Woman Wins First Phase of
PremPro Breast Cancer Trial

MARYCLAIRE DALE / AP 4oct2006

PHILADELPHIA - A jury ruled Wednesday that a hormone replacement drug at least partially caused an Ohio woman's breast cancer, but the panel must return to determine whether drug maker Wyeth is liable for damages.

Jennie Nelson, 66, of Dayton, had taken Prempro for five years to treat menopausal symptoms before being diagnosed with breast cancer in 2001.

The jury awarded $1 million to Nelson and $500,000 to her husband in compensatory damages. She will get the money only if she proves in the trial's second phase that Wyeth failed to issue sufficient warnings or was otherwise negligent or reckless.

"Other plaintiffs lawyers will see this as an indication that it's possible to prove causation in a Prempro case, and that will be encouraging to plaintiffs and unwelcome news for Wyeth," Seton Hall law professor Howard M. Erichson said.

"But ultimately, if Wyeth prevails in the second phase, then Wyeth will be 2-and-0 in the Prempro litigation and that will be the significant news," he said.

Madison, N.J.-based Wyeth won the first Prempro case last month when a federal jury in Little Rock, Ark., rejected a similar claim filed by a 67-year-old woman there.

About 5,100 women have filed suits over Wyeth hormone drugs Premarin and Prempro, but just a handful are scheduled for trial this year. The Philadelphia case is the second to go to trial.

Wyeth said the company acted responsibly, noting that the Food and Drug Administration in 1995 called hormone replacement drugs the most extensively researched medicines in the United States.

"We are going to show that the company acted responsibly and reasonably by performing and reporting studies that examined the known and potential benefits and risks of hormone therapy, and also in keeping all parties involved - the FDA, physicians and patients - informed of the risks and benefits," spokesman Christopher Garland said.

The verdict came only hours after Common Pleas Judge Norman Ackerman replaced a juror on the panel, which had been meeting for six days, with an alternate and told them to start deliberating anew.

The trial's second phase is scheduled to start Oct. 14 and is expected to last several weeks.

Nelson underwent a double mastectomy, chemotherapy and radiation, according to her lawyer, Tobi Millrood. Her mother also had breast cancer after menopause, but the chance of a genetic link between the two cases is very low, he said.

"The medical evidence overwhelmingly showed that Wyeth's drug Prempro caused her breast cancer," Millrood said.

The hormone drugs are still on the market, but sales have dropped sharply since 2001, the last year before government studies suggested a link between hormone therapy and some diseases.

Wyeth maintains that it is impossible to prove that Prempro caused individual cases of breast cancer.

Wyeth shares rose 26 cents to close at $51.18 Wednesday on the New York Stock Exchange.

source: http://www.mercurynews.com/mld/mercurynews/business/15679122.htm 5oct2006

PremPro Plaintiff, Husband Win $1.5 Million in Damages

PETER LOFTUS / Wall Street Journal 5oct2006

PHILADELPHIA — A Philadelphia jury found Wednesday that Wyeth's PremPro hormone-therapy drug was a significant cause of breast cancer in a 66-year-old woman, and awarded $1.5 million in compensatory damages.

The verdict in Pennsylvania state court, reached on the sixth day of jury deliberations, was Wyeth's first loss in litigation involving about 5,000 lawsuits claiming PremPro and a related drug caused breast cancer and other diseases. Many of the suits were prompted by government studies showing a link between the drugs and increased risk for the diseases.

But Wyeth, Madison, N.J., soon will have a chance to reverse the damages in Wednesday's loss. A second phase of the trial is set to begin Oct. 12 in which the plaintiff, Jennie Nelson of Dayton, Ohio, will have to prove that Wyeth failed to adequately warn of PremPro's risks. If the jury finds in favor of Wyeth in the second phase, Mrs. Nelson cannot collect any damages, including those awarded Wednesday, her lawyer said.

If the jury finds against Wyeth in the second phase, however, it may then award additional, punitive damages.

