Bayer's New Yaz Warning Labels Miss The Mark

Posted on April 14, 2010 by Greenberg & Bederman

For the better part of a year, we here at Greenberg and Bederman have been closely monitoring developments over the Bayer Corporation’s line of birth control pills. Yaz, Yasmin and its generic version Ocella are all immensely popular and incredibly profitable for the German drug manufacturer.  Aside from simply preventing pregnancy, Bayer markets the secondary benefits of Yaz and Yasmin, which include prevention of certain types of acne, as well as relief from some of the more traumatic emotional disturbances that can come with menstruation.

What separates Yaz and Yasmin from other forms of oral contraceptive is that these pills contain a synthetic variation of the normal birth control ingredient progestin. This variation is called drospirenone, and while it can contribute to less acne and relief from emotional trauma, it also significantly raises potassium levels in the bloodstream. Elevated potassium levels can cause deep vein thrombosis, which is the formation of blood clots in the major veins and arteries in the legs. If the blood clots break apart and travel, they often get pulled into the pulmonary bloodstream, which can lead to pulmonary embolisms. Or the pieces of the blood clot can travel to the heart or brain, which can lead to heart attacks or strokes. It’s important to mention that these birth control injuries aren’t one-in-a-million occurrences. They happen with unfortunate regularity.

These incidents led to studies by Swissmedic, which is the Swiss equivalent of the FDA, and by the British Medical Journal. Both of these studies concluded that women who use oral contraceptives with drospirenone experience a higher rate of blood clots than women who use other forms of hormone based oral contraceptives. Since Yaz, Yasmin and Ocella are the only pills that actually use drospirenone, it went without saying that the study was about these three birth control pills.  In its public relations defense, Bayer simply appropriated a line in both studies in which it was implied that the clotting side effects were “similar to those in other birth control pills,” but they neglected to mention that both the studies said that the risks were not only similar, but significantly higher as well.

As of last July (which was about the time that these birth control pills started to come under scrutiny,) the number of women worldwide who died as the result of complications from clotting (strokes, heart attacks or pulmonary embolisms) stood at around fifty. There have also been thousands of cases of non-fatal pulmonary embolisms, strokes and heart attacks, as well as some cases of gall bladder disease. Bayer hasn’t been forthcoming with the numbers  regarding deaths or injuries, but since they have not stopped marketing or selling these drugs, we have to assume that the numbers have only gone up.

As a result of all of these injuries and deaths, Bayer is facing an increasing number of lawsuits.  So far, there have been approximately 1,100 separate instances of litigation against Bayer over injuries and deaths that have occurred among users of Yaz and Yasmin.  All of the cases that have been filed in Federal court have been consolidated under multi district litigation so that there is consistency in pretrial discovery. To learn about Yaz lawsuits, read our article called “Understanding Yaz Class Action Lawsuits”.

The Food and Drug Administration (FDA) has been addressing these concerns at its usual pace, which is maddeningly slow. The closest they have come to even sanctioning Bayer was to force them to re-do their controversial marketing campaign because they believed it to be both misleading and contrary to the FDA approved labeling that Yaz and Yasmin have as part of their packaging. While you can certainly make the argument that the FDA’s actions here were important, they are inadequate  when you think of the things that could be done.

And that’s one of the more frustrating elements of this whole scenario. A pharmaceutical company puts out a product that carries a significantly higher risk of use than any of the similar products on the market, but the pharmaceutical company fails to mention this higher risk in any of its advertising, marketing or labeling. This leads to injuries and deaths due to consumers not being properly informed. And after years of delays the FDA decides to simply allow Bayer to put the following “new label” on Yaz and Yasmin:

WASHINGTON - Bayer HealthCare said Friday it has added new information about the risks of blood clots to its contraceptive pills Yaz and Yasmin. In cooperation with the Food and Drug Administration, the company said it added new labeling stating that the risks of blood clots with Yaz and Yasmin are similar to those with other oral contraceptives. The statements are based on two large, multiyear studies of more than 120,000 women taking contraceptives in the U.S. and the U.K.

What this means is that Bayer is simply saying that Yaz and Yasmin are risky, but so is every other birth control pill on the market. This is incredibly disingenuous. What should be on the label is the truth, which is that Yaz and Yasmin are significantly more dangerous than any other form of oral contraceptive.

We fail to understand why the FDA would crack down on Bayer for misleading advertising but not do so on misleading labeling. If two major studies claim that Yaz and Yasmin are more dangerous, then why would the FDA allow Bayer to claim that the pills are no different?

Greenberg and Bederman is currently offering legal help to women in the Washington, D.C. area who have been injured and hospitalized due to complications from Yaz, Yasmin or Ocella. Since the Food and Drug Administration is hesitant to take substantive action, it is up to the victims to take action. By taking your injury case to court, you could not only receive compensation for your injuries and medical bills, but you could also let Bayer know that there are consequences to selling and marketing dangerous products. You could tell them that there are actual people being affected by their decisions, and that there is more to running a business than the balance sheet at the end of the fiscal quarter.

Greenberg and Bederman has been helping injury victims in Maryland, Virginia and Washington, D.C. for twenty five years, and that includes people who have been injured by faulty or dangerous pharmaceutical drugs. If you or a loved one has been injured from taking Yaz or Yasmin,contact our yaz lawyer, Andy Bederman, for a free yaz legal consultation today.
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