Posts Tagged ‘Prempro’
Is Prempro, the hormone drug known to increase the risk of breast cancer, a public hazard?
If a judge in Pinellas County determines that it is, hundreds of thousands of documents now under seal in lawsuits against the drug’s manufacturer nationwide could be released for the public to inspect.
A hearing on the matter is scheduled for Monday, though attorneys were negotiating a possible resolution late Thursday.
More than 9,000 women have sued Pfizer’s Wyeth unit, the maker of Prempro and Premarin, claiming its bestselling hormone drugs caused breast cancer and stroke. The vast majority of those lawsuits have been consolidated in federal courts in Arkansas, Pennsylvania and Nevada.
Pfizer yesterday questioned the verdicts.
"The company believes that neither the awards of punitive damages nor the liability verdicts were supported by the evidence or the law," spokesman Chris Loder said. The company plans to challenge both decisions.
"The company stands by its belief that its subsidiaries acted responsibly," Loder said.
Plaintiffs’ lawyers say the verdicts are further proof that their cases are strong.
The verdicts show that "when jurors hear how Wyeth put huge profits over the safety of patients, they will react with a strong message of outrage," Esther Berezofsky, one of Barton’s lawyers, said in a statement.
Tom Kline, cocounsel for plaintiffs in about 40 other Prempro cases, said the punitive awards "showed that juries clearly believed that Wyeth hid the risks of breast cancer from doctors and patients, making the defense of these claims harder down the road."
There have been larger verdicts in pharmaceutical cases involving individual plaintiffs – a Texas jury awarded one plaintiff $253 million, later reduced to $26 million by an appeals court, in litigation against Merck & Co. Inc. over the arthritis drug Vioxx. But yesterday’s jury award in Philadelphia nonetheless was significant, another Center City plaintiffs’ lawyer said.
Pfizer Inc. has been hit with more than $100 million in two punitive-damage awards – one decided and the other unsealed yesterday – from Philadelphia juries.
Both cases involve Prempro, a hormone-replacement drug made by Wyeth, which recently was acquired by Pfizer. Plaintiffs said the drug was linked to their breast cancer.
The total includes $28 million awarded yesterday to Donna Kendall of Decatur, Ill.
In the second case, Philadelphia Common Pleas Court Judge Sandra Moss yesterday unsealed a verdict reached earlier this year that awarded $75 million in punitive damages to another Illinois resident, Connie Barton, over her Prempro-linked breast cancer.
"Those are large punitive verdicts, make no mistake about it," said Howard M. Erichson, a Fordham University law professor who has studied pharmaceutical litigation.
About 1,500 of 10,000 similar cases are pending in Philadelphia, a common jurisdiction for large liability cases, attorneys say.
The juries are sending a message that they are angry about the corporate conduct in the cases, Erichson said. The $75 million likely will be reduced because it far exceeds the $3.5 million Barton received in compensatory damages, he added.
"This is a pretty good-sized punitive-damage award," said Sol Weiss, whose firm, Anapol Schwartz, tries pharmaceutical lawsuits in jurisdictions around the country. "The jury believed that the [drugmakers] were not straight with what they knew about the cancer risks."
New York-based Pfizer and lawyers for the plaintiffs even disagreed over how to count wins and losses in hormone-replacement therapy cases to date.
While plaintiffs’ lawyers point to recent verdicts in their favor, Pfizer argues that judges have set aside some decisions and plaintiffs have dropped some cases, turning the legal tide in the company’s favor.
More than six million women have taken hormone-replacement medicines to treat menopause symptoms including hot flashes, night sweats, and mood swings. Until 1995, many patients combined Premarin, Wyeth’s estrogen-based drug, with progestin-laden Provera, made by Pharmacia & Upjohn, a company also acquired by Pfizer.
Wyeth, which had not reserved funds to cover losses in the litigation, combined the two hormones in Prempro. The drugs are still on the market. Pfizer, the world’s biggest drugmaker, completed the $68 billion purchase of Wyeth on Oct. 15. Pfizer reported net income of $8.1 billion last year on sales of $48.3 billion.
