The rejected appeal comes on the heels of a Pfizer report that it had put aside $772 million to settle lawsuits from women who claimed the pills caused them to develop breast cancer.

Prempro is a medication containing estrogen plus progestin. It is often prescribed to treat symptoms of menopause, such as hot flashes, vaginal dryness, mood swings, difficulty sleeping, and decreased sexual desire. Wyeth, which was later bought by Pfizer, had promoted the drugs as safe and claimed they offered women added benefits such as protection against heart disease and dementia.

However, a study as part of the Women’s Health Initiative (WHI) that looked at the effects of HRT in menopausal and post-menopausal women, was abruptly halted after early data showed HRT put women at risk for breast cancer. Since then, about 10,000 Prempro breast cancer lawsuits have been filed.

A large number of the Prempro trials have resulted in multi-million dollar awards against the drug maker after juries found that the drug company knew that the dangers associated with HRT but actively tried to cover up the risks.

SOURCE: Hormone Replacement Therapy › Supreme Court rejects Prempro breast cancer lawsuit appeal

As we all know, numerous studies later showed that HRT did far from make women healthier. It increased their risk of breast cancer and heart disease. Despite the studies, some doctors continue to prescribe hormone therapy to their patients battling symptoms of menopause. Is it a wrong decision?

Dr. James Dilliard, who writes a column for the East Hampton Star, says not necessarily. Choosing to take HRT should be a thoughtful decision that women should make only after discussing their risks with their doctors.

The difference between now and 10 or 20 years ago, when HRT drugs were being heavily advertised, is that women and their doctors are now armed with the research to help them make more informed decisions.

“The right answer is that you have discussed with your doctor all the risks and benefits of hormone replacement in light of all the research and relative to your health status, risks, and family history,” Dr. Dillard says, “and that together you have agreed that it is worth the risks, for you.”

SOURCE: Hormone Replacement Therapy › Research helps women make more informed decisions about HRT

The Women’s Health Initiative bought the story to light in 2002, when a trial on the effects of HRT on menopausal and post-menopausal women revealed that women who took the combined hormone therapy were at greater risk of breast cancer. Studies also showed that the HRT elevates a woman’s risk of other conditions such as ovarian cancer, heart attacks, strokes, deep vein thromboembolism, pulmonary embolisms, gallbladder cancer and non-Hodgkin’s lymphoma.

Unfortunately, Delores died from what her family says were complications of HRT. Last month, her family filed a lawsuit in the Tyler Division of the Eastern District of Texas against HRT manufacturers Wyeth, Pifzer, Pharmacia and Upjohn Co., and Watson Pharmaceuticals claiming the drug companies covered up the risks of HRT. The Whatley family also is alleging assault and battery, as well as negligent and intentional infliction of emotional distress, against the drug manufacturers. They are seeking damages for loss of love, affection, service and support, and medical and funeral expenses, and are requesting a jury trial.

Source: Southeast Texas Record

SOURCE: Hormone Replacement Therapy › Family claims HRT killed their mother

The news is just another blow to Prempro, a combination of estrogen and progestin that was widely prescribed to women as a treatment for menopausal symptoms. Prempro and other HRTs were once thought to improve a woman’s health as she entered postmenopausal years; however, results from a Women’s Health Initiative (WHI) shook that belief when the findings of that study revealed women on HRT were at an increased risk of breast cancer and cardiovascular disease. Since 2002, when the findings were released, sales of HRT medications like Prempro have plummeted and lawsuits against companies like Wyeth have escalated.

According to the new trial, which reviewed women from WHI age 50 to 79, after five years on Prempro 67 women died from non-small cell lung cancer compared with 39 on a placebo. The study group included both current and former smokers.

“This is a new finding that tells us women who smoke shouldn’t take estrogen and progestin for menopause symptoms,” said Rowan Chlebowski, the study author and a researcher at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center.

According to the study, among the women classified as current or former smokers, there were 56 deaths among women taking hormones and 34 deaths among women on a placebo. Among the women classified as nonsmokers, there were 9 deaths for women on HRT and 5 deaths for those taking a placebo.

