Powerful drug companies, like Wyeth, promoted their HRT meds Premarin and Prempro to doctors and heavily targeted older women with their commercials. They hired respectable figures, like actress Lauren Hutton, to announce her support. “There’s nothing more important than protecting your health,” she said. “Believe me, the time to protect your future is now.”

Another ad showed an actress playing the role of a doctor: “When considering menopause, consider the entire body of evidence,” she said.

An ironic statement, really, when you consider the evidence that was beginning to mount against HRT in the years those ads were running, data that Wyeth kept under wraps to protects its billion-dollar empire. It wasn’t until the Women’s Health Initiative (WHI) began to uncover shocking evidence about HRT that the world became privvy to it.

WHI, which was studying the causes of mortality and morbidity in menopausal and post-menopausal women, quickly halted its study on hormone therapy in 2002 when it found that women who took the drugs were at much greater risk of developing breast cancer. It also showed that women who took HRT were at an increased risk of heart attack, stroke and blood clots, and that there was no evidence to support HRT manufacturers’ claim that HRT protected women against dementia.

Now victims are finally having their day in court. Two recent lawsuits filed against Wyeth by two women who were diagnosed with breast cancer following use of HRT, have resulted in a combined $110 million judgment against the Wyeth. More victims will likely see justice soon, as another 10,000-plus other product liability suits have been filed over the HRT drugs across the country.

Source: New York Times

SOURCE: Hormone Replacement Therapy › HRT ads built trust, but breast cancer diagnoses changed opinions

This week, Pfizer, which recently acquired Wyeth, the makers of the hormone replacement therapies (HRT) Prempro and Premarin, were hit with more than $100 million in two punitive-damage awards from Philadelphia juries. The two plaintiffs, Connie Barton and Donna Kendall, claimed the drugs caused their breast cancer.

The evidence was startling. Plaintiffs attorneys proved that Wyeth launched a massive campaign to push the benefits of its HRT drugs to doctors and the general public while knowingly dismissing or downplaying other institutes’ data that revealed an increased risk of breast cancer with the use of combination hormone therapy. The company went to such lengths as to hire ghostwriters to write articles for reputable medical journals that minimized the breast cancer risk and exaggerated the benefits of HRT.

It wasn’t until the government-initiated Women’s Health Initiative (WHI) that everything changed. WHI was a 15-year study launched in 1991 that aimed to address the most common causes of death, disability and poor quality of life in postmenopausal women, including cardiovascular disease, cancer and osteoporosis. In 2002, WHI halted the estrogen-plus-progestin trial after investigators found that the associated health risks of the combined hormone therapy out weighted the benefits. The 2002 report showed there was a 24 percent increase in the risk for breast cancer due to estrogen-plus-progestin HRT.

Since then, more than 10,000 other product liability suits have been filed over the HRT drugs in across the country, 1,500 of which have been filed in the Philadelphia court. Many of the cases are filed in Philadelphia because Wyeth’s headquarters were located there.

“Wyeth had no concern whatsoever for the health of the patients. They were only concerned about their profits,” says Michael Richmond, a jury foreperson in a Prempro trial.

Sales of Prempro and Premarin exceeded $2 billion a year before 2002. Last year, $1.4 billion in estrogen drugs and $400 million in estrogen-progestin combination drugs were sold in the United States.

More Information
HRT Jury Verdict Chart

Sources:
Beasley Allen Law Firm
New York Times

SOURCE: Hormone Replacement Therapy › Two breast cancer survivors awarded $100 million in HRT lawsuits

According to court documents, ghostwriters for Wyeth wrote 26 articles that appeared in 18 different medical journals between 1998 and 2005 emphasizing that hormones protect against osteoporosis, heart disease and dementia and down-playing the risks. In 2001, Wyeth benefited by reaping nearly $2 billion in sales of its HRT drugs Premarin and Prempro, making them among of the most prescribed drugs in the U.S.

But at what cost did Wyeth benefit?

In 2002, the Women’s Health Initiative (WHI), a research initiative initiated by the National Institutes of Health to look into some of the major health problems of older women, was abruptly halted after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke. One of the thousands of victims is Geraldyne Frambs of Sacramento, Calif.

In the mid-1980s, Frambs was prescribed and began taking HRT. In 2003, she was diagnosed with breast cancer. Now she wants justice. This week, attorney Ted G. Meadows with Beasley Allen Law Firm filed a lawsuit on behalf of Frambs against Wyeth Inc., Weyth Pharmaceuticals Inc., Pharmacia & Upjohn Company LLC, Pharmacia Corporation, Pharmacia & UpJohn LLC, Greenstone Ltd, Barr Laboratories Inc., Barr Pharmaceuticals and ESO Lederle Inc.

The lawsuit alleges that the cancer, subsequent surgery, treatment, injury and damage to Frambs were caused by her use of HRT. The complaint alleges that the defendants were negligent by not assuring that their products did not cause users to suffer from foreseeable unreasonably dangerous side effects and serious health problems, and that they should have known the serious risks women were put under by using drugs that were defective at the time of production. Furthermore, the complaint alleges that the defendants willfully deceived the plaintiff by concealing the true facts concerning the hormone therapy drugs, which the defendants, as manufacturers, marketers and distributors of the products, had a duty to disclose to the plaintiff.

