Momentum Building in Pradaxa, Yaz Litigation

Southern District of Illinois

U.S. District Court for the Southern District of Illinois

Separate multidistrict litigation (MDL) over the blood thinner Pradaxa and the Yaz line of birth control pills is making steady progress, according to Chief Judge David Herndon of the U.S. District Court for the Southern District of Illinois. Herndon, who has presided over the Yaz/Yasmin/Ocella MDL for more than three years and took leadership of Pradaxa litigation in August 2012, said that so far there have been no setbacks.

Litigation for the oral anticoagulant drug Pradaxa has advanced well into the discovery phase, with attorneys now busy processing tens of thousands of evidential documents from each side. A total of 177 Pradaxa cases are currently pending in the MDL, and attorneys will soon begin taking depositions from representatives of Boehringer Ingelheim, the drug’s Germany-based manufacturer.

More than 1,500 cases from the Yaz MDL have been settled since last summer, and more continue to pour in. Approximately two dozen suits were transferred to the MDL just this month. Yaz manufacturer Bayer has reportedly settled a total of 3,490 cases, and thousands more are now pending in state and federal courts.

According to the U.S. Judicial Panel on Multidistrict Litigation, 9,455 pending actions have been transferred to the Yaz MDL as of Jan. 14.

Pradaxa Use Linked to Hundreds of Deaths

Introduced to the market in October 2010, Pradaxa was developed as a simpler and more effective alternative to warfarin, a 58-year-old blood thinner used to prevent strokes, pulmonary embolism and other health risks associated with blood clots.

Doctors prescribe warfarin and Pradaxa to prevent these issues in the 2.2 million Americans suffering from a form of atrial fibrillation, the most commonly diagnosed heart rhythm abnormality. Patients with this condition experience a five times greater risk for stroke, and their strokes are twice as likely to be fatal. And because therapy with Pradaxa doesn’t require regular blood monitoring by a doctor, as warfarin does, its sales skyrocketed.

While clinical trial results confirm that patients on Pradaxa suffer fewer strokes than those on warfarin, both blood thinners pose a deadly risk for excessive bleeding. Doctors can administer an antidote to correct bleeding events related to warfarin, but no such antidote exists for Pradaxa.

In its first two years on the market, Pradaxa garnered nearly $1.5 billion in worldwide sales. But in that same time frame, the drug was linked to more than 500 deaths in the United States. In 2011 alone, Pradaxa use accounted for 3,781 adverse events in patients, including reports of stroke, hemorrhage, acute kidney failure and about a dozen cases of liver failure.

Hundreds of lawsuits against Boehringer are now pending, and some attorneys involved with the litigation predict the drugmaker will face thousands more claims over the next few years.

Dangers of Yaz, Yasmin & Ocella

Drospirenone, a synthetic birth control hormone sold as Yaz, Yasmin and Ocella, has also spurred thousands of lawsuits related to numerous side effects. The side effects can range from common and mild to severe and debilitating.

Bayer advertised Yaz as a miracle drug, one that could cure menstrual conditions like premenstrual dysphoric disorder (PMDD) and hormone-related acne, in addition to preventing pregnancy. But not long after Yaz and its sister drugs achieved widespread prominence, serious concerns about their safety began to arise.

Studies dating back to 2006 — the year Yaz was released — indicated that drospirenone can cause severe complications in women with coronary artery disease, cerebrovascular disease, uncontrolled hypertension and several other conditions.

By 2011, results from an FDA study also indicated a 74 percent increased risk for blood clots in Yaz users when compared with other oral contraceptives. The potential complications of these incidents can be dire.

Venous thromboembolisms, or blood clots in the lower leg or thigh, sometimes break free into the bloodstream and cause life-threatening adverse effects elsewhere in the body. Blood clots that become lodged in the main artery of the lung cause a dangerous condition called pulmonary embolism. If it reaches the brain, the blood clot can trigger a stroke, leaving the patient seriously disabled or even dead.

In October 2012, Bayer set aside $264 million to cover litigation over Yaz and Yasmin in the United States. The company has already agreed to pay $750 million toward 3,490 Yasmin-related blood clot claims, with an alleged 3,800 additional blood clot cases currently pending.