Source: Bloomberg.com

SOURCE: Hormone Replacement Therapy › Prempro increases risk of dying from small cell lung cancer

Last February, the New England Journal of Medicine concluded that HRT was in fact linked to a surge of breast cancer cases and that women who took a combination of progestin and estrogen for more than five years doubled their risk of breast cancer – a statistic far greater than originally thought. It also showed that a typical 50-year-old woman has less than a 1 percent chance of developing breast cancer, and if she takes HRT for less than four years, her risk of breast cancer drops back down to normal. Also, HRT now contains far less estrogen and progestin.

The new information gives women who are having a difficult time suffering through the symptoms of menopause the opportunity to make a more educated decision about whether to take HRT. Dr. Marcia Stefanick, a professor of medicine at Stanford University, says that before making a decision a woman should assess whether she is at high risk for breast cancer.

Women who are considered high risk for breast cancer include those with a family history of the disease, women who have had children after the age of 30 or have never had children, and women who started menstruating before age 11. Age is also a factor, as older women are at higher risk for the disease.

SOURCE: Hormone Replacement Therapy › More studies help women make educated decisions about HRT

For years, HRT was considered the cure-all for menopausal symptoms that range from hot flashes and riding the emotional roller coaster to bone loss and osteoporosis. But a 2002 study by the Women’s Health Initiative (WHI) and funded by the National Institutes of Health stopped women and their doctors in their tracks when the research revealed that the risks of HRT far outweighed and outnumbered the benefits. The WHI report stated that long-term use of estrogen/progestin therapy led to a 26 percent increase in breast cancer, not to mention a laundry list of other serious side effects.

The American Cancer Society suggests women talk with their own doctors before deciding whether HRT is right for them. The organization also suggested women heed the advice of the WHI, which includes not continuing or starting HRT to prevent heart disease; to discuss their risk of heart attack, stroke, blood clots and breast cancer before taking HRT for osteoporosis prevention; and to perform regular breast self-exams and schedule annual mammograms.

Using HRT for the short-term may be a safer alternative, the report states, however, “Given these results, we recommend that clinicians stop prescribing this combination for long term use. ‘Primum non nocere’ [First, do no harm] applies especially to preventive health care.”

SOURCE: Hormone Replacement Therapy › October is breast cancer month; time to evaluate breast health

A study published in the January issue of Cancer Epidemiology, Biomarkers and Prevention found that women who used combination hormone therapy for three or more years had a higher risk of lobular cancer.

The study was led by Dr. Christopher Li of the Fred Hutchinson Cancer Research Center and was designed to evaluate the relationship between combination hormone therapy and lobular breast cancers. Previous research indicated that five or more years of combined hormone therapy use was necessary to increase overall breast cancer risk. The study led by Dr. Li found that women who took combined hormone therapy for three years or more had four times the usual risk of lobular breast cancer.

The incidence of invasive lobular cancer rose by 52% in the United States between 1987 and 1999, and cases of ductal-lobular breast cancer rose by 96% during that time. According to Dr. Li, their research “suggests that the use of post-menopausal hormone-replacement therapy, specifically the use of combined estrogen-plus-progestin preparations, may be contributing to this increase.” Following the announcement of the results of the Women’s Health Initiative in July 2002, hormone therapy use fell sharply.

The incidence of breast cancer dropped more than 8% between 2001 and 2004. Beasley Allen law firm has been involved in extensive litigation dealing with hormone therapy and breast cancer. We are convinced that there will be more litigation in this area of concern. Ted Meadows and Melissa Prickett from our firm are handling cases for clients at this time.

SOURCE: Hormone Replacement Therapy › Hormone therapy update

The panel ruled Oct. 12 that the company owed the women $35.1 million in compensatory damages. Jurors in state court in Reno concluded today that Wyeth, the largest maker of hormone- replacement medicines, should also pay Arlene Rowatt, Jeraldine Scofield and Pamela Forrester punitive damages for concealing the breast-cancer risks of its Prempro and Premarin drugs.

“We got the word out that a lot of women have been injured by this type of behavior by this company,” Rowatt said after the verdict. She said she was “ecstatic” with the award. Lawyers for Wyeth, the largest maker of hormone-replacement therapies, said the company will appeal the verdict.

The three women’s suits, which were combined for trial, are among about 5,300 against Madison, New Jersey-based Wyeth over its menopause drugs. As many as 6 million women took the pills to treat menopause symptoms such as hot flashes and mood swings before a 2002 study highlighted the drugs’ links to cancer.

