Yaz Lawsuit

Bayer also found itself under scrutiny for deceptive claims made while marketing Yaz.

In 2008, the FDA said that Yaz was shown not to be effective for common premenstrual symptoms, just a rare and serious form of them and that Yaz’s success was misleadingly overstated.

In fact, the FDA sent Bayer a warning letter, citing the company for running two false and misleading television ads about Yaz.

According to the letter, the ads overstated the drug’s efficacy, promoted it for conditions like a premenstrual syndrome for which the drug is not approved and minimized serious risks associated with the drug.

In February 2009, Bayer agreed to spend $20 million on a corrective advertising campaign to counteract misimpressions created by the original television spots – a lot of money to correct something Bayer either knew or should have known from the beginning.

Instead, recent studies have shown that this marketing was not only misleading but also dangerous.

These independent studies have found that Yaz carries higher blood clotting risks than other leading birth control pills.

While all birth controls come with some risk, Yaz is unique in that it contains a hormone called drospirenone that some experts believe may trigger more blood clots than other birth control pills because of elevated levels of potassium in the body.

In March 2011, Bayer announced the results of a large study that offers insight into the increased risk of venous thromboembolism (VTE), or blood clots, when using the Pill.

The study notes that the risk of a blood clot is highest during the first year of using the combination oral contraceptives (COC’s such as Yaz), and even higher in the first six months of use, as well as greatest when restarting the same or a different Pill after a four week or greater break.

In October 2011, the FDA released the results of a study of 800,000 women that found women taking Yaz had a 75% greater chance of experiencing a blood clot than women taking the older birth control pills.

In addition, BMJ released its own study of 1.2 million Danish women studied over eight years which concluded that women who took birth control pills that contain drospirenone (such as Yaz) were at least twice the risk of venous thromboembolism compared with users of older birth control pills.

As the risks associated with Yaz came to light, one had to question the integrity of Bayer’s original studies that found no increased risks.

Additionally, in a controversial Yaz FDA Advisory Panel meeting, there were reports of professional conflicts of interests and irregularities in the panel’s decision.

Where did Bayer draw the line between corporate interests and patients safety?

In France, Bayer found themselves involved in yet another birth control controversy in France when the National Security Agency for Medicines and Health Products (“ANSM”) announced birth control, Diane-35 would no longer be sold.

An investigation was also launched into Méliane, another of the newer generation contraceptives manufactured by Bayer.

Melanie has also been linked to life-threatening blood clots.

As always, if you or family members are considering birth control options, please consult with your doctor when making the decision that is right for you.

The controversy surrounding the FDA’s advisory panel on the benefits and risks of Yaz and Yasmin birth control pills has two parts – the professional conflicts of interests of the panel members and possible evidence of irregularities in the panel’s decision have come to light.

Professional Conflicts of Interest in Yaz Oversite

Some members of the panel were revealed to have funding ties to Bayer, conflicts that the FDA did not disclose.
The British Medical Journal (BMJ) reports that at least four members of a recent special safety committee advising the US Food and Drug Administration on the safety of drospirenone had financial ties to its manufacturer, Bayer, raising questions about the rigor with which the agency minimizes potential conflicts of interest. Bayer sells drospirenone under four popular birth control brands – Yaz, Yasmin, Beyaz, and Safyral, all of which remain on the market.

The FDA ordered the review by a special safety committee after three articles published in the BMJ found an increased incidence of venous thromboembolism among users of drospirenone. However, the committee did not see internal Bayer documents in which Bayer scientists determined that Yasmin’s rate of all serious adverse events was “10 fold higher than that with the other products.”
The special safety committee of FDA advisers concluded that the benefits of these birth-control pills outweighed the risk of blood clots. The committee’s decision ended with a 15-11 vote, with all the doctors linked to Bayer voting with the majority.
The FDA defends its action by stating that they never release panelists’ personal financial ties to the public. They also claim to always ensure that past relationships between panelists and drug companies do not affect their financial interests or give the appearance of creating a conflict.

