder.Both Premarin (conjugated estrogens tablets USP), approved by the FDA in 1942, and Prempro (conjugated estrogens/medroxyprogesterone acetate tablets), approved by the FDA in 1994, treat moderate to severe symptoms of menopause and help reduce the chances of osteoporosis.Provera has been FDA-approved since 1959. Since 1983, the American College of Obstetricians and Gynecologists has recommended that any woman with an intact uterus who chooses, after consultation with her doctor, to take estrogen to treat debilitating menopausal conditions or postmenopausal osteoporosis should also take Provera to reduce the risk of endometrial hyperplasia, which is a risk factor for uterine cancer.Safety information, including about breast cancer, has long been included in the product labeling of the Premarin Family of products as well as other postmenopausal hormone therapies.Hormone therapy remains a good health care choice for the appropriate woman seeking the relief of moderate to severe menopausal symptoms, including hot flashes, night sweats, vaginal atropy and the prevention of postmenopausal osteoporosis.Pfizer continues to support the use of hormone therapy and recommends that it be used at the lowest dose for the appropriate duration consistent with treatment goals and risks for the individual woman. We also urge all women to follow established guidelines for mammographic evaluation.






