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Yaz

The Yaz injury case attorneys at the Drug Law Center are currently reviewing and investigating evidence from clients who have suffered serious injuries or died prematurely after using the popular birth control pill.

Introduction

Yaz Drug RecallYaz (estrogen/progestin) is a popular birth control pill that contains both ethynyl estradiol and drospirenone to prevent pregnancy. Some doctors prescribe Yaz as a treatment for moderate cases of acne in females who are 14 years and older after they have begun their menstrual cycles and want an effective contraception medication. However, since it was first made available the medical marketplace, there has been significant controversy on whether the contraception pill is safe because it is more than likely to trigger the development of life-threatening blood clots when compared to other birth control pills. Some patients taking Yaz have experienced a stroke, serious breathing problems, and death.

The History of Yaz

The FDA first approved Yaz, the popular oral birth control pill, in March 2006 for the treatment of preventing pregnancy. By October 2006, the FDA extended the approval of Yaz for the treatment of premenstrual dysphoric disorder and in January 2007 for the treatment of moderate forms of acne.

When the drug was first launched in 2006, its popularity rose steadily amongst its competition until it was seated as the number one contraceptive pill in the United States. In recent years, Bayer Healthcare Pharmaceuticals has generated over $800 million annually in Yaz sales. This number dropped slightly in the last few years after thousands of women began filing Yaz injury lawsuits claiming that Bayer’s drug caused them serious harm.

Misleading Advertisements

Most consumers of medical products receive information through some form of media advertisement. In 2010, Bayer began and aggressive television advertising campaign that asked young women what they thought of the contraceptive pill. Many of the advertisers responded that taking Yaz would prevent common symptoms associated with birth control pills and the effects of premenstrual syndrome. However, the Food and Drug Administration never approved the medication for that condition, but instead, the drug was approved for premenstrual dysphoric disorder (PMDD).

Research studies indicated that many young women believed the medication also treated mild acne, which it does not. As a result, the FDA declared that the television advertisements had been misleading women in providing information that was not accurate or true. Even though many believed that the ads were deceptive, Yaz rose to the number one position as the most use birth control pill and the United States.

Who Should Not Take Yaz?

The individual suffering with hepatic dysfunction should avoid taking Yaz or any birth control product that contains ethynyl estradiol and drospirenone. Women should discuss all their health issues, conditions, and problems with their doctor before taking Yaz, especially if they have any of the following including:

  • Adrenal insufficiency
  • Renal impairment
  • High-risk potential of developing venous or arterial thrombotic disease
  • Smokers
  • Cardiovascular disease
  • Pulmonary embolism or deep main thrombosis
  • Coronary artery disease
  • Uncontrolled hypertension
  • Diabetes mellitus with vascular disease
  • Acquired or inherited hyper coagulopathies
  • Thrombogenic rhythm disease or thrombogenic valvular disease
  • Headaches with focal neurological symptoms or women 35 years or older suffering from migraine headaches
  • Breast cancer survivors
  • Those sensitive to progestin or estrogen
  • Depression
  • Protein C deficiency disease

Yaz Side Effects

All prescription medications and over-the-counter drugs have some form of side effects and adverse reactions that could be life-threatening or mild. The most common Yaz side effects include:

  • Headaches
  • Bloating
  • Vomiting or nausea
  • Stomach cramps
  • Irregular/missed periods
  • Spotting (vaginal bleeding) between menstrual cycles
  • Unusual changes during periods
  • Irritability
  • Bile flow issues causing yellowing eyes or skin
  • Head pain
  • Swelling of the abdomen
  • Full breasts caused by milk production
  • Fatigue
  • Tenderness, swelling, pain in the breast
  • Mood changes
  • Scalp hair loss
  • Increasing care growth
  • Vaginal discharge or itching
  • Fluid retention in the feet and ankles
  • Contact lens problems

Severe Yaz side effects include:

  • Benign liver cell tumors
  • Blood clots in the lung and veins
  • Cervical dysplasia (abnormal cervix lining cell growth)
  • Heart attack
  • Hepatitis
  • Liver cancer
  • Inflammatory ball disease
  • High bloodstream potassium levels
  • High bloodstream fat levels
  • Blood clot-related blood vessel obstruction
  • Water retention
  • Systemic lupus erythematosus
  • Gallbladder disease
  • Stroke
  • Brown/yellow patches on the skin

Yaz and the FDA

  • April 2012 – The U.S. FDA (Food and Drug Administration) released a Safety Announcement after the results of the study became public concerning women taking birth control pills containing drospirenone (synthetic progesterone), including Yaz. The study was in regard to the potential risk of these women developing blood clots. The conclusion of the study revealed that these women did have a higher risk for developing blood clots compared to other birth control pills that contain progestin.The FDA was quick to add that the reviewed studies “did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those [medications] that do not. The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risks of blood clots.”
  • April 2012 – The Food and Drug Administration released an update on prescribing information contained in the Black box warning for Yaz. These warnings involved “Cigarette Smoking and Serious Cardiovascular Events”. The highlights included:
    • “Women over 35 years old who smoke should not use Yaz.
    • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.”
    • Contraindications to Yaz include “renal impairment, and renal insufficiency, a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, breast cancer or other estrogen or progesterone-sensitive cancer, liver tumors or liver disease, pregnancy.”
  • May 2011 – The FDA has issued a Safety Announcement to consumers about birth control pills containing drospirenone. The announcement provided additional information on the female sex hormones drospirenone that prevents ovulation where eggs are released from the ovaries. The FDA was warning women that using these types of birth control medicines pose a risk of developing blood clots. Even so, the FDA stated that:
    • “If your birth control pill contains ethynyl estradiol and drospirenone, do not stop taking without first talking to your healthcare
    • Know the symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath…
    • If you smoke are over 35 years of age, you should not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood clots.”

