According to Bayer AG, the German pharmaceutical giant has shelled out $142 million so far, in settlements of U.S. lawsuits claiming that its Yaz, Yasmin and Ocella line of birth-control pills caused blood clots.
Bayer, said today in its Stockholders’ Newsletter for the first quarter, that it has resolved 651 cases alleging its Yasmin and Yaz contraceptives caused blood clots that can lead to heart attacks, deep vein thrombosis, pulmonary embolism and strokes.
The company said it paid $142 million in the settlements, for an average of about $218,000 a case.
According to experts, Bayer's strategy is to avoid the possibility of a large jury award in these clot cases; settlements provide a fixed and determinable amount when it comes to the cost of resolving these cases.
Bayer's Hit could be as high as $2.65 Billion
Bayer’s update comes after financial analysts estimate that the drugmaker may have to pay more than 2 billion euros ($2.65 billion) to resolve all the cases over the contraceptives.
FDA New Warning Label
The U.S. Food and Drug Administration April 10 ordered Bayer and other contraceptive makers to strengthen blood-clot warnings on their products.
FDA Drospirenone Blood Clot Triple Risk
Pills like Bayer’s Yasmin, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers have found they may triple the risk for clots.
The FDA examined data on more than 835,000 women who took pills containing drospirenone, including Bayer’s Yasmin line.
Yasmin was the No. 4 oral contraceptive in the U.S. in 2011, with 4.6 percent of the market as of September, according to data from IMS Health.
Bayer’s contraceptives generated $1.58 billion in sales in 2010, making them one of the drugmaker’s biggest-selling drugs.
Federal 11,900 Suits
As of April 18, Bayer faced 11,900 lawsuits over Yaz and Yasmin in the U.S. involving about 14,000 plaintiffs, the company said.
YAZ Gallbladder Cases
Bayer is rejecting women’s claims that the contraceptives damaged their gallbladders or caused them to suffer from gallstones.
Yasmin Bellwether Trials on Hold
The cases filed in federal courts were consolidated before U.S. District Judge David Herndon in East St. Louis, Illinois, for pretrial proceedings.
The Judge David R. Herndon, of the U.S. District Court for the Southern District of Illinois, extended a stay for the bellwether process on April 19, delaying all deadlines for the third time this year.
The bellwether process was established in the Yaz MDL to allow the parties to prepare a small group of cases for early trial dates and help gauge how juries are likely to respond to certain evidence that is presented throughout the litigation. Bellwether trials are often scheduled in complex pharmaceutical litigation to help facilitate settlement negotiations.