The lawsuit seeks recovery of all monies the plaintiff paid for the products; to be compensated for the cost of medical care as a result of the use of the products including past medical expenses, wage loss, pain, suffering, disability and emotional distress.

Read Frambs’ complaint: Frambs v Wyeth (HRT Lawsuit)

Sources:
New York Times
Beasley Allen

SOURCE: Hormone Replacement Therapy › Wyeth paid ghostwriters to sway doctors to prescribe HRT

“Even though this share seems low, ovarian cancer remains highly fatal, so accordingly this risk warrants consideration,” the researchers, led by Lina Steinrud Morch of Copenhagen University, wrote.

The risk of ovarian cancer from hormone replacement therapy remained steady among variables such as duration of use, formulation of hormones, estrogen dosage, or how it was administered. Earlier studies, however, suggested cancer risk diminished about two years after therapy was stopped.

The findings add fuel to the Women’s Health Initiative (WHI) study that was halted in 2002 after data suggested the use of HRT put women at a much greater risk for breast cancer, ovarian cancer, strokes and cardiovascular disease. Those findings contradicted the claims of HRT makers, who told physicians the hormones actually warded off such conditions.

Since the WHI findings became public, use of HRT has dropped considerably. Since 2001, drug maker Wyeth has experienced a 50 percent drop in sales of its HRT Prempro, and has been faced with numerous lawsuits from women harmed by the drug.

Sources:
Reuters
New York Times

SOURCE: Hormone Replacement Therapy › Study: HRT puts women at greater risk for ovarian cancer

Iowa Sen. Charles E. Grassley, a member of the Senate Finance Committee, is leading the investigation into the drug industry’s influence on doctors. As part of the investigation, Sen. Grassley has sent letters to Wyeth and DesignWrite, a medical writing company, asking for details on scientific reports that were prepared by DesignWrite for Wyeth and to describe the authors’ extent of involvement and any fees paid.

“Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling,” Sen. Grassley wrote to Wyeth’s chairman and chief executive, Bernard J. Poussot, according to the New York Times story.

Prempro was one of the more widely used hormone replacement therapies prescribed for women to combat symptoms of menopause, such as hot flashes, night sweats, mood swings and decreased sexual desire. It was thought that hormones had an added benefit – that taking HRT reduced a woman’s chance of breast cancer and heart disease. However, the Women’s Health Initiative in 2002 found that taking HRT measurably increased a woman’s risk for serious conditions including breast cancer, ovarian cancer and heart disease. Since then, Wyeth has faced numerous lawsuits claiming the drug company misled the public about the safety of its hormone therapy.

SOURCE: Hormone Replacement Therapy › Study finds Wyeth paid ghostwriters to promote Prempro

Wyeth Pharmaceuticals caught wind of the book and its author’s claims that estrogen reduced a woman’s risk for both breast and genital cancers, and began distributing the book to physicians across the country. Soon after, sales of Wyeth’s HRT drug Premarin took off, growing to more than 30 million prescriptions each year.

But the Women’s Health Initiative of 2002 showed dramatically different results, finding the use of hormone replacement therapy linked to an increased risk of breast cancer, cardiovascular disease, heart attacks and blood clots.

This is the basis of at least 22 federal lawsuits that have been filed over a period of two days against Wyeth, according to The West Virginia Record.

“The WHI and NCI studies released in July 2002 changed the way doctors and scientists viewed estrogen – not only does estrogen hormone therapy fail to prevent disease, it substantially increases the risk of causing disease,” the suit states.

The plaintiffs claim they suffered bodily injury, pain and suffering, disability, disfigurement, mental anguish and the loss of their capacity to enjoy life. The suit contends that Wyeth should be held liable because it did not perform adequate pre-clinical testing nor did it conduct post-marketing surveillance to determine the product’s safety. Wyeth also did not provide adequate warnings of long-term use of HRT, instead continuing to market its medication to physicians, according to the lawsuit.

The 13-count lawsuit seeks unspecified compensatory and punitive damages.

SOURCE: Hormone Replacement Therapy › Wyeth faces more lawsuits for promoting sales despite concerns

In 1997, two women – one in Kansas and the other in New York – were becoming frustrated with the lack of beneficial and comprehensive health care information available to them, especially on the topic of menopause. So they teamed together and formed ProjectAWARE.

The mission of this nonprofit organization is to provide “menopausal and pre-menopausal women with complete and comprehensive information regarding all resources, therapies, and research data currently available, so that armed with this knowledge, women can make informed decisions regarding every healthcare option.”

ProjectAWARE, also known as the Association of Women for the Advancement of Research & Education, has since built to a team of eight and, through its website, gives detailed information about hormone replacement therapy (HRT), including synthetic HRT, natural (bio-identical) HRT, and alternatives to hormones, such as herbal remedies.

