Consolidation of Thousands of Yaz Cases Will Test Bayer’s Resolve to Fight

As of August 15, 2010, there were about 6,350 Yaz lawsuits pending in the U.S. District Court for the Southern District of Illinois served upon Bayer on behalf of persons alleged to have suffered personal injuries, some of them fatal, from the use of Bayer’s oral contraceptive products Yasmin, Yaz or Ocella, a generic version of Yaz distributed by Bayer Laboratories, Inc. in the U.S. market. Plaintiffs seek compensatory and punitive damages, claiming, in particular, that Bayer knew or should have known the alleged risks and should be held liable for having failed to disclose them or adequately warn users of Yasmin and YAZ. Even with this high number, additional lawsuits are anticipated. Bayer believes that it has meritorious defenses and intends to defend itself vigorously. State and federal courts are seeking the most effective way to manage these cases, which are increasing daily.

Last year, in mid-February 2010, the New Jersey Supreme Court consolidated all state court lawsuits against Bayer Phamaceuticals for injuries and damages allegedly arising from the use of the oral contraceptives Yaz, Yasmin, and Ocella.  Those cases are now part of Yaz, Yasmin and Ocella Litigation, Case No. 287 (Bergen County), and have been assigned to the New Jersey state court Judge Brian R. Martinotti, who has already issued his Initial Case Management Order for this litigation. All of the suits involve allegations that Bayer failed to properly research their birth control pills or adequately warn about the increased risk of serious and potentially life-threatening side effects from the birth control pills containing drospirenone, such as a stroke, heart attack, pulmonary embolism, deep vein thrombosis or gallbladder disease.

The U.S. District Court for the Southern District of Illinois has indicated that at least fifty “bellwether” trials will occur in the federal MDL, which will likely begin in early 2012. If the litigation does not settle before the bellwether Yaz trials and Yasmin trials begin, the results of those cases may lead to a settlement for other cases based on how the juries respond to the evidence and value the plaintiffs’ damages in the Yasmin and Yaz injury claims.

For a Yaz lawyer, there has been a tremendous effort made in preserving the rights of injured women across the country.

Lawyers Review Case Management in Yaz Litigation

Currently there are 891 Yaz birth control cases that have been filed in federal courts around the country and consolidated in the United States District Court for the Southern District of Illinois.  These cases are consolidated for coordinated pretrial discovery in what is known as an MDL (multidistrict litigation.  Any case filed in a federal court anywhere in the country is sent to the Southern District of Illinois. At the March 4, 2010 status conference Judge Herndon confirmed that Bayer, the defendant, has produced over 10 million pages of documents in response to discovery requests.  The court continues to work with the parties on protocols for managing the cases. The outcome of these bellwether trials are often useful in allowing the parties to gauge the strengths and weaknesses of their cases, potentially leading to Yaz settlement amounts. 

Yaz Lawsuits Allege Misrepresentation of Side Effects

Bayer and its subsidiary Berlex, currently face about 7,000 Yaz lawsuits and Yasmin lawsuits over the birth control pills Yaz and Yasmin, still, many other pharmaceutical companies have entered into the market with generic versions of Yaz. Bayer is currently indicating that they intend to fight the cases and do not have any plans to settle Yaz or Yasmin lawsuits. Yaz and Yasmin both contain a combination of the hormones ethinyl estradiol and drospirenone. Drospirenone impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. Currently the Yasmin and Yaz injury suits have been centralized for pretrial proceedings in the federal court system as well as several states. In federal court, all cases filed throughout the country are being handled out of the U.S. District Court for the Southern District of Illinois for coordinated management during discovery.

Thus far, approximately 10% of the cases filed against Yaz, Yasmin and Ocella, involve women who allege that they suffered a heart attack or stroke from Yaz. Approximately 40% of the cases involve venus thromboembolisms, which include deep vein thrombosis and pulmonary embolisms from Yaz. The remaining claims involve Yasmin or Yaz gallbladder removals and injuries, with many of the cases resulting in women having their gallbladder removed. In the blood clot study, published last week in the British Medical Journal, researchers from Boston indicated that Beyaz, Yaz and Yasmin should not be the first choice of birth control pill for women, due to the double risk when compared to women taking older pills containing levonorgestrel.

Bayer and Berlex have been warned several times about false and misleading statements made in advertisements for Yasmin and Yaz, which failed to adequately warn about the serious Yaz side effects. In 2003, Berlex was warned by the FDA that Yasmin advertisements downplayed risks associated with the drug and implied it was superior to other birth control pills, which is not true. The FDA indicated that the ads raised significant public health and safety concerns. In 2009, Bayer HealthCare began running a $20 million advertising campaign to correct misrepresentations made about Yaz safety in ads.

Yaz Gallbladder Disease Highest Risk Among Birth Controls

In addition to the potential risk of serious and potentially life-threatening Yaz blood clots, many otherwise healthy young women who have used the birth control pill Yaz or Yasmin have experienced painful gallbladder problems that could ultimately require surgery for gallbladder removal. The FDA has warned the manufacturers of Yaz (sometimes spelled as Yas) and Yasmin (sometimes spelled as Yazmin) at least four times for improper marketing and manufacturing techniques, starting as far back as July 2003, and continuing through 2009.
Yasmin and Yaz are birth control pills manufactured by Bayer Healthcare. The generic form of these drugs, Ocella, is a brand marketed and distributed by Teva Pharmaceuticals. Yasmin was approved by the FDA in 2001, Yaz in 2006, and Ocella in 2008. The Yaz group of drugs contains a compound created by Bayer called drospirenone, which is a “fourth generation” progestin. Drospirenone is believed to elevate the levels of potassium in the blood stream. Elevated levels of potassium in the blood can lead to a condition known as hyperkalemia, which can cause heart rhythm disturbances. Before the introduction of Yasmin, no other birth control pill was marketed in the United States with drospirenone, which is unlike other progestins available. It is a diuretic, which creates unique risks with Yaz and Yasmin and could lead to serious gall bladder problems like gallbladder disease.
In 2009, Bayer was forced to run a $20 million corrective advertising campaign to address problems with Yaz advertisements that stressed the potential benefits in treating acne and symptoms of PMS, while minimizing the potential risk of blood clots. The ads were found to be in violation of a 2007 agreement Bayer made with the FDA after earlier deceptive advertising campaigns. For the next several years, Bayer is now required to submit any future Yaz advertisements in the United States to the FDA for approval before they are aired. Bayer currently faces about 7,500 Yaz lawsuits and Yasmin lawsuits, which allege that Bayer has failed to adequately warn about the increased risk of health problems associated with the birth control pills.