Drug Safety Developments

Discovery Rule Exception in Hormone Replacement Cases Ruled a Jury Question

Quoted from http://www.law.com/jsp/article.jsp?id=1202471427352

Discovery Rule Exception in Hormone Replacement Cases Ruled a Jury Question

Amaris Elliott-Engel

The Legal Intelligencer

September 01, 2010

 

In a decision that restores 1,000 hormone replacement therapy mass tort cases to the Philadelphia Common Pleas Court's caseload, the state Superior Court said it is a question of fact, not a question of law, whether the plaintiffs could have known at the time of their diagnoses with breast cancer that the alleged cause of their cancer was their HRT prescriptions.

The manufacturers of HRT drugs argued that the plaintiffs' two-year statute of limitations ran from the day they were diagnosed with breast cancer, while the plaintiffs argued that an alleged link between HRT drugs and breast cancer was not known prior to the release of the Women's Health Initiative study on July 9, 2002. The study received wide-ranging notoriety because the study was discontinued out of the concern that the study participants taking HRT were showing a higher rate of breast cancer than the control group, among other reasons.

The three-judge Superior Court panel agreed with the plaintiffs, finding that the discovery rule may have tolled their statute of limitations until the release of the WHI study. The court said it is jurors, not judges, who must decide if the plaintiffs made reasonable efforts to discover that the alleged cause of their breast cancer may have stemmed from third-party drugmakers.

"Knowledge of an injury alone is not sufficient to trigger such inquiry," Judge Mary Jane Bowes wrote for the court in Coleman v. Wyeth. "One must have some reason to suspect that the injury was caused by a third party to impose a duty to investigate further. Where the injury is one that may result from non-tortious conduct, such as a disease, that point may be difficult without resolving factual issues." One appellate lawyer said the court's decision in Coleman could have an impact on other mass tort cases beyond HRT cases.

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Philadelphia jury clears Prempro in two breast-cancer cases

Quoted from http://www.philly.com/inquirer/breaking/business_breaking/20100818_Philadelphia_jury_clears_Prempro_in_two_breast-cancer_cases.html

Philadelphia jury clears Prempro in two breast-cancer cases

By Linda Loyd

INQUIRER STAFF WRITER

A Philadelphia Common Pleas Court jury said Wednesday that two women's breast cancers were not linked to Wyeth's menopause drug, Prempro.

After less than four hours of deliberation, the jury rejected claims by Sharon Buxley, 66, a Tennessee resident formerly of Allentown, and Joy Henry, 75, of Harrisburg, that the hormone-replacement therapy helped cause their cancers.

The jury found that Prempro was "not a factual cause" in the development of the breast cancer.

 

The plaintiffs argued during the four-week trial before Common Pleas Court Judge James Murray Lynn that Pfizer Inc.'s Wyeth subsidiary knew the treatment could promote the growth of cancer and should be held legally liable.

Pfizer attorney Beth Wilkinson spoke to jurors afterward. "They clearly understood the science. They had a very good grasp of the issues." She said medical experts who are practicing physicians told the jury "they didn't believe there was evidence that Prempro caused breast cancer in these women."

In 2002, a National Institutes of Health-sponsored study concluded the menopause drug posed an increased cancer risk. Millions of women have taken hormone-replacement drugs.

Plaintiffs attorney Zoe Littlepage vehemently disagrees with Wyeth's claims of success in the long-swirling litigation.

"There have been 15 trials; plaintiffs won 11 of them," she said. "Fifteen juries have deliberated, and 11 of those juries have said the women win. In almost all the verdicts, the judge reduced the putative damage amounts because the numbers have been so high."

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Pfizer Seeking to Duck Prempro Cancer Liability, Lawyer Argues at Trial

Quoted from http://www.bloomberg.com/news/2010-08-17/pfizer-seeking-to-duck-prempro-cancer-liability-lawyer-argues-at-trial.html

Pfizer Seeking to Duck Prempro Cancer Liability, Lawyer Argues at Trial

By Jef Feeley - Aug 17, 2010

A Pfizer Inc. unit is seeking to duck responsibility for two women’s breast cancers linked to its Prempro menopause drug, a lawyer argued at the end of a trial.

Pfizer’s Wyeth subsidiary rejected Sharon Buxton’s and Joy Henry’s claims that its hormone-replacement medicine helped cause their cancers in the face of a wealth of evidence to the contrary, Zoe Littlepage, a lawyer for the women, told a state court jury today in Philadelphia.

“Wyeth accepts responsibility for not a single breast cancer,” Littlepage said in closing arguments in the trial of the two women’s lawsuit against the drugmaker. The pair seek at least $100,000 total in damages in the first phase of the case.

More than 6 million women took the 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 Women’s Health Initiative, a National Institutes of Health-sponsored study, concluded they posed an increased cancer risk.

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

Wyeth’s witnesses testified during the five-week trial that researchers haven’t conclusively found Prempro causes breast cancer, and Buxton’s and Henry’s lawyers didn’t produce enough evidence linking their cancers to the drug to win, Beth Wilkinson, one of the company’s attorneys, told jurors.

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Pfizer Wins New Trial of Lawsuit Over Menopause Drugs

Quoted from http://www.bloomberg.com/apps/news?pid=20601127&sid=aEIEyohInpt0

Pfizer Wins New Trial of Lawsuit Over Menopause Drugs

By Jef Feeley

May 6 (Bloomberg) -- A Pfizer Inc. unit won a re-trial of a Pennsylvania lawsuit over its menopause drugs that ended in a first jury’s award of $1.5 million in damages, the company said.

