The Yaz Lawsuit: Duty to Warn
by Tania Houspain, PharmD 2011 | houspian@myhousecallmd.com
You’re at the new happening lounge with your three closest model-looking girlfriends catching up on girl talk. Of course, in the tradition of female gossip, the subject turns to sex and then birth control. One of your girlfriends starts gushing about her amazing new birth control that not only helped her avoid pregnancy but also decreased her PMS bloating and acne. All your friends are in awe of this great new birth control and you all agree that you’re going to request it at your next doctor’s visit. You buying all this? 
While this may not be the most realistic dramatization, this is the scene painted by Bayer in advertisements for their birth control products, Yaz and Yasmin. It’s this kind of casual, direct-to-consumer advertising that not only helped Yaz get on the list of the Top 200 Drugs sold in the US but also got Bayer in trouble with the FDA and, more recently, with the legal system.
Why is Bayer in trouble?
The class action lawsuit filed against Bayer claims that Yaz and Yasmin increase the likelihood of women forming blood clots more than other birth control pills. To make matters worse the lawsuit states that Bayer was aware of the increased risk with using these two birth control products but downplayed the risk with casual commercials that over exaggerated their uses.
Is it true?
First and foremost, all birth control pills with an estrogen component (refer to the article 28 Days a Month, 13 Months a Year… for the details of birth control) 
can increase the risk of blood clots forming. A clot is a clump of blood cells, tissue, and other parts of blood that stick together. The problem with a clot is that once it starts to move through your arteries it may get stuck in narrower arteries and stop blood flow to the tissues beyond that point. Imagine what would happen if blood supply were cut off from certain parts of your body due to a clot. In case you don’t want to imagine the consequences, we’ve broken it down for you:
-
Lungs (a clot here is called a Pulmonary Embolism):
-
Difficulty breathing
-
Coughing up blood
-
Sharp chest pain
-
Heart palpitations
-
-
Heart (a clot here is called a Myocardial Infarction or heart attack)
-
Crushing chest pain (like an elephant standing on your chest)
-
Irregular heart beats
-
-
Brain (a clot here is called a Cerebrovascular Accident or a stroke)
-
Inability to move or feel parts of your body
-
Inability to speak
-
Disorientation
-
-
Leg (a clot here is called a Deep Vein Thrombus; an example is shown above)
-
Leg pain
-
Swelling of leg
-
Bulging veins in leg
-
Redness, inflammation, or discoloration of the skin of the leg
-
-
Eyes (a clot here is called a Retinal Vein Occlusion)
-
Eye pain
-
Blindness in affected eye
-
In all of these tissues, if the clot isn’t taken care of right away the lack of blood and oxygen to the area can cause long-term damage and consequences. The take away: blood clots are a serious matter. This risk of blood clots is why, when you ask for birth control, your doctor asks if you smoke (no, he doesn’t want to bum a smoke off of you), checks your age and takes a look at your medical history. Women who smoke more than 15 cigarettes a day, who are over 35 and who have certain medical conditions are more likely to form blood clots. Using estrogen-containing birth control in these women is generally not recommended.
If all birth control pills cause blood clots (and this is a medically known fact), why is Bayer getting sued?
It seems as though Yaz and Yasmin may carry an extra risk of blood clots due to their second active ingredient, drosperinone. Drosperinone comes from a family of compounds known as diuretics. No, they don’t give you diarrhea but drugs in this class do make you pee more (they are often called “water pills”). They’re usually given to people with high blood pressure causing them to pee out some extra water and decrease their blood volume and subsequently their blood pressure. Drosperinone is a very mild diuretic and is given in very small doses in the birth control pill so you don’t lose that much body water. 
The diuretic effect is thought to cause just enough water loss to decrease bloating-related symptoms. Drosperinone also resembles certain hormones in your body so scientists believe that is may help curb the hormonal problems some women experience during their menstrual cycle (think irritability). Sounds great but here comes the catch: The problem with drosperinone is that it causes your body to hold on to more potassium that it usually would. Normally your body naturally maintains the ideal balance of electrolytes like potassium and sodium by either reabsorbing them in your kidneys or allowing you to pee them out (for a full breakdown of the kidney’s incredible electrolyte-regulating abilities, see the diagram below…are you as impressed with the kidney as we are?). Drosperinone has the potential to increases potassium levels to a dangerous level (referred to as hyperkalemia), which causes irregular heart rhythms. It is medically proven that irregular heart rhythms increase the likelihood of forming blood clots. The FDA knew about all of these side effects caused by Yaz and Yasmin before approving them and these potential risks are listed under the warnings section of the package inserts.
The Most Important Question: Did Bayer downplay the risks and over exaggerate the benefits of Yaz and Yasmin?
That question will have to be answered in a courtroom but some facts are available to us. In 2008 the FDA sent Bayer an eight page WARNING LETTER (bolded and all caps to emphasize the seriousness of the matter) telling the company that changes needed to be made to their commercials for Yaz and Yasmin. The problems the FDA cited in regards to the commercials were the representation of the medications’ effects on PMS, acne, and the minimization of risks.
PMS Claims
In the letter, the FDA reminds Bayer that Yaz was never approved for treatment of PMS but for PMDD (Pre-Menstrual Dysphoric Disorder). PMDD is a much more severe form of PMS that interrupts a woman’s ability to function in her normal life and needs to be diagnosed by a healthcare provider. Yaz and Yasmin were never evaluated for the treatment of PMS so any claims Bayer made about these medications helping with PMS are false. 
