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Yasmin, YAZ, Ocella Injury Lawsuit

What is Yasmn, YAZ, Ocella

YAZ, also known as Yasmin or by its generic name Ocella is a birth control pill originally developed and manufactured by Berlex Laboratories, (a U.S affiliate of Schering AG). YAZ, Yasmin, Ocella (drospirenone and ethinyl estradiol) is a combination birth control pill which contain two types of hormones: estrogen and a progestin. It is the only 24/4-day pill with the unique hormone, drospirenone (drsp) and its manufacturer boasts that the product provides additional health benefits other then pregnancy prevention.

In 2006 Bayer AG acquired Berlex Labs and began marketing the product as a “different type of birth control pill”. The company claims that YAZ is the only birth control pill which can help treat the emotional and physical symptoms of PMDD (Premenstrual Dysphoric Disorder) while also reducing the effects of moderate acne. It the top-selling birth control pill in the United States with nearly 11-20 percent of the birth control pill  market share. In 2008, more than $600 million dollars of YAZ sales were made in the U.S.

Dangerous Side Effects Experienced After Taking Yasmin, YAZ, Ocella

yasminyazTragically, Yaz birth control has been found to cause a range of serious side effects, some of which have even resulted in sudden death. Some serious adverse events reported after using Yasmin, YAZ and/or Ocella include:

  • Heart Attack
  • Cardiac Arrhythmias
  • Stroke
  • Pulmonary embolism (an artery in the lung is blocked)
  • Blood Clots (Non-Vaginal)
  • Kidney Failure
  • Seizures
  • Deep Vein Thrombosis (DVT)
  • Gallbladder Disease
  • Hepaic Adenomas
  • Sudden Death

If you, or someone you love, experienced any of these symptoms after taking Yasmin, YAZ or Ocella and would like the attorneys at Nolan Law Group to review your case, please contact us.

FDA Birth Control Warnings

On several occasions Bayer AG/Berlex has been reprimanded the Food and Drug Administration over questionable advertising campaigns which suggest that Yasmin/Yaz has less side effects than other contraceptive medications. In 2003, 2008 and 2009 the FDA issued Bayer AG/ Berlex a warning letters regarding false claims being made in their television commercials, citing them for violations of certain Federal Food, Drug, and Cosmetic Act provisions. The warnings focused on the companies claim that YAZ has the ability to treat premenstrual syndrome (PMS) and all types of acne, while omitting or minimizing the significant risks associated with the drug.

If you, or someone you love, have been injured using Yasmin, YAZ or Ocella, and would like the attorneys at Nolan Law Group to review your case, please contact us.

Recent Yasmin, Yaz, Ocealla News/Articles/Links

As a result of the FDA warning letters, Bayer AG/Berlex stopped running the misleading ads about the birth control, and were forced to modify their advertising campaign, which cost the company almost $20 million dollars. Per stipulations in the settlement agreement, Bayer AG/Berlex must also submit all future TV ads to the FDA for pre-approval.

If you, or someone you love, have experienced birth control side effects from using Yasmin, YAZ or Ocella, and would like the attorneys at Nolan Law Group to review your case, please contact us.

Legal Rights

If you or someone you love have experienced birth control side effects after using Yasmin, YAZ or Ocella, you have the right to file a legal claim. Our attorneys can help you determine if you have a case and how to file a claim. All claims are handled on a contingency fee basis, meaning you do not have to pay attorney fees unless you are awarded compensation.

If you would like the attorneys at Nolan Law Group to review your case, please contact us.

YAZ Blog Entry 7/27/09: What Makes It Different and the FDA’s Involvement

By Stephanie L. Stalter- Associate

The popular birth control, Yaz and Yasmin (generically known as Ocella), differ from other oral contraceptives in that they contain a unique progestin component known as drospirenone.  Drospirenone, only recently approved for use in the drug in 2001, is not used in any other birth control pill approved in the United States.

Drospirenone creates a risk of increased potassium levels which can lead to hyperkalemia—a condition that, in many people, disrupts normal heart rhythms.  Disrupting normal heart rhythms can be fatal: disruption can slow the blood flow through the heart to the point that blood clots form.  Blood clots in the heart can lead to heart attack or can travel to other parts of the body—such as the lungs or the brain—thus causing pulmonary emboli or strokes. Therefore, because the birth control pill contains drospirenone, Yaz and Yasmin pose new and additional risks to young women who use oral contraceptives.

