Yaz

  • Yaz Medical Record Review & Outsourcing Services

Yaz (drospirenone+synthetic ethinyl estradiol) is manufactured by Bayer HealthCare Pharmaceuticals Inc. The drug approved by the FDA on March 16, 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 the 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 the mucus in the cervix and also by changing the uterine lining, thereby preventing pregnancies. Yaz 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 through 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.

Lawsuit Allegations:

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.

Evidences:

  • 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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