News Tagged ‘Pharmaceutical

Study finds Wyeth paid ghostwriters to promote Prempro

A federal study revealed that the company Wyeth paid ghostwriters to write articles for medical journals that were favorable to the drug company’s hormone replacement therapy (HRT) Prempro, even after the drug was found to raise a woman’s risk for breast cancer, according to the New York Times.

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Wyeth faces more lawsuits for promoting sales despite concerns

In the 1960s, a New York gynecologist wrote a book called “Feminine Forever,” in which he recommended for menopause, stating that women on the hormone replacement drug “will be much more pleasant to live with and will not become dull and unattractive.”

Wyeth Pharmaceuticals caught wind of the book and its author’s claims that 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.

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FDA approves Premarin cream to treat dyspareunia

Wyeth Pharmaceuticals recently announced FDA approval of its Premarin Vaginal Cream to treat moderate to severe dyspareunia, or painful sexual intercourse, according to RTT News.

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Wyeth to stop making HRT, focus on cancer research

Wyeth, the company that makes hormone replacement therapies Prempro and Premarin, announced today that it is ending its research in its signature areas of contraceptives and menopause treatments to focus on other female problems such as ovarian and breast cancers, according to the Associated Press/Washington Post.

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High court may bar claims for FDA-approved drugs

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 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.

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Lawsuit filed over HRT drugs blamed for breast cancer

A Jasper County woman has filed a federal lawsuit against Pfizer and Wyeth, claiming the hormone therapy drugs manufactured by the companies caused her breast cancer.

Scharlotte Fitzgerald says she began taking hormone replacement drugs in 1994. In 2001 she was diagnosed with breast cancer.

Fitzgerald and her husband Larry filed a personal injury suit against the drug companies in the Beaumont Division of the Eastern District of Texas on Nov. 2. They are seeking in excess of $75,000 in damages.

“This lawsuit asserts claims for negligence; strict product liability for failure to warn, strict product liability for design defect; and breach of implied warranty against the defendants responsible for the design, manufacture, production, testing, study, inspection, mixture, labeling, marketing, advertising, sales, promotion and/or distribution of those hormone therapy products that caused her breast cancer,” the plaintiffs’ original complaint states.

The plaintiffs’ claim that the defendants had an obligation to provide warnings about risks and side effects of their hormone therapy drugs as soon as it was aware of them. The suit alleges that the drug companies failed to disclose “an increased incidence and risk of strokes, blood clots, heart attacks, breast cancers and ovarian cancer from these drugs.”

Plaintiffs also assert that the defendants made claims regarding health benefits of the drugs and should have known “that these claims were false and misleading.”

The defendants also gave a false impression that adequate pre-marketing clinical testing and research and post-marketing surveillance had been done, the plaintiffs claim.

“Plaintiff would not have ingested the hormone therapy drugs … or would have discontinued their use, or would have used safer alternative methods, had defendants disclosed the true health consequences, risks, and adverse effects, including the increased incidence and risk of breast cancer and other illnesses, caused by their hormone drugs,” the complaint states.

In the first claim against defendants, the plaintiff alleges that the companies were negligent by failing to exercise reasonable care in designing, manufacturing, testing and distributing the hormone replacement drugs.

“Defendants knew or should have known that their hormone therapy drugs caused unreasonable harm and dangerous side effects that many users would be unable to remedy by any means,” the petition states. “Despite this, defendants continued to promote and market their hormone therapy drugs for use by consumers, including plaintiff, when safer and more effective methods of countering the negative health effects of menopause were available.”

The petition also includes claims for strict liability through failure to warn and design defect.

“These hormone therapy drugs were each dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchased them,” the suit says. “They were more dangerous than plaintiff contemplated. The risk of each of these hormone therapy drugs outweighs its utility.”

The companies also breached implied warranty, the suit said, because the sold the drugs as being of “merchantable quality and safe and fit for their intended use.”

Scharlette Fitzgerald is seeking damages to exceed $75,000, attorney fees, costs of suit and other relief that the court may deem just and proper.

Her husband, Larry Fitzgerald is also seeking monetary damages for his loss of spousal services, society and companionship.

Hormone therapy led to cancer

A North Dakota woman has filed a federal lawsuit against several companies, claiming the hormone replacement drugs she was prescribed led to breast cancer. Sharon Hesch of Minot, is seeking at least $75,000 and additional punitive damages against Wyeth Inc., Wyeth Pharmaceuticals Inc., Pharmacia and Upjohn Co., and Pfizer, Inc. Hesch”s husband, James, is included as a plaintiff.

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Wyeth must pay $134.1 million in menopause drug lawsuit

Wyeth must pay $134.1 million, including $99 million in punitive damages, over its mishandling of menopause drugs that helped cause three Nevada women’s cancers, a jury ruled.

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Wyeth fights more than 5,000 hrt lawsuits nationwide

giant Wyeth, ordered by a Washoe County jury to pay millions to three Northern Nevada women who claimed the company’s hormone replacement drugs caused their breast cancer, also is fighting more than 5,000 legal battles, a spokesman said Thursday.

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Jury awards 3 women $134.5 million in hormone therapy lawsuit

Reno, Nev., (AP) – A jury has levied a $134.5 million judgment against the maker Wyeth in a lawsuit filed by three Nevada women who contended that the company’s hormone-replacement drugs had caused their breast cancer.

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