The risks associated with this popular birth control pill are severe; many women who took Yaz or Yasmin have died or been seriously injured because of the serious health risks associated with the drug.  In fact, the FDA received over fifty reports of Yaz and Yasmin-related deaths between 2004 and 2008, most involving increased levels of potassium and occurring in women as young as 17 years old.  Imagine how many went unreported!  A growing number of lawsuits have been filed by or on behalf of these women, charging the drug manufacturer with inadequately warning them of the increased risks Yaz and Yasmin pose to those women who use the oral contraceptive.

While the public-at-large and many physicians may not recognize an adverse reaction to drospirenone, the health risks have been known for longer than many realize.  In 2002, the British Medical Journal reported some practitioners’ concern about the drug as a result of 40 cases of venous thrombosis among women taking it.  Also, in 2003, the Journal published a paper that detailed reports of thromboembolism deaths and injuries thought to be caused by Yaz and Yasmin.

The FDA has been reprimanding Yaz and Yasmin manufacturers for misleading and inadequate television advertising for the drug for quite some time.

In one warning letter to the pill manufacturer, the FDA stated that the 2003 Yaz and Yasmin commercial entitled “Goodbye Kiss” was misleading to consumers.  The ad implied to consumers that the drug was clinically superior to other oral contraceptives.  The FDA stated that it was unaware of any evidence demonstrating that the drug was superior to other oral contraceptives or that drospirenone was clinically beneficial.  More correctly, the FDA was only aware of the added clinical risks associated with Yasmin and Yaz.  Second, while the ad noted drospirenone’s tendency to increase potassium, that effect was portrayed as a benefit of the drug rather than its true nature as a significant health risk.  The FDA stated “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.”  As a result of the FDA’s 2003 warning letter, the drug manufacturer was ordered to immediately discontinue the television ads and all other similar promotions.

Since then, new commercials for the popular birth control have aired, but not without further FDA involvement.  Last October, the FDA again admonished Yaz and Yasmin manufacturers for television advertising for the drug, finding that the ads, again, misled consumers.  This time, two separate ads were found to be misleading in violation of numerous regulations because they “encourage[d] use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with YAZ.”  The ads broadened the indications of the drug by implying that it treated not only symptoms of premenstrual dysphoric disorder (PMDD) but also symptoms of PMS, a less serious condition.  This was problematic considering the fact that the drug had never been evaluated for treatment of PMS.  The most startling aspect of these commercials is the downplaying of the risks involved with taking Yaz and Yasmin:  There were distracting visuals, numerous scene changes, and background music playing as the serious health risks were being communicated.  The FDA stated “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.”  As a result of this warning letter, the FDA required Bayer, the Yaz and Yasmin manufacturer, to cease running these ads and any similar misleading promotions.  Bayer was also required to run correction ads, an uncharacteristic move for the FDA.  The new corrective ad is meant to clear up the misconceptions conveyed in Yaz’s previous advertising campaigns.  Correcting these misleading ads cost Bayer upwards of $20 million and will hopefully curtail further misleading information about this popular birth control pill.

Discouraging Bayer from running misleading ads may not, however, be as easy as originally thought.  Bayer has received yet another warning from the FDA, this time for its sponsored links on internet search engines.  The FDA found the Yaz sponsored link to violate various regulations because it omitted risk information associated with the use of the drug, overstated its indications, and did not use the full established name of the drug being promoted.  Promotional materials are required to disclose risk and other information about the drug but the sponsored link for Yaz merely states “YAZ Prevents Pregnancy, May Help Moderate Acne and PMDD” and provides a link to the Yaz website.  Such a listing is misleading because it fails to mention any risk information, thus implying the drug is safer than it has been shown to be.

If you, or someone you love, have experienced birth control side effects from using Yasmin, YAZ or Ocella, and would like the attorneys at Nolan Law Group to review your case, please contact us.

YAZ Blog Entry 8/21/09: Eye on Litigation

YAZ lawsuits are increasing throughout the country.  As of recently, a total of 32 federal lawsuits have been filed throughout the United States on behalf of YAZ victims.  These suits state claims sounding in strict liability, negligence, and failure to warn.

On July 24, 2009, lawyers representing YAZ victims filed a petition with the United States Judicial Panel on Multidistrict Litigation seeking consolidation and centralization of all federal Yasmin and YAZ suits in front of Judge Carr in the United States District Court for the Northern District of Ohio.  Consolidating all of the cases in a multidistrict litigation (MDL) would bring all individual cases in front of one judge for pretrial purposes, such as discovery, depositions, and settlement discussions.  Utilizing an MDL promotes efficiency and consistency—rather than having many individual cases throughout the country, each and every case is grouped in front of a single court prior to trial.  The Panel will hold a hearing on September 24, 2009 to determine if consolidation in the MDL is appropriate.

