Prempro verdict favors drugmaker

— Handing another Little Rock courtroom victory to Pfizer Inc., a federal jury on Friday found that while one of the company’s subsidiaries failed to adequately warn doctors about the risks of taking its hormone drug, the failure didn’t cause a Conway woman’s breast cancer.

After deliberating for about nine hours, beginning Thursday, the jury rejected Barbara Lewis’ claims for damages against two Pfizer subsidiaries, Wyeth and Upjohn, which made the two hormone drugs that were combined by Wyeth to make Prempro.

Pfizer now owns both Wyeth and Upjohn.

The verdict capped the seventh trial in Little Rock over Prempro since 2006. Of those, the only one ending in the plaintiff’s favor was in 2008, when a jury awarded Donna Gail Scroggin of Little Rock $2.7 million in compensatory damages and $27 million in punitive damages.

The punitive damages were thrown out by U.S. District Judge Bill Wilson, who also presided in this week’s trial. His ruling was overturned by the 8th U.S. Circuit Court of Appeals in St. Louis. The parties later settled the punitive-damages issue for an undisclosed sum.

New York City-based Pfizer said in a statement Friday that it is “pleased” with the Lewis verdict and that it has a “strong record of success” in the litigation over the drug.

“Hormone therapy medicines are an important treatment option for many women with debilitating symptoms of menopause,” the company said.

Frank Woodson, a Montgomery, Ala., attorney representing Lewis, noted that the jury answered “yes” on a form asking whether the evidence showed Wyeth failed to warn doctors about the risks of taking Prempro or Premarin, one of the drug’s components.

He said he couldn’t explain why the jury didn’t find that the drug caused Lewis’ cancer.

“If we had tried the case in front of four different juries, we might have won with some juries and lost with some juries,” Woodson said. “That’s just the nature of the beast.”

Lewis likely will appeal the verdict, he said.

Lewis, a nurse, began taking Prempro in 1995 to alleviate uncomfortable symptoms of menopause, such as hot flashes and night sweats.

The drug combines Wyeth’s estrogen-only Premarin, which is derived from the urine of pregnant mares, and Upjohn’s Provera, a synthetic progestin.

In 2002, Lewis stopped taking the drug after reading a news report about a study that had linked Prempro to breast cancer.

When her symptoms again became unbearable, however, she started taking a lower-dose version of the drug in the fall of 2003, only to end up being diagnosed with breast cancer a month later.

In the trial that began Dec. 5, Lewis contended that Wyeth and Upjohn should have conducted their own study to address growing concerns about the extended use of the estrogen and progestin combination.

Lyn Pruitt, a Little Rock attorney representing the drug companies, told jurors that the companies revealed all risks known at the time on FDA-approved labels intended for doctors and patients.

In addition to its findings in favor of Wyeth, the jury found Friday that Upjohn had not inadequately warned doctors about the risks of taking Provera.

Wilson had instructed jurors that a medication’s warning is considered inadequate if it is not sufficient for a reasonable doctor to understand the risk.

In August, a federal jury in Little Rock reached a verdict similar to the one in Lewis’ case, finding that Wyeth and Upjohn failed to adequately warn patients about breastcancer risks but that they were not responsible for a Hot Springs Village woman’s breast cancer.

Nationwide, Pfizer has won 14 hormone-therapy cases and lost nine, according to the company, which said some of the verdicts are being appealed. Thousands of other cases across the country have been settled.

The lawsuits followed a 2002 study of Prempro by the National Institutes of Health. Expected to last 15 years, it was halted after 4 1/2 years when researchers realized the risks of breast cancer were starting to outweigh the potential heart and brain benefits.

Prempro is still prescribed for menopause, although Woodson said Pfizer has increased its warnings about the breast-cancer risk and lowered the recommended dosage.

Arkansas, Pages 9 on 12/22/2012

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