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FDA Chief: Bayer Withheld Yasmin Blood Clot Data

According to the former head of the U.S. Food & Drug Administration (FDA), Bayer researchers withheld data about increased reports of certain types of blood clots in Yasmin users. The pharmaceutical giant reportedly failed to include a significant increase in the reporting rate for venous thromboembolisms (VTEs) in a 2004 review of Yasmin’s safety. To date, Bayer faces more than 10,000 lawsuits over injuries allegedly caused by their blockbuster birth control products.

Yasmin Lawsuit Update 7/31/12: The number of lawsuits filed against pharmaceutical giant Bayer on behalf of women allegedly injured by Yaz and Yasmin continues to grow by leaps and bounds around the country, as the federal multidistrict litigation (MDL) for the cases recently surpassed asbestos as the largest in the nation. All of the complaints involve similar allegations which state that Bayer knew – or should have known – about the health risks involved with its blockbuster birth control pills, but that it failed to inform the public and medical communities about this risk.

Yasmin Blood Clot Lawsuit Update 7/23/12: Last week, a Florida man filed a medical malpractice lawsuit which claimed that his wife died following plastic surgery as the result of a Yasmin-induced pulmonary embolism that could have been prevented if her doctors had taken her off the drug prior to surgery. The complaint notes that proper standards of medical care outlined in the Physician’s Desk Reference indicate that “oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery.”

Yasmin Lawsuit Update 7/9/12: After nearly six months of settlement negotiations, Bayer has reportedly reached agreements with approximately 33 different law firms to resolve at least 1,444 Yaz and Yasmin lawsuits. All of the claims were filed on behalf of women who suffered blood clot-related injures after taking the company’s blockbuster birth control pills.

Free Yasmin Lawsuit Evaluation: If you or a loved one suffered a blood clot after taking Yasmin, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the problem?

December 5, 2011 – Former FDA commissioner David Kessler’s scathing report was released today by lawyers representing former users of Bayer’s Yasmin line of best-selling birth control products. Kessler and four other experts submitted their opinions to the FDA, which will be discussing the safety and efficacy of Yasmin and its sister drug Yaz at a hearing on December 8th.

Law firms suing Bayer have cited reports of at least 50 deaths tied to the so-called ‘fourth generation’ contraceptives between 2004 and 2008. The lawsuits claim that the company failed to adequately warn patients of the health risks associated with their products, and of marketing the drugs for unapproved uses. The first cases are scheduled to go to trial early next year in Illinois and state court in Philadelphia.

Bayer generated nearly $1.6 billion in sales from its contraceptives in 2010, making them far and away the company’s best-selling products. The birth control pills, which contain a synthetic hormone known as drospirenone, have been at the center of the controversy surrounding the drugs’ safety.

In October, the FDA issued a press release warning the public that women taking drospirenone-containing contraceptives were nearly 75% more likely to suffer blood clots than women taking older forms of birth control containing a hormone known as levonorgestrel.

According to Kessler, Bayer failed to report information about the risk of blood clots from an internal study, as well as from two cases of clots in women taking Yasmin prior to the drug’s approval.

“Had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin’s NDA [new drug application] could be made. These facts would impact the agency’s risk-benefit equation about the drug and whether it could be approved,” Kessler said.

Do I Have a Yasmin Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Yasmin lawsuits. We are handling individual litigation nationwide and currently accepting new blood clot cases in all 50 states.

Free Confidential Case Evaluation: Again, if you developed a blood clot after using Yasmin, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.

Free Confidential Case Evaluation

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