Many women who suffered arterial events such as strokes or heart attacks have been waiting since 2009 for Bayer to come to the negotiating table. The women claim that Bayer’s oral contraceptives Yaz, Yasmin and Beyaz caused their injuries. Bayer has now agreed to set aside $56.9 million to compensate these women. It’s up to each individual woman to decide whether to participate in the program that Bayer is offering.

Since 2011 Bayer has paid $2 billion to settle claims of women who suffered venous events such as pulmonary embolisms and deep vein thrombosis. But under the deal now on the table, the approximately 1200 injured women with arterial – related injuries would share $46.9 million, with another $10 million available for those women and families who can demonstrate that their injuries were particularly severe or that a family member died from the arterial event. The settlement program amounts to an average of $50,000 per woman.

The Court has ordered the lawyers for all potential claimants to submit certain forms on behalf of their clients before Friday August 7th at 11:59 EST. The women whose lawyers submit the forms will then have until September 12th to decide if they want to Opt-In to the program.

Nearly 20,000 women have brought claims against Bayer for its failure to warn about Yaz’s association with increased risk of clotting.  Women suffered deep vein thromboses, pulmonary embolis and death.  Although Bayer has paid out approximately $1.7 billion in settlements to Yaz claimants approximately 3400 claims remain.

U.S. District Judge David Herndon expressed disappointment that Bayer has been unwilling or unable to settle out of court.  Most of the remaining cases involve catastrophic injuries to women with patent foramen ovale and/or arterial clotting.

On February 13, 2015, Judge Herndon issued a case management order that provides for all Yaz actions that were initially transferred from outside of Southern Illinois to return to their home courts. And the trials originally scheduled for May 4, 2015 have been cancelled or continued.  The Judge has scheduled a Yaz trial to begin in his courtroom on June 15, 2015.  

Beyaz is Bayer Healthcare Phamaceuticals’ newest birth control pill. In its latest marketing ploy, Bayer enriched its Yaz product. The new pill includes levomefolate calcium, which is designed to increase folate levels in women to help prevent neural tube birth defects. Neural tube birth defects include spina bifida and encephalopathy.

Prevention of birth defects is a good thing. But like Yaz, Beyaz contains ethinyl estradiol and drospirenone. With this troubling combination, Beyaz also carries the same increased risk of blood clots, pulmonary emboli, deep vein thrombosis, gallbladder disease and other potentially life-threatening side effects.

Do women need “fortified Yaz“?  No. Folate, also known as folic acid, is naturally found in green vegetables such as spinach, asparagus and broccoli. Since the early nineties, the FDA has required adding folic acid to grains and cereals. A U.S. woman can meet her daily requirement of folic acid by eating a bowl of breakfast cereal.   

The Food and Drug Administration approved Yaz and Yasmin based on research that Bayer provided saying that the drugs were safe. We’ve been saying all along that the research was suspect and that, in fact, the drug is more risky than other birth control pills with no added benefits. The danger, we said, was the drugs’ unique ingredient, drospirenone.

In April, two independent studies were published concluding that Yaz and Yasmin are, in fact, two to three times more likely to cause potentially lethal blood clots than competing birth control pills. The studies can be found here and here.

Now the FDA has taken notice. Yesterday, it released a "safety announcement" concerning the drugs. As part of it’s "ongoing safety review of birth control pills that contain drospirenone" (Yaz and Yasmin were the first and hold the largest market share), the FDA says it will take another look at the risks the drugs carry. It will look most closely at the risk of death resulting from blood clots:

A blood clot that forms in a deep vein in the body is called a deep vein thrombosis (DVT). A DVT is a rare side effect of taking birth control pills. A blood clot can break loose from the vein, move through the body to the lung, and cause a serious problem in the lung, called a pulmonary embolism (PE). This can lead to death.

The FDA says that it will do two things to see whether Yaz and Yasmin do, in fact, have a higher risk of blood clots and death. First, it will be looking closely at the new studies. Second, it has commissioned its own "large study exploring the association of blood clots with hormonal contraception." It says that the results of that study are "currently being finalized and reviewed."

Depending on what it determines, the FDA could (1) do nothing, (2) work to take the drugs off the market, or (3) order a stronger warning so that women who use the drugs know the risks.

Meanwhile, the 6000 lawsuits brought by women injured after using the drugs march toward trial. The first cases will be tried next year.
 

Today a consumer rights group reports on the risks of blood clots, strokes, and heart attacks that Yaz and Yasmin pose to women using these birth control pills.  The California-based group, called The Civil Justice Research Project, also reports on the the federal lawsuits that have been filed against Bayer by the hundreds of women who have suffered serious injury after taking Yaz.  The story mentions our co-counsel on the Yaz cases, A.J. De Bartolemeo of Girard Gibbs, and quotes Mike Danko:

Bayer just isn’t telling women what they need to know.  No woman would take Yaz if she knew that it was no more effective than other birth control pills but was more risky.

