Yaz On Trial : Yaz Birth Control Lawsuit : Info on Yasmin & Ocella Side Effects

Legal news! In a recent Case Management Order (CMO) signed by Judge Herndon, any new plaintiffs in the Yaz and Yasmin litigation can now file their individual cases directly in the MDL proceeding.

As you may recall from our earlier blog post, in October 2009 all federal lawsuits concerning Yaz, Yasmin and Ocella were centralized and coordinated into a special kind of case known as an MDL (MDL is an abbreviation for MultiDistrict Litigation). The purpose of an MDL is to take all pending federal cases throughout the country that deal with a similar issue and transfer the cases to one federal judge for coordinated pretrial proceedings to save time and resources. The MDL concerning Yaz, Yasmin and Ocella is called In re: Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, MDL Case No. 2100, and it is being overseen by the Honorable Chief Judge David R. Herndon of the Southern District of Illinois.

Before this new Case Management Order (CMO) lawsuits were being filed by women in their state then transferred to the MDL. Now the CMO allows any new plaintiffs to file their cases directly into the MDL, which is a big time and money saver for all involved.

Here’s a blurb from the CMO:
“In order to eliminate delays associated with transfer to this Court of cases filed in or removed to other federal district courts, and to promote judicial efficiency, any plaintiff whose case would be subject to transfer to MDL 2100 may file his or her case directly in the MDL Proceedings in the Southern District of Illinois.”

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Bayer recently released its Annual Report for 2009. The report is 274 pages long. Here are the highlights:

• By Bayer's count, as of February 15, 2010, about 1,100 lawsuits were filed against it by women injured by Yaz or Yasmin (that sure is a lot of people, and most only expect that number to grow in the future).

• Yaz and Yasmin are Bayer’s best-selling pharmaceutical products for at least the second year in a row (this goes back to our post last week about the huge profits Bayer has made from the sale of Yaz and Yasmin over the years).

• Bayer has been creating new versions of Yaz and Yasmin. Bayer has submitted new Yaz and Yasmin oral contraceptive pills containing folate (a natural source of vitamin B) to the FDA for approval for sale in the United States. Bayer is calling these new versions “Yaz Plus” and “Yasmin Plus.” In addition to these new pills, Bayer has also created a contraceptive patch, which it calls “Yaz Flex.” The FDA still needs to approve these new versions of Yaz and Yasmin before Bayer can release them to the market. We will be watching the development of these new products. 

So despite the filing of approximately eleven hundred Yaz lawsuits by women who have suffered life-changing injuries or by their families, Bayer continues to reap huge profits from the Yaz franchise and has plans for new ways to squeeze even more money from the drugs in the future.

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Even though thousands of women have suffered severe injuries after taking Yaz and hundreds of lawsuits have already been filed, Bayer Pharmaceuticals is still airing commercials and running full page ads touting Yaz as the #1 most dispensed oral contraceptive in the U.S. with over 26 million prescriptions filled as of December 2009.

The number #1 most dispensed oral contraceptive in the U.S. – 26 million prescriptions – these things mean money, big money. The New York Times reported that the Yaz and Yasmin franchise had worldwide sales of about $1.8 billion in 2008. That same New York Times article has a graph showing the top-selling oral contraceptives between January and June 2009, which includes Yaz, Yasmin and Ocella in the top five. In fact, Bayer itself has a list of its top 20 best-selling products in 2009, and the Yaz and Yasmin products are number one on that list.

But Bayer wasn’t the only one to cash in on the success of these pills. Teva Pharmaceuticals who owns Barr Laboratories which distributes Ocella, the generic version of Yasmin, has made serious profits off this pill. In this press release, Teva said Ocella was launched in July 2008, and sales for that year were $170.2 million. Just this month Teva reported that its sales in North America for the fourth quarter had increased 35% compared with the fourth quarter of last year and that these sales benefited from the launch of the generic version of Yasmin.

