YAZ, Ocella, and Yasmin are oral contraceptives that produced over $1 Billion in sales in the United States and $1.8 Billion worldwide in 2008. These birth control pills are oral contraceptives that have been heavily marketed by Bayer HealthCare Pharmaceuticals, Inc., however, the FDA has found that past marketing campaigns were misleading as it minimized the potential health risks that have been associated with these oral contraceptives. These health risks include sudden death, cardiovascular problems, blood clots, heart attacks, stokes, and gallbladder disease.
If you believe that you or a loved one has suffered serious medical problems related to the use of YAZ, Yasmin, or Ocella, please contact a doctor immediately. Additionally, if you have lost a loved one who was taking one of these birth control medications from a sudden heart attack, stroke, pulmonary embolism, or gallbladder disease, please report the incident to the deceased's doctor and FDA. For more information on YAZ, Yasmin, or Ocella lawsuits, please feel free to contact Texas YAZ, Ocella, and Yasmin Lawyer Jason Coomer or use our online submission form.
Yaz, Yasmin, and Ocella Birth Control Medications Contain Drospirenone (DRSP) that has been Associated with Serious Health Risks
YAZ and Yasmin are combined oral contraceptive (COC) pills that contain ethinylestradiol (EE) and drospirenone (DRSP). These birth control medications are manufactured by Bayer HealthCare Pharmaceuticals, Inc., while Ocella is the generic equivalent of Yasmin that is manufactured by Barr Laboratories. Each of these birth control medications contain ethinyl estradiol and the new "fourth generation" progestin drospirenone (DRSP). Drospirenone is known for increasing the risk for hyperkalemia and these DRSP oral contraceptives have been associated with adverse health effects such as Death, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Strokes, Heart Attacks, Gallbladder Disease, and other health problems.
YAZ Marketing Campaign Created Annual Revenues of over $600 Million, but Overstated Drug Benefits and Understated Drug Dangers
The FDA has found that Bayer's marketing campaign that was directed at young women for the birth control drug, YAZ, was misleading. The misleading marketing campaign allowed YAZ to become the best-selling oral contraception pill in the United States with annual sales revenue of over $600 million in 2008, but understated the birth control medications' health risks.
Through the efforts of the FDA and several states' Attorney Generals, the manufacturer and marketer of the oral contraceptive YAZ was required to run a $20 million advertising campaign for the purpose of correcting previous YAZ marketing statements and will be required to submit all future YAZ ads for the next six (6) years to the FDA for screening.
The YAZ ads allegedly overstated the pill's ability to improve women’s moods and clear up acne, while not fully warning of the drug's potential serious side effect health risks including Death, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Strokes, Heart Attacks, Gallbladder Disease, and other health problems.
Recent FDA and Attorney Generals Take Action to Correct the YAZ Marketing Campaign Making Sure Bayer Does Not Understate Drug Dangers and Risks
In October 2008, the FDA took action against Bayer sending a warning letter to Bayer saying that two television ads overstated the drug’s benefits while understating its risks. The FDA warning letter stated that two 60 second direct to consumer broadcast television advertisements entitled "Not Gonna Take it" and "Balloons" submitted by Bayer HealthCare Pharmaceuticals, Inc. were "misleading because they broaden the drug's indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug". Further, that these televisions advertisements "misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act".
The FDA had approved YAZ as a birth control pill that has a side benefit in treating a very specific mood-related psychological problem called "premenstrual dysphoric disorder" and improving moderate acne, however, Bayer overstated the drug's efficacy and minimized its potential dangers.
FDA Action against Yasmin for Minimizing Health Risks in 2003 Suggests Bayer May Have Had Prior Knowledge of Misleading Marketing that Minimized YAZ Health Risks
The contraceptive medication, YAZ, closely resembles another birth control medication, Yasmin. Both drugs contain contain ethinyl estradiol and the "fourth generation" progestin drospirenone (DRSP). Yasmin has been the subject of a similar FDA warning letter in 2003 that warned the manufacturer and marketer that their marketing advertisements were understating potential health risks and overstating the benefits of the birth control medication. At that time Yasmin was manufactured and marketed by Berlex Laboratories.
