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

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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Many women are reporting that they developed blood clots after taking Yaz, Yasmin or Ocella. For those of you who may not know what a blood clot is, a blood clot is caused when blood hardens (coagulates) within a blood vessel in the body or in the heart. The problem is that blood clots can become dangerous, even life-threatening, if not treated immediately.

Part of the controversy surrounding Yaz, Yasmin and Ocella is that recent medical studies have found that drospirenone or drsp, the synthetic hormone in these birth control pills, is associated with a significantly higher risk of venous thrombosis (blood clots in the veins).

There are two main types of blood clot complications:

"Thrombosis" involves a clot that forms in a blood vessel and creates a blockage, obstructing the blood flow. A common form of this is known as deep venous thrombosis or DVT, when a blood clot occurs in the veins, usually in the legs.

"Embolism" involves a blood clot that forms in one part of the body, then frees itself and travels through the blood stream until it ends up getting stuck in a blood vessel in another part of the body, such as the lungs, heart, or brain.

Blood clots can cause other life-threatening health complications such as a Pulmonary Embolism or Stroke.

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One of the most impressive things we’ve found while learning more about Yaz, Yasmin and Ocella, are the number of women who are talking about their experiences with these birth control pills. In spite of everything these women and their families have been through, they are getting out there, speaking out on forums, blogs and social networking websites to let other women know about their experiences on Yaz, Yasmin and Ocella and some of the side effects they have suffered. Many of these women have experienced blood clots, strokes, pulmonary emboli, gallbladder problems and other serious health complications.

Check out some of these forums:

Yasmin Survivors Forum, Facebook: I am a Yaz Survivor, Yaz Forum

Women aren’t just talking about their experiences – they are taking action. Dozens of lawsuits have been filed on behalf of women who suffered severe side-effects after taking Yaz, Yasmin and Ocella, and these women plan on holding the makers of these drugs accountable.

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When I first learned that Yaz was the top selling birth control pill in the country I thought about what made it so popular. Of course many of us remember the multimillion dollar commercials, but what also stuck out in my mind was an old Yaz promotion by Bayer Pharmaceuticals called “The YAZ: Step Up and Go Beyond Contest” with Project Runway Judge and Marie Claire fashion director Nina Garcia. 

As Garcia described it, “We're taking an iconic accessory—the birth control case—and asking aspiring designers to take a shot at redesigning it into a chic, more sophisticated carrying case that they could slip into their purses." Contest winners were announced during Fashion Week in fall 2008 and the contest winner received a $10,000 prize to enroll in design classes or purchase of special design materials and software, courtesy of Bayer HealthCare, Garcia, and Step Up Women's Network.

It’s a great idea and innovative advertising – but the problem is that Yaz isn’t just something stylish to carry around – it’s a drug – a medication that could have potentially dangerous side effects, including strokes, pulmonary embolisms, deep vein thrombosis, and gall bladder disease. I’ve spoken to many women who have suffered these side effects needlessly. Bayer’s advertising is very clever, but it doesn’t do enough to let women know about the risks of Yaz. Women have a right to know not just what they are putting in their purses, but what they are putting in their bodies.

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All of the hormones that go into Yaz and Yasmin are manufactured in a laboratory. In that respect, the drugs are no different than any other birth control pill. What makes Yaz and Yasmin so unique is that they contain the hormone drospirenone, or "DRSP."  DRSP, which has never before been used in a birth control pill, is "synthetic." A synthetic hormone is one formulated to be molecularly similar to a hormone found in the human body, but not "bio-identical" to it. 

DRSP was designed to be molecularly similar to the naturally occuring human hormone progesterone. DRSP is no more effective at its job than either progesterone or one of the man-made hormones in other birth control pills that are bio-identical to progesterone. However, DRSP is more dangerous and more frequently causes serious side effects, including clotting.

                         Progesterone                                                 Drospirenone (DRSP)

 

Why would Bayer use a synthetic hormone if it is more dangerous, but no more effective, than an easily manufactured bio-identical hormone? The short answer is money. A drug company can't patent a bio-identical hormone, since is an exact copy of what nature produces. Only a synthetic hormone can be patented. And only with a patent can a drug company protect the market share its advertising campaign wins over.

No synthetic hormone means no patent. No patent means no huge profits.
 

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The  San Francisco Daily Journal ran a front-page story on the Yaz cases recently, and by doing so helped to get the word out about the dangers of Yaz and Yasmin.

Susan Galinis discussed her stroke and the effect it has had on her family.  Mike Danko was quoted concerning the latest on the Yaz lawsuits generally, and Galinis' lawsuit in particular.  Other Yaz lawyers were interviewed as well.

Bayer refused to comment on Susan's lawsuit.

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Yaz in the News:

As reported by Bloomberg News, in late September 2009, Swissmedic, the Swiss regulatory authority for drugs and medical devices, began an investigation into Yaz after a woman died from a pulmonary embolism while taking the birth control pill.

On October 22, 2009, Swissmedic released the results of its investigation but, unfortunately for us English-speakers, those findings were only released in German. Bayer was quick to offer their translation and issue a press release stating that “Swissmedic Sees No Higher Risk for Drospirenone Pills.” However, as Jim Edwards of BNET pointed out, upon further examination it isn’t clear that Bayer’s translation is 100% accurate.

From our understanding of the Swissmedic report, the study is still subject to peer review and a final report will be released at a later date with more information about the final results. In the meantime, if you are able to read German, feel free to take a look at the current report and let us know what you think.
 

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All birth control pills come with some risk, but what many people don’t know is that there is medical evidence showing that the hormone used in Yaz, Yasmin and Ocella known as drospirenone, or "drsp," substantially increases that risk.

Earlier this year the British Medical Journal published two studies which found that birth controls which contain drsp substantially increase a woman’s risk of blood clots, what doctors refer to as “thrombosis.” One study was conducted in Denmark and the other in the Netherlands.

In addition to these two reports, the British Medical Journal also published a paper about Yasmin. The paper said that it had received reports about women who suffered a “thromboembolism as a suspected adverse drug reaction to the new oral contraceptive Yasmin.”

Why this matters: There is medical evidence showing that the hormone used in Yaz, Yasmin and Ocella can cause blood clots, and blood clots can cause life-threatening health complications such as a stroke or pulmonary embolism. Women and their families need to know the additional risks before taking these drugs.

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