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Pfizer Ordered to Pay $34.3 Million in HRT Lawsuit

MedpageToday

WASHINGTON -- A Philadelphia jury ordered Pfizer to pay $28 million in punitive damages, and $6.3 million in compensatory damages to a breast cancer survivor who used a trio of the company's hormone replacement drugs.

On Friday, the jury decided that the drugs, conjugated estrogen (Premarin), conjugated equine estrogen and progestin (Prempro), and medroxyprogesterone (Provera), contributed to plaintiff Donna Kendall's cancer and that the drug company failed to adequately warn consumers about the risks associated with the drugs, Reuters reported.

On Monday, the jury decided the amount of the punitive damages.

Court documents from an earlier hormone replacement therapy case against Wyeth Pharmaceuticals, involving a different woman, were also unsealed this week. They had been kept secret because the Kendall case was being tried in the same courthouse.

In the earlier case, which was decided in October, a jury ordered Wyeth to pay plaintiff Connie Barton $75 million in punitive damages after connecting her breast cancer to Prempro, according to the Associated Press.

When Pfizer acquired Wyeth and Pharmacia & UpJohn, it also acquired hundreds of personal injury lawsuits involving the drugs according to Reuters.

Kendall, 66, had been taking Prempro and Provera for a total of 11 years after being diagnosed with breast cancer in 2002.

"Today signals a resounding victory for not only Donna Kendall, but for all women who suffered breast cancers at the hands of Wyeth and Upjohn," Kendall's attorney Tobi Millrood told Reuters on Monday.

Wyeth and Pharmacia & Upjohn have argued that the drugs were approved by the FDA, and that risks of the medications are included on the drugs' labels.

"We are disappointed with the verdicts in these cases," said Pfizer spokesman Chris Loder in a statement. "We believe that neither the awards of punitive damages nor the liability verdicts were supported by the evidence or the law."

Loder said Pfizer said it would challenge both verdicts.

Premarin, approved by the FDA in 1942, and Prempro, approved in 1994, are used to treat moderate to severe symptom of menopause. Provera, a progestin approved in 1959, is indicated for treatment of abnormal uterine bleeding, secondary amenorrhea, or to reduce endometrial hyperplasia in postmenopausal women who are also taking estrogen pills.

The use of hormone therapy dropped dramatically when findings from the Women's Health Initiative, which tested Prempro and Premarin, revealed that hormone therapy increased the risk of cardiovascular disease, stroke, and breast cancer. A 2008 study confirmed the Women's Health Initiative findings by again linking use of hormone replacements to a significant increase in risk for stroke. A more recent study linked hormone therapy to a 38% increased risk for ovarian cancer.

But Pfizer maintains that hormone therapy "remains a good healthcare choice for the appropriate woman seeking the relief of moderate to severe menopausal symptoms, including hot flashes, night sweats, vaginal atrophy, and the prevention of postmenopausal osteoporosis."

The company's position got backing this week from the International Menopause Society, which issued an statement endorsing hormone replacement therapy for a limited time to relieve the symptoms of menopause in women without a history of cardiovascular disease.