The article talks about the "corrective" ad campaign the FDA required Bayer to run, noting that — at least  according to some — Bayer’s corrective commercials were "too confusing and jargon-filled to be effective." The article links to one of the commercials.

We’re excited to report that The Danko Law Firm has teamed up with the Yaz lawyers at Girard Gibbs LLP in San Francisco to jointly represent the victims of Yaz and Yasmin in lawsuits against Bayer.  Girard Gibbs is a nationally known class action firm with a long history of representing those harmed due to the wrongdoing of large corporations.

Together we’ve launched a new blog to help spread the word about the dangers of these drugs and to provide information about the pending lawsuit.

Follow our Yaz blogging at the new site, Yaz On Trial.

The legal talk show Lawyer2Lawyer invited Mike Danko and an FDA expLawyer2Lawyer Podcastsert, Professor James T. O’Reilly from the University of Cincinnati College of Law, to discuss Yaz and the Yaz lawsuits.  Mike talked about the lawsuits while Professor O’Reilly provided his insights on what the FDA does and, more importantly, does not do when approving a drug for the market.

Bayer was invited to come on the show but didn’t accept.

It is an interesting discussion that can be heard on line.

The San Francisco Daily Journal has reported on the status of the Yaz litigation.  The paper interviewed a number of Yaz lawyers, including Mike Danko.   Susan Galinis spoke about her lawsuit:

I’m hoping to get the word out to other women about how dangerous that drug is. . It devastated my whole life.

As usual, Bayer delined comment about its drug, except to offer the usual lawyer-speak:

Bayer’s oral contraceptives have been and continue to be extensively studied worldwide and are safe and effective when used according to product labeling.

The trendy Yaz and Yasmin birth control pills are unlike any others because they contain a new synthetic hormone, drospirenone. Bayer has aggressively marketed the drugs, especially to young Yazwomen, as a cure for everything from acne to pre-menstrual syndrome. Unfortunately, Bayer did not adequately test the drug before bringing it to market, and it now ignores two studies on Dutch and Danish women suggesting that the drugs are more dangerous than other birth control pills that don’t contain the synthetic hormone. 

Women who take Yaz or Yasmin have suffered a list of harmful side effects. One of the most common is blood clots. Blood clots may lead to debilitating strokes, pulmonary emboli and heart attacks. Women on Yaz or Yasmin have also been stricken by disease and damage to the gallbladder, liver, and pancreas, among other conditions.

The Food and Drug Administration has now decided that Bayer’s television commercials were misleading, because they undersold the risks of the drug while at the same time overstating its benefits. In addition, the consumer protection group Public Citizen warns all women against using either Yaz or Yasmin, and instead suggests sticking to a pill that does not contain drospirenone.

Yaz and Yasmin are no more effective than traditional birth control drugs, but they appear to be more dangerous. Nonetheless, because of Bayer’s aggressive and misleading advertising, they are now Bayer’s most popular drugs. In fact, the drugs are the most popular birth control pills in the world. Last year alone, Bayer sold $1.8 billion worth of Yaz and Yasmin .

Not surprisingly, with that type of money on the line, Bayer continues to promote the drugs, regardless of their risks.

I admire clients who find the strength to tell their stories on television.  It takes guts. When Susan Galinis said she wanted to do just that, I warned her that it would be difficult and, well, embarassing.  She said she didn’t care.  If she could persuade just one woman to switch from Yaz to a traditional birth control pill, it would be worth it.  

On Monday, Susan appeared on local Fox, ABC, and NBC stations. She showed to the cameras pictures that, until now, she hadn’t shown to anyone outside her family. 

After Susan’s story aired, I received dozens of calls from Yaz survivors who asked me to thank Susan for getting the word out, or to offer her their help and support.  Some called to ask for more information or just to talk about their own experiences.  One talked about a friend she lost to Yaz.  I appreciate hearing from anyone whose life has been impacted by this drug.  

http://cdn.abclocal.go.com/static/flash/embeddedPlayer/swf/otvEmLoader.swf?version=&station=kgo&section=&mediaId=7072836&cdnRoot=http://cdn.abclocal.go.com&webRoot=http://abclocal.go.com&site=

 

We’re working on all of our Yaz and Yasmin cases with a Yaz law firm in San Francisco.  We chuckled over the fact that Bayer had no problem speaking to reporters before the first news segment aired. But once Bayer actually saw Susan and heard what she had to say, the company apparently could think of no response and refused to speak with the reporters who produced the later segments.

Susan, you "done good."