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

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.
 

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Bayer's Yaz commercials are misleading. The FDA determined that they overstated the drug's benefits, and minimized the drug's risks (PDF). So the FDA yanked them off TV.  It also ordered Bayer to televise new commercials that set things straight.  The FDA ordered Bayer to spend $20 million doing it thinking, that way, every woman would get the word.  But did Bayer follow through?

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Drugs can heal, but they can also cause harm. Deciding which drug is best for the patient is something that takes training. That's why drugs must be prescribed by doctors.

The argument for allowing drug companies to advertise on television is that an "educated patient is a better patient." That's true. But drug commercials are not educational. They are designed for marketing purposes.  A commercial's only purpose is to get you to buy something, not to tell you what you need to know to make the best decision as a consumer.

Like commercials for any other product, drug commercials highlight the product's benefits and downplay the risks. When a commercial does include information about risks, the warning is usually wrapped with "emotive imagery" that isn't consistent with the words used.  That blunts the warning's effectiveness.

As a result of drug commercials, doctors are now asked by their patients to prescribe a particular brand drug -- something that was unheard of years ago. A doctor may now find herself in the position of having to explain to the patient how the patient has been misled by the drug company's advertisements.  That can make things uncomfortable for the doctor.  So when the patient has been taken in by the "buzz" that an effective commercial creates, the doctor feels pressure to prescribe a medication that she might not otherwise prescribe. Drug commercials therefore get in the way of the doctor/patient relationship, and disrupt the therapeutic process.

It took us years to realize that tobacco commercials served society no good purpose and so should be taken off television. It's now time to put an end to drug commercials as well.

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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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Yaz packages come with a "patient package insert."  The insert is supposed to give women the information they need to decide whether they should use Yaz or, instead, use some other birth control pill.  The insert contains lots of information about the drug, including possible side effects. Unfortunately, however, it leaves out the one bit of information women would want to know most:  Yaz is no more effective than other available birth control pills, but is more dangerous.

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Earlier this year, the Food and Drug Administration (FDA), wrote a warning letter to the makers of Yaz about their advertising campaigns, which the FDA characterized as “misleading” because, among other things, many of the Yaz ads “fail[ed] to communicate any risk information” about use of the drug.

Interestingly, this was not the first time the makers of Yaz and Yasmin had received such warnings. In both 2003 and 2008, the FDA sent similar warning letters. Despite all of the FDA’s warnings, the drug manufacturers continued to use the same questionable marketing strategies to promote Yaz.

In the 2009 warning letter, the FDA told Bayer that:

...for promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug.

According to the FDA, these Yaz ads did not contain that important risk information. The letter warns that the manufacturers overstated both the benefits of Yaz and the conditions that Yaz was approved to treat, making the ads “incomplete and misleading."

The FDA warning letter concluded that Bayer should immediately pull the ads and discontinue the use of any other similar materials.

Even after receiving two previous warning letters from the FDA about their misleading advertisements, the makers of Yaz and Yasmin continued to use these questionable advertising practices. These ads incorrectly led some women to believe that Yaz was safer than it really is.

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Susan, a client of ours, was recently interviewed by a local news agency. As you will see Susan suffered a stroke a month after she started taking Yaz. Needless to say, Susan’s life has been forever changed.  She asked us to put her story out there so other women would know what she went through after taking Yaz.

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Have you seen the new Yaz commercial? You know, the one that begins with the main actress saying:

You may have seen some Yaz commercials recently that were not clear. The F.D.A. wants us to correct a few points in those ads.

It turns out that the “Yaz commercials” the actress is talking about are the very ads that were the subject of an FDA warning letter (PDF) in 2008 to Bayer (the manufacturer of Yaz and Yasmin). The FDA’s letter addressed two of Bayer’s Yaz commercials, entitled "Not Gonna Take it" and "Balloons.”

The warning letter stated that these commercials were “misleading” and “over-promised the benefits while minimizing the risks associated with Yaz.” The FDA also said that the ads were misleading because they implied that Yaz could treat PMS and “help keep skin clear.” In fact, Yaz was only approved to treat the more severe symptoms of PMDD (Premenstrual Dysphoric Disorder) and moderate acne, as opposed to more severe or less severe forms of acne..

The FDA also noted that, in addition to overstating the benefits of Yaz, Bayer also minimized the risks, which the FDA said was “particularly troubling as some of the risks being conveyed are serious, even life-threatening.”

