Drug Safety Developments

Pfizer to Pay $1.8 Million in Prempro Punitive Damages

Quoted from http://www.businessweek.com/news/2013-08-07/pfizer-to-pay-1-dot-8-million-in-prempro-punitive-damages-1

Pfizer to Pay $1.8 Million in Prempro Punitive Damages

By Jef Feeley August 07, 2013

Pfizer Inc. must pay about $1.8 million in punitive damages to a Connecticut woman who developed breast cancer after taking the company’s Prempro menopause drug, a judge concluded.

U.S. District Judge Janet Bond Arterton’s Aug. 5 ruling brings the amount Pfizer must pay Margaret Fraser over her claims the hormone-replacement medicine caused her cancer to $5.76 million. A jury in New Haven, Connecticut, awarded Fraser and her husband $4 million in compensatory damages in April 2012 after finding the world’s largest drugmaker liable for her injuries.

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Pfizer Loses Prempro Ruling, Must Pay $10.4 Million

Quoted from http://www.businessweek.com/news/2012-07-21/pfizer-must-pay-10-dot-4-million-in-prempro-lawsuit-court-rules

Pfizer Loses Prempro Ruling, Must Pay $10.4 Million

By Jef Feeley on July 21, 2012

Pfizer (PFE) (PFE) Inc. must pay $10.4 million in damages to a woman who blamed the company’s Prempro menopause drug for her breast cancer, an appeals court said.

Jurors properly awarded Audrey Singleton, who sued Pfizer’s Wyeth unit over Prempro, compensatory and punitive damages for the company’s marketing of the drug, the Pennsylvania Superior Court ruled yesterday. Singleton’s lawyers alleged that Wyeth hid the drug’s health risks and a jury awarded her damages on those claims in 2010.

“Wyeth’s concerted effort to misdirect physicians from the dangers of Prempro illustrates the consciousness that its conduct was not at all reasonable,” the three-judge panel said in upholding the jury’s findings.

The ruling comes as Pfizer officials are working to settle lawsuits over the menopause drugs. The drugmaker has settled about 60 percent of cases over the medicines and paid out $896 million, executives said in a May filing with the U.S. Securities and Exchange Commission. The company has set aside an additional $330 million to resolve the remaining cases.

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Pfizer Cleared of Liability in Prempro Breast Cancer Case

Quoted from http://www.businessweek.com/news/2012-05-30/pfizer-cleared-of-liability-in-prempro-breast-cancer-case

Pfizer Cleared of Liability in Prempro Breast Cancer Case

By Jef Feeley and John Dillon on May 30, 2012

Pfizer Inc. (PFE) isn’t liable for the breast-cancer death of a woman who died after taking menopause drugs made by the company’s units, a Connecticut jury ruled.

Jurors in federal court in Bridgeport deliberated about five hours over two days before finding Pfizer’s Wyeth unit provided proper warnings about the health risks of its Prempro hormone-replacement pill to Lynn Moss. The 62-year-old nurse died in December 2006 “after a protracted battle with breast cancer,” according to court filings.

“This verdict affirms the fact that Wyeth acted responsibly by communicating accurately the risks and benefits of its hormone therapy medicines,” Chris Loder, a Pfizer spokesman, said in an e-mailed statement...

Lawyers for Moss’s family, who pressed on with her lawsuit after her death, said in an e-mailed statement today that they were disappointed with the jury’s verdict.

“There is a great deal of evidence that was excluded from this trial that we believe hampered the jury’s ability to appropriately consider all of the issues,” Neal Moskow, one of the family’s attorneys, said in the statement.

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Pfizer Ordered to Pay $4 Million in Damages in Prempro Case

Quoted from http://www.businessweek.com/news/2012-04-20/pfizer-ordered-to-pay-4-million-in-damages-in-prempro-case

Pfizer Ordered to Pay $4 Million in Damages in Prempro Case

By Jef Feeley on April 20, 2012

Pfizer Inc. (PFE) must pay at least $4 million in damages to a woman who developed breast cancer after taking the company’s Prempro menopause drug, a jury in Connecticut ruled.