The jury voted 7-1 that Mrs. Nelson's ingestion of Wyeth's drugs was a "factual cause" of her breast cancer, with which she was diagnosed in 2001 after taking PremPro since 1996 to treat menopausal symptoms. She had previously taken another Wyeth drug, Premarin, since 1995. The jury also voted 7-1 to award Mrs. Nelson $1 million, plus $500,000 to her husband.

"We're happy and relieved we've gotten this far," Mrs. Nelson's attorney, Ken Suggs, told reporters after the verdict. "But we're only halfway through the trial and we have work to do."

Another Nelson attorney, Tobias Millrood, said the jury "carefully deliberated complex scientific issues and found this drug caused Mrs. Nelson's breast cancer."

Mr. Suggs said Mrs. Nelson, who had both of her breasts removed and underwent chemotherapy and radiation therapy to treat her cancer, wouldn't be available for comment until after the second phase of the trial is over.

Wyeth had argued during the trial that Mrs. Nelson had other risk factors for breast cancer, such as a family history of cancer. Wyeth also argued that it's impossible to prove that individual cases of breast cancer were caused by its drugs.

"We're disappointed in the jury's decision," Wyeth spokesman Christopher Garland said. "We respectfully disagree there's any scientific basis to support the finding of a causal link between Wyeth's hormone therapies and the plaintiff's breast cancer. This is one case and one jury's verdict. It can in no way be used to extrapolate future results" in the litigation, he added.

Mr. Garland said that during the second phase of the trial, Wyeth plans to show the company acted responsibly by performing studies of hormone therapy's risks and benefits. Wyeth also kept regulators, doctors and patients informed of these risks and benefits, Mr. Garland said.

Wyeth won the first PremPro trial last month in federal court in Little Rock, Ark.

One legal expert said the structure of the trial made it difficult to read too much into Wednesday's verdict. If the jury finds against Wyeth in the second phase, it would be a "significant setback" for Wyeth, said Howard Erichson, law professor at Seton Hall Law School in Newark, N.J.

"If the jury finds no liability" in the second phase, Prof. Erichson added, "Wyeth still will not be pleased for the jury to have found that a product still on the market was the cause of the plaintiff's breast cancer."

Wednesday's verdict was reached just a few hours after the Pennsylvania judge in the case removed one juror and replaced him with an alternate. No reason was given for the action. The jury began deliberations Sept. 26 after a two-week trial, and deliberated for more than 30 hours, including the three hours of deliberations with the replacement juror.

The same jury of five men and three women will hear the second phase of the trial.

Wyeth's drugs are still on the market, but publicity surrounding the government studies has caused Wyeth sales of Premarin-related products to drop to $909 million last year from $2.1 billion in 2001, the last full year before the key government studies began emerging.

Wyeth shares closed up 26 cents at $51.18.

p.A18

Jury Says Wyeth Drug Caused Breast Cancer

It awards $1 million to a woman who used Prempro.
The damages could be reversed in the next phase of the trial.

Dow Jones/AP 5oct2006

PHILADELPHIA — A Philadelphia jury found Wednesday that Wyeth's Prempro hormone-therapy drug was a significant cause of breast cancer in a 66-year-old woman and awarded $1.5 million in compensatory damages.

The verdict in state court, reached on the sixth day of jury deliberations, was Wyeth's first loss in litigation involving about 5,000 lawsuits claiming that Prempro and a related drug caused breast cancer and other diseases. Many of the suits were prompted by government studies showing a link between the drugs and increased risk for the diseases.

But Madison, N.J.-based Wyeth will have a chance to reverse the damages. A second phase of the trial is to begin Oct. 12 in which the plaintiff, Jennie Nelson of Dayton, Ohio, will have to prove that Wyeth failed to adequately warn of Prempro's risks. If the jury finds in favor of Wyeth in the second phase, Nelson cannot collect damages, including those awarded Wednesday, one of her lawyers said.