The site also touches on the possible link between HRT and breast cancer and other serious illnesses, and gives background on studies and trials that have made HRT a controversial subject over the past few years.

One of the best resources I’ve found on the site are the personal, heartfelt stories of women detailing their journey through menopause and beyond. As women, we find strength in numbers. Just knowing that someone else is experiencing the same symptoms or fears as she approaches “the change,” gives us added confidence to tackle the rough road ahead.

SOURCE: Hormone Replacement Therapy › ProjectAWARE answers questions about menopause

The U.S. Supreme Court will hear arguments today in the first of two cases this term that consumer advocates fear could shut courthouse doors to patients injured by FDA-approved drugs or medical devices.

Legal experts say the cases could also affect lawsuits already filed by tens of thousands of Americans challenging the safety of blockbuster drugs such as Celebrex and Prempro and a host of medical devices.

The case before the court today was brought by the family of a New York man who suffered severe medical complications when a balloon catheter burst during a procedure to clear his arteries. The second case, involving claims for injuries allegedly caused by Rezulin, a now-withdrawn drug used to treat diabetes, will be heard in February.

Pharmaceutical manufacturers have long complained that the expense of defending injury claims has slowed research into new medications and driven up costs for patients. Because Congress granted the Food and Drug Administration the authority to determine whether products are safe and effective, manufacturers argue that state judges and juries should not be allowed to second-guess the FDA once a product is approved for use.

State damage claims put pharmaceutical makers in a “Catch-22 between complying with FDA regulations on the one hand and still being subject to state liability on the other,” said Rob Clark, a government affairs director for Medtronic Inc., which made the cardiac catheter.

But plaintiffs’ lawyers and consumer groups say that the FDA has approved some drugs and devices based on sloppy or falsified test data, adding that lawsuits are the only way evidence of drug risks or drug maker fraud has come to light.

A report issued Friday by three members of the FDA’s own Science Boardfound that the agency was so poorly organized and short of funds that it could not adequately protect the public from dangerous drugs.

A ruling for Medtronic would “take away the last possible safety net against unfettered corporate misbehavior and negligence,” said Karen Barth Menzies, a Newport Beach lawyer who has represented plaintiffs in cases against drug makers.

Menzies sees these “preemption” cases as a new battlefront in the tort-reform wars in the wake of limits imposed by Congress and state legislatures in recent years on class actions and medical malpractice claims.

Charles Riegel sued Medtronic, claiming his injuries were caused by the catheter’s negligent design, manufacture and labeling, despite the fact the device had won FDA approval. Riegel died in 2004 of causes unrelated to the angioplasty, and his widow took over his claim. Her case was thrown out by a U.S. District Court judge and then by the U.S. Court of Appeals.

The prospect that the high court may bar injury claims for FDA-approved pharmaceuticals helped precipitate the $4.85-billion settlement of Vioxx claims last month, according to lawyers involved in the negotiations.

Lawyers representing plaintiffs who took the popular painkiller insisted on language that would allow the settlement to close and compensation be paid even if the high court sides with Medtronic. Vioxx maker Merck & Co. took the drug off the market in 2004 after a study showed it doubled the risk of heart attack and stroke in patients taking it for more than 18 months.

The question in the catheter case is whether Congress intended to bar state common law claims when it gave the FDA authority to regulate medical devices in 1976. Widespread injuries reported by women who used the Dalkon Shield intrauterine device and other products had earlier prompted California and a few other states to impose some labeling and design requirements in the absence of federal standards.

The 1976 federal statute specifically said that states couldn’t maintain requirements that were different from federal standards. But Congress didn’t specify that those federal standards preempted state common law claims, and device manufacturers didn’t argue that they did until recently, said Allison Zieve, a lawyer with Washington-based Public Citizen Litigation Group who will be arguing for Donna Riegel before the court.

In rejecting the Riegel suit, the lower courts reasoned that if the plaintiffs reached trial and won, the damages would amount to a state “requirement” different from FDA requirements because the complaint depended on state law.

Glenn Lammi, chief counsel with the Washington Legal Foundation, said continuing to allow injury claims under state law could create “a patchwork of rules” governing product design and use that “creates confusion among consumers” and raises costs. The foundation, a group that advocates restrictions on lawsuits, submitted an amicus brief on behalf of the company.

Beyond the issue of whether patients have the right to sue under state law, Medtronic’s Clark insisted the company was not responsible for Riegel’s injuries because his doctor used the catheter improperly, inflating the balloon beyond the pressure specified on the FDA-approved instructions.

Zieve disagrees that the label was adequate, calling the instructions “confusing and misleading.” However, she said the preemption argument was more central to the case, calling it “essentially a get out of jail free card.”

If the court upholds Medtronic’s position, Zieve said, it means that “no matter who messed up, you can’t sue the company.”

December 4th, 2007 by Molly Selvin with Los Angeles Times

SOURCE: Hormone Replacement Therapy › High court may bar claims for FDA-approved drugs