As many as 50 deaths have been attributed to YAZ / Yasmin ® oral contraceptives to date. In 2003 and again in 2008 the Federal Food and Drug Administration (FDA) issued severe warnings in connection with the advertising claims made by the manufacturer, Bayer. Robinson, Calcagnie & Robinson has filed cases against the manufacturers of Yasmin®, Yaz® and Ocella® for injuries suffered by women who took these oral contraceptives.

The Defective Pharmaceuticals & Medical Devices litigation group at Robinson, Calcagnie & Robinson has experienced trial lawyers who focus on representing plaintiffs in oral contraceptive litigation. If you, or a family member, have suffered serious injury, coma or death stemming from the use of Yaz®, Yasmin® or Ocella®, contact the personal injury attorneys at Robinson, Calcagnie & Robinson today to schedule an appointment.

Click Here for a YAZ / Yasmin Lawsuit Evaluation.

The oral contraceptives Yaz ®, Yasmin ® and its generic equivalent Ocella® have been linked to serious circulatory and gallbladder diseases. A key in ingredient in these drugs is believed to raise blood potassium levels to a dangerous level resulting in several potential injuries, including:

• Heart attacks
• Strokes
• Blood Clots
  • Pulmonary embolism (PE)
  • Deep vein thrombosis (DVT)
• Liver tumors
• Death
• Heart attacks (and other cardiac events, such as arrhythmias)
• Strokes and TIA
• Kidney (renal) disease
• Gallbladder removal
• Pancreatitis
• Myocardial infarctions
• Other thrombosis events
  

In addition certain women may be at elevated risk of injury when using these contraceptives, including women with high blood pressure, high levels of blood potassium, kidney or liver impairment, adrenal gland abnormalities or women who are obese or diabetic.

Symptoms of blood clots require immediate medical attention and may include:

• Sudden severe headaches
• Unusual swelling or pain in extremities
• Sharp or crushing chest pain
• Coughing up blood
• Eye problems such as blurred / double vision or complete loss of vision
• Pain in the back of the lower leg

Click Here for a YAZ / Yasmin Lawsuit Evaluation.

Yasmin®, Yaz® and Ocella® are the first, and only, birth control medications on the market which utilitze the fourth generation formulation of synthetic progesterone called drospirenone, coupled with a type of estrogen called ethinylestradiol. This unique formulation has a diuretic effect which can increase the blood potassium levels in users, resulting in development of blood clots, gallbladder damage and other injuries. Untreated, these symptoms may result in severe injury and even death.

Yasmin® was approved by the FDA in 2001 for both birth control and treatment of Premenstrual Dysphoric Disorder (PMDD) and later Yaz was also approved for treatment of severe acne. The highly popular oral contraceptive Yasmin® and its descendants Yaz® and Ocella® have increased risk of blood clots, heart attacks and strokes similar to those linked with other birth control medications and devices like the Nuvaring ®and Ortho Evra® patch, however, Yasmin® and its descendants have added the serious risk of severe gallbladder disease. Often surgical removal of the gallbladder is the only option for treatment.

Bayer, the manufacturer of both YAZ and YASMIN received warnings in 2003 for YASMIN® and 2008 for YAZ® from the Federal Food and Drug Administration (FDA) for both overstating the benefits and minimizing the serious safety risks of the oral contraceptive drugs. Under a federal law that prohibits promotion of drugs for uses not approved by the Federal Food and Drug Administration (FDA) Bayer was required to mount a $20 million advertising campaign to correct its previous misleading YAZ advertisements.

Yaz® lawsuits are lengthy and difficult endeavors that require a tremendous amount of investigation and work. A law firm must navigate several strict filing rules, including state or federal deadlines, in addition to determining which pharmaceutical companies, patch manufacturers, healthcare providers or companies in the distribution chain should bear responsibility for contributing to the death or injury. Robinson, Calcagnie & Robinson evaluates every lawsuit on an individual basis before determining whether the firm will represent a plaintiff. This evaluation may include reviewing medical records from prescribing doctors, hospitals, pharmacies and the Offices of the City or County Medical Examiner, and speaking with key witnesses near the victim at or near the time of their death or injury. Upon a favorable review of this information by our team of medical experts and attorneys, clients will be retained and a product liability lawsuit will be filed against all defendants responsible for the client’s damages.

