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YAZ/Yasmin/Ocella

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YAZ and Yasmin are oral contraceptives manufactured by Bayer Healthcare. With combined sales of over $1.64 billion in 2009 alone, YAZ and Yasmin are Bayer's top sellers and the leading birth control medications in the United States.* However, YAZ, Yasmin and Ocella (the generic version, manufactured by Barr Pharmaceuticals), which are nearly identical in composition, have been linked to dangerous side effects such as stroke, heart attack or even death. The FDA has issued warnings (see sidebar) and lawsuits have been filed alleging the manufacturer(s) engaged in misleading advertising and failed to properly warn consumers of the potentially life-threatening side effects and dangers.

If you or a loved one has suffered injuries or even death while taking YAZ/Yasmin/Ocella, you may be entitled to financial compensation. However, it is important to contact an attorney as soon as possible before the statute of limitations (a limit on the amount of time you can file a lawsuit) expires and you lose your legal rights.

Compensation for YAZ/Yasmin/Ocella Injuries

Four Generations of "The Pill"

On Mother's Day 2010 "The Pill" celebrated its 50th anniversary, amidst controversy that its latest incarnation (i.e., the combination of drospirenone and ethinyl estradiol) may be more dangerous than some of its predecessors. Here is a brief timeline of the evolution in birth control pills:

  • The first birth control pill, introduced in the 1960s, contained high doses of estrogen and was quickly found to increase the risk of blood clots, heart attacks and strokes.
  • The 1970s marked the next generation of birth control pills. Comprised of a lower dose of estrogen combined with a synthetic progestin (e.g., lovenorgestrel), they lowered the risk of blood clots but caused weight gain and acne in some women.
  • With the third generation of the pill came new synthetic progestins, including desogestrel. Unfortunately, these pills put patients at risk for both deep vein thrombosis and pulmonary embolisms.
  • The fourth generation of the pill officially began when Yasmin entered the market in 2001. Several recently published studies suggest that the other synthetic progestins in earlier generations of birth control pills are safer than the drospirenone in YAZ, Yasmin and Ocella.

Hundreds of reports of injury and death have been submitted to the FDA in association with YAZ, Yasmin and Ocella. Patients who suffer harm from taking these drugs may wish to file a personal injury lawsuit against the manufacturer seeking compensation for medical expenses, lost opportunities, pain and suffering, punitive damages (for wrong or malicious behavior) and other expenses. If a loved one has died, the family may sue the manufacturer for defective drug death damages, including hospital and funeral expenses, emotional distress, punitive damages and lost financial support the deceased would have provided.


 

YAZ, Yasmin and Ocella contain a combination of the hormones drospirenone and ethinyl estradiol. Drospirenone — a "fourth-generation" synthetic progestin (see sidebar) never before used in the United States — is believed to raise potassium levels in the bloodstream (hyperkalemia) and put patients at an increased risk for serious, life-threatening conditions such as heart rhythm disturbance and strokes. Other serious side effects that have been associated with YAZ, Yasmin and Ocella include:

  • Deep vein thrombosis (blood clot in the legs)
  • Pulmonary embolism (blood clot in the lungs)
  • Heart attack
  • Pancreas damage
  • Gallbladder damage
  • Breast lumps
  • Kidney disease
  • Liver damage
  • Death

In the long term, many of these conditions can be detrimental to a person's medical and financial well-being and quality of life. For example, patients who suffer a stroke may have long-term communication problems, loss of movement and loss of brain function. If you or a loved one has been injured as a result of taking YAZ, Yasmin, or Ocella, you should speak to an experienced pharmaceutical attorney to discuss the possibility of filing a lawsuit to recover compensation for your damages and injuries.

YAZ/Yasmin/Ocella Liability

Not Gonna Take It – FDA Pulls Bayer's YAZ Commercials

YAZ was approved by the FDA for preventing pregnancy and for treating the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) and moderate acne in women who wish to use an oral contraceptive as their method of birth control. In 2008, the FDA issued a warning letter to Bayer and ordered them to pull two of their YAZ commercials. "Not Gonna Take It" featured images of energetic, euphoric, playful women singing "We're Not Gonna Take It" as they kicked, punched, and pushed words describing symptoms such as irritability, moodiness, bloating, acne and anxiety. Similarly, in "Balloons," the song "Goodbye To You" played as balloons containing the same words floated away. The ads also featured women with clear, acne-free skin.

The FDA admonished Bayer, saying the ads were misleading for the following reasons:

  • Broadening of Indication. The ads featured symptoms commonly associated with PMS (premenstrual syndrome), a less serious and more common condition than PMDD. The ads also implied that the drugs treated all types of acne, when it is in fact only approved for moderate acne.
  • Overstatement of Efficacy. The ads incorrectly implied that YAZ will render the women symptom-free and give them clear, acne-free skin, without substantial evidence to support such claims.
  • Minimization of Risk. The distracting visuals, numerous scene changes, background music and other audio and visual components distract from and make it difficult for viewers to process and comprehend the serious and even life-threatening risks.

As a result of the FDA's actions, Bayer agreed to spend $20 million on new advertising to counter the misleading information conveyed in these ads.

In general, a drug is considered defective if the risks outweigh the benefits. The defect may be found in the design itself or in the manufacturing or marketing (e.g., misleading advertisements, inadequate warning labels) process. Common legal theories asserted in defective drug cases include negligence, fraud/intentional misrepresentation, and breach of warranty. Though product and pharmaceutical laws vary by state, most states have strict liability. Strict liability means that if a drug is unreasonably dangerous for its intended use, the manufacturer and other people in the supply chain are automatically liable (without the need to prove negligence) for any injuries or deaths that occur as a result of taking the product.
 

YAZ/Yasmin/Ocella Lawsuits

According to Bayer, over 1,100 lawsuits have already been filed with respect to these medications. Many of these lawsuits allege that the risks of adverse events stemming from use of Yaz, Yasmin and Ocella were higher than those of other available contraceptives, and that the manufacturer(s) overstated the benefits of the medication and failed to warn women of the risk of serious and life-threatening injury.

If you or a loved one has been injured by one of these medications, a qualified personal injury or wrongful death lawyer can determine what legal arguments apply to your case.

*Source: Associated Press




Did You Know?

Nearly 12 million women in the United States and more than 100 million women worldwide use oral contraceptives.

Source: Food and Drug Administration