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Published: Sunday, 5/31/2009

Paulding woman sets sights on justice after suffering ailments blamed on Bayer birth-control pill

BY ERICA BLAKE
BLADE STAFF WRITER

Angela Beck thought the pain in her shoulder was simply a pinched nerve - an annoying ache that would be relieved with one visit to her local chiropractor.

But a pinched nerve, if that's what it was, wouldn't explain her shortness of breath, the sweat forming on her body, the fact that she was tired.

Nearly two years after she was diagnosed with several pulmonary embolisms, or blood clots in her lungs, the Paulding, Ohio, wife and mother of three is suing one of the world's large pharmaceutical companies.

Mrs. Beck filed a lawsuit last week in U.S. District Court in Toledo against Bayer Group.

Mrs. Beck, one of several women who attorneys say developed problems after taking one of the company's products, said she was not aware of what the lawsuit claims are the many side effects and risks associated with taking the birth-control pill, Yaz.

"I'm hoping that they either fix the problem, whatever it is that is causing the stroke, or at least let people know that there is a higher risk of it," said Mrs. Beck, now 40.

"Yes, it's promising all these other [benefits,] but you're also taking a greater risk for a health issue. You've got to be told so you can weigh the options," she said.

Attorneys David Zoll and Pamela Borgess claim several women suffered serious medical problems as a result of taking Yaz birth control pills. Attorneys David Zoll and Pamela Borgess claim several women suffered serious medical problems as a result of taking Yaz birth control pills.
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According to its Web site, Yaz bills itself as the only oral contraceptive that is "proven to treat emotional and physical symptoms" of Premenstrual Dysphoric Disorder, a severe form of premenstrual syndrome. It also claims to help treat moderate acne.

But in its television advertisements run prior to fall of 2008, the drug company failed to disclose some of the medication's adverse effects and overstated some of its benefits, according to a warning letter the U.S. Food and Drug Administration sent to the company.

It was these promises made to consumers through their advertisements that Toledo attorneys David Zoll and Pamela Borgess claim resulted in several women suffering from serious medical problems.

And for a Tiffin woman, the result was death, the attorneys allege.

Two lawsuits have been filed recently in U.S. District Court in Toledo against Bayer and its subsidiaries.

The suit on behalf of Angela and Martin Beck last Wednesday asks for compensation for the four days Mrs. Beck was hospitalized and her subsequent care.

The lawsuit also asks for punitive damages in excess of $75,000.

On May 11, Candace Fries of Tiffin filed a lawsuit, also in Toledo's federal court, against the company as the administrator of her daughter's estate.

Her daughter, Stephanie Hoover, 25, a wife and the mother of two young children, died May 22, 2006, as a result of a stroke.

She, too, had been prescribed Yaz, the lawsuit said.

"It doesn't contain the warnings that it ought to nor does it share with women the potential risks that exist with this potential dehydration," Mr. Zoll said of the drug. "There's been death, stroke, embolism. Women of all ages, but sometimes very young women."

According to the lawsuits, the drug was defective "due to inadequate warning."

The lawsuits outline the time line in which the company developed, marketed, and dispensed the drug and claim that its advertisements and warnings did not adequately inform consumers about the dangers the drugs imposed.

Mr. Zoll said Yaz is different from other oral contraceptives in that it contains two hormones: One affects the release of the egg; the second interferes with the lining of the uterus.

"All contain this first hormone, which could induce some risk," Mr. Zoll said. "The flip side is the second hormone, the unique part of Yaz, and they fail to disclose this information."

The second hormone is responsible for making the consumer lose water, Mr. Zoll said. The loss of water leads to blood clots, he added.

It's this allegation that has led to other lawsuits being filed across the country against Bayer, Mr. Zoll said. He said 10 suits have been filed and he anticipates more.

Rose Talarico, deputy director of communications for Bayer Healthcare Pharmaceuticals, said the company was aware of the lawsuits, including the one filed on behalf of Mrs. Fries. "But we can't comment on pending litigation," she said.

In the FDA's four-page warning letter to the company written in October, 2008, Bayer was told of violations found in two of its 60-second direct-to-consumer TV advertisements.

Specifically, the two commercials "misleadingly suggest that Yaz is effective in a broader range of patients and conditions than has been demonstrated by substantial evidence or substantial clinical experience."

The company was told to "immediately cease dissemination of violative promotional materials" and to submit a "comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed."

"This is a pretty historic thing that the FDA did when they came down on them about their ad," Mr. Zoll said. "First time we know that the FDA made a company run an ad campaign to correct information."

Mr. Zoll said his firm likely will file other lawsuits against the company in the near future. Both Mrs. Beck and Mrs. Fries contacted the Toledo office after seeing the attorneys' newspaper advertisement about the possibility of lawsuits against Bayer.

Both cases have been assigned to Judge James Carr. No court dates have been set in either case.

Now, two years after her time in the hospital, Mrs. Beck said she is thankful that her body showed her signs of a problem before it was too late. She said she first started taking Yaz as a measure to help another medical problem and has not taken any oral contraceptive since.

"I think about it all the time and I worry about getting [pulmonary embolisms] again all the time. I take an aspirin every other day just to prevent it and any time I get pain, I worry," she said. "It's something that will never leave my mind."

Contact Erica Blake at:

eblake@theblade.com

or 419-213-2134.



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