A Philadelphia judge yesterday ruled lawyers for the plaintiff, Merle Simon, must ask another jury to consider whether Pfizer’s Pharmacia & Upjohn subsidiary hid the health risks of its Provera hormone-replacement drug. In December, an appeals court reinstated Simon’s original verdict after it was thrown out by the trial court, giving the judge the option of ordering a new trial.

“We anticipate we have a good opportunity to win another verdict on behalf of Mrs. Simon,” Jim Morris, one of the woman’s lawyers, said in a telephone interview today. “We intend to push forward with this case until justice is served.”

More than 6 million women have taken hormone-replacement medicines to treat menopause symptoms such as hot flashes, night sweats, and mood swings. Until 1995, many patients combined Premarin, an estrogen-based drug made by Wyeth, with progestin- laden Provera, made by Upjohn.

Wyeth later combined the two hormones in Prempro. The drugs are still on the market. New York-based Pfizer, the world’s largest drugmaker, completed its $68 billion purchase of Wyeth in October.

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Wyeth Seeks New Trial in Nevada Prempro Case

Quoted from http://www.law.com/jsp/article.jsp?id=1202457652653

Wyeth Seeks New Trial in Nevada Prempro Case

Sandra Chereb

The Associated Press

May 05, 2010

Wyeth Pharmaceuticals Inc. asked the Nevada Supreme Court for a new trial over its hormone replacement drugs, arguing Monday that a Reno jury wasn't properly instructed on punitive damages before awarding three women a multimillion dollar judgment on claims the drugs caused their breast cancer.

Lane Heard, a Washington, D.C., lawyer representing the Madison, N.J.-based pharmaceutical giant that has since been acquired by Pfizer Inc., said the jury's "premature" deliberation of punitive damages and comments about Wyeth executives' salaries made by the women's attorneys prejudiced jurors against the company.

Jurors in 2007 initially awarded Jeraldine Scofield of Fallon, Arlene Rowatt of Incline Village and Pamela Forrester of Yerington a combined $134.5 million. But after a bailiff overheard a discussion and jury confusion became apparent, Washoe District Judge Robert Perry ordered them to reconsider.

They slashed $100 million from the compensatory judgment, awarding a combined $35 million to the women for past and future medical expenses, pain and suffering. Following a separate hearing, they then imposed $99 million in punitive damages intended to punish the company.

 

Forrester died eight months later.

Once the jury deliberated without being instructed, "it was not a fair and impartial jury," Heard said, arguing that after the judge determined jurors prematurely awarded punitive damages, a new trial, with new jurors, should have been ordered.

Perry later reduced the overall judgment to $58 million -- still the largest personal injury award in Nevada history -- ruling that the original award was excessive.

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Manassas Park woman sues drug company over breast cancer

Quoted from http://www.washingtonpost.com/wp-dyn/content/article/2010/01/01/AR2010010101724.html

Manassas Park woman sues drug company over breast cancer

By Jennifer Buske

Washington Post Staff Writer

Sunday, January 3, 2010

Tina Griffin says she was never really sick a day in her life, at least not until 2002.

While on a weekend vacation with friends, the Manassas Park resident found a lump in her right breast during her shower. She had been taking Premarin and Prempro, two hormone therapy drugs that have been under scrutiny for potentially causing breast cancer.

"I know that nothing else would have caused the cancer," said Griffin, 60. "I don't get sick and rarely even get a headache. I am a very strong lady."

Griffin is one of about 10,000 women nationwide who have filed lawsuits against Wyeth, the division of Pfizer that produces Prempro and Premarin, claiming that the drugs caused them to get breast cancer, legal teams for the plaintiffs said in a statement. Pfizer does not agree that studies have shown that the drugs cause breast cancer.

Griffin's case is pending in a New Jersey court. Pfizer says most suits have been withdrawn, dismissed or resolved in the company's favor, but a handful of cases have resulted in awards for the plaintiffs....

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Pfizer Units Win Dismissal of 23 Menopause Drug Suits

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a1PJmlu0r6mE

Pfizer Units Win Dismissal of 23 Menopause Drug Suits

By Patricia Hurtado

Dec. 16 (Bloomberg) -- Pfizer Inc.’s Wyeth and Pharmacia & Upjohn units and Teva Pharmaceutical Industries Ltd. won dismissal of at least 23 lawsuits filed by women who claimed menopause drugs caused their breast cancer, a New York judge ruled.

Pfizer, the world’s largest drugmaker, and other drug companies were sued in New York State Supreme Court in 2005 by Elizabeth Ansley. She and other plaintiffs allege in separate complaints they were diagnosed with breast cancer after being prescribed hormone therapy medications including Premarin, Prempro and Provera.

Ansley, a resident of New York, alleged drugmakers made claims regarding the health benefits of their hormone therapy drugs that were “false and misleading” which thereby “fraudulently induced physicians and patients alike to use their drug with the false assumption that such drugs had been sufficiently tested.”

“While plaintiffs’ proffered evidence is extensive, a review of the material and the record as a whole contain no evidence of fraud, misrepresentation or deception,” New York State Supreme Court Justice Martin Shulman said in a decision filed Dec. 14 and made public today.

Still Debating

Shulman granted defendants’ motion for summary judgment, or dismissal before trial, on lawsuits brought by Ansley and the 22 other plaintiffs. He also concluded the plaintiffs didn’t file their complaints within the state three year statute of limitations.

The judge cited the “ongoing medical debate as to the risks versus benefits of taking HRT,” he wrote. “Though this debate does not appear to be settled, the potential risk of contracting breast cancer from taking HRT medication was well known and at all times out there in the stream of public information.”

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