There are a number of medications available in the United States that have been approved by the FDA to prevent pregnancy in women who elect to use an oral contraceptive, like Yaz, a popular drospirenone-based birth control pill manufactured by Bayer Healthcare. Unfortunately, many of the newer-generation birth control pills on the market today have been linked to serious and potentially life-threatening side effects. Yaz, for example, belongs to a class of oral contraceptive that is believed to cause heart attack, stroke, gallbladder disease, deep vein thrombosis, and pulmonary embolism injuries in users. If you used Yaz or Yasmin in the past, and you have since suffered one or more of these serious side effects, contact a reputable Yaz injury lawyer today for legal help. You may have grounds to file a Yaz lawsuit against Bayer, in order to seek fair and timely reimbursement for your injuries.
Women who take Yaz in an effort to prevent pregnancy may be exposing themselves to serious and potentially life-threatening side effects, and as Mark Woods of New York University School of Medicine told the AP, “I can see no real group of patients that this drug benefited over existing alternatives. Without any clear benefit, and given the potentially catastrophic risk, I voted [in the 2011 FDA panel, that the benefits of drospirenone-containing drugs do not outweigh their potential harm].” With this in mind, some alternatives to Yaz for pregnancy prevention in women include the following:
Yaz is a combination birth control pill that contains both estrogen and a new generation of synthetic progesterone called drospirenone, and is designed to prevent ovulation and cause changes in the cervical and uterine lining, making it more difficult for sperm to reach the uterus and for fertilized eggs to attach to the uterine wall. Yaz has also been approved to treat moderate acne in women fourteen years of age or older. What many people may not know is that Yaz, and its parent company, Bayer Healthcare Inc., have recently been criticized in the media for not being honest about the harmful side effects that may be associated with the drug, many of which have resulted in permanent health issues and even fatality.
Yaz is an extremely popular oral contraceptive marketed by Bayer as an effective means of pregnancy prevention and moderate acne treatment, as well as a treatment for the symptoms of premenstrual dysphoric disorder. However, recent research has linked the use of Yaz to serious and potentially fatal side effects, including the following:
To date, at least 100 deaths and thousands of injuries have been linked to Yaz treatment, and studies have shown that Yaz users may be as much as two- to three-times more likely to suffer blood clot-related injuries than women who take older oral contraceptives.
According to an independent review issued by the FDA in 2011, “there has long been concern about the risk of both arterial and venous cardiovascular complications imparted by the use of combined hormonal contraceptives (CHCs),” and “an increased risk of venous thromboembolism (VTE) (deep venous thrombosis [DVT] and pulmonary embolism [PE]) is well established and has been consistently reported.” In order to evaluate the potential risk of blood clot injuries associated with Yaz treatment, the FDA examined 835,826 cases where women between the ages of 10 and 55 used at least one prescription for a study CHC between January 1, 2011 and December 31, 2007. According to the findings of the FDA researchers, the use of drospirenone-based birth control pills like Yaz was associated with a higher risk of VTE and other blood clot-related side effects in women.
One of the reasons Yaz is considered to be such a dangerous drug is that it is a “fourth generation” combination birth control pill, meaning it contains a newer type of synthetic progestin called drospirenone. According to a warning letter issued to Bayer by FDA officials, drospirenone may lead to serious heart and health problems, including heart attack, stroke and blood clots. Drospirenone-based oral contraceptives are believed to be so harmful for women, because the synthetic progesterone increases the level of potassium in the blood, which may result in hyperkalemia, a condition that can cause cardiac arrest and kidney failure.
As more information comes to light about the alleged risk of blood clots and other side effects from Yaz, women across the country are coming forward and pursuing legal action against Bayer. To date, thousands of Yaz lawsuits have already been filed against Bayer and its affiliate companies over complications from the oral contraceptive, and the drug maker has reportedly settled roughly 8,250 cases for $1.8 billion. Since 2009, more than 12,000 Yaz injury claims have been centralized in the Southern District of Illinois for coordinated pretrial proceedings as part of a multidistrict litigation (MDL), with additional cases filed in state courts across the country. Some of the more recent legal actions taken against Bayer over alleged Yaz side effects include the following:
2010 – Lawsuits are filed in Canada alleging an increased risk of heart attack and stroke from Yaz and Yasmin birth control pills.
March 2010 – A class action lawsuit is filed against Bayer in Canada, on behalf of women who believe they were harmed by side effects of the birth control pill.
September 2011 – The first Yaz bellwether trials are scheduled to begin, involving plaintiffs who claim to have suffered pulmonary embolism and other thromboembolic events from the oral contraceptive.
2012 – U.S. District Judge David Herndon cancels the Yaz trial scheduled for January 2012, and orders mediation instead.
April 2012 – Bayer states that it will not resolve any Yaz or Yasmin lawsuits following the FDA warning label change. The drug company agrees to pay at least $110 million to resolve 500 complaints alleging fatal blood clots from Yaz and Yasmin.
August 2012 – Bayer settles close to 1,900 lawsuits for $402.6 million, which is an average of $212,000 per case. The company announced its decision to set aside $610.5 million for potential Yaz settlement agreements.
December 2014 – Judge Herndon orders 33 Yaz and Yasmin cases involving an arterial thrombotic event (ATE) or patent foramen ovale (PFO) be prepared for early “bellwether trials” to begin in 2015.
