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Bayer Sets Aside Funds to Cover Yaz/Yasmin Gallbladder Lawsuit Settlements

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So far, Bayer has negotiated lawsuit settlements in about 4,800 cases, paying out more than $1 billion to plaintiffs who claimed injuries from birth control pills Yaz and Yasmin. All of these lawsuits involved women who had complications related to blood clots, such as deep vein thrombosis, pulmonary embolism, and stroke.

While both sides continue in mediation over these types of cases, Bayer has now opened the door to potential settlement negotiations for women who claim to have suffered gallbladder disease after taking the pills.

Some Plaintiffs Suffer from Gallbladder Disease

Though most women filing claims against the company do so because of blood clot-related injuries, a sizeable segment have suffered complications related to gallbladder disease, including inflammation, abdominal pain, jaundice, fever, gallstones, and more, some requiring surgery to remove the gallbladder.

Studies have indicated that the fourth-generation progestin used in Yaz and Yasmin, called “drospirenone,” increases risk of blood clots more than those progestin (levonorgestrel) used in older pills. The FDA issued a safety communication on April 10, 2012, noting that they were requiring new warnings on drospirenone-containing pills indicating they may be associated with a higher risk of blood clots than other progestin-containing pills.

Gallbladder side effects have received less attention than those related to blood clots, but there has been research on the potential connection between drospirenone and gallbladder problems.

Studies Indicate Some Potential for Increased Risk

For a 2011 study published in the Canadian Medical Association Journal, researchers looked at the data from nearly 3 million women using birth control pills for at least six months. They found that those taking pills that contained newer progestins like drospirenone, desogestrel, and norethindrone, had a slightly higher risk of gallbladder problems than those taking pills containing the older progestin, levonorgestrel.

A 2012 study, on the other hand, examined data from the U.K. General Practice Research Database and found no evidence that drospirenone- or levonorgestrel-containing birth control pills increased risk of gallbladder disease. (Contraception, September 2012)

The Hormone-Gallbladder Connection

How might birth control pills affect the gallbladder? Because the gallbladder has estrogen receptors in it, and these receptors attract cholesterol, additional estrogen can actually increase the cholesterol in the gallbladder. In turn, can increase the risk of thickened bile in the gallbladder, which can lead to gallstones and inflammation.

Progestin, as well, can have an effect on the gallbladder. Because it can actually inhibit the organ from releasing bile, that bile can build up inside, again increasing the risk for gallstones.

Bayer Sets Money Aside

In recent news, Bayer has agreed to a settlement of up to $24 million for about 8,000 lawsuits involving plaintiffs suffering from gallbladder problems allegedly as a result of taking Yaz and/or Yasmin. If this agreement goes forward, each plaintiff who had to have the gallbladder surgically removed would receive only about $3,000 each in damages. Those who did not go through surgery would receive about $2,000 each.

Though these amounts may be small by comparison to those being paid in blood clot-related cases, it is still a significant step forward for plaintiffs. In the past, Bayer has denied that their medications could have any link to increasing risk for gallbladder disease. They continue to hold to this argument despite the settlement agreement.