Ind. Woman Sues Over Alleged Yaz Pulmonary Embolism

Ind. Woman Sues Over Yaz Pulmonary Embolism

By Jessica Tyner

Megan Higgins of Indiana is just one of the latest women to file a lawsuit against Bayer Healthcare Pharmaceuticals Inc., the makers of the popular birth control pills Yaz and Yasmin, and Teva Pharmaceutical, the manufacturer of generic Yaz birth control pill Gianvi, over alleged pulmonary embolism.

According to her Yaz lawsuit, filed on Oct. 18, 2013, Higgins “suffered from a pulmonary embolism diagnosed on or about November 7, 2010, as a result of her direct use of Yasmin and Gianvi. However, due to Defendants’ fraudulent concealment and/or misrepresentation of material facts, Plaintiff did not discover, nor could she have discovered that her injuries were the result of Defendants’ wrongdoing and Plaintiff’s ingestion of Yaz and Gianvi until June of 2012.”

Like many birth control blood clot victims , Higgins thought it was a fluke — after all, blood clots and complications from clots can simply happen. She says she was never told that taking Yasmin and Gianvi could result in an increased risk of blood clots and pulmonary embolisms. 

History of Yasmin, Yaz and Gianvi Birth Control

Yasmin was first approved by the U.S. Food & Drug Administration (FDA) in 2001, and Yaz followed in 2006. Gianvi was introduced in 2010. During the early 2000s, Yasmin commercials were seemingly ubiquitous. For a while, Yasmin was believed to be safer than older versions of the pill because it was a different chemical makeup than “third generation” pills, which were common in the 1990s.

Drospirenone is new, and it’s an active ingredient in Yasmin. According to the Yasmin lawsuit: “One possible mechanism of action is that drospirenone causes an increase in potassium levels in the blood, which can lead to a condition known as hyperkalemia (elevated blood potassium level) if the potassium levels become too high. Hyperkalemia can cause heart rhythm disturbances, such as extra systolies, pauses or bradycardia. If left untreated, hyperkalemia can be fatal. If hyperkalemia disrupts the normal heart rhythms, the flow of blood through the heart can be slowed to the point that it permits blood clots to form. Blood clots in the heart can then lead to heart attacks, or the clots can break off and travel to the lungs where they can cause pulmonary embolism, or can travel to the brain and cause strokes.”

During the years that Yasmin was available, the FDA received more than 50 reports of women dying from complications related to the drug, and one of the women was only 17 years old.

According to the Yaz lawsuit, two studies from 2009 “found significantly increased risks associated with Yasmin and Yaz over other types of birth control pills. The first assessed the risk of venous thrombosis in women who take hormonal contraception and was conducted on women ages 15-49 with no history of heart disease or any other malignant disease. The study concludes ‘oral contraceptives with … drospirenone were associated with a significantly higher risk of venous thrombosis than oral contraceptives with evonorgestrel.’” 

Higgins claims that Bayer and Teva knew about the high risks when she was prescribed Yasmin and Gianvi, but chose not to warn consumers or the medical community.

“As a direct and proximate result of using Yaz and Gianvi, Plaintiff suffered from severe and personal injuries, including but not limited to, pulmonary embolism, as well as physical pain and mental anguish, diminished enjoyment of life, and medical, health, incidental and related expenses,” her Yaz lawsuit claims. “Prior to Plaintiff Megan Higgins’ use of Yaz and Gianvi, Defendants knew or should have known that use of Yaz and Gianvi created a higher risk of pulmonary embolism, including, but not limited to, second generation oral contraceptives, and that, when taken as directed, such use was unreasonably dangerous to consumers.”

Higgins is suing Bayer for defective manufacturing, design defect, defect due to inadequate warning, negligence, breach of warranty, negligent representation/fraud, unjust enrichment, false advertising and punitive damages. Her Yaz lawsuit has joined the ongoing multidistrict litigation (MDL) currently pending against Bayer.

The Yaz lawsuit is Megan Higgins v. Bayer Healthcare Pharmaceuticals Inc., et al., Case No. 3:13-cv-10852, in the U.S. District Court for the Southern District of Illinois. It has been added to the ongoing Yaz MDL, In Re: Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, MDL No. 2100, in the U.S. District Court for the Southern District of Illinois.

Did You Have a Blood Clot? 

Are you one of the many women who took Yaz, Yasmin or Gianvi and suffered a blood clot or related complication? If this happened to you, you likely have a Yaz legal claim. Find out more about what to do next at the Yaz/Yasmin, Beyaz & Ocella Birth Control Pill Class Action Lawsuit Settlement & Investigation. After submitting your information, an attorney will contact you if you have a case for a free Yaz claim review.