During one commercial in particular, women can be seen pushing away giant floating words such as “irritability,” “bloating” and “fatigue.” Obviously this is meant to imply that Yaz helps get rid of these symptoms. Any woman watching that commercial will think “Yeah, I do feel that way when I’m PMS-ing.” The commercials never take the time to explain that PMDD is a much more severe form of PMS and Yaz should not be taken for more mild symptoms. Bayer’s boo-boo.
Acne
The FDA also sternly warned Bayer about claims regarding acne. In one commercial the narrator says, “It can also help keep your skin clear” and the camera zooms in on the faces of women with clear skin. Creepy, but it gets the message across. 
The FDA never approved Yaz to “help keep your skin clear.” It was approved only for moderate acne vulgaris. It was also never shown to produce completely clear skin like the commercial would have us believe. The study data showed that it helped decrease the number of pimples when compared to doing nothing. That being said, zooming in on faces with beautiful glowing skin may be a tad misleading compared to what the actual data shows.
Minimization of Risks
We’re all familiar with drug commercials with the voice over guy telling us all the possible side effects and risks, rapid-fire style, at the end. So why is Bayer in trouble with the FDA when it seems everyone does that? Well, in addition to skimming over the serious complications that can result from using this drug, the commercials seem to also try to distract the viewer’s attention away from the serious statements being made. While the voice over guy is talking, music is playing and women are leaping around on screen (possibly overwhelmed with the joy that comes with using Yaz?). The FDA felt that this was way too distracting and did not convey the seriousness of the possible side effects. The FDA felt that Bayer did not take their duty to warn consumers seriously, focusing solely on selling their product.
In response to the WARNING LETTER, Bayer changed their commercials and clarified the points the FDA had requested. The commercials emphasized that Yaz only helps with PMDD and not PMS. The edited version explained that Yaz and Yasmin don’t completely get rid of acne but can help decrease pimples. There is also more emphasis placed on the possible risks. See the new version of the commercial below.
It’s great that they complied with the FDA’s demands but this may be a case of too little too late. The commercials were running for a significant amount of time before the FDA requested changes. In the meantime, women saw these commercials and went to their doctors’ offices requesting Yaz and Yasmin for birth control. Some of these women should not have been on Yaz and Yasmin due to the increased risk of blood clots but Bayer did not properly informed them of the increased risk that these drugs carried (although we would hope their doctors would discuss such issues). Now many women who developed a blood clot while on Yaz are coming forward stating that they had no risk of forming blood clots before starting Yaz and were unaware that the medicine could cause clots. Trouble in River City.
Who will win the lawsuit?
Three words: Settle, settle, settle. In the past, when drug companies are sued for issues like this they try to settle. They’ve spent millions of dollars developing and marketing their drug and lawsuits create bad press and bad karma for them and their drug. In addition, the lawyers handling the lawsuit on behalf of the patients have every motivation to settle since they’re working on a contingency basis (meaning they don’t get paid unless they win or settle). The physicians who prescribed Yaz or Yasmin for patients who didn’t necessarily qualify to be taking the medication (PMS and mild acne) are also being sued by some of their patients. The outcome in those cases is a little harder to predict due to the case-by-case nature of the suit.
The Moral of the Story
Do NOT walk away from this article thinking that you should not take birth control or that new medications cannot be trusted. The moral of the story is to ask questions and be informed. Drug companies are multi-million dollar corporations focused on increasing their bottom line. While the FDA does everything it can to try to protect you, oversights like this do happen. That’s why, as the patient and as a consumer, you need to be informed (and by informed we mean information beyond direct-to-consumer commercials). Commercials for drugs are just like commercials for anything else. They are intended to sell you a product regardless of whether or not you need it. Trust your health professionals and ask plenty of questions. One more time for the people in the back of the room: Ask questions.
Questions? E-mail Tania: houspian@myhousecallmd.com (It’s never too early start practicing for your next visit)
References:
Bayer Warning Letter. Abrams, Thomas. Department of Health and Human Services. Oct 3, 2008.
Yaz Package Insert. Bayer Health Care. April 2007.
Did you know that there are 13 months in a year? Maybe not true for everyone, but true if you’re a woman using birth control pills. How is that possible you ask? Let’s do the math. There are 365 days a year and 28 days worth of pills in each month’s supply of birth control, while we’re all aware that most months have 30 or 31 days. So 365 divided by 28 gives us 13. That’s right. Women have to pay for an extra month’s worth of medication. This is unheard of for any other medicine. With no medical reason to only give 28 days worth of pills when 30 or 31 would work just as well, what’s a woman to do? Maybe we can embrace this special month that only we get, by naming it. I personally like the way “Notpregnantember” rolls off the tongue. Really though, short of demanding two more pills from your pharmacist every month, a request that sadly the pharmacist can’t possibly oblige, what’s a woman to do if she’s really put off by this extra co-pay and daily pills? Women can choose to be informed consumers. There are a multitude of products out there that work just as well, if not better than, the traditional birth control pill and they don’t require us to cross days 29-31 off our calendars or make up new names for imaginary months, as fun as this may be.
