Category: Yaz/Yasmin and Ocella

Bayer released a series of Saturday-morning-style cartoons for sales representative training purposes, which they seemingly hoped would motivate their sales reps to continue marketing their birth control drugs, including Yaz. One particular cartoon is entitled “IndiYaz A Jones and the Temple of Estradiol.” Estradiol is a hormone that is contained in the Yaz contraceptive, which is sold by Bayer. The cartoons, created by an animator at Bayer in 2008, were apparently only meant for internal training purposes. They contain a variety of different pitches that can be imitated and articulated by the sales representatives at Bayer.

The cartoons contain dialogue about the drug in a theatrical format, as if IndiYaz A Jones is searching for the pills. The cartoons are supposed to mimic the classic Indiana Jones movies starring Harrison Ford. These odd cartoons were only used for training purposes, and were not intended to be released to the public. When a YouTube user got a hold of the episodes and posted them online, Bayer demanded the cartoons be promptly removed.

Yaz and Yasmin birth controls can be dangerous, no matter what an experienced sales representative or a cartoon tells you. They may leave women with horrific side effects, including heart attack, stroke, deep vein thrombosis or pulmonary embolism.

If you have suffered a heart attack, stroke, deep vein thrombosis or pulmonary embolism while taking YAZ® or Yasmin®, contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, to help you assess any claims that you might have against the YAZ® or Yasmin® manufacturers.

As previously reported, in December 2011, the Federal Drug and Administration (FDA) ruled that the label warning on Bayer Yaz and Yasmin regarding the increased risk of blood clots was inadequate. The decision followed a nine-hour hearing during which the FDA’s Advisory Committee listened to testimony and, according to the FDA website, “discuss[ed] the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel.”

As part of its December 2011 ruling, the FDA ordered that Bayer revise its label to warn of the higher risk of blood clots, although no timetable for the changes was set. In April 2012, Bayer announced that it was changing its label to report that some studies show that the risk of blood clots for women taking Bayer Yaz or Yasmin may be three times higher than women who were taking pills containing levonorgestrel or some other progestins. However, the label will also note that other studies have shown there to be no greater risk for blood clots. A summary of the results of the FDA-funded study will also be included.

If you have suffered a heart attack, Yaz stroke, deep vein thrombosis or pulmonary embolism while taking YAZ® or Yasmin®, contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, to help you assess any claims that you might have against the YAZ® or Yasmin® manufacturers.

In June 2012, a study, published in the New England Journal of Medicine, reported that that birth control products containing combined estrogen-progestin, such as Yaz or Yasmin, may double a woman’s risk of stroke and heart attack compared to other hormonal contraceptives. The study, based on data compiled over 15 years from more than 1.5 million women between the ages of 15 and 49, compared the heart risks from other forms of hormonal contraception. The researchers found that women using birth control which combined low-dose estrogen with progestin, such as Yaz or Yasmin, were up to twice as likely to suffer a heart attack or stroke as a woman who did not use a hormonal contraception. The study went on to further note that women with high blood pressure or diabetes or were over the age of 35 were at an even higher risk.

The labels on Yaz and Yasmin were revised in April 2012, following the December 2011, ruling by the Federal Drug and Administration (FDA) that the label warnings on Yaz and Yasmin regarding the risk of blood clots were inadequate.

If you have suffered a Yaz stroke, heart attack, deep vein thrombosis or pulmonary embolism while taking YAZ® or Yasmin®, contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, to help you assess any claims that you might have against the YAZ® or Yasmin® manufacturers.

Following the December 2011, ruling by the Federal Drug and Administration (FDA) that the label warnings on Yaz and Yasmin failed to adequately warn against the increased risk of blood clots, Bayer began contacting Plaintiffs across the country to settle their Yaz lawsuit. In April 2012, a Bloomberg article reported that Bayer had already settled more than 600 cases involving women who had suffered a heart attack, Yaz stroke, deep vein thrombosis or pulmonary embolism for a combined total of $142 million dollars. The breakdown of the average recovery is difficult to predict as the cases are individually evaluated based on the specific injury. Unfortunately, at this time, Bayer is not negotiating the settlement of women who allegedly developed Yaz gallbladder disease as a result of taking the drug, but Plaintiffs’ counsel are still hopeful of their ultimate resolution.

