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

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

I recently stumbled across a story about Yaz describing another one of its clever advertising campaigns. Bayer Pharmaceuticals, the manufacturer of Yaz, hired Lo Bosworth, a young actress on the popular MTV reality show "the Hills" to be the new spokesperson for Yaz in Canada. The story explains that last year the Hills star spent time in "Toronto and then Vancouver doing media interviews, where she focused on the fact that Yaz can lead to fewer symptoms like headaches and cramps during that time of the month."

This isn't the first time Bayer has attempted to promote Yaz as a treatment for "time of the month" symptoms, but it is something that Yaz has come under fire for in the United States previously. In October 2008, the U.S. Food and Drug Administration (FDA) sent a Warning Letter to Bayer stating that a number of Yaz commercials “encourage[d] use of YAZ in circumstances other than those in which the drug has been approved, over-promise[d] the benefits and minimize[d] the risks associated with YAZ.” The FDA, in its 2008 Yaz warning letter, found that the Yaz commercials made it seem as though the drug could treat PMS symptoms like cramps and headaches, when Yaz was only approved to treat the more severe symptoms of premenstrual dysphoric disorder (PMDD). The FDA also took issue with the fact that Yaz was being advertised as a way to "keep skin clear," suggesting that Yaz could be used to treat all forms of acne, when the FDA had only approved its use to treat moderate acne specifically. As a result of the FDA's findings, Bayer had to run a $20 million advertising campaign to clarify the real uses and possible side effects of Yaz.

Not long after receiving the FDA Warning Letter, Bayer hired Lo Bosworth as a Yaz spokesperson for its marketing campaign in Canada, where the FDA has no jurisdiction. The video below, based off of Bayer’s Canadian press release about Yaz, touts a whole laundry list of "benefits" that Yaz purportedly offers. You have to wonder whether these statements would pass muster with FDA, or whether the FDA would find them to be misleading just as it did with some of the US commercials.

As the Yaz spokesperson, Bosworth stated that “I have to be in control of my life at all times – especially my health. I need to make sure I’m taking care of myself..." For most women, staying in control of their lives and health involves knowing the real risks and uses of a birth control pill before they decide to take it.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link