Bayer AG (BAYRY:US) said settlements of U.S. lawsuits over claims that its Yasmin line of birth-control pills caused blood clots in women have increased to more than $402 million.
Bayer, based in Leverkusen, Germany, has resolved almost 1,900 cases (BAYRY:US) in which it’s alleged that its Yasmin and Yaz contraceptives caused clots that can lead to heart attacks and strokes, the company said today in a stockholders’ newsletter. Bayer said it has paid $402.6 million in settlements of one category of clot cases, for an average of about $212,000 a case.
Bayer also more than doubled its reserve for Yaz cases, setting aside 496 million euros ($610.5 million), the company said. The drugmaker set aside a total of about 200 million euros in 2010 and 2011, according to securities filings.
“We believe we have made appropriate provisions for most of the cases we consider to be worthy of settlement with these accounting measures,” Bayer officials said in an e-mailed statement.
Drug-industry analysts, such as JPMorgan Chase & Co.’s Richard Vosser, have said Bayer may have to pay more than 2 billion euros to resolve all the cases over the pills.
In April, the U.S. Food and Drug Administration ordered Bayer and other contraceptive makers to strengthen blood-clot warnings on their products.
Pills like Bayer’s Yasmin, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers 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, according to the FDA report. 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 $1.1 billion in sales in 2011, making them the drugmaker’s biggest-selling drugs after Betaseron, a multiple sclerosis medication and Kogenate, a medicine to treat hemophilia, according to data compiled by Bloomberg.
Bayer released its stockholders’ newsletter on the same day it raised its 2012 revenue and earnings forecasts, citing increased sales of crop chemicals and drugs as well as favorable exchange rates.
Bayer said revenue will gain about 4 percent to 5 percent this year to 39 billion euros to 40 billion euros, excluding currency and portfolio changes. The company previously forecast a sales increase of about 3 percent.
Bayer’s American depositary receipts (BAYRY:US), each representing one ordinary share, rose 1.92 percent to $75.95 in over-the counter trading today in New York. Shares in Germany climbed 1.3 percent to 61.60 euros.
The $610.5 million Bayer set aside this quarter is to pay the company’s costs beyond what insurance will cover for legal fees and accords, including cases that haven’t been settled, a spokesman, Guenter Forneck, said in a telephone interview today. Bayer isn’t disclosing the amount of its insurance coverage.
In the newsletter, the drugmaker’s executives said Bayer faced more than 12,000 lawsuits over the Yasmin line of contraceptives, including claims that they caused blood clots in some women and damaged gallbladders in others.
So far, Bayer has agreed to settle 1,877 cases in which women blame the company’s contraceptives for causing clots in their veins. “Such injuries are alleged in about 6,000 claims and therefore in fewer than half the cases served to date,” Bayer officials said in the publication.
“This indicates they are making progress putting these Yaz suits over the vein clots behind them,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in a phone interview.
Michael Burg, a Denver-based lawyer for women suing over the Yasmin line, said Bayer has refused to settle cases alleging the contraceptives also caused clots in women’s arteries.
“Those cases involve some of the more serious injuries and we look forward to trying them,” he said in a telephone interview today.
The drugmaker is rejecting women’s claims that the contraceptives damaged their gallbladders or caused gallstones, Burg said.
Wave of Litigation
Since 2009, the German drugmaker has faced a wave of litigation over the birth-control pills. Lawyers suing the company cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. Plaintiffs’ lawyers contend in court filings that Bayer officials marketed the contraceptives for unapproved uses and misled women about their risks.
The cases filed in federal courts were consolidated before U.S. District Judge David Herndon in East St. Louis, Illinois, for pretrial proceedings.
Herndon scheduled a series of trials so juries could begin weighing claims that Bayer and its units marketed Yaz and other contraceptives as safer than rivals’ products while knowing they posed a higher clot risk.
At Bayer’s suggestion, Herndon called in Stephen Saltzburg, a George Washington University law professor, to serve as a mediator. Saltzburg’s job was to explore the possibility of “settlements in this litigation,” Herndon said in a December order.
The judge put the trial schedule on hold while Saltzburg met with lawyers for the drugmakers and former Yaz users.
Saltzburg said earlier this month that settlement talks are continuing between the company and women’s lawyers and progress is being made in resolving cases.
“There are always some holdouts, but I think we will settle the bulk of these cases next year,” Saltzburg told an Illinois newspaper July 5.
The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis).
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