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

Potassium – most of us probably know that we can get potassium from eating certain foods like bananas and oranges, but for those of us whose last biology class was more than a few years back, we may forget what potassium actually does in the body. Potassium is mineral that helps the kidneys function normally and it is also an electrolyte. An electrolyte is a substance that conducts electricity in the body, along with sodium, chloride, calcium, and magnesium. Potassium is crucial for your heart to function properly, and maintaining a healthy level of potassium is important to your health.

So how does this relate to Yaz? The Yaz birth control pill, along with Yasmin and Ocella, contains the synthetic progestin known as drospirenone, which can increase potassium levels in the blood. The problem is that increased potassium levels can lead to a potentially dangerous condition known as hyperkalemia. Possible complications from hyperkalemia include:

• Arrhythmias (abnormal heart rhythms)
• Cardiac arrest
• Changes in nerve and muscle (neuromuscular) control

Women with conditions such as kidney, liver or adrenal disease should not take Yaz because it can cause serious heart or health problems, including hyperkalemia. Other medications can also increase potassium levels in the blood, which could be very dangerous if taken in conjunction with Yaz.

As the FDA said in its 2003 Warning Letter to Bayer (the manufacturers of Yasmin), “Women taking Yasmin must be concerned about drug interactions that will increase potassium, in addition to the drug interactions common to all COCs [oral contraceptives]. Therefore, these women and their healthcare providers must weigh Yasmin's additional health risks when considering Yasmin over COCs [oral contraceptives] without drospirenone.”

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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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Many of our clients have suffered blood clot injuries after taking Yaz, Yasmin or Ocella. One of the most serious blood clot injuries is “deep vein thrombosis” – also known as “DVT” – which is when a blood clot forms in the veins, usually the legs. If not treated in time, a DVT can lead to other serious health problems such as a pulmonary embolism or a stroke. Part of the controversy surrounding Yaz, Yasmin and Ocella is that recent medical studies have found that the synthetic hormone contained in these birth control pills known as drospirenone is associated with a significantly higher risk of patients developing DVT and other related health problems.

Recently Baltimore’s local NBC news station ran a story about how hospitals and doctors are treating people who have been diagnosed with a DVT or related injuries:

NBC Baltimore (WBAL): Treating Deep Vein Thrombosis

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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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We appeared before Judge Herndon in East Saint Louis last week for the first hearing in the Yaz and Yasmin cases.  This was the Judge's opportunity to meet some of the Yaz lawyers who have not appeared in his court before and to make sure that the cases are moving forward to resolution as quickly and smoothly as is possible given the circumstances.

Before the hearing, Bayer agreed to turn over many of its documents pertaining to the drugs' development and testing.  Bayer has told us to expect to receive about a million pages of documents within the next few weeks, and another 30 million pages or more in the months to come.

We expect to begin organizing and analyzing the documents almost immediately upon receiving them.  We anticipate that many of the documents will concern drospirenone, the key ingredient in Yaz, Yasmin and Ocella.  We will be searching the documents for evidence of what Bayer knew about the dangers of drospirenone and when.

Next hearing before Judge Herndon: December 17. 

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Yaz lawsuit news! Ms. A.J. De Bartolomeo, one of the authors of this blog and a partner at Girard Gibbs LLP, was appointed today to the Plaintiffs’ Steering Committee in the Yasmin/Yaz MultiDistrict Litigation (MDL). As one of only two female attorneys to be appointed to the Plaintiffs’ Steering Committee, we know she’ll do a great job representing women across the country.

Also, a little FYI for those of you out there who may not know what a “Plaintiffs’ Steering Committee” is: a Plaintiffs’ Steering Committee, or PSC (lawyers love acronyms), is typically formed in a complex MDL case where many similar cases are consolidated into one court to be heard before one judge. Because there are so many individual Yaz cases, in order to keep the courtroom from getting packed full with dozens of lawyers, the court selects a small committee of Yaz attorneys to direct the litigation as it moves forward. The judge handling the Yaz cases has selected A.J. as one of the attorneys to serve on that small committee and to make sure that the interests of the Yaz victims are properly protected.

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One of our clients, Susan Galinis, suffered a stroke after taking Yaz, and she is not alone. There are now multiple lawsuits filed by women and their families who suffered strokes after taking the birth control pills Yaz, Yasmin and Ocella.

Although we sometimes hear about strokes in the news, many people don't know what a stroke really is. The vast majority of strokes are ischemic strokes, which occurs when the flow of blood to a part of the brain is interrupted or seriously reduced. This prevents oxygen and necessarily nutrients from getting to the brain causing brain cells to die, leading to a loss of brain function in the affected areas.

This disturbance in blood flow can be caused by obstruction of a blood vessel due to a blood clot. Medical studies have found that the hormone used in Yaz, Yasmin and Ocella known as drospirenone or drsp was associated with a substantially higher risk of venous thrombosis, a medical term for blood clots in the veins.

After having a stroke many women experience life altering side-effects such as loss of mobility and memory, as well as difficulty with speech and communication.

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We've spoken to many women who have developed blood clots after taking Yaz, Yasmin and Ocella. Some of these women have been diagnosed with deep venous thrombosis or DVT, a medical term for blood clots found in the veins and most commonly in the legs. Other women have been diagnosed with a pulmonary embolism which means there is a blood clot or many clots blocking the lungs. Because a pulmonary embolism almost always occurs in conjunction with deep vein thrombosis, some doctors refer to the two conditions together as venous thromboembolism (VTE).

A pulmonary embolism or PE is when there is a blockage of the main arteries of the lungs. A PE can occur when a blood clot travels through the bloodstream and creates a blockage in the pulmonary artery. It's unusual to experience a solitary pulmonary embolism. In most cases, multiple clots are involved. The lung tissue served by each blocked artery is robbed of fuel and can die, which makes it more difficult for your lungs to provide oxygen to the rest of your body.

Immediate symptoms can range from shortness of breath, chest pain and coughing up blood, to collapse and even death. The Mayo Clinic reports that about one-third of people with an undiagnosed and untreated pulmonary embolism don't survive. When the condition is diagnosed and treated promptly, however, that number drops dramatically. Please contact your doctor immediately if you experience unexplained shortness of breath, chest pain or a cough that produces bloody sputum.

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