Annual sales of Wyeth’s hormone-replacement drugs exceeded $2 billion before the 2002 Women’s Health Initiative study, sponsored by the U.S. National Institutes of Health, suggested women using the medicines had a 24 percent higher risk of breast cancer. The drugs, which are still on the market, generated more than $1 billion in sales in 2006.

Ignored Risks

Lawyers for Rowatt, Scofield and Forrester argued in the Reno case that Wyeth officials ignored Prempro’s health risks and failed to properly warn doctors and consumers about the drug’s cancer link to boost profits.

Wyeth’s lawyers insisted the company conducted extensive safety tests on the drugs and warned of the risks through prescription labels and information sheets. The Reno verdict is the company’s fourth trial loss in suits over the drugs.

“The verdict is an extreme aberration,” said Heidi Hubbard, an attorney for Wyeth. “It is inconsistent with the end result of all other hormone-therapy cases tried to date, and is inconsistent with the evidence. We are confident the Nevada Supreme Court will give the flawed verdict careful scrutiny.”

Jurors considered ordering Wyeth to pay more than $1 billion in punitive damages before settling on the lower number, said Emery Pierce, 22, a supervisor for United Parcel Service who served on the panel.

Pierce said jurors were upset that Wyeth used misleading information on its labels for the Premarin and Prempo menopause drugs.

‘Care Enough’

“There’s no way they provided an adequate warning,” the Reno resident said. “They didn’t seem to care enough that breast cancer kills people.”

Having a jury find Wyeth’s conduct warrants a punitive- damage award should be a concern for the company, said Michael Kelly, a Wilmington, Delaware-based lawyer who represents drugmakers in product-liability cases.

“The punitive award shows that the jury found there was a conscious indifference to patient safety,” Kelly said. “That’s not the kind of reputation a pharmaceutical company wants to have.”

The Reno verdict was the fourth loss for Wyeth since lawsuits over the menopause drugs began going to trial in August 2006. It’s the largest verdict so far in the hormone-replacement therapy cases and the eighth-largest verdict of any kind in the U.S. this year, according to Bloomberg data.

Prempro Trials

The company has won two federal-court suits that have come to trial over Prempro and Premarin as well one case filed in state court in Philadelphia. Three other Philadelphia juries found the medicines contributed to the development of breast cancer in women and ordered the company to pay a total of $3 million in damages. Judges later threw out those verdicts.

Until 1995, many menopausal women combined Premarin, Wyeth’s estrogen-based drug, with progestin-laden Provera to relieve their symptoms. That year, Wyeth combined the two hormones in its Prempro pill after winning the U.S. Food and Drug Administration’s approval of the treatment.

Rowatt, 67, Scofield, 74, and Forrester, 64, all used Wyeth’s hormone replacement drugs for different lengths of time, according to court records. Rowatt was awarded $31 million in punitive damages by the Reno jury, Scofield $33 million and Forrester $35 million.

Rowatt, a retired Defense Department worker, used the drugs for more than seven years. Forrester, a former administrative assistant, used them for more than nine years. Scofield, a homemaker, was on hormone-replacement therapies for 15 years.

‘Deserved This’

All three women sat through the entire five-week trial. After the initial verdict was handed down last week, the trio cried as they hugged Zoe Littlepage, one of their lawyers. “You so deserved this,” the lawyer told them.

The jury initially awarded the plaintiffs $134.5 million, or more than $43 million each. The panel had to reconsider that verdict after Judge Robert Perry learned part of the figure was intended to punish Wyeth for its mishandling of the drugs.

Jurors cut that award to a total of $35.1 million in compensatory damages for the three women after spending several hours reconsidering their verdict on Friday.

Wyeth lawyer Dan Webb today asked Perry to throw out the punitive-damage verdict because of the jury error. The judge refused.

The jury told these three women “that their lives and suffering have value,” Littlepage said. The decision shows “what a courageous Nevada jury thinks of what Wyeth has done.”

According to a company-funded study presented today in Washington, Wyeth’s drug Pristiq, the first non-hormone menopause pill, reduces symptoms such as hot flashes more effectively than placebo. Pristiq was delayed by regulators for additional safety tests.

October 16th, 2007

SOURCE: Hormone Replacement Therapy › Wyeth must pay $134.1 million in menopause drug lawsuit

The company won 15 of the 18 lawsuits that have been tried, according to company information. Two others were settled, and one was in the plaintiff’s favor.

Lawyers for the three women who were awarded more than $120 million in jury awards in Reno have disputed Wyeth’s claims.