Jurors in federal court in New Haven ruled April 18 that Pfizer’s Wyeth unit was liable for causing Margaret Fraser’s cancer and that Prempro was an “unreasonably dangerous product,” Greg Bubalo, one of Fraser’s lawyers, said in a telephone interview today. The panel also found Wyeth should pay punitive damages over its handling of the drug, he said.

The jury concluded that Wyeth’s handling of the drug “was reckless and they had misrepresented the risks and benefits of its drug to patients and doctors,” Bubalo said. A federal judge will decide later how much in punitive damages Pfizer must pay, he said.

More than 6 million women took Prempro and related menopause drugs to treat symptoms such as hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, topped $2 billion before the release of the Women’s Health Initiative, a National Institutes of Health-sponsored study.

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Pfizer Must Pay $45 Million in Prempro Cases, Court Rules

Quoted from http://www.businessweek.com/news/2012-01-04/pfizer-must-pay-45-million-in-prempro-cases-court-rules.html

Pfizer Must Pay $45 Million in Prempro Cases, Court Rules

January 04, 2012, 12:17 PM EST

By Jef Feeley

 

Jan. 4 (Bloomberg) -- Pfizer Inc. must pay more than $45 million in damages to two women who blamed the company’s menopause drugs for their breast cancers, an appeals court ruled.

Connie Barton and Donna Kendall, two Illinois women who sued Pfizer units Wyeth and Pharmacia & Upjohn over their menopause medications, deserved both compensatory and punitive damages over the companies’ handling of the drugs, a panel of the Pennsylvania Superior Court ruled yesterday.

“We are very disappointed with the court’s decisions in these cases and continue to believe there was no basis in fact or law for the jury verdicts,” Chris Loder, a spokesman for New York-based Pfizer, said in an e-mailed statement. Pfizer officials will ask the Pennsylvania Supreme Court to review the lower court’s findings, he said.

More than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer. At one point, Pfizer and its units faced more than 10,000 lawsuits over the medications.

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Pfizer Has Settled About Half of Prempro Cases, Adds to Reserve

Quoted from http://www.bloomberg.com/news/2011-12-15/pfizer-has-settled-about-half-of-prempro-cases-adds-to-reserve.html

Pfizer Has Settled About Half of Prempro Cases, Adds to Reserve

By Jef Feeley - Dec 15, 2011 8:38 AM ET

Pfizer Inc. (PFE), the world’s largest drugmaker, has settled almost half of the lawsuits over its menopause drugs and increased the funds set aside to resolve the cases, the company said in a regulatory filing.

Pfizer and its Wyeth and Pharmacia & Upjohn units have resolved about 46 percent of suits that claimed the companies’ hormone-replacement medicines, including Prempro and Premarin, caused breast cancer, according to the Securities and Exchange Commission filing. Pfizer said it added $68 million to the $772 million it already reserved for the cases.

“We have recorded a charge of $260 million in the first nine months of 2011 that provides for the minimum expected costs to resolve all the remaining hormone-replacement actions,” Pfizer officials said in the Nov. 10 filing.

More than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, exceeded $2 billion before the release of the Women’s Health Initiative study sponsored by the National Institutes of Health.

Until 1995, many menopausal women combined Wyeth’s Premarin, an estrogen-based drug, with progestin-laden Provera, made by Pfizer’s Upjohn unit, to relieve their symptoms. Wyeth combined the two hormones in its Prempro pill. Pfizer, based in New York, acquired Wyeth in 2009.

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Pfizer Loses $72.6 Million Verdict in Breast Cancer Suit

Quoted from http://www.businessweek.com/news/2011-12-06/pfizer-loses-72-6-million-verdict-in-breast-cancer-suit.html

Pfizer Loses $72.6 Million Verdict in Breast Cancer Suit

December 06, 2011, 3:58 PM EST

By Jef Feeley, Chris Yasiejko and Phil Milford

 

Dec. 6 (Bloomberg) -- Pfizer Inc. must pay $72.6 million in damages to three women who contended they developed breast cancer after taking the company’s menopause drugs, a Philadelphia jury decided.

Jurors in state court deliberated over two days before finding today that hormone-replacement drugs made by Pfizer’s Wyeth and Pharmacia Upjohn units were responsible for cancer in Susan Elfont, Bernadette Kalenkoski and Judy Mulderig. The panel awarded Elfont $20 million; Kalenkoski, $27.85 million; and Mulderig, $24.75 million.

