Lawsuit funding is NO LONGER AVAILABLE on Yaz / Yasmin
Because both drugs create a higher risk of potentially fatal blood clots among other serious health issues, litigation has been ongoing for the birth control pills against German company Bayer Healthcare Pharmaceuticals. Claims have been made about the company’s wrongful and misleading commercials, as well as claims of fraudulent, deceitful and misleading information about health risks for marketing and advertising campaigns.
Bayer’s marketing and advertising campaigns for Yaz and Yasmin have also been in controversy. Copies of company e-mails have been attained and were even included in the litigation discovery files of the lawsuits against the company. The 2002 e-mail from Kimberly Schillace, a former Berlex executive, was being used by the plaintiff’s lawyers to prove Bayer’s wrongful misrepresentation of the product.
Schillace had sent an e-mail to Dr. Judith Reichman, an LA-based gynecologist who frequents The Today Show, regarding a contract. Attorneys dispute that the e-mails support the claim of Bayer’s intention to market the product for unapproved use. Schillace, in the e-mail, said that Reichman will “definitely mention the off-label benefits of our products.”
More than 10,500 lawsuits have been filed against Bayer as of February 2012, with claims that consumers weren’t warned of the very harmful side effects. Plaintiffs have filed Yaz lawsuits because of heart and blood disorders among other health risks due to one of the ingredients found in the birth control pills.
A multi district legislation (MDL) is now underway to handle these claims. A judicial panel had also ordered to transfer the lawsuits filed in federal courts to the US District Court for the Southern District of Illinois. These cases filed are very similar and will be handled and managed by one judge.
Bayer faces a lot of various claims because of these two contraceptive pills. One of which is the wrongful marketing and advertising of the products – exaggerating the benefits of acne reduction and extenuating the serious side effects. Accusations against Bayer Healthcare Pharmaceuticals include not performing enough research for Yaz and Yasmin, not issuing ay recalls after reported life-threatening side effects and failing to emphasize the risks associated with the pills.
There have reportedly been approximately a hundred deaths and around a thousand injuries linked to Yaz and Yasmin. Claims against the two contraceptive pills are negligence, fraudulent concealment, strict product liability, deceit and fraud, breach of express and implied warranties, fraudulent and negligent misrepresentation, and medical monitoring.
Bayer suggested that Yaz has the ability to treat Premenstrual Syndrome or PMS and acne at any level of severity when in fact, Yaz was only approved to treat Premenstrual Dysphoric Disorder or PMDD and moderate acne. Bayer overstated the effectivity of the product to treat these circumstances.
According to Bayer Healthcare Pharmaceuticals, the company has settled 8,250 cases related to Yaz and Yasmin for $1.7 billion as of March 2014. More cases are still ongoing in state and federal courts. Bayer currently has attained a reserve stash to settle more individual lawsuit cases with plaintiffs affected by the adverse Yaz and Yasmin contraceptive pills.
Yaz and Yasmin and the FDA
In December 2008, an FDA panel voted favorably to strengthen the warnings on the labels of the drugs. The FDA black box label on both Yaz and Yasmin labels warn women smokers that the cancerous habit in conjunction with the drugs increase the risk of cardiovascular side effects, however, this is evidently insufficient of a warning for its other side effects and health risks.
The FDA had issued a warning letter to Bayer President and CEO Reinhard Franzen regarding their misleading television commercials back in October 2008. Two 60-seconds commercials of Bayer for the product Yaz called “Not Gonna Take It” and “Balloons” were deemed misleading because they broaden the drug’s indication more than the approved indication and usage of the FDA, overemphasize the effectivity of the drug, and downplay the risks associated with Yaz. Because of these, the commercials of Bayer for Yaz have violated laws in relation to the Federal Food, Drug and Cosmetic Act and FDA regulations.
As a response to the warning, Bayer pulled out the commercials and spent $20 million on a separate campaign to correct the false advertising that was made in the initial commercials. In addition to scrapping the original advertisements, the company also agreed to get approvals for future ad campaigns before releasing them to the public. Three years after the FDA warning regarding the television commercials, studies have raised even more questions about the safety of the drug.
The FDA sent another warning letter to Bayer Healthcare Pharmaceuticals in 2009 regarding the quality of ingredients found in the manufacturing plant of the company in Germany during a routine inspection. Other issues at the plant involved dirty equipment and inadequate testing of the final products.
In April 2010, the FDA published in the MedWatch: The FDA Safety Information and Adverse Event Reporting Program some warnings regarding Yaz and Yasmin. Thromboembolism or thromboembolic disorders and other vascular problems can result as a side effect from Yaz and Yasmin users, according to several studies. The studies revealed that Yasmin users were at higher risk of venous thromboembolism as compared to users of levonorgestrel containing COCs.
Bayer advertised Yaz in such a way hat it covered it bad side and overpromised its good side. Yaz was never approved for the use of treating symptoms of PMS, but the company did imply that it could be of use for the above stated syndrome; therefore promoting off-label use.
Along with the British Medical Journal, the FDA had also published studies that presented linkages between the hormones in Yaz and a significant increase in the risk of blood clots, pulmonary embolism and deep vein thrombosis.
Yaz and Yasmin were rated as the second highest for the number of problems recorded by the FDA in the previous year. This ranking was made by the QuarterWatch report of the Institute for Safe Medicine Practices on May 2012.
The American College of Obstetricians and Gynecologists stated on October 2012 published warnings against birth control pills containing drospirenone, due to the fact that it may give a higher risk of blood clots to individuals who take these kinds of pills.
No official recalls have been made regarding Yaz and Yasmin in spite of numerous critics, scientists and the like are insisting that these drugs be recalled. It is shocking to see that the FDA still hasn’t recalled Yaz and Yasmin, even after receiving reports of over 50 deaths in women that took Yaz or Yasmin. In addition to death reports, the FDA has also sanctioned more than 20,000 instances of blood clot injuries (i.e. pulmonary embolism or deep vein thrombosis) linked to the drugs. As many as 5,806 pulmonary embolism reports were filed and 4,800 deep vein thrombosis reports in women taking Yaz or Yasmin, according to research.