Lawsuits mounting over alleged health risks of Bayer's Yaz contraceptive, lawyers filing lawsuits for Blood clots from yaz, Yasmin.
Published: Monday, July 11, 2011, 2:35 PM Updated: Monday, July 11, 2011, 2:55 PM
Susan Todd/The Star-Ledger By Susan Todd/The Star-Ledger
jcummins.jpgTim Farrell of The Star-LedgerJoan Cummins stands near a photo of her daughter, Michelle, who died last year of a pulmonary embolism. Cummins believes her daughter's death occurred as a result of her use of Yaz, a birth control pill made by Yaz.
Michelle Pfleger, a teenager from Hackettstown, was familiar enough with the birth control pill Yaz to ask for it when she visited her doctor before heading off to college.
She had seen the advertisements on television about how the drug could help clear up mild acne, relieve premenstrual irritability and, if she needed it, could prevent her from getting pregnant.
“Some of her friends were on it,” her mother, Joan Cummins, said recently, “and she thought it was a good one.”
But in May, Cummins filed a lawsuit against Bayer Healthcare, the drug company that sells Yaz, alleging that the birth control pill caused her 18-year-old daughter’s death nearly a year ago. Pfleger died after a blood clot lodged in her lung, causing her to go into cardiac arrest as she made her way to class at Elon University in North Carolina.
In one of the latest court battles pitting consumers against a giant drugmaker, Cummins and thousands of others are alleging Bayer did not provide adequate warnings about the health risks associated with Yaz, and they are blaming the drug for causing blood clots, heart attacks, strokes and, in some cases, sudden deaths.
“Her death was so unexpected,” Cummins said. “Once we researched it, we felt very strongly that this was the cause of my daughter’s death, that the embolism was caused by Yaz.”
In an e-mailed response to questions about the mounting litigation against Bayer, spokeswoman Rose Talarico said the company would “defend itself vigorously” against the lawsuits.
“Bayer stands behind the safety of its oral contraceptives, which are safe and effective when used as directed and according to product labeling and good clinical practice,” she said. “The lawsuits filed by plaintiffs focus on side effects that are warned about in the labeling for Yaz and Yasmin.”
Yaz and its predecessor, Yasmin, are part of a group of oral contraceptives, including widely used generics such as Ocella, that contain a combination of the estrogen ethinyl estradiol and drospirenone, a synthetic hormone.
Both drugs were made by Berlex Labs, which was acquired in 2006 by Bayer Healthcare, the U.S. division of Bayer AG, the German pharmaceutical company. The Food and Drug Administration approved Yasmin in 2001, and five years later they allowed Berlex to begin selling Yaz, another version of the drug.
The two pills, backed by marketing campaigns, quickly became top-sellers, generating hundreds of millions in annual sales for Bayer. Last year, annual sales of Yaz reached $361 million, according to Pennsylvania-based SDI Health, which tracks sales of prescription drugs. Annual sales of Yasmin have declined since 2008 when the drug generated $329 million.
When they were approved by regulators, the pills were considered an advance over older forms of oral contraceptives because they were taken for 24 days rather than the usual 21, which was believed to benefit women because it created less hormonal fluctuation.
But early on, there were concerns about the health risks associated with drospirenone. A year after Yasmin went on the market, the nonprofit consumer advocacy group Public Citizen placed the drug on its list of “Do not use pills.”
The group warned consumers that drospirenone caused elevated blood levels of potassium, which could trigger serious heart problems. It also said that Yasmin did not work better than older oral contraceptives that were less likely to cause blood clots and other dangerous side effects.
Sidney Wolfe, director of Public Citizen’s Health Research Group, said even as a prescription drug’s safety risks become better understood, it can take years for regulators to insist on stronger warnings or for a drug to be removed from the market. “When you have enough evidence to suggest that there is no unique benefit and there are unique risks, that should be it,” Wolfe said.
The mounting litigation, he said, also will have little impact on whether the drug is ever removed from the market. “If companies think they will make more money by continuing to sell a drug, they will,” Wolfe said. “That’s the calculus, if they make more money than they will lose in litigation.”
In the case of Yaz, the mounting product liability lawsuits generally argue that Bayer provided inadequate warnings about the health risks for women taking the drospirenone-containing birth control pills.
More than 900 lawsuits have been filed in Bergen County — one of four courts where the mass tort litigation will be heard. Hundreds of other cases are filed in courts in Philadelphia, California and Illinois.
“We feel physicians and patients should have been advised with a stronger warning. That’s one of the tenets of the case,” said Cherry Hill attorney Greg Spizer, whose firm is handling about 200 lawsuits related to Yaz.
“Warnings are vital so physicians and patients can make sound decisions,” he said. “That’s the heart of what these cases are about.”
Ongoing studies of the drugs continue to reveal more information about the potential dangers of drospirenone-containing contraceptives.
In June, FDA regulators acknowledged new evidence that raised more questions about the safety of Yaz and birth control pills like it, including the top-selling generic Ocella.
The agency posted a notice on its website saying it was aware of studies recently published in the British Medical Journal that showed oral contraceptives containing drospirenone were two to three times more likely to cause blood clots than other birth control pills.
According to Lisa Spitzer MSW at the yaz Birth Control Pills Helpline "We are receiving calls Daily from women, mothers, Daughters and wives who have complications from Yaz"."The Yaz Trials have begun and it is not to late to seek justice form injuries form Yaz"
“Bayer so effectively mass marketed this, it became the contraceptive du jour,” she said. “It was the pill most women were getting.”
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