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

Bayer has introduced a new birth control pill, Natazia. Bayer doesn’t claim that Natazia is any more effective than Yaz for preventing birth. And unlike the case with Yaz, Bayer doesn’t claim Natazia is approved to treat PMDD, acne, or any other condition.

If Natazia is no better than Yaz, why is Bayer introducing it?

Interestingly, Natazia doesn’t contain drospirenone, or DRSP. That’s the special ingredient that makes Yaz and Yasmin so unique. We think DRSP may be what’s causing our clients to suffer strokes, pulmonary emboli, and gall bladder disease.  Bayer, on the other hand, continues to insist that DRSP is safe and effective for use in a birth control pill. We want to know why Bayer, if it believes DRSP to be safe and effective, has decided not to use the ingredient in its new pill.  We think the answer might lie in the documents dealing with Natazia's development.

Bayer refuses to turn over the Natazia documents we and the other Yaz plaintiffs' lawyers want. Bayer contends that the documents are irrelevant, since they deal with a drug that shares no ingredients in common with Yaz.  According to Bayer's legal brief (pdf):

Not one plaintiff in these coordinated proceedings has alleged any wrongdoing with respect to Natazia or any injury or loss relating to Natazia – a medicine that shares no active ingredient with Yaz or Yasmin. Discovery requests relating to Natazia are therefore irrelevant and beyond the scope of permissible discovery.

Bayer is missing the point. It is the fact that the new medicine shares no active ingredient with Yaz or Yasmin that makes the documents so interesting.

The judge is expected to decide in the next few weeks whether Bayer has to turn over the documents. 

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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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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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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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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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Lawyer2Lawyer is a legal talk show that brings together lawyers with opposing views from across the country.  On its show devoted to the growing number of Yaz lawuits, Lawyer2Lawyer interviewed Mike Danko and Professor James O'Reilly, from the University of Cincinnati College of Law.  Mike discussed the basis for the lawsuits, while Professor O'Reilly discussed the FDA's role in the drug's approval and its monitoring of Bayer's advertising.

 

Listen on line, or read the transcipt:

 

Announcer:

This is Lawyer2Lawyer, the award-winning legal podcast with J. Craig Williams and Robert Ambrogie.

West Coast meets East Coast, and yes! they are attorneys.

Bringing you the latest legal news and observations every week with the leading experts in the legal profession. Produced here on the Legal Talk Network.

Craig:
Welcome to Lawyer2Lawyer on the Legal Talk Network. Thank you for listening today. I’m Craig Williams from a very sunny California.

Bob:
And this is Bob Ambrogie from just outside of Boston, Massachusetts where I practice law and write a couple of blogs…

[sponsor information…]

Craig:
Today’s show is about Bayer Healthcare Pharmaceuticals, who is facing a growing number of lawsuits claiming that the company concealed the health risks associated with top-selling birth control pills Yaz and Yasmin.
 

Continue Reading...

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As reported by Kate Moser of the Recorder, over the past few months, women from all across the country have brought lawsuits against the makers of Yaz, Yasmin or Ocella for side effects and health conditions they suffered after taking those birth control pills.

Recently, these lawsuits were coordinated and combined into a special kind of case known as an MDL (MDL is an abbreviation for MultiDistrict Litigation).

The purpose of an MDL is to transfer all pending federal cases throughout the country that deal with a similar issue to one judge. The idea is that having one judge hear all similar cases is more efficient and allows the cases to move along quickly to avoid wasting money and resources. The decision whether cases should be transferred and combined into an MDL is made by a panel of seven federal judges known as the United States Judicial Panel on MultiDistrict Litigation (JPML). The Panel has a brochure describing its role.

The two main jobs of the Panel are:

1. To determine whether similar cases that have been filed in different courts involve enough common factual questions so that the panel can transfer these cases into one court; and
2. To select the specific court and judge to be assigned to manage those cases.

The Panel has recently transferred the Yaz and Yasmin cases into one MDL called In re: Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (master docket number 09-2100). Judge David R. Herndon of the United States District Court of the Southern District of Illinois has been assigned to oversee this MDL.

Because of this coordination, any person who filed a federal lawsuit against Yaz or Yasmin, is likely to have her case brought within the umbrella of this MDL along with dozens, if not hundreds, of other similar cases.

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