February 2015 – Judge Herndon issues a case management order accusing Bayer of attrition, or wearing people down, as part of its defense strategy in the Yaz litigation.
June 2015 – Trial is set to begin in a product liability complaint filed by Pamela Schubert, a resident of Chester, Illinois, who claims to have suffered a stroke and an arterial thrombotic event after taking Yaz.
Since Yaz first entered the market in the United States in 2006, its manufacturing company, Bayer, has received several warnings from the FDA, regarding its misleading marketing of the oral contraceptive and the potential for Yaz to cause serious blood clot-related injuries in users. The following are some of the most important FDA warnings involving Bayer and Yaz:
October 2008 – The FDA fined Bayer for its deceptive advertising practices, which included making misleading claims in several Yaz advertisements about the benefits of the birth control pill. According to a warning letter issued to Bayer by the FDA, the Yaz commercials were overstating the benefits of the drug while intentionally distracting viewers from the list of the drug’s harmful side effects.
December 2008 – An FDA panel voted in favor of including stronger warnings on Yaz birth control pills, indicating that Yaz may increase the risk of serious cardiovascular side effects in women who smoke.
August 2009 – The FDA sent Bayer a warning letter regarding the quality of ingredients discovered during a routine inspection of the company’s manufacturing plant in Germany, where investigators found “significant deviations from U.S. current good manufacturing practices.”
May 2011 – FDA officials issued a safety announcement “informing the public about new information that is being assessed as part of the FDA’s ongoing safety review of birth control pills that contain drospirenone,” in order to evaluate the risk of blood clots in women using the prescription drugs.
September 2011 – The FDA issued a drug safety communication indicating that it “has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills” like Yaz.
September 2011 – The FDA compiled a list of questions and answers regarding the alleged risk of injury associated with Yaz, after reviewing two 2011 studies that examined the potential for Yaz to cause blood clot side effects in users.
October 2011 – The FDA issued a statement regarding the preliminary findings of a study the agency itself conducted, which found that women have at least a 1.5-fold increased risk of developing a blood clot after taking Yaz or another drospirenone-based birth control pill.
December 2011 – The FDA scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the risks and benefits of Yaz and other drospirenone-containing oral contraceptives.
April 2012 – The FDA calls for an update to the Yaz warning label indicating that some studies show a three-time increased risk of blood clots for drospirenone users, while other studies have found no additional risks.
A growing body of research has established a possible connection between drospirenone-containing birth control pills like Yaz and an increased risk of serious and potentially life-threatening side effects, like blood clots, pulmonary embolism, heart attack, stroke and deep vein thrombosis. Some of the more recent Yaz side effect studies include the following:
2007 – Two studies published as part of the post-marketing requirements established by the FDA failed to find any link between drospirenone-containing medications and blood clot injuries.
2009 – Two separate studies warn that women taking Yaz may be twice as likely to develop a blood clot injury, compared to women using other forms of birth control.
October 2011 – A study published in the British Medical Journal involving more than one million Danish women found that women taking new-generation birth control pills like Yaz faced at least twice the risk of blood clots, compared to women taking older oral contraceptives containing levonoregstrel.
October 2011 – Federal regulators released the preliminary results of an FDA-funded study, which evaluated the risk of blood clot injuries in women using several different hormonal birth control products. According to the FDA’s findings, women taking Yaz or another drospirenone-containing birth control pills have about a 75% increased risk of suffering blood clots, compared to those taking other hormonal contraceptives.
November 2011 – Health Canada announced stronger warnings on Yaz and Yasmin labels regarding the alleged risk of blood clot injuries, following a review of drospirenone-containing contraceptives, which found a 1.5- to three-times increased risk of blood clots among women taking the medications.
September 2012 – A study published in the medical journal Contraception finds women who take Yaz and other fourth-generation birth control pills are 77% more likely to suffer venous thromboembolic events, and twice as likely to suffer arterial thromboembolic events.
Many women first began using Yaz because they believed it would help regulate their menstrual cycles. What they didn’t expect was for Yaz to put them at risk for potentially life-threatening complications, like blood clots, heart attack, stroke and deep vein thrombosis. Despite these alleged risks, within two years of its approval, Yaz had become the most popular oral contraceptive on the market in the United States, reaching sales of $781 million in 2009. Yaz injury claims brought against Bayer in recent years accuse the drug manufacturing company of the following:
The side effects associated with Yaz are extremely serious and can lead to major, life-altering complications for some victims. For example, stroke victims may experience difficulty communicating after the incident, as well as permanent loss of both movement and brain functions, and heart attacks are the leading cause of death for both men and women worldwide. Victims of severe injuries or death resulting from the use of Yaz are not at fault. If you or a loved one has suffered a Yaz injury, contact a Yaz attorney as soon as possible to discuss the possibility of filing a lawsuit against Bayer Healthcare. There are already a number of Yaz lawsuits pending against Bayer for serious injuries and wrongful deaths allegedly caused by the medication, and more Yaz injury claims are expected to be filed in the future. If you believe you have been injured by side effects of Yaz, you may be entitled to compensation for your injuries. Contact an experienced Yaz attorney today for legal help.