The suits are against Bayer Pharmaceuticals Corporation and other Bayer related companies—companies responsible for the manufacturing of Yasmin and YAZ products.

Bayer is a global medical conglomerate which has reported sales in the billions of dollars since the launch of Yasmin and YAZ in the birth control market in 2001.  This birth control has been reported as one of the highest earning drugs manufactured by Bayer in recent years.  In 2008, Bayer made more than $600 million dollars from it!

Despite the growing numbers of lawsuits against it, Bayer is still raking in huge profits from women who use YAZ and Yasmin.  It recently published its 2009 Second Quarter Financial Report labeling the group of YAZ contraceptives to be its best selling pharmaceutical line with an increase of 4.1% since last quarter.  Its combined sales from these drugs amounted to an astonishing $915 million for just the first half of 2009!  Showing just how large of a company Bayer is, these YAZ products account for about 12.32% of all of Bayer’s pharmaceutical sales during this second quarter of 2009.

Interestingly, Bayer’s report mentions another type of progestin that may be used in its drugs.  In October 2008, Bayer announced European approval for the launch of a new oral contraceptive using yet another new synthetic progestin called Dienogest.  In its release, Bayer states “For the first time, the use of estradiol in oral contraceptives is made possible with Qlaira® through the combination of estradiol with the progestin dienogest in a unique dosing regimen.”  The product is currently unavailable in the United States; it is only available in certain European countries, including Germany.  However, Bayer states that “further launches are planned for the fall of 2009.”  This will be an interesting development if the drug is approved for use in the United States.

Two recent articles published in the British Medical Journal confirm the dangerous risks posed by YAZ and Yasmin.  One of those studies assesses the thrombotic risk associated with the oral contraceptive and the other likewise assesses the increased risk of venous thrombosis in women using these contraceptives.

If you, or someone you love, have experienced birth control side effects from using Yasmin, YAZ or Ocella, and would like the attorneys at Nolan Law Group to review your case, please contact us.

Yasmin/Yaz and Increased Risk Of Gallbladder Injuries

By Kevin P. Horan – Associate

While it is now well-known that the birth control pills Yasmin, Yaz, and Ocella are assocated with increased risk of blood clots, pulmonary embolism, deep vein thrombosis (“DVT”), heart attack, and stroke, recent reports indicate that these birth control pills may also be connected to gallbladder problems as well.

Yaz and Yasmin contain drospirenone, a diuretic that can drastically increase a woman’s potassium levels. This condition is known as hyperkalemia. Increased potassium levels can lead to both blood clots and gallbladder damage.

Recent data suggests a spike in gallbladder disease and the presence of gallstones among otherwise healthy women. The only connection appears to be that these women are all taking one of these drospirenone-containing birth control medications.

Gallstones are formed by a concentration of bile constituents. While the cause of gallstones varies, some stones form when there is too much cholesterol or bilirubin in the bile. (Bile is a liquid that helps the body digest fats.) Other stones form if there are not enough bile salts or if the gallbladder fails to empty properly.

It is believed that Yaz can increase cholesterol levels in bile while simultaneously decreasing gallbladder movement, leading to gallstones.

Recent reports of injuries ranging from chronic gallstones to gallbladder removal surgery are coming from all across the country. In cases of gallbladder removal, a procedure known as a cholecystectomy, the victim can suffer from impaired digestion, bloating, gas, heartburn, constipation or diarrhea. In addition, many of those who undergo gallbladder removal surgery must make drastic changes to their diet and eating habits.

Symptoms that may occur include:

  • Abdominal pain in the right upper or middle upper abdomen:
  • May be recurrent
  • May be sharp, cramping, or dull
  • May spread to the back or below the right shoulder blade
  • May be made worse by fatty or greasy foods
  • Occurs within minutes of a meal
  • Fever
  • Yellowing of skin and whites of the eyes (jaundice)

Additional symptoms that may be associated with this disease include:

  • Abdominal fullness
  • Clay-colored stools
  • Excess gas
  • Heartburn
  • Indigestion
  • Nausea and vomiting

If you, or someone you love, experienced any of these symptoms after taking Yasmin, YAZ or Ocella and would like the attorneys at Nolan Law Group to review your case, please contact us.