Yaz

  • yaz

Yaz (drospirenone + synthetic ethinyl estradiol) is manufactured by Bayer HealthCare Pharmaceuticals Inc. The drug was approved by the FDA on March 10, 2006. Bayer advertised 'Yaz' as a new generation pill for birth control that could not only prevent pregnancy but also help women lose weight, cure acne, and help with premenstrual moodiness.

Yaz is a birth control pill used to avoid pregnancy. It is also used to treat premenstrual dysphoric disorder (PMDD) and certain types of acne. Yaz contains a combination of a new generation of synthetic progesterone called 'drospirenone' (3 mg) and synthetic ethinyl estradiol (0.02 mg). Yaz acts by preventing ovulation, thickening of mucus in the cervix, and also by changing the uterine lining, thereby, preventing pregnancies. Yaz strip contains 24 active pills that include the hormones and four inactive pills. Most birth control pills include seven inactive pills; thus, Yaz gives the patient an increased dose of hormones throughout the month.

The new generation synthetic progesterone 'drospirenone,' which is similar in chemical content to diuretic Spironolactone, has been associated with an increase in blood clots, pulmonary embolisms, heart attacks, strokes, gallbladder disease, and elevated potassium levels. Drospirenone also has anti-androgenic properties that work against testosterone and other hormones.

Some of the other brand names with similar hormonal compositions by Bayer HealthCare Pharmaceuticals Inc. are Yasmin, Beyaz, Safyral, and Ocella.

Serious Alleged Injuries may include:

  • Death
  • Venous thromboembolism
  • Deep venous thrombosis
  • Pulmonary emboli
  • Stroke
  • Ischemic stroke
  • Arterial thrombotic events
  • Hospitalized acute myocardial infarction
  • Gall bladder dysfunction followed by surgical removal of the organ

FDA Safety Warnings:

  • In 2007, the FDA expanded Yaz uses to include treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have experienced at least one period (menstruation). In 2008, the FDA stated that Yaz’ presumed success in treating acne was misleadingly overstated.
  • In December 2008, an FDA panel voted in favor of strengthening warnings on YAZ birth control pill labels, this resulted in the addition of the black-box warning on all Yaz packaging cautioning women who smoke about an increased risk of serious cardiovascular side effects that may occur if they use either drug.
  • On April 10, 2012, the FDA after completing its review of observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills, concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.
  • No permanent Yaz recall has been made yet. The presence of the drug still remains in the market with a warning label change that mentions an increased risk of blood clots for all birth control pill users and not just Yaz.

Legal Updates:

Lawsuits filed by plaintiffs alleged that the pills caused blood clots, gallbladder issues, heart attacks, and strokes. Lawsuits also alleged that Bayer knew or should have known of the alleged risks and failed to disclose them or adequately warn the users, fraudulent concealment, negligence, and many more. They also accuse Bayer of not doing enough research and failing to issue a recall after reports showed risks.

Women who suffered from side effects after taking Yaz and related pill Yasmin, both for birth control filed more than 17,000 lawsuits against Bayer. The cases filed in Pennsylvania, New Jersey, and California state courts were centralized in Illinois federal court.

At its height, more than 17,000 files with multiple plaintiffs per file had been brought in four jurisdictions, making it the largest multi-district litigation in the nation.

Yaz, Yasmin, and Ocella birth control lawsuits filed against Bayer were consolidated in 2009 into a mass tort program in Pennsylvania, a federal multidistrict litigation (In re: MDL 2100 - Yasmin and YAZ (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, presided by U.S. District Judge David R. Herndon), and consolidated litigations in New Jersey and California.

Bellwether trials in Philadelphia and in the MDL that were gearing up in 2012, stayed as Bayer began to settle thousands of blood clot claims involving pulmonary embolisms, deep vein thrombosis and/or gallbladder injury. Only 360 cases remained pending in the Philadelphia Complex Litigation Center.

On August 6, 2015, Bayer announced to set aside almost $57 million as settlement amount to resolve arterial blood clot claims including heart attack and stroke without admission of wrongdoing or liability.

 

News:

Jul 29, 2019: Lack Of Potency Led To Generic Yaz Birth Control Pill Recall: On July 23, 2019 FDA announced a recall on generic Yaz (drospirenone and Ethinyl estradiol) birth control pills sold by Jubilant Cadista Pharmaceuticals Inc. due to the risk of ineffective birth control, which may lead to unwanted pregnancies, even when taken as directed. 

According to the notice, the pills were ineffective as the absorption of the active ingredients was decreased, which left women with inadequate protection against becoming pregnant.

Ethinyl estradiol and drospirenone tablet is a generic estrogen/progestin combination oral contraceptive, widely used by women to treat symptoms of the premenstrual dysphoric disorder, prevent pregnancy, and treat moderate acne.

The recall affected one lot of the generic Yaz pills distributed across the United States. It contains 3mg/0.01 mg packed in a carton with 3 blister cards, each card contains 28 film-coated, biconvex tablets with 24 round active pink tablets, and four inert while colored tablets. Lot number 183222 with NDC number 59746-763-43 and expiration date of 11/2020 was affected by the recall. The company stated that they are notifying customers by email and sending a recall notification letter and response forms to return the product.

Yaz lawsuits were consolidated under MDL No. 2100, presided by Judge David R. Herndon in the Southern District of Illinois. As of January 2019, no cases are pending in the MDL.

Jun 19, 2018: Bayer Denies Claim Made By Plaintiff In A Related Yaz Case: A New Jersey State Appeals Court found loopholes in the expert report of a woman who blamed Bayer AG's Yaz and Yasmin birth control pills for her gallbladder disease. The pharmaceutical giant denied the claim made by the plaintiff to restore the litigation.

The lawsuits concerning Yaz-related pulmonary embolism were the first to go for a state court trial, followed by gallbladder injury cases and the final round would include blood clot injuries.

By May 2014, Bayer settled more than 8,200 lawsuits over pulmonary embolisms, heart attack, and deep vein thrombosis (DVT), spending nearly $1.7 billion. As of May 2018, 63 Yaz and Yasmin lawsuits are pending in the multidistrict litigation (MDL No. 2100; In Re: Yasmin and Yaz Marketing, Sales Practices and Products Liability Litigation), which was formed in 2009 and is presided by Judge David R. Herndon in the Southern District of Illinois.

Evidence:

  • Indication of Yaz usage in Medical Records
  • Pharmacy records indicating usage of Yaz
  • Images of Yaz pills
  • Follow-up complications and their treatment after initiation of Yaz pills in medical records

Medical Record Review and claim validation of Yaz case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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