Lawsuits

August 2015 – Bayer Healthcare Pharmaceuticals, the manufacturers of Yaz, agreed to pay out almost $57 million to settle numerous lawsuits filed by plaintiffs in state and federal jurisdictions alleging that the birth control pill caused heart attacks and strokes. This includes lawsuits that were filed in California, New Jersey, and Pennsylvania state courts.

The pharmaceutical giant agreed to make a payment to resolve the cases but did not admit to liability or wrongdoing. However, the settlement serves as a bellwether case to help other attorneys determine exactly how juries will respond when presented with similar evidence in individual cases nationwide.

October 2013 – A $1.4 billion payout by Bayer Healthcare Pharmaceuticals will settle nearly 6800 Yaz lawsuits. The settlement comes just a short while after the U.S. Food and Drug Administration cited Bayer about selling their product using false advertising, making women believe the product to deliver better health benefits without producing serious side effects common to other birth control drugs.

Yaz Lawsuits

Many women have stepped forward after suffering injuries when taking Yaz oral birth control pills and filed lawsuits against Bayer healthcare pharmaceuticals to obtain the financial compensation they deserved for their damages. Two of these lawsuits include:

  • Yaz Stroke Injury Lawsuit Filed by a Chicago Woman against Drug Maker BayerApril 2014 – $14 million has been awarded by an Illinois jury to resolve a Yaz stroke injury lawsuit where the plaintiffs suffered a life-threatening stroke after taking the birth control medication. The plaintiff received the award after proving that her doctor never should have prescribed the birth control drug because she suffered underlying risk factors for developing blood clots. It took just 13 days for the plaintiff to suffer a stroke after she was first prescribed the birth control pill in 2007.

    Her attorneys claim that the doctor was aware, or should have been aware, that his patient had an increased potential of suffering a stroke caused by blood clots that could have been avoided had she not taken the oral contraception pill.

    Even though this jury award is large, the drug manufacturer is facing many more days in court defending themselves against Yaz class action lawsuits because they insufficiently warned consumers of the potential dangers of developing blood clots. Some of these cases have already been consolidated in MDL (multidistrict litigation) cases filed in the Southern District of Illinois.

  • Yaz Blood Clot Injury Lawsuit Filed by Kentucky WomanMay 2014 – Bayer Pharmaceuticals is facing one more Yaz blood clot injury lawsuit, this time filed by a Kentucky woman who claims she sustained a life-threatening blood clot after taking the popular oral contraceptive pill. Lawsuit documents reveal that the plaintiff was prescribed Yaz by her doctor to prevent pregnancy and took the drug according to instructions by the pharmaceutical manufacturer. Shortly afterward, her doctors diagnosed with pulmonary embolism.

    The attorneys working on her behalf have filed a lawsuit claiming that Bayer Pharmaceuticals failed to provide warnings of the potential risk of taking the medication and had a duty to warn her, her doctor, and other consumers of the potential side effects. The plaintiff has claimed that had she understood how dangerous the medication was a producing serious side effects, she would have avoided taking the medication and found other alternative methods for preventing pregnancy.

Receive Monetary Compensation for My Yaz Lawsuit

The birth control drug injury attorneys at the Drug Law Center are currently investigating and evaluating potential Yaz lawsuits for class-action cases and individual claims. Many of our clients have taken oral birth control pills and suffered serious side effects including strokes, heart attacks, pulmonary embolism, deep main thrombosis, cardiac arrhythmia, gallbladder disease and sudden death.

If you or a loved one has been injured after taking Yaz for a short or long time, contact us today so we can begin the process of handling your financial compensation claim. We are currently accepting all birth control injury cases through contingency fee arrangements. This means we provide you immediate legal representation without the need for an upfront payment. Our law firm will postpone all payments for our legal services until after we have successfully resolved your case at a jury trial or through a negotiated settlement.

Schedule an appointment to speak with one of our attorneys now to discuss the merits of your case through a complementary, case evaluation. Any information you share with us will remain confidential.

 

Sources:

https://www.fda.gov/Drugs/DrugSafety/ucm299305.htm

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021676s009lbl.pdf

https://my.clevelandclinic.org/health/articles/pms-and-pmdd

http://www.mayoclinic.org/drugs-supplements/drospirenone-and-ethinyl-estradiol-oral-route/proper-use/drg-20061917

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