Bayer documents unsealed through the federal litigation in Illinois concerning these drugs’ safety gave further insight into some of the panelists’ relationships with Bayer:

• Dr. Paula Hillard, a professor of obstetrics and gynecology at Stanford School of Medicine, served as a paid consultant to Bayer;
• Julia Johnson conducted four clinical trials, including one of drospirenone as hormone replacement, for Bayer or its subsidiary Berlex, a manufacturer of drospirenone.
• Elizabeth Raymond, a senior medical associate at Gynuity Health Projects in New York, conducted studies funded by Barr Pharmaceuticals, now part of Teva, which has a licensing agreement with Bayer for generic versions of Yaz.
• Anne Burke, assistant professor of gynecology and obstetrics at Johns Hopkins University in Baltimore, has received research funding from Bayer-Berlex and Durament, which has a licensing agreement with Bayer for generic versions of Yaz and Yasmin.

The FDA did allow all four of the panelists with connections to Bayer to vote but did remove the voting rights of one individual. Public-Interest doctor Sidney M. Wolfe was not allowed to vote on the issue because he had publically criticized the drugs’ safety.

Irregularities in the Yaz Panel’s Decision

A coalition of women’s health groups alleges that key questions directed to the panel members were vague and confusing. The group also claims that a number of the panelists are currently practicing obstetricians and gynecologists, raising concerns over their intellectual conflicts of interests as they have made individualized patient decisions regarding the safety of oral contraceptives.
The confusing wording relates to how the FDA Advisory Panel was questioned regarding the risks versus benefits of using DSRP-containing oral contraceptives (such as Yaz/Yasmin). The Panelists were asked whether “the benefits of DSRP-containing oral contraceptives for the prevention of pregnancy outweigh their risks.”

Those panelists that voted “no” (risks do not outweigh benefits) appeared to be comparing the risks of Yaz/Yasmin to the risks of those oral contraceptives not containing DRSP. These panelists further noted the availability of safer forms of oral contraceptives as their rationale.

On the other hand, those panelists that voted “yes” (risks outweigh benefits) appeared to be comparing the safety of oral contraceptives containing DRSP to the risks of pregnancy. Ann Burke, a panelist who voted “yes” explained her vote saying:

“I don’t think I was expecting it to be more effective than other pills on the market, and while I acknowledge that there does seem to be a moderately increased risk, it’s still lower than the risks of pregnancy. And like some other folks who have spoken, a no vote sounded like it would be – to take the product off the market. I’m not quite sure that’s necessary at this point.”

As seen in the responses from both the “yes” and “no” voters, their understanding of the question greatly affected their focus and possibly their final decision on the benefits and risks of Yaz and Yasmin. The coalition of women’s groups has not asked the FDA to hold a new meeting. Instead, they request a review of policies to ensure this does not happen again.

France’s National Security Agency for Medicines and Health Products (“ANSM”) announced today that swift action has been taken to halt the sale of the hormonal acne drug, Diane-35. Linked to the deaths of four women recently, the drug manufactured by Bayer was also being prescribed as a birth control pill in Europe. Women in France will need to find a new birth control/acne medication within the next three months.

French investigators have also requested that the European Medicines Agency (an agency similar to the FDA that harmonizes all medicine agencies in the European Union, including France) change prescription guidelines for so-called third and fourth generation oral contraceptives after these drugs were found to carry a higher risk of blood clots as compared to earlier versions.

In addition to today’s action, France’s ANSM initiated an investigation into Méliane, another of the newer generation contraceptives manufactured by Bayer. Meliane has also been linked to life-threatening blood clots.

France has indicated that the investigations will not end with Diane-35 and Meliane. Bayer’s Yasmin line (Yaz, Yasmin, and Ocella) are also newer generation contraceptives that have been linked to blood clots and are likely to be added to the French investigation. In the United States, there have been just short of 23,000 adverse health reports where Yaz was found to be the primary suspect. A controversial Yaz FDA Advisory Committee met in regards to the adverse side effects reported, yet failed to make serious headway regarding the injuries because of the controversy.

In the United States, Bayer finds themselves deeply entrenched in Yaz lawsuits with regards to Yaz, Yasmin, and Ocella. Just last November, Bayer announced a $750 million settlement to 3,490 claimants and those settlements will continue to grow as more women come forward to report their injuries.

So with serious injuries continuing to mount, evidence of overstated success already demonstrated, and overseas investigations ongoing, one can only hope that manufacturers like Bayer work to fix the damages they have already caused.

TorHoerman Law encourages women that experienced a blood clot after taking Yaz, Yasmin or Ocella to contact a medical professional as soon as possible.

At this time, TorHoerman Law is no longer filing Yaz Lawsuits. Contact a bad drug lawyer from TorHoerman Law for all inquiries regarding the Yaz Lawsuit.