Included among the claims are five Yasmin and Yaz class action lawsuits; three filed in the United States and two filed in Canada, according to Bayer’s 2009 annual report released late last month.

All of the lawsuits involve similar allegations that side effects of Yaz, Yasmin and Ocella increase the risk that women may suffer a stroke, heart attack, pulmonary embolism, deep vein thrombosis, gallbladder disease or other injury. The plaintiffs claim that Bayer failed to adequately research the birth control pills or warn about the increased risks when compared to other available forms of oral birth control.

Yaz and Yasmin are two similar birth control pills that are both manufactured by Bayer, containing a combination of ethinyl estradiol and drospirenone, a new type of progestin. Ocella, which is a generic version of Yasmin, is distributed by Barr Laboratories, Inc. However, Bayer indicated in the annual report that they are taking over Barr’s defense in certain Ocella lawsuits under the terms of their licensing agreement.

Drospirenone, or drsp, impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. This can cause a condition known as hyperkalemia, which is linked to potentially life-threatening heart problems and other health issues. Yaz litigation claims allege that the oral contraceptives have been responsible for at least 50 deaths in the U.S. alone, with some estimating the number is closer to 60.

Many of the lawsuits also claim that Bayer over-promoted Yaz and Yasmin, alleging that the drug maker advertised additional benefits over other birth control pills without fully disclosing the potential increased risk of problems from Yasmin and Yaz. The FDA has previously penalized Bayer for deceptive advertising in connection with the birth control pills. Last year, the pharmaceutical company was required to spend $20 million to run a corrective advertising campaign after promoting unapproved and unsubstantiated health benefits of Yaz while downplaying side effects.

According to Bayer’s annual report, the drug maker expects that the number of lawsuits will continue to climb. Yaz and Yasmin lawyers are continuing to review potential cases for women who have suffered injuries, and some estimates suggest as many as 25,000 women could file a suit over the birth control pills.

Despite the lawsuits and purported health risks, Bayer raked in $1.7 billion from Yaz, Yasmin, and a low-strength version of Yasmin called Yasminelle in 2009. Sales overall for the company’s birth control pills was up 4.6 percent over 2008 numbers.

Bayer announced earnings on Tuesday for the three months ending on September 30, indicating that they will rely on the sales of Yasmin, the newer Yaz and the low-dose Yasminelle, to help push it through the current economic recession. The birth control pills all contain a combination of ethinyl estradiol, which is used in many oral contraceptives, and drospirenone, a unique type of progestin that is only found in these drugs and a generic Yasmin version sold under the brand name Ocella.

Drospirenone, or drsp, impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. This can cause a condition known as hyperkalemia, which is linked to potentially life-threatening heart problems and other health issues.

The increase in sales of Yasmin and Yaz comes as the birth control pills face increasing scrutiny, including media coverage of two recent studies that found drospirenone-based birth control carry an increased risk of blood clots when compared to some older contraceptives.

Bayer also disclosed on October 8 that they have already been served with at least 129 Yasmin or Yaz lawsuits, which allege the drug caused women to suffer a variety of different injuries, including strokes, heart attacks, pulmonary embolism, deep vein thrombosis, gallbladder disease and sudden death.

On October 1, the U.S. Judicial Panel on Multidistrict Litigation issued an order that consolidates the federal Yasmin litigation in an MDL, or multidistrict litigation. The cases have been centralized before U.S. District Judge David R. Herndon in East St. Louis for coordinated handling. In addition, a number of Yasmin and Yaz cases are consolidated in Pennsylvania state court in Philadelphia.

Yaz and Yasmin lawyers who are pursuing claims are receiving more and more inquiries from potential clients as the media coverage of the lawsuits and studies has increased. Some speculate that several thousand women will ultimately file a Yaz or Yasmin lawsuit.

The complaints claim that Bayer failed to properly research their birth control pills, provided inadequate warnings and that the drugs should have been recalled after post-marketing reports began to show that the risk of potentially life-threatening side effects of Yasmin and Yaz outweigh any potential benefit provided over other available oral contraceptives.

Last month, Bayer also received a warning from the FDA over conditions at the German plant which manufactures ingredients contained in Yaz, Yasmin and Yasminelle. The FDA indicated the drug giant sent out potentially low-quality batches of drosperinone and attempted to justify the shipments by only looking at the “average” quality of all shipments, as opposed to the quality of each individual batch.