Yasmin and Yaz Litigation Update

December 4, 2009, 11:00AM. By Jane Mundy

San Francisco, CAThere is nothing on the labels of Yasmin or Yaz alerting doctors to the fact that the fourth generation oral contraceptive poses twice the risk of blood clotting as earlier generation contraceptives. Are women aware of that risk? Do they realize that the second generation alternative is much safer? "These are claims made in the current Yasmin and Yaz litigation," says attorney Mark Crawford.

Crawford and many other attorneys throughout the US, including Len Jacoby of Jacoby & Meyers, are filing claims against Bayer Healthcare Pharmaceuticals, the makers of Yasmin and Yaz. They allege on behalf of injured patients that the drug company inadequately alerted doctors and their patients of the increased clotting risks associated with its oral contraceptives. "We represent young women who have suffered serious injuries such as pulmonary embolisms, deep vein thromboses, strokes and heart attacks," says Crawford.

In August 2009, the British Medical Journal published two studies that found that Yaz, Yasmin, and Ocella lead to a higher risk of venous blood clots, or venous thrombosis, than other oral contraceptives available on the market. The BMJ reported that the Dutch College of General Practitioners recommended that its members prescribe the second generation birth control pills instead of Yasmin and Yaz.

Bayer's Direct-to-Consumer Campaign

"We are interested in how Bayer induced consumers to use their drug through a misleading 'direct-to-consumer' advertising campaign," says Jacoby. "Bayer advertised Yaz as 'Birth Control Plus,' meaning it could help with PMS symptoms, even though marketing of the drug for that indication was not approved by the FDA."

"By marketing Yasmin and Yaz off-label, Bayer captured a significant share of the oral contraceptive market," adds Jacoby. "The FDA has since reached an agreement with the Bayer in February 2009 that required Bayer to spend $20 million on a corrective counter-campaign to withdraw its claim regarding PMS symptoms."

Yasmin and Yaz Litigation

Crawford says that individual Yasmin/Yaz cases that were filed in federal court or removed from state court to federal court are now coordinated for pre-trial purposes. In the federal courts, cases are now centralized before Judge Herndon in the US District Court for the Southern District of Illinois as part of an MDL, or multidistrict litigation, where discovery and pre-trial litigation will be conducted.

Judge Herndon will appoint a group of attorneys to serve in leadership roles and perform certain actions on behalf of all plaintiffs who have filed a Yaz or Yasmin lawsuit against Bayer.

"As another avenue of resolution, cases are often filed and coordinated in state courts," Crawford explains. "For instance, a petition for coordination was filed in California by plaintiffs' counsel. A hearing set for January 6 in Los Angeles will determine whether all California state court Yaz cases will be coordinated. If appropriate, a single judge will be assigned to handle all the discovery and pretrial litigation for the cases pending in California state court."

Federal vs Sate Litigation

More often than not, the drug company defendants prefer that cases be coordinated in the federal court system rather than the state court system. "Drug companies may feel they obtain an advantage by having a single federal district court judge make decisions affecting all cases no matter where they are filed. What's more, federal courts place a greater scientific burden on the plaintiffs before they go to trial, and they require a unanimous jury verdict (whereas most state courts don't require a unanimous verdict). Oftentimes the drug companies will try to convince state court judges to defer at the outset to the federal coordinating judge's decisions. But we have found that while state court judges are willing to cooperate with the federal coordinating judge and consider his or her rulings (and vice versa), they maintain their judicial independence in handling the cases."

Will Your Case be tried on a Federal or State Level?

Where you live and who your defendants are will determine whether you end up in Chicago federal court for pretrial purposes or in state court. Generally, state courts have jurisdiction over cases involving more than one defendant from the same state. For example, if a Kentucky citizen names a Kentucky defendant (such as the prescribing doctor), then the case will be maintained in Kentucky state court. The case cannot be removed to federal court. The defendants are named on a case by case basis by the plaintiff and her lawyer, depending on the circumstances of that case.

Currently there are several dozen cases filed in California state court. "McKesson, based in California, is the distributor of Yaz and often is named as the defendant in California cases," Crawford explains. "This means the case will stay in California state court and cannot be removed by the defendant to federal court."

Bayer is located in Wayne, New Jersey and Pittsburgh, Pennsylvania, so if you live in either of these sates, your case likely will be maintained and tried in the state courts. Crawford believes that both states will play a big role in litigation.

Crawford says it is important to pursue litigation at both the federal and state levels. "The interests of the state courts are a counterbalance to the federal court, and we will have many cases pending in both forums," he says. "These judges and the attorneys often work in a cooperative manner to efficiently move the litigation forward…Many cases will be filed in each forum, so it is important that we keep a healthy and dynamic relationship at both the federal and state levels."

Attorney Mark Crawford has a special expertise in drug company litigations and is a partner with the law firm of Skikos, Crawford, Skikos, Joseph & Millican with offices in California and Ohio. Len Jacoby is a founding member of the national law firm of Jacoby & Meyers. Both firms represent patients who have suffered injuries from Yaz or Yasmin.