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CASE UPDATE: Bayer Settled Gallbladder Injury Lawsuits
March 15, 2013 - Bayer entered into an agreement to settle lawsuits filed by plaintiffs who claim to have suffered gallbladder injuries from the company's Yasmin and Yaz birth control pills. Bayer agreed to pay up to $24 million to settle gallbladder injury claims consolidated in the U.S. District Court for the Southern District of Illinois, as well as in state courts in California, New Jersey, and Pennsylvania.
Under the agreement, Bayer will pay $2,000 to plaintiffs who suffer gallbladder injuries and $3,000 to individuals who had their gallbladders removed.
At this time, TorHoerman Law is no longer accepting plaintiffs in the Yaz Lawsuit.
Yaz, Yasmin, Beyaz and Ocella (the generic version of those drugs) are referred to as combinational oral contraceptives (OCs) because they contain both estrogen and progestins not found in other OCs. These oral contraceptives contain a type of progestin called drospirenone. Drospirenone is known to carry some health risks not seen with other forms of the hormone which could result in stroke, pulmonary embolism, deep vein thrombosis, gallbladder disease or other life-threatening injuries.
The one-time poster child of birth control prescriptions, Yaz has quickly become one of the riskiest oral contraceptives available.
Released in 2006, it was the top-selling birth control pill in the U.S and was marketed by Bayer as “a quality of life treatment” to combat acne and severe premenstrual depression. Yaz generated sales of nearly $2 billion in its first year alone, making it at one time the leading birth control pill on the market and Bayer HealthCare Pharmaceutical’s top-selling drug.
Bayer positioned Yaz as the “go-to drug brand for women under 35.” Promoted as the choice for women seeking relief from premenstrual symptoms and acne, Yaz’s marketing touted the birth control pill as one with multiple benefits.
“Yaz is the only birth control pill proven to treat the physical and emotional premenstrual symptoms that are severe enough to impact your life,” claimed many of the advertisements; advertising statements that have since been removed.
Bayer also found itself under scrutiny for deceptive claims made while marketing Yaz. In 2008, the FDA said that Yaz was shown not to be effective for common premenstrual symptoms, just a rare and serious form of them and that Yaz’s success was misleadingly overstated. In fact, the FDA sent Bayer a warning letter, citing the company for running two false and misleading television ads about Yaz. According to the letter, the ads overstated the drug’s efficacy, promoted it for conditions like a premenstrual syndrome for which the drug is not approved and minimized serious risks associated with the drug. In February 2009, Bayer agreed to spend $20 million on a corrective advertising campaign to counteract misimpressions created by the original television spots; a lot of money to correct something Bayer either knew or should have known from the beginning.
Instead, recent studies have shown that this marketing was not only misleading but also dangerous. These independent studies have found that Yaz carries higher blood clotting risks than other leading birth control pills.
While all birth controls come with some risk, Yaz is unique in that it contains a hormone called drospirenone that some experts believe may trigger more blood clots than other birth control pills because of elevated levels of potassium in the body.
In March 2011, Bayer announced the results of a large study that offers insight into the increased risk of venous thromboembolism (VTE), or blood clots, when using the Pill. The study notes that the risk of a blood clot is highest during the first year of using the combination oral contraceptives (COC’s such as Yaz), and even higher in the first six months of use, as well as greatest when restarting the same or a different Pill after a four week or greater break.
In October 2011, the FDA released the results of a study of 800,000 women that found women taking Yaz had a 75% greater chance of experiencing a blood clot than women taking the older birth control pills. In addition, BMJ released its own study of 1.2 million Danish women studied over eight years which concluded that women who took birth control pills that contain drospirenone (such as Yaz) were at least twice the risk of venous thromboembolism compared with users of older birth control pills.
As the risks associated with Yaz came to light, one had to question the integrity of Bayer’s original studies that found no increased risks. Additionally, in a controversial Yaz FDA Advisory Panel meeting, there were reports of professional conflicts of interests and irregularities in the panel’s decision. Where did Bayer draw the line between corporate interests and patients safety?
In France, Bayer found themselves involved in yet another birth control controversy in France when the National Security Agency for Medicines and Health Products (“ANSM”) announced birth control, Diane-35 would no longer be sold. An investigation was also launched into Méliane, another of the newer generation contraceptives manufactured by Bayer. Melanie has also been linked to life-threatening blood clots.
As always, if you or family members are considering birth control options, please consult with your doctor when making the decision that is right for you.
February 28, 2013 - According to the 2012 Bayer Annual Report, Bayer settled with 4,800 individuals claiming injuries from Yaz, Yasmin, and Ocella.
Although Bayer has already spent $1 billion to settle with those who have suffered venous clot injuries (deep vein thrombosis or pulmonary embolism), Bayer acknowledged that there are still about 3,200 pending unsettled claims with individuals who endured similar injuries.
April 10, 2012 - After studies reported as high as a threefold increase in the risk of blood clots for Yaz and similar products, the FDA has ordered Yaz, Yasmin, Beyaz, Safyral, and some generics to change their label warnings. The new labels are required to report the findings of the studies. The increased warnings come from the recommendation of an outside panel of medical experts.
December 8, 2011 – 11 of the 26 members of the FDA Advisory Committee voted that the benefits of using a DSRP-containing oral contraceptive (such as Yaz or Yasmin) do not outweigh the risks.
October 24, 2011 – The FDA released the results from a study of combination birth control pills containing estrogen and drospirenone, such as, as compared to older birth control drugs which contain estrogen only. This six-year study of more than 800,000 women found that woman taking Yaz had a 75 percent greater chance of experiencing a blood clot than women taking the older birth control pills.
At the same time, British Medical Journal (BMJ), a leading journal for doctors worldwide, published a study involving 1.2 million Danish women at reproductive age that showed Yaz users having at least a 2x risk of venous thromboembolism as compared to users of older birth control pills.
March 25, 2011 - Bayer announced the results of a large study which warned women about the increased risk of taking Yaz.
The study noted that the risk of a blood clot is highest during the first year of using the combination of oral contraceptives (COC's such as Yaz), and even higher in the first six months of use, as well as greatest when restarting the same or a different pill after a four week or greater break.
February 10, 2009 - The Food and Drug Administration and the attorneys general of 27 states have required Bayer to spend at least $20 million on an advertising campaign intended to clarify deceptive consumer drug advertising for its top-selling oral contraception pill, Yaz.
Regulators say that the ads which aimed to make Yaz the "go-to drug" for women under the age of 35 overstated the drug's ability to improve women's moods and clear up acne while playing down its potential health risks.
October 3, 2008 - The FDA sent Bayer a warning letter as a result of their distracting and misleading ads that gave the impression that using Yaz resulted in clear, acne-free skin as well as allowing women to say "good-bye" to their Premenstrual Dysphoric Disorder (PMDD) symptoms. The FDA warned Bayer that there was no evidence or clinical experience to demonstrate this, and they would need to pull the ads.
Last Modified: February 26th, 2020 @ 02:33 pm
TorHoerman Law is no longer accepting or pursuing cases against the manufacturers of Yaz, Yasmin, Beyaz, and Ocella.
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