According to a recent Bloomberg article, Yaz remains the fourth best-selling oral contraceptive on the market, earning Bayer $1.5 billion in 2010. It is projected that Bayer may ultimately pay over $2 billion dollars to settle the pending lawsuits, which at one time totaled more than 11,000 cases. Bayer’s counsel is continuing to schedule meetings with law firms nationwide to discuss settlement.

If you have suffered a Yaz stroke, heart attack, deep vein thrombosis or pulmonary embolism while taking YAZ® or Yasmin®, contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, to help you assess any claims that you might have against the YAZ® or Yasmin® manufacturers.

Recently, the Plaintiffs’ Steering Committee in the Yaz and Yasmin litigation opposed a motion to exclude the opinions of former Food and Drug Administration (FDA) commissioner, David Kessler, concerning possible conflicts of interest.  The Plaintiffs’ attorneys have asked Judge Herndon, who is overseeing the federal Yaz and Yasmin cases, to allow in evidence showing that conflicts of interest may have tainted the meetings of an independent advisory committee to the FDA that was asked to consider the health risks associated with Yaz and Yasmin.

Specifically, it is alleged that four members of the FDA advisory committee that voted not to remove Yaz and Yasmin from the U.S. market received significant sums of money from Bayer and Bayer Pharmaceuticals, the manufacturers of Yaz and Yasmin.  Ultimately, the FDA advisory committee voted 15-11 to keep the oral contraceptives on the market, concluding that the benefits of Yaz and Yasmin outweigh the risks.  Plaintiffs contend that either Bayer hid the ties to the four members of the advisory committee from its experts or its experts intentionally omitted the ties from their reports.  Not surprisingly, the FDA has defended the findings of its advisory committee.

As previously reported, Judge Herndon recently ordered both sides to mediation, which postponed the initial trial date to April 30, 2012, if mediation is not successful.

If you feel you have experienced any side-effects from taking YAZ® or Yasmin®, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the YAZ® or Yasmin®  manufacturers.

The first federal Yaz trial is not moving forward as planned.  While the highly anticipated trial was originally scheduled to begin the second week of January 2012, Judge Herndon, who is overseeing the federal Yaz cases in the Southern District of Illinois, has now ordered both sides to mediation.

On December 31, 2011, Judge Herndon appointed Professor Stephen Saltzburg of George Washington School of Law as Special Master, for the purposes of mediation.  Professor Saltzberg previously handled the mediation in over 25,000 Seroquel lawsuits.  In his Order, Judge Herndon opined that the interests of the plaintiffs and defendants will be “better served” by entering into mediation.  He further ordered the parties to meet with Professor Saltzburg without delay and to negotiate in good faith.  Pending the outcome of the mediation, Judge Herndon’s December 31, 2011, Order has stayed the scheduling in the balance of the bellwether federal cases.

However, Judge Martinotti, who is overseeing the New Jersey Yaz cases in Bergen County, New Jersey, has advised counsel for both parties to continue with bellwether discovery, including depositions.  While probably hopeful that the mediation in the federal case will have a positive effect on all Yaz cases, nationwide, Judge Martinotti likely does not want to delay the New Jersey cases, in the event that a settlement is not reached.  A Case Management Conference is currently scheduled for February 2012.

Interestingly, the alternative plan to send the parties to mediation comes on the heels of the Food and Drug Administration (FDA) voting 21 to 5 that the label on Yaz and Yasmin did not adequately warn users about the risk of blood clots, which is higher than other oral contraceptives.  The FDA further found that the label did not adequately warn about the increased risks for those users who smoke or are overweight.

If you feel you have experienced any side-effects from taking YAZ® or Yasmin®, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the YAZ® or Yasmin®  manufacturers.