So it seems like it’s a pretty simple equation for these pharmaceutical companies: little pill = big profit.

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Claudia Coffey of Fox 5 in Washington D.C. just reported on a story about another young woman, Jessica, who suffered from a blood clot in her leg after taking Yaz. Jessica says that her leg swelled up about twice its normal size and started turning purple. She was in the ICU for three days and in the hospital for six days. The story also mentions the FDA warning letter for Yaz regarding possible quality control problems in a factory in Germany. (You may remember that this is not the first time the FDA has warned the makers of Yaz.) Ms. Coffey also reported that the FDA sent her an email confirming that they are aware of adverse event reports with Yaz, but that they are unable to disclose whether specific label negotiations to the medication are being conducted.

Watch the Fox 5 news story: Locals Join Lawsuit Against Bayer's Yaz

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I just read a story that aired in Tennessee on NewsChannel 5 about a woman named Leah. Leah was a twenty year old student at Tennessee Tech and on her way to becoming a nurse when, last January, her college roommate discovered her passed out in the shower. Leah’s roommate called 911 and told them that she was pale and breathing heavily. Leah woke up and spoke to her mom over the phone, telling her that “she was scared, and that she was tingling all over.” Less than an hour later, Leah passed away.

Ultimately, it was discovered that Leah died of a pulmonary embolism (a blood clot in her lung). When Leah’s family asked how this could have happened to a healthy twenty year old woman, an emergency room doctor informed them that the birth control pill Leah started taking six months before, Yaz, could have caused the blood clot.

Leah’s family is devastated by the loss of their daughter. "She didn't have to die. She didn't have to die because of a pill," said Leah’s mother.

Not wanting her daughter’s death to have occurred in vain, Leah’s mother is determined to warn others about the drug and the serious potential side effects of taking Yaz.

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Since Judge Herndon appointed the Plaintiffs’ Steering Committee for the Yaz and Yasmin Multi-District Litigation (MDL) the main focus has been case organization, specifically what procedures are needed for efficient case management.

To keep this matter from getting too cluttered and costly, Judge Herndon and those of us on the Plaintiffs’ Steering Committee and defense counsel have focused on the case management and organizational issues early on, which we hope will make everything run more smoothly down the road in the litigation. At the December status conference, we discussed details such as the protocol for protecting confidential information in the case, how new complaints filed on behalf of injured women and their families will be organized, and what additional procedures may be required since Bayer is a foreign company. At the close of the conference we were also introduced to Ms. Debra Ward, the Judge’s new law clerk specifically assigned to the Yaz and Yasmin MDL proceeding. Ms. Ward will be assisting Judge Herndon in organizing the case going forward.

In summary, the Court is primarily in organizational mode at this time. As Judge Herndon said during the December status conference, “the Court would like this case to move along efficiently and effectively. Both sides are working diligent[ly] and in good faith to move this litigation at a fast pace and court is encouraged by that. [The] Court has had to intervene very little.”

The next status conference in the case is March 4, 2010.

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Ever wonder why we started our blog? Find out why!

Yaz on Trial author and Girard Gibbs' Partner A.J. De Bartolomeo was recently interviewed about blogging, the lawsuits against the makers of Yaz, Yasmin and Ocella, and her recent appointment to the Plaintiffs' Steering Committee in the Yaz and Yasmin Multi-District Litigation. Here's an excerpt from the interview:

Lisa Kennelly: Why did you decide to start a blog?

A.J. De Bartolomeo: Earlier this year we were contacted by a mother of 3-year old twins who had suffered a stroke and permanent brain damage after taking the birth control pill Yaz (which incidentally is the top-selling birth control pill sold in the U.S.). We began investigating her claims further and soon learned that she was not alone and that many women had suffered severe health side effects after taking the birth control pills Yaz, Yasmin and Ocella. The injuries ranged from strokes to blood clots to gallbladder disease and many other serious health problems. When we spoke to these women and their families they repeatedly questioned why they hadn't heard about these health risks and wanted to know what was going on with the lawsuits against the makers of Yaz, Yasmin and Ocella.