Click Here for a YAZ / Yasmin Lawsuit Evaluation.

Note: If you believe you have a potential Yasmin®, Yaz® or Ocella® lawsuit, keep any and all containers and boxes that are still in your possession. Do not return or destroy any remaining pills.

Publication Petition to the FDA to Ban Third Generation Oral Contraceptives Containing Desogestrel due to Increased Risk of Venous Thrombosis (HRG Publication #1799)

FDA Sanction Letters to Defendants Relating to Yaz/Yasmin

Below are a series of FDA letters relating to Drospirenone-containing oral contraceptives.
Since the introduction of Yaz, Yasmin and Ocella into the market, there have been a total of 4 FDA Warning Letters relating to Drospirenone-containing oral contraceptives.

7/10/03 FDA Letter #1 Requiring Discontinuation of Misleading Yasmin Ads

a.       Improperly Implied Superiority to Other Oral Contraceptives:  FDA found Yasmin ads “are misleading because they imply superiority to other COCs (and thus do not offer the same product benefits as Yasmin Tablets) when such has not been demonstrated by substantial evidence or substantial clinical experience.”
 
b.      Ads Minimized Health Risks of Yasmin:  “Thus, by failing to add the necessary context to clarify that increased blood potassium is a safety risk rather than a clinical benefit, the ad misleadingly represents or suggests that Yasmin is safer than has been demonstrated by substantial evidence or substantial clinical experience.  The TV ad not only misleads consumers about the efficacy of Yasmin, the ad also minimizes important context about the health risks of the drug.”
 
c.       Order to Discontinue Ads:  FDA ordered Defendants to “immediately discontinue the TV ad and all other promotional materials and activities for Yasmin that contain the same or similar violative presentations.

10/3/08 FDA Letter #2 Requiring “Bayer to immediately cease dissemination” of its “Not Gonna Take It” and “Balloons” Ads

a.       Bayer’s "Not Gonna Take it" and "Balloons" Ads Are Misleading:  “FDA requires Defendants to cease “two 60-second direct-to-consumer (DTC) broadcast television advertisements (TV Ads) entitled ‘Not Gonna Take it’ (ZYRA-6323) and ‘Balloons’ (ZYRA-6567) for YAZ (drospirenone and ethinyl estradiol) Tablets (YAZ) submitted by Bayer HealthCare Pharmaceuticals, Inc. (Bayer) under cover of separate Forms FDA-2253 … are misleading because they broaden the drug's indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug.  Thus, the TV Ads misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), 352(f)(1) & 321 (n), and FDA's implementing regulations. 21 CFR 201.1 OO(c)(1); 201.128; 202.1 (e)(5)(iii) & (e)(6)(i).”
 
b.      Misuse of Selective PMDD Symptoms to Suggest PMS Relief:  “The totality of the visual and audio presentations in both TV ads suggest that YAZ approved to treat women with any severity of the symptoms presented, including women with PMS, when this is not the case.“  “[G]iven the overlap in certain symptoms between premenstrual syndrome (PMS) and PMDD, and the material limitation on YAZ’s PMDD indication (that it has not been evaluated for the treatment of the less serious condition, PMS), the TV Ads misleadingly suggest that YAZ is appropriate for treating women with PMS, who may not be appropriate candidates for this drug.”
 