The warning letter concluded that Bayer should stop running the ads immediately, and work on putting together a corrective campaign about the real uses and risks of Yaz that were both truthful and non-misleading.

So, it was actually in response to this warning letter that the makers of Yaz and Yasmin began to air the new commercial to “clear up” misconceptions! Check out that commercial below.

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At this point you probably know that Yaz, Yasmin and Ocella are related birth control pills, but do you know how they’re related? Here’s a little background info we’ve picked up in our research.

Yasmin was originally developed in 2001 by a German pharmaceutical company called Berlex Laboratories. Yasmin was unique in that it contained a new type of hormone known as drospirenone, or “drsp.” The same drsp hormone was used by Berlex again when it developed the birth control Yaz several years later.

Yaz hit the U.S. market in 2006 and shortly thereafter Bayer Healthcare bought Berlex, acquiring the Yaz and Yasmin birth control pills in the process. As reported by Natasha Singer in an article in the New York Times, Bayer marketed Yaz as a different kind of birth control and touted it as effective not only in preventing pregnancy but also as a treatment for PMDD (Premenstrual Dysphoric Disorder) and moderate acne. Bayer advertised Yaz as a way to “Go Beyond Birth Control with Yaz” and promoted the new pill as a quality of life medication.

Yaz and Yasmin are two of Bayer’s best selling medications and, according to Ms Singer's article, the company earned $1.8 billion on the successful positioning of Yaz and Yasmin in the last year alone.

In July 2008, another drug manufacturer, Teva Pharmaceutical Industries Ltd., jumped in on the action when it released a generic version of Yasmin called Ocella, which also contains the drsp hormone.

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Birth control pills, or oral contraceptives, have been around for decades.  But what you may not know is why Yaz, Yasmin and Ocella are different than other birth control pills.

Like many other oral contraceptives, Yaz and Yasmin are called “combination” birth control pills because they contain two types of hormones: estrogen and progestin. Yaz and Yasmin (also known by the generic name Ocella) contain a relatively new type of progestin hormone known as drospirenone, or “drsp” and a type of estrogen called ethinyl estradiol.

The problem is that medical studies have shown that birth controls containing drsp may cause more serious health risks than other birth control pills. In fact, the British Medical Journal recently featured a Dutch medical study and a Danish medical study, both of which concluded that birth control pills containing drsp have a higher risk of causing thrombosis (a fancy medical term for blot clots).  Blood clots can be life-threatening; if a clot travels to the lungs it can cause a pulmonary embolism, while a clot that travels to the brain can lead to a stroke.

Yaz and Yasmin are two of the top-selling birth control pills in the United States, and because they contain drsp, they may put women at greater risk for developing serious health complications. In fact, the FDA has warned that women with high levels of potassium levels shouldn’t take Yaz or Yasmin because drsp may also cause an increase in potassium, which can be life-threatening.

Women should check with their doctors for more information about potential Yasmin, Ocella and Yaz side effects.
 

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You might have read about some of the warning letters the FDA sent to the makers of Yaz and Yasmin for misleading advertising – maybe you’ve even seen the Yaz commercial that clarifies the risks of Yaz at the FDA’s request – but did you know that the FDA has actually been warning the makers of Yaz and Yasmin about this sort of advertising since 2003?

In 2003, the FDA sent the first of three warning letters (PDF) to the manufacturer of Yasmin for its advertisements, stating that the:

TV ad misleadingly overstates the efficacy and safety of Yasmin by suggesting that Yasmin is unique and therefore clinically superior to other birth control pills because it contains the chemically different progestin drospirenone.

Yasmin was the first in a line of birth control pills to contain the hormone drospirenone. The FDA’s letter said that the commercial, named “Goodbye Kiss,” over-promoted the effectiveness and safety of Yasmin. Check out this excerpt from the letter:

[The] FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other [oral contraceptives] or that the drospirenone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone.

The FDA's warning letter concluded that the makers of Yasmin should remove the ad immediately and stop the use of any other similar promotional materials.

The trend of misleading advertising by the makers of Yasmin, and eventually Yaz, dates all the way back to 2003! It’s been more than five years since the FDA first called them out for minimizing the risks associated with the Yaz/Yasmin hormone drsp. Yet, despite many FDA warning letters about this issue, the makers of Yaz and Yasmin continued to use these questionable advertising practices well into 2009.

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