Recent Blog Posts

Yaz/Yasmin Settlements Grow to $142 Million

Jennifer Williams — Thu, 26 Apr 2012 21:28:00 GMT

Bloomberg news reported today that Bayer announced it has settled 651 cases alleging that its birth control pills, Yaz and Yasmin, caused sometimes-fatal blood clots that can lead to deep vein thrombosis, pulmonary embolisms, heart attacks and strokes. According to Bayer, the company has paid $142 million in the settlements, for an average of about $218,000 a case.

The Bayer report also stated that the drugmaker "is only settling claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) after a case specific analysis of medical records.”

On April 13, 2012, Bloomberg had reported that Bayer had agreed to settle the first 500 suits for about $110 million.

According to the Bloomberg report, this settlement update comes less than two weeks after Richard Vosser, a JPMorgan Chase & Co. analyst, said Bayer may have to pay more than $2.65 billion to resolve all the cases over the contraceptives Yasmin and Yaz.

The Yaz/Yasmin franchise of oral contraceptives generated $1.58 billion in sales in 2010.

Bayer Reportedly Settled 500 Yaz / Yasmin Lawsuits

Jennifer Williams — Tue, 17 Apr 2012 19:56:00 GMT

Last week Bloomberg news reported that Bayer AG, Germany's largest drugmaker, has agreed to pay at least $100 million to settle about 500 lawsuits involving Bayer's oral birth control pills, Yaz and Yasmin. The settlements come after several years of litigation involving cases filed by women who suffered deep vein thrombosis and pulmonary embolism while taking Yaz and Yasmin.

According to reports, the settlements require Bayer to pay an average of approximately, $220,000 per case to resolve claims that Yaz and Yasmin caused blood clots that were sometimes fatal. The clots can also lead to heart attacks and strokes.

Bayer had previously disclosed settlements in about 70 similar Yaz and Yasmin lawsuits. Bayer has said it will continue to consider settling individual lawsuits in the United States on a case-by-case basis.

If you took Yaz, Yasmin or Ocella and suffered a pulmonary embolism, deep vein thrombosis, heart attack or stroke, there is still time for our lawyers to provide you with a free case evaluation. Contact one of our Yaz / Yasmin Lawyers today.

FDA Announces Label Change for Yasmin and Yaz

Jackson Allen Williams, LLP — Tue, 10 Apr 2012 22:33:00 GMT

The FDA announced to today that the drug labels for drosperinone-containing birth control pills, including Yasmin and Yaz, will be changed to include warnings regarding the increased risk of blood clots for women taking these pills. According to the announcement the new label will

report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

The FDA advises women to talk to their doctors about their risk for blood clots before deciding which birth control method to use and advises healthcare professional to consider the risks and benefits of drospirenone-containing birth control pills and a woman's risk for developing a blood clot before prescribing these drugs.

This announcement follows hearings held by the FDA in December regarding this thromboembolic risk for Yasmin and Yaz. The hearings highlighted the numerous women who have suffered deep vein thrombosis, pulmonary embolism and even death while taking these birth control pills. Our lawyers attended the FDA hearings and one of our clients' presented their story to the FDA.

If you suffered from a blood clot (deep vein thrombosis, pulmonary embolism, stroke) while taking Yasmin or Yaz, contact one of our lawyers today for a free consultation.

Bayer Reports Settling 70 Yaz & Yasmin Lawsuits

Jennifer Williams — Fri, 02 Mar 2012 21:44:00 GMT

In its 2011 Annual Report released today, Bayer admits it has settled 70 Yaz/Yasmin lawsuits. According to the report Bayer had reached agreements, without admission of liability, to settle the claims of approximately 70 plaintiffs in the U.S. as of February 13, 2012.

Earlier this week, the Judge overseeing the Yaz/Yasmin MDL litigation delayed all deadlines in the bellwether trials by 60 days. Judge Herndon further ordered that the initial bellwether trial, originally scheduled to begin January 9, 2012, is delayed until further order from the court.

These two announcements indicate that the settlement process is making some progress. Judge Herndon obviously would like to allow the parties additional time to settle the upwards of 6,000 cases involving VTEs including pulmonary embolism, deep vein thrombosis, and stroke.

Bayer's annual report included this additional information regarding the Yaz and Yasmin litigation:

Additional lawsuits are anticipated.
Bayer believes that it has meritorious defenses and will continue to defend itself vigorously against all claims that are not considered for settlement. Based on the information currently available, Bayer has taken appropriate accounting measures for anticipated defense costs and agreed settlements.
However, going forward and depending on further developments of the Yasmin™/ YAZ™ litigation, it is possible that the company's global liability insurance program may not be sufficient or fully applicable to cover all expenses and potential liability (if any) resulting from this litigation.

MDL Judge Appoints Special Master to Mediate Yaz/Yasmin Cases

Jennifer Williams — Wed, 04 Jan 2012 19:54:00 GMT

In an order filed on December 31, 2011 the federal judge presiding over the Yaz/Yasmin MDL litigation, officially delayed the start of the first bellwether trial slated to begin next Monday, January 9, 2012. Judge Herndon, who had indicated in the fall that he would press for settlement of these lawsuits, has ordered the parties to begin settlement negotiations with a special master, Stephen Saltzburg. The special master is a neutral third-party charged with overseeing settlement discussions and mediations between the parties.

Stephen Saltzburg, law professor at George Washington School of Law, handled the mediation of approximately 26,000 Seroquel lawsuits over the last several years.

Judge Herndon's order indicates that he thinks the plaintiffs and defendants in this litigation would be best served by attempting to settle these cases now rather than move forward with the first bellwether trial. Herndon has ordered both sides to meet with the Special Master "without delay" and to negotiate in "good faith."

New Article Suggests Bayer May Have Promoted Yaz/Yasmin