c.       Overstated Acne Benefits:  “[T]he TV Ads suggest that YAZ is approved for acne of all severities when this is not the case… These presentations fail to adequately convey that, as noted in the PI, ‘YAZ is indicated for the treatment of moderate acne vulgaris...’  The percentage of subjects assessed by the Investigator's Static Global Assessment (ISGA) with a 'clear' or 'almost clear' rating at day 15 of cycle 6 was 15% and 21% for subjects receiving YAZ versus 4% and 9% of placebo subjects in Studies 1 and 2, respectively. … [These studies] do not demonstrate that YAZ results in clear, acne-free skin for a typical woman; rather, these results demonstrate that it reduces the amount of acne lesions more than placebo but does not result in completely clear skin for these women. Thus, the TV Ads misleadingly overstate the efficacy of the drug.”
 
d.      Distracting Background and Action in Ads Minimize Risk:  “The audio communication of serious risk disclosures during the ‘major statement’ is minimized by distracting visuals, numerous scene changes, and other competing modalities such as the background music which combine to interfere with the presentation of the risk information. In ‘Not Gonna Take It’, the fast-paced visuals depict various women looking at pictures, trying on clothes, chatting at a cafe, stretching/exercising in a park, and walking down the street while the audio component describes the major risks associated with YAZ.  Similarly, in ‘Balloons,’ the background music plays as fast-paced visuals depict various women running in a park, sitting on a scenic waterfront, smiling, walking out of a coffee shop, driving and singing, walking out on a balcony, using an elevator, walking through the street to join friends, in addition, to a pigeon on a building ledge and balloons being released and floating away. These complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed. This is particularly troubling as some of the risks being conveyed are serious, even life-threatening. The overall effect of the distracting visuals, graphics, concurrent supers and background music is to undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that YAZ is safer than has been demonstrated by substantial evidence or substantial clinical experience.”
 
e.      Order for “Bayer to Immediately Cease Dissemination”:  “DDMAC asks Bayer to immediately cease dissemination of violative promotional materials for YAZ that are the same as or similar to those described above… Because the violations described above are serious, we request, further, that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.”

3/26/09 FDA Letter #3 Finding Bayer’s Yaz Internet Links “in violation of the Federal Food, Drug, and Cosmetic Act and FDA implementing regulations

8/5/09 FDA Letter #4 Finding Failed to Properly Test Yaz/Yasmin Ingredients Shipped to the United States

a.       “U.S. Food and Drug Administration (FDA) Investigator Jose Cruz and Chemist Miguel Martinez[‘s] inspection revealed significant deviations from U.S. current good manufacturing practices (CGMP) in the manufacture of non-sterile API’s [active pharmaceutical ingredients, for Yaz and Yasmin].”

i.      Bayer’s “Laboratory controls are deficient in that your firm has established procedures that allow for the averaging of out-of-specification (OOS) and within-specification analytical test results from separate samples. The use of these approved procedures resulted in API batches being released to the U.S. market based on passing averaged assay results.”

b.      “In all cases, your firm concluded that no analytical errors had been identified and that the values were true DOS results. Your firm concluded that these OOS results were within the accepted variation of the analytical method and that the quality of these batches was not affected. We disagree with your rationale and conclusion. An assay test is used to determine potency, not method variability. The validation of your analytical method should address robustness or variability, while system suitability is designed to address instrument variation performance, which was met in each of these instances. We believe that these results were true ODS values and that these batches should not have been released for distribution.”
 
c.       “You state that this is appropriate averaging and in line with the FDA OOS guidance document. We disagree with your rationale and interpretation of the FDA OOS guidance. Your firm prepares two to three separate samples, which are assayed individually. We expect you to treat each of these results independently, and not to average an OOS result with a passing individual result. The hiding of an OOS result in the average is an unacceptable practice.”
 
d.      “Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm's compliance with CGMP, this office may recommend withholding approval of any new applications or supplements listing your firm as an API manufacturer. In addition, failure to correct these deficiencies may result in FDA denying entry of articles manufactured by your firm into the United States.”

Click here to view a recent BMJ Study showing that risk of blood clots in YAZ/Yazmin users is double the risk of most oral contraceptives on the market.

Click here to view the Dutch Warning for DSRP/ EE oral contraceptives.