Nevada residents Jeraldine Scofield, Arlene Rowatt and Pamela Forrester testified that they developed breast cancer after taking Premarin, an estrogen replacement, and Prempro, a combination estrogen, and progestin to offset the symptoms of menopause.

They claimed in their lawsuit that Wyeth produced a dangerous product, failed to adequately test the drugs and failed to provide warnings about the drugs’ risks.

After two days of deliberations, the jury agreed with the women’s claims and ordered Wyeth to pay $43.5 million each to Scofield and Rowatt, and $47.5 million to Forrester.

The jury will deliberate at 10 a.m. today about punitive damages.

October 12th, 2007

SOURCE: Hormone Replacement Therapy › Wyeth fights more than 5,000 hrt lawsuits nationwide

It was the largest award to date against Wyeth, of Madison, N.J., which faces more than 5,000 similar lawsuits across the country in state and federal courts.

The panel deliberated for two days before announcing its verdict late Wednesday in favor of Jeraldine Scofield, 75, of Fallon; Arlene Rowatt, 67, of Incline Village; and Pamela Forrester, 64, of Yerington.

A Wyeth spokesman, Douglas Petkus, said Thursday that the company would have no comment. But in an e-mail message to The Associated Press, he noted that 20 similar cases had gone to trial or been otherwise resolved. Of those, he said, three were resolved in favor of the company, two plaintiff verdicts were set aside by the courts and three cases were dismissed on summary judgment. Twelve other cases were dropped by the plaintiffs before trial, he said.

During the trial concluded here, the women testified that they had started taking Premarin, an estrogen replacement, and Prempro, a combination of estrogen and progestin, to help offset menopausal symptoms, but were taken off the therapy when they developed breast cancer.

Wyeth lawyers said the company sponsored or participated in studies on the risks of breast cancer, and detailed the risks on warning labels included with each bottle of the drug.

Last October, Wyeth reached an undisclosed settlement with a fourth woman who had been part of the lawsuit. That woman, Carol McCreary, was found to have breast cancer in 2001 after taking Prempro for about 33 months. She died in April at 59.

To learn more about the link between hormone replacement therapy and breast cancer, visit www.hrt-legal.com.

October 12th, 2007

SOURCE: Hormone Replacement Therapy › Jury awards 3 women $134.5 million in hormone therapy lawsuit

The jury also must decide whether Wyeth failed to adequately test their drugs Premarin, an estrogen replacement, and Prempro, a combination estrogen and progestin, before putting them on the market and whether it failed to warn doctors about the drugs’ risks.

“Wyeth didn’t do (breast cancer) studies because the results could be embarrassing and could be costly,” Zoe Littlepage, a lawyer for Jeraldine Scofield of Fallon, Arlene Rowatt of Incline Village and Pamela Forrester of Yerington, told the jury.

The company’s decision to produce, market and sell a dangerous product affected thousands of women, and the company should be held responsible, Littlepage said during her closing argument in Washoe District Court.

Wyeth lawyer Heidi Hubbard said microscopic analysis showed the cancers each of the three women suffered are different, and no one can say why they developed. But each woman had a list of risk factors that could have contributed to their diseases.

“So many women get breast cancer, and we don’t know to this day what causes it; and researchers are trying to find the cause so they can find the cure,” Hubbard said.

“This case is about a medication that’s an appropriate treatment option for many women,” she said. “To this day, (the drugs) are the most effective available for menopausal symptoms.”

Scofield, 75, Rowart, 67, and Forrester, 64, began taking hormone replacement drugs years ago to offset hot flashes and other discomforts associated with menopause. But when each developed breast cancer, they stopped the drugs and underwent treatment.

The lawyers for the three women, who have sat in the front row of the courtroom every day of the trial, said Wyeth knew there were links between their drugs and the cancers but ignored the dangers in favor of skyrocketing sales.

The warning labels the company put on the drugs sounded more like reassurances than alarms, Littlepage said. Doctors testified if they knew then what they know now about the breast cancer risks, they never would have prescribed the drugs long-term as the company promoted them, she said.

Dan Webb, another Wyeth lawyer, challenged those claims.

Wyeth helped sponsor or participated in 63 studies to look at whether hormone replacement drugs increased the risk of breast cancer, he said. When the results came in, the company followed a directive from the U.S. Food and Drug Administration and created warning labels that detailed the risks, he said.