In 2006, Bayer HealthCare Pharmaceuticals, Inc. acquired Berlex Laboratories. Bayer now markets both oral contraceptives, YAZ and Yasmin which had sales of about $1.8 Billion in 2008.
Health Risks Related to the Oral Birth Control Mediations
Yaz, Yasmin, and Ocella
YAZ, Yasmin, and Ocella contain drospirenone (DRSP), a synthetic progestational compound that can cause serious side effects and has been associated with serious health problems including formation of dangerous blood clots, strokes, pulmonary embolisms (PE), gallbladder disease, deep vein thrombosis (DVT), heart attacks, and sudden death. Yaz and Yasmin are combined oral contraceptive (COC) pills that contain ethinylestradiol (EE) and drospirenone (DRSP). Both have been linked to blood clots and cardiovascular events as well as other serious health risks.
While it has long been known that taking a combined oral contraceptive (COC) pill with a combination of estrogen and a progestin hormone can increase the risk of stroke and blood clots in the legs and lungs, the health risks of newer synthetic should have been deceptively marketed as having less health risks with other benefits that the contraceptives do not have.
In October 2008, the Food and Drug Administration (FDA), concerned with the improper advertising of the YAZ/Yasmin/Ocella birth control drugs, issued a warning letter to the Bayer Corporation to cease unlawful promotion. Also, women who have taken these popular oral contraceptives reported serious side effects, including blood clots, stroke, gallbladder complications and heart attack as a result of taking the drugs.
It is thought that these birth control medications contain hormones the effect cholesterol metabolism and excretion into the gallbladder thereby affecting the cholesterol concentration and crystallization of bile acids in the secretions leading to gall stones and its sequelae as well as can lead to clots, strokes, or heart attacks.
Manufacturing Concerns for the Oral Birth Control Mediation, Yaz
In September 2009, the Food and Drug Administration issued another warning letter that its inspectors had uncovered testing problems at Bayer's plant in Berghamen, Germany. The FDA inspectors said the company measured the quality of its drug ingredients based on an average of several samples, instead of reporting individual tests results. Bayer shipped eight drug batches to the U.S. that were tested using the method, which the FDA does not accept.
In this August 5, 2009 FDA Warning Letter to Bayer, the agency told the drug company that about eight batches of ingredients used in the drugs Yaz, Yasmin, and Angeliq "should not have been released for distribution".
Off Label Drug Marketing of Yaz, Yasmin, and Ocella Birth Control
Off label drug marketing occurs when a drug is marketed beyond its approved FDA uses. When combined with false certifications to the United States Government, off label healthcare whistleblower fraud claims can arise. For more information on Off Qui Tam Fraud Claims.
Pharmaceutical Fraud, Bad Drug, and Product Liability Lawsuits
Product Liability Lawsuits including YAZ Lawsuits, Ocella Lawsuits, Yasmin Lawsuits, Drospirenone (DRSP) Lawsuits, and other defective drug & false marketed drug cases, can be complicated lawsuits. This is especially true if a young woman is killed by a defective drug or suffers catastrophic injuries from using a deceptively marketed drug.
Because of the complexity of these lawsuits, product liability claims including defective drug claims are often consolidated into one federal court or jurisdiction for resolution. This process typically helps the court and the parties so that they do not have to litigate the same issues multiple times.
As a Texas Pharmaceutical Fraud, Bad Drug and Product Liability lawyer, Jason Coomer commonly works with other Lawyers throughout the United States as well as in Texas. In working with other YAZ, Yasmin, and Ocella lawyers, we seek compensation from negligent drug companies and other companies that have severely injured or killed young women selling dangerous products, medications, and drugs that they should have known were dangerous, but intentionally mislead consumers and hid dangerous health risk in order to sell more product to make a profit.
If you have suffered a serious injury that you believe is related to the use of YAZ, Yasmin, or Ocella or a woman close to you has suffered serious health problems or has died while using YAZ, Yasmin, or Ocella, it is important to contact a doctor and the FDA to report the incident. If you have any questions about a Yasmin, Ocella, or YAZ lawsuit or this webpage, feel free to contact Austin Texas Ocella, Yasmin, YAZ Attorney, Jason S. Coomer.