By The Associated Press

Posted November 23, 2009

A Philadelphia jury has ordered Wyeth Pharmaceuticals to pay a woman $75 million in punitive damages after finding a link between her breast cancer and a hormone-replacement drug.

 The punitive damages in the case of Connie Barton were unsealed yesterday, the same day of a verdict in the case of Donna Kendall, who was awarded $6.3 million in compensatory damages and $28 million in punitive damages, said Esther Berezofsky, an attorney for Barton.

Last month, the jury awarded Barton $3.75 million in compensatory damages and found Wyeth willfully hid evidence of a cancer link.

 The punitive award for Barton, of Peoria, Ill., had been sealed until yesterday because Kendall’s case was being heard in the same courthouse. A handful of Prempro lawsuits have gone to trial out of several thousand filed across the country.

Wyeth, based in Madison, was acquired by New York drugmaker Pfizer Inc. for $68 billion last month. A spokesman for Pfizer said the company will challenge both verdicts.

“We are disappointed with the verdicts in these cases,” Pfizer spokesman Chris Loder said in a statement.

“The company believes that neither the awards of punitive damages nor the liability verdicts were supported by the evidence or the law.”

Barton, 64, a retired hospital records clerk from Peoria, took Prempro for five years before her 2002 cancer diagnosis.

Wyeth, in court arguments, told jurors that women are now fully informed of the risks and benefits of Prempro, a combination estrogen-progestin pill.

Kendall, 66, of Decatur, Ill., took combination estrogen-progestin therapy from 1991 to 2002, including the last four years on Prempro, and was diagnosed with breast cancer in 2002, said her attorney, Tobi Millrood.

In her case, Wyeth was ordered to pay $16 million of the punitive damages and Upjohn Co., which is now a division of Pfizer, was ordered to pay $12 million, Millrood said.

“Today’s verdict is a resounding victory not only for Donna Kendall but for women around the country,” Millrood said.

Sales of Prempro have plummeted since 2002 when a large federal health study, the Women’s Health Initiative, was stopped when researchers saw more breast cancers in those on Prempro.

A study this year shows that lung cancer seems more likely to prove fatal in women who are taking the combination drug.

By RADHA CHITALE
ABC News Medical Unit
Sept. 3, 2009

At $2.3 billion, it’s a record-breaking settlement that includes the largest fine ever levied in U.S. history, but drug industry experts say that the hefty sum Pfizer agreed to Wednesday will do little to curb highly profitable, unethical marketing behaviors by some companies. The sum folds in civil and criminal penalties related to illegal prescription drug marketing, bringing the investigation of the pharmaceutical behemoth by the U.S. Department of Justice to a close.

Associate Attorney General Tom Perrelli, center, Health and Human Services Secretary Kathleen Sebelius, left, and Assistant Attorney General for the Civil Division Tony West, take part in a news conference to announce Pfizer will pay a record $2.3 billion civil and criminal penalty over unlawful prescription drug promotions on Wednesday, September 2, 2009 in Washington.

The settlement includes $1.3 billion in criminal fines related to promoting the arthritis and menstrual pain drug Bextra for uses and in doses not approved by the FDA, putting patients at increased risk for heart attack and stroke. Pfizer voluntarily removed Bextra from the market in 2005.

But promoting off-label drug use to physicians is commonplace. Ethics experts and policy makers say more stringent government oversight is necessary, but that as long as the profits are bigger than the penalties, drug companies are unlikely to revise their marketing model.

“This suit shows that Pfizer controlled what physicians and consumers believed to be the effectiveness and safety of Bextra in ways not supported by the real science Pfizer had done and was not approved by the FDA,” said Dr. Jon Abramson, a pharmaceutical safety and ethics expert at the Harvard Medical School. “Those are the necessary ingredients of blockbuster drugs.”

Pharmacia and Upjohn Company, Inc., a subsidiary of Pfizer, will plead guilty to one criminal count of violating the U.S. Food, Drug, and Cosmetic Act in promoting off-label Bextra use.

Lavish Trips for Prescribing Doctors

Part of Pfizer’s marketing campaign included lavish “consultant meetings” in exotic locations that physicians were paid up to $1,500 to attend, in the hopes that they might increase the number of prescriptions they wrote, according to a lawsuit filed by John Kopchinski, a former Pfizer sales representative.

“At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives,” Kopchinski said, in a statement. “I couldn’t do that.”

Department of Health and Human Services Secretary Kathleen Sebelius called the settlement today “historic,” not only because of its size but because Pfizer agreed to a Corporate Integrity Agreement, which she said would offer some transparency in how the company researches and markets its drugs, including what kind of financial incentives the company offers doctors who prescribe Pfizer drugs.

I think it is a fair assumption to say that most people who smoke wish they had never started.  Unfortunately, it is a very rare occasion to quit smoking on the first attempt.  I personally know of a woman who used cigarettes as a weight loss tool.  She died of emphysema at the age of 57.  The woman was my mother-in-law.  Not only is smoking debilitating to your health, it is just downright expensive.

            It is no wonder that the public was excited when Pfizer introduced Chantix and received approval by the F.D.A. in May, 2006 as a smoking cessation drug.  Here was medication that promised them freedom from their dependence on cigarettes.  Sadly, it didn’t take long to discover that Chantix had some potentially tragic side effects. 

            The United States Food and Drug Administration issued an Early Communication to the public and health care providers on November 20, 2007 that they were evaluating “…adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior…”  Tragically, this announcement came too late for some. 

            As I have said, I have seen the powerful grip that cigarettes can have and the desperation to break free.  I have also spoken to individuals who have taken Chantix and have experienced its heartbreaking effects.   If you or someone you love has been a victim of these side effects, you don’t need to go through this alone.  I would like to invite you to visit my website at www.dreamlegalteam.com.  Feel free to fill out an online consultation form or engage in a live chat.  Once again, the website is www.dreamlegalteam.com.  Don’t wait.

          Good, bad or ugly, tell us what you think of this blog!