Five Women File Yaz Blood Clot Lawsuit

A new lawsuit filed by five women against Bayer Healthcare, makers of the Yasmin and Yaz birth control pills, has been consolidated with other, similar cases in multidistrict litigation (MDL no. 2100), located in the U.S. District Court for the Southern District of Illinois. Judge David Herndon is overseeing Yaz & Yasmin MDL proceedings. Plaintiffs allege the drug maker concealed the risk of certain side effects, including blood clots and pulmonary embolisms.

The women involved in the latest Yaz blood clot lawsuit to be incorporated into the MDL make similar allegations. They each used Yaz or Yasmin for around a year before developing pulmonary embolisms that required multiple surgeries and procedures to treat, and are now taking anticoagulants for the foreseeable future. Plaintiffs say the Yaz pulmonary embolism risk was not adequately labeled by Bayer.

Yasmin received FDA approval in April 2001, and Yaz in 2006. Both are progestin-based contraceptives, and contain the relatively new drospirenone, a synthetic version of the naturally-occurring female hormone progesterone. Unlike older contraceptives, drospirenone has not had the benefit of decades of observational data and clinical trials. Court documents from the latest Yaz blood clot lawsuit cite studies (conducted prior to the FDA granting approval to the products) which suggest both Yasmin and Yaz were more dangerous than first or second generation birth control pills.

Potassium blamed for increased pulmonary embolism risk

The Yaz lawsuit points to an increase in potassium levels as one of the culprits. Such an increase can lead to hyperkalemia which, if untreated, can cause heart arrhythmia and the formation of blood clots. Unchecked, blood clots in the heart can cause cardiopulmonary arrest, or migrate to the lungs or brain.

Between 2004 and 2008, the FDA received more than 50 reports of fatalities among users of Yaz and Yasmin. In a recent Yaz blood clot lawsuit, those deaths were “associated with cardiac arrhythmia, cardiac arrest, pulmonary embolism and stroke.”

The FDA has warned Bayer against misleading the public on no less than three occasions. Central to the controversy is the company’s advertising campaign, which allegedly overstated the efficacy of the pills while downplaying the risks. Bayer ultimately agreed to a multi-million dollar advertising campaign warning the public of the risks.

The FDA issued a Safety Precaution in 2012, which stated:

“The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.”

Yaz linked to VTE in Dutch study

Both Yaz and Yasmin have been widely condemned by the global medical community. A Dutch study published in the British Medical Journal showed a link between Yaz and venous thrombo-embolism (VTE). The report concluded that women who took drospirenone-based oral contraceptives may double their risk of developing VTE compared to women on levenorgestrel. In France, pharmacists have stopped reimbursing patients for Yaz and Yasmin prescription costs, and Bayer is known to have settled at least one major lawsuit in Europe. In the U.S., Bayer has settled over 3500 lawsuits relating to the pills.