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N.J. manufacturers cannot be sued for claim that their drugs caused breast cancer, panel says

Quoted from http://www.nj.com/news/index.ssf/2011/09/nj_manufacturers_cannot_be_sue.html

N.J. manufacturers cannot be sued for claim that their drugs caused breast cancer, panel says

Published: Thursday, September 29, 2011, 8:39 PM Updated: Thursday, September 29, 2011, 8:39 PM

By MaryAnn Spoto/The Star-Ledger The Star-Ledger

TRENTON — Putting more than 150 lawsuits over hormone replacement therapy into question, a state appellate panel today said two New Jersey manufacturers cannot be sued by two women who claim the synthetic drugs they took for years caused their breast cancer.

The decision — 3½ years in the making — was a victory for Pfizer Inc., whose subsidiaries, Wyeth Pharmaceuticals Inc. and Upjohn Co., have been accused of failing to provide adequate warning of the risk of breast cancer from their drugs used to treat the symptoms of menopause.

The dismissals do not set precedent for courts outside of New Jersey — there are lawsuits based on the same evidence proceeding in other states — but the decision calls into question the future of more than 150 lawsuits put on hold in New Jersey while this appeal was pending.

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Pfizer’s Prempro Didn’t Cause Woman’s Cancer, Jury Concludes

Quoted from http://www.bloomberg.com/news/2011-07-28/pfizer-s-prempro-didn-t-cause-woman-s-cancer-jury-concludes.html

Pfizer’s Prempro Didn’t Cause Woman’s Cancer, Jury Concludes

By Sophia Pearson and Jef Feeley - Jul 28, 2011 6:32 PM ET

Pfizer Inc. (PFE)’s Prempro menopause drug wasn’t the cause of a West Virginia woman’s breast cancer, a jury ruled today in rejecting her claim for damages.

Jurors in federal court in Charleston, West Virginia, found that hormone therapy medicines made by Pfizer’s Wyeth and Upjohn units weren’t a cause in the development of Leah Royce Hines’s breast cancer.

“While we have great sympathy for Mrs. Hines and her family, this verdict affirms the fact that science cannot determine what caused or contributed to any individual woman’s breast cancer, except in rare circumstances where genetics plays a role,” Chris Loder, a Pfizer spokesman, said in an e-mailed statement.

More than 6 million women took Prempro and related menopause drugs to treat symptoms such as hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, topped $2 billion before the release of the Women’s Health Initiative, a National Institutes of Health-sponsored study.

Until 1995, many menopausal women combined Premarin, Wyeth’s estrogen-based drug, with progestin-laden Provera, made by Pfizer’s Upjohn unit, to relieve their symptoms. Wyeth combined the two hormones in its Prempro pill.

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Pfizer Rejected By U.S. High Court on $58 Million Prempro Award

Quoted from http://www.bloomberg.com/news/2011-06-20/pfizer-rejected-by-u-s-high-court-on-58-million-prempro-award.html

Pfizer Rejected By U.S. High Court on $58 Million Prempro Award

By Greg Stohr - Jun 20, 2011 10:08 AM ET

The U.S. Supreme Court refused to hear a Pfizer Inc. (PFE) unit’s appeal of a $58 million award to three Nevada women who contracted breast cancer after taking the company’s Premarin and Prempro menopause drugs.

The rebuff leaves the award as the largest to be upheld on appeal in thousands of hormone-replacement drug suits. More than 6 million women took Prempro and other menopause drugs before a 2002 study highlighted their links to cancer. Pfizer and its units at one point faced more than 10,000 claims, according to lawyers for former users.

The Nevada Supreme Court concluded that jurors properly held Pfizer’s Wyeth unit responsible for hiding the breast- cancer risks of Premarin and Prempro. The original 2007 award totaled $134.1 million to Arlene Rowatt, Jeraldine Scofield and Pamela Forrester. The trial judge later reduced the verdict to $57.6 million.

At the Supreme Court, Wyeth argued that the judge should have ordered a new trial rather than reduce the award. The company contended that the jury was swayed by an “improper and inflammatory” closing argument by the women’s lawyer.

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