BAYER BIRTH CONTROL LITIGATION AT CRITICAL STAGE

This is the next of a series of columns on how the law can impact your life. Each month we will focus on various aspects of the law relating to personal injuries, those that happen both on-the-job and otherwise, including mishaps which occur in driving vehicles, using products and receiving medical care. The column will also respond to legal questions relating to personal injury that are sent to us.

Healy Scanlon Law Firm is comprised of eight trial attorneys, two of whom are from Ireland. We are located downtown at 111 West Washington Street, Suite 1425, Chicago, Illinois 60602 (800-922-4500 or 312-977-0100). www.HealyLawFirm.com. The firm concentrates in the representation of injured victims of all types of accidents.

Readers are encouraged to call or write with questions concerning personal injury law.

Bayer Birth Control Litigation at Critical Stage

Birth control pills such as Yaz, Yasmin, Ocella, Beyaz, Safyral and Vestura have been linked to blood clots, pulmonary embolism, deep venous thrombosis (DVT), gallbladder disease, and even heart attack and stroke. These drugs all contain the same synthetic hormone-drospirenone. Drospirenone changes the body's normal blood-clotting ability, sometimes causing blood to clot unnecessarily within a blood vessel, artery, or vein. These abnormal blood clots can become dislodged from the vessel and begin to travel through the blood stream, potentially causing a blockage that starves the heart of blood flow. A clot may also become lodged in the brain, lungs, or the heart itself.

While all birth control pills pose some risk of blood clots, the U.S. Food and Drug Administration (FDA) has relied upon several epidemiological studies that reported the risk of blood clots for women using drospirenone-containing birth control is higher than for women who use birth control pills containing an alternative hormone known as levonorgestrel.

In May 2011, the FDA released a Safety Announcement concerning these dangerous birth control pills, citing the studies reporting increased risks. In September 2011, the FDA issued a second announcement stating that it "remains concerned" about the potential for increased risk of blood clots with drospirenone-containing birth control pills.

In December, an FDA advisory panel comprised of medical experts voted 21-5 that the labels for Bayer's birth control pills did not adequately reflect the risk of the product in light of its purported benefit. While the panel stopped short of removing these drugs from the marketplace, the panel did recommend the labels be revised to include additional information.

Just one month after the advisory panel meeting, U.S. District Court Judge for the Southern District of Illinois, David R. Herndon issued an order postponing what would have been the first trial related to Bayer Healthcare Pharmaceuticals, Inc.'s birth-control drugs, Yaz and Yasmin. The trial, which was set to begin January 9, 2012, was delayed at the request of Bayer's attorneys, who also requested the court order mediation in the hope of reaching a settlement with at least some of the plaintiffs involved in the multi-district litigation.

Multi-District Litigation

Multi-district litigation (MDL) refers to a special procedure in federal court cases designed to speed the process of handling complex cases, where many potential plaintiffs may exist. MDLs are formed when common factual issues are involved in multiple cases pending in different federal court districts. A Panel on Multidistrict Litigation determines whether a particular case should be consolidated into an MDL. Cases subject to the MDL are transferred to one court for all pretrial proceedings and discovery issues. If the case is not settled or dismissed at that stage, the case will be remanded back to the court in which it was originally filed for trial.

The recently-postponed Bayer litigation is part of an MDL in the U.S. District Court for the Southern District of Illinois. Currently, there are over 8,000 cases and over 11,000 plaintiffs involved in that particular litigation.

Bellwether Cases

In MDL cases, it is typical to select a small group of plaintiffs to represent all of the plaintiffs in an MDL. These are known as "bellwether" cases. These cases proceed to trial first and the results of those cases act as an indicator for future trials. The results may be used to help shape the parties' expectations and to value claims for settlement purposes, but each plaintiff may choose to continue with their own individual trial.

The bellwether trial in the Bayer case has now been postponed until April 30, 2012, as the parties attempt to mediate a settlement.

Interestingly, in that case, a former FDA commissioner has issued a report critical of Bayer, stating that the FDA's decision to keep Yaz on the market in December was tainted by undisclosed potential conflicts of interest. The former commissioner stated in his report, "the FDA advisory committee was not independent of Bayer."

While Bayer has changed the way it markets and advertises Yaz and Yasmin, these drospirenone-containing drugs remain on the market. Women taking these drugs should become aware of the risks and alternatives available to them through their medical providers.

Healy Scanlon Law Firm has actively investigated and litigated pharmaceutical cases to successful results, and has investigated claims associated with Yaz, Yasmin and other birth control drugs. If you or anyone you know has suffered a deep vein thrombosis (DVT), pulmonary embolism, gallbladder disease, heart attack or stroke after taking Yaz, Yasmin, Ocella, Syeda, Beyaz or Safyral, you should seek competent legal advice.

By: Martin Healy, Jr.

Patrick C. Anderson