If the jury finds against Wyeth in the second phase, however, it may then award additional, punitive damages.

The jury voted 7 to 1 that Nelson's use of Wyeth's drugs was a "factual cause" of her breast cancer, with which she was diagnosed in 2001 after taking Prempro since 1996 for menopausal symptoms. She had previously taken another Wyeth drug, Premarin, since 1995. The jury voted 7 to 1 to award Nelson $1 million, plus $500,000 to her husband.

"We're happy and relieved we've gotten this far," Nelson's attorney, Ken Suggs, told reporters after the verdict. "But we're only halfway through the trial and we have work to do."

Another Nelson attorney, Tobias Millrood, said the jury "carefully deliberated complex scientific issues and found this drug caused Mrs. Nelson's breast cancer."

Suggs said Nelson, who had both of her breasts removed and underwent chemotherapy and radiation therapy to treat her cancer, wouldn't be available for comment until after the second phase of the trial is over.

Wyeth had argued during the trial that Nelson had other risk factors for breast cancer, such as a family history of cancer. Wyeth also argued that it was impossible to prove that individual cases of breast cancer were caused by its drugs.

"We're disappointed in the jury's decision," Wyeth spokesman Christopher Garland said. "We respectfully disagree there's any scientific basis to support the finding of a causal link between Wyeth's hormone therapies and the plaintiff's breast cancer. This is one case and one jury's verdict. It can in no way be used to extrapolate future results" in the litigation, he added.

Wyeth won the first Prempro trial last month in federal court in Little Rock, Ark. Prempro is a treatment for menopausal symptoms.

Garland said that during the second phase of the trial, Wyeth plans to show the company acted responsibly by performing studies of hormone therapy's risks and benefits. Wyeth also kept regulators, doctors and patients informed of these risks and benefits, Garland said.

Wyeth's drugs are still on the market, but publicity surrounding the government studies has caused sales of Premarin-related products to drop to $909 million last year from $2.1 billion in 2001, the last full year before the government studies emerged.

Wyeth shares closed up 26 cents at $51.18 after falling as low as $50.60 when the verdict was announced.

source: http://www.latimes.com/business/la-fi-wyeth5oct05,1,5578646.story 5oct2006

US jury says Wyeth drug caused woman's breast cancer

JON HURDLE / Reuters 4oct2006

PHILADELPHIA — A jury on Wednesday awarded a woman $1 million and her husband $500,000 in compensatory damages after finding that Wyeth's <WYE.N> hormone replacement drug Prempro was a cause of her breast cancer.

The trial in the Philadelphia Court of Common Pleas now moves into a second phase to begin on October 12, in which the jury will decide whether Wyeth failed to warn of the dangers of Prempro.

The jury of five men and three women may award additional punitive damages if it finds Wyeth failed to warn. However, if it finds that the company adequately warned of the drug's risks no damages will be payable, including the compensatory damages awarded by the jury on Wednesday.

"The plaintiff has the burden of proof that the defendant's conduct is negligent, and that it failed to adequately warn of the dangers," Judge Norman Ackerman instructed the jurors.

The lawsuit charged that Wyeth was negligent in the testing, manufacture and marketing of its hormone replacement therapy drugs.

"We disagree that there is any scientific basis to support the jury's finding of a causal link between hormone replacement therapy and the plaintiff's breast cancer," Wyeth spokesman Chris Garland said.

"This is one jury's verdict and cannot be used to predict the outcome of future cases," he added.

In the first federal Prempro trial, a jury last month in Little Rock, Arkansas found Wyeth was not negligent and had adequately warned patients and doctors of the cancer risk associated with the drug.

Wyeth is facing some 5,000 lawsuits involving its hormone replacement drugs.

"Lawyers all around the country are watching what happens in these cases to get a sense of whether Prempro plaintiffs have a chance of winning," said Howard Erichson, professor of law at Seton Hall Law School in Newark, New Jersey.

Deutsche Bank analyst Barbara Ryan predicted that few Prempro plaintiffs will win punitive damages because Wyeth immediately changed the drug's label to reflect an increased cancer risk after a federally sponsored trial showed long-term use of the drug in combination with the female hormone replacement estrogen caused a 26 percent higher risk of breast cancer in women aged 50 to 79 who had not undergone hysterectomies.

"Right away they appropriately relabeled the drug, which resulted in a 60 percent decline in the number of prescriptions" for Prempro, Ryan said. "So the company has very strong defenses against punitive damages."

The plaintiff, Jennie Nelson, 67, of Dayton, Ohio, took Prempro for about six years and blamed it for her breast cancer. As a result of the cancer, she underwent a mastectomy and chemotherapy and radiation therapy.

The jury deliberated for about 33 hours over six days before reaching its verdict.

It had appeared to be deadlocked by the second day, but was urged to continue its deliberations by the judge. About three hours before the verdict was announced, the judge replaced one male juror with an alternate.

Nelson's attorneys declined to comment on the reason for the juror replacement, but said the deliberation time reflected a jury that had taken a careful approach to its task.

The market shrugged off the news and Wyeth shares finished off their earlier highs but still up 26 cents at $51.18 on the New York Stock Exchange.

Additional reporting by Anna Driver and Ransdell Pierson in New York.

source: http://www.boston.com/business/articles/2006/10/04/jury_says_wyeth_drug_caused_womans_breast_cancer/ 5oct2006

Philadelphia Jury Says Wyeth’s PremPro Caused Cancer

eCanada Now 4oct2006

Wyeth (NYSE: WYE) announced today that the case of Jennie Nelson v. Wyeth, in the Philadelphia Court of Common Pleas will continue to the second, or liability, phase following today’s jury decision in the first phase of the trial. During the first part of this bifurcated (two-phase) trial, the jury found that the plaintiff’s use of hormone therapy was a cause of her breast cancer and determined compensatory damages of $1.5 million. The next phase will determine if Wyeth is liable and is required to pay those damages. If the jury finds Wyeth is liable, punitive damages may also be considered in the second phase.The Company is disappointed by the jury’s decision and respectfully disagrees that there is any scientific basis to support the jury’s finding of a causal link between Wyeth’s hormone therapies and the plaintiff’s breast cancer.

In the second phase of the trial, which will begin on October 12, Wyeth intends to show that the Company acted reasonably by performing and supporting studies that examined the known and potential benefits and risks of hormone therapy and in keeping the U.S. Food and Drug Administration, physicians and patients informed of those risks and benefits. The FDA noted in 1995 that hormone therapies are the most extensively researched medicines in the U.S.

The trial began on September 13, 2006 before The Honorable Norman Ackerman. The plaintiff alleged that she developed breast cancer as a result of the use of PREMPRO(TM), a product marketed by Wyeth.

source: http://www.ecanadanow.com/science/health/2006/10/04/philadelphia-jury-says-wyeths-prempro-caused-cancer/ 5oct2006

Links:

• HRT side-effects: Food and Drug Administration update about hormone replacement therapy for postmenopausal woman http://www.fda.gov/bbs/topics/NEWS/2004/NEW01022.html
• More information from the Food and Drug Administration about estrogen and estrogen and progestin therapy http://www.fda.gov
• Two studies from the Women’s Health Initiative: Taking estrogen and taking estrogen and progestin for post menopausal women http://www.nhlbi.nih.gov/whi/
• Hormone Replacement Therapy http://www.nlm.nih.gov
• Medical information on Premarin side-effects and menopause http://www.medicinenet.com
• Women’s Menopause Health Center http://www.womens-menopause-health.com
• FDA Hearings OCt 7, 2003 Original at: http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3992T1.htm
• HRT side-effects pro-con. Mayo Clinic: Hormone therapy for menopause: Who should take it and what are the alternatives? http://www.mayoclinic.com