“The FDA knows more about research on drugs than the plaintiffs,” Webb said. “When (the women) say we didn’t properly test, it’s not true. Wyeth clearly understood the breast cancer risk and put it on the label.”

The women’s civil lawsuit seeks unspecified damages, but Littlepage told the jurors that they should look at how the company spent its money to promote the drugs when considering an appropriate amount. Those totals were in the millions of dollars.

October 10th, 2007

SOURCE: Hormone Replacement Therapy › Prempro lawsuit goes to the jury

Brett Hendricks, a former sales representative for Wyeth, provided riveting testimony regarding his twenty-one year career with the largest manufacturer of hormone replacement therapy drugs that outlined the organized deception of doctors and patients that plaintiffs contend overstated the benefits of HRT therapy while concealing the risks.

“That’s how we were trained,” Hendricks said. “To offset any bad publicity, we would redirect and emphasize the benefits of the product and say the benefits far outweighed any problems that might be out there.”

On the stand, Hendricks confirmed Wyeth’s marketing strategy that had already been laid out in the millions of pages of documents produced by Wyeth and others in the HRT litigation that has been pending for more than five years. Wyeth sales representatives were encouraged to engage in aggressive, one-on-one sales tactics with prescribing physicians to supplement the manufacturer’s advertising plan which included overselling the benefits of HRT drugs, discrediting scientific studies that raised any questions about safety (especially breast cancer risks), criticizing physicians who chose safer alternative drugs or counseled their patients on the option of not taking any HRT drugs at all, and pushing menopausal women to take combination hormone product drugs from the onset of menopause (or perhaps even before) and to continue taking the drugs throughout the rest of their lives.

In July of 2002, the Women’s Health Initiative (“WHI”) study was published and confirmed what many had long suspected – that Prempro and combination hormone replacement products (including Wyeth’s Premarin taken in combination with Pfizer’s Provera or another progestin such as medroxyprogesterone) are associated with an increased risk of hormone-positive breast cancers as well as other health risks, including heart attacks, strokes, blood clots, and ovarian cancer, etc.

The WHI Study (which was funded by the United States government, after manufacturers of hormone replacement drugs failed to conduct proper studies to evaluate the risks of HRT-induced breast cancer) led to a fundamental shift in the manner in which HRT drugs were prescribed. Today, physicians and patients are being told that HRT is not right for every woman, and instead should only be considered by those for whom the symptoms of menopause are severe and interfering with their lives. In addition, patients have been encouraged to use HRT drugs for the shortest time possible and at the lowest possible doses.

In fact, the Prempro product ingested by most women prior to 2002 no longer exists, and instead was replaced by a lower dose product (although it is not yet known whether a lower dose actually equates to a lower breast cancer risk). There is also a strong movement in the medical community to investigate other drugs for menopausal symptoms and osteoporosis, including SERMs (selective estrogen receptor modulators) and natural or bioidentical hormones that more closely resemble those that are made by a woman’s body. Prempro, for example, includes an estrogen compound derived from the urine of pregnant horses and chemically synthesized progestin (which is a necessary additive since estrogen alone has long been known to cause uterine cancer, but also eliminates many of the benefits that have been shown with use of estrogen alone and increases the risks of breast cancer).

The pharmaceutical industry has long maligned alternative therapies for menopausal patients, but evidence continues to mount that the HRT-induced breast cancer epidemic noted in recent breast cancer registries might have been avoided if women had been given more information in order to make meaningful decisions regarding treatment options years ago.

The Reno HRT trial is expected to last for a few more weeks. Alley, Clark, Greiwe & Fulmer will be trying the first HRT case in Florida in Pinellas County in June of 2008. This will be the first wrongful death claim to be brought to trial in the national litigation. The case was brought on behalf of a Clearwater grandmother who was diagnosed in early 2002 at the age of 59 with hormone-positive lobular breast cancer (the type most strongly associated with use of HRT drugs), just months prior to announcement of the WHI study results. Her cancer was very aggressive and had already spread to brain and bones by that time. After fighting valiantly for several years, she lost her battle and died late last year before her case was scheduled for trial. The lawsuit is now being prosecuted by her loving husband of forty-one years on behalf of her estate and survivors.

October 5th, 2007

SOURCE: Hormone Replacement Therapy › HRT sales rep whistleblower admits improper promotion