Based on those conversations, my co-counsel, Mike Danko and I decided to start our blog, Yaz on Trial. We felt that something was needed to get the word out to women and educate people about the health risks associated with these drugs and a blog seemed a great way to do that. We recognize that mass litigation, like the Yaz and Yasmin lawsuits, can be very complicated and difficult to understand, so we wanted to create an outlet for women and their families to get a clear understanding of how the litigation is playing out. One thing led to another and Yaz on Trial was born.

Lisa Kennelly: What has been most rewarding about blogging?

A.J. De Bartolomeo: The most rewarding thing about blogging is having the opportunity to connect to people through the blog itself. We speak to women every day who have questions about the litigation against the makers of Yaz and Yasmin, and we have found that typically when one person has a question, many others have the same question as well. The blog is a great way to help answer some of those questions and keep people informed about the litigation. A good example is our post about the Yasmin and Yaz Multi-District litigation. Several people had questions about what Multi-District Litigation was and found that post very helpful.

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We speak with women on a daily basis who want to know more about what’s going on with the Yaz and Yasmin lawsuits. Many have heard that it’s a type of lawsuit known as a "mass tort." Naturally, the next question we hear is “so what is a mass tort?”

A mass tort typically involves multiple personal injury cases where the victims are injured in a similar way by a specific product, drug, or event. Because all of the victims’ claims typically share common legal or factual questions, the courts recognize that sometimes it makes more sense for the common questions for all the lawsuits to be resolved by a single judge in one court. Once the common questions are resolved, the individual cases are sent back to the individual courts for trial.

I took a look online for more information about Mass Tort cases and found some interesting info. A blog dedicated entirely to Mass Tort Litigation is talking about the Yaz and Yasmin lawsuits. A few months ago, Elizabeth Chamblee Burch, who is one of the authors of the blog and an Assistant Professor of Law at Florida State University College of Law, wrote that the Yaz and Yasmin lawsuits might be centralized. This is because lawsuits that involve hundreds of victims can become really complicated and disorganized when they proceed on an individual basis (imagine hundreds of cases brought against the same companies in all different courts spread throughout the whole country); centralizing these cases helps to prevent this. Just as Ms. Burch predicted, the federal lawsuits against Yaz and Yasmin were centralized and are now part of a Multi-District Litigation.

So here's the basic breakdown: if a large number of people suffer similar injuries after using a common product, then frequently those individuals’ legal claims many be coordinated into a mass tort lawsuit, which is usually centralized in one court with one judge in order to resolve any common questions.

Hope that helps sort out some of the confusion, but feel free to ask or comment if there are any other questions.

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The press continues to get the word out about the potential side effects of the birth control pills Yaz and Yasmin. Yesterday, a California consumer protection group called The Civil Justice Research Project reported on the status of the litigation and the claims brought by women and their families who have suffered after taking Yaz, Yasmin or Ocella. The group reported that some women have suffered strokes, pulmonary emboli and heart attacks after taking these birth control pills.

In addition to the health concerns, the group also reported on Bayer’s “aggressive advertising,” noting that the FDA found that some of the Yaz commercials were misleading, because they undersold the risks of the drug while at the same time overstating its benefits. Although the article acknowledged that Bayer ran a multi-million dollar corrective ad campaign, it also explains that some find those corrective ads to be “too confusing and jargon-filled to be effective.”

Two of the authors of this blog, Yaz attorneys A.J. De Bartolomeo and Mike Danko, and were also mentioned in the article for their work representing injured women in the Yaz and Yasmin lawsuits. Articles like this one really help spread the word about the potential side effects of Yaz, Yasmin and Ocella, and keep people informed about what’s happening with the lawsuits.

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