Pfizer shares closed yesterday up 17 cents, or a bit less than 1 percent, at $18.53.
Annual sales of Wyeth’s hormone-replacement drugs topped $2 billion before the 2002 Women’s Health Initiative study, sponsored by the National Institutes of Health, suggested that women using the medicines had a higher breast-cancer risk.
Wyeth faced its first punitive award over Prempro in January 2007, when a Philadelphia jury granted damages to Mary Daniel, an Arkansas woman who said the drug had caused her breast cancer. A judge threw out the award seven months later. The case is on appeal, and the amount of punitive damages remains under seal.
In October 2007, jurors in state court in Reno, Nev., awarded a total of $99 million in punitive damages to three women who blamed the drug for their breast cancers. That figure later was reduced to $35 million and is being appealed.
A federal jury in Arkansas awarded Donna Scroggin $27 million in bad-conduct damages against Wyeth and Upjohn over her Prempro claims. An appeals court threw out the award this year and ordered a new trial on the punitive-damage issue.
Not to worry, it will only take a few hours for them to make this money back.
Pfizer Inc. must pay about $75 million in punitive damages to an Illinois woman who developed cancer after taking one of the drugmaker’s menopause treatments, people familiar with a sealed verdict in the case said.
A Philadelphia jury ordered Pfizer’s Wyeth unit on Oct. 26 to pay the bad-conduct award, which is about 20 times larger than the $3.7 million in actual damages the panel awarded to Connie Barton over her use of Wyeth’s Prempro menopause drug, according to people with direct knowledge of the verdict.
A judge ordered Barton’s punitive-damage award sealed at Wyeth’s request until the trial of another Prempro lawsuit in the same courthouse is completed. Lawyers in that case say jurors won’t start deliberating on that suit’s claims for another three weeks.
“The company believes there is no basis in fact or in law for the jury verdict in the Barton case,” Pfizer spokesman Christopher Loder said. “We plan to ask the judge to reject both the compensatory and punitive awards. We anticipate that if the judge doesn’t grant the company a judgment notwithstanding the verdict, we will appeal.”
Loder said he couldn’t comment on the amount of the punitive damages verdict because of a court order banning disclosure of it while a related trial is in progress.
Women who take the hormone replacement therapy (HRT) drug Prempro not only increase their risk of breast cancer, but their risk of death from lung cancer as well, according to a study conducted by researchers from the Medical Center at the University of California-Los Angeles and presented at a meeting of the American Society of Oncology.
“This is a new finding that tells us women who smoke shouldn’t take estrogen and progestin for menopause symptoms,” said study author Rowan Chlebowski.
Prempro, manufactured by Wyeth, was a best-selling treatment for the symptoms of menopause until 2002, when the Women’s Health Initiative study revealed that HRT significantly increased women’s risk of breast cancer and cardiovascular disease. Sales of the product plunged, although it still generated $1.1 billion for the company in 2008.
Menopause can lead to unpleasant symptoms such as hot flashes, fatigue, dizziness, headaches, muscle weakness, nausea and rapid heart beat.
The current study was based on an analysis of 16,608 participants in the original Women’s Health Initiative study. The researchers found that current and former smokers who took Prempro were significantly more likely to die from lung cancer than women who received a placebo pill instead. This pattern held for non-smokers as well, although there were significantly fewer deaths than among smokers.
Nearly 80 percent of lung cancer cases in women are caused by tobacco use.
There were also more cases of lung cancer diagnosed in women taking HRT than those taking a placebo, but this difference did not achieve statistical significance.
The type of cancer in the study is known as non-small cell lung cancer, and accounts for 85 to 90 percent of all lung tumors. Both worldwide and in the United States, lung cancer kills more people than any other form of cancer. Roughly 200,000 new cases are diagnosed and approximately 160,000 people die from the disease in the United States each year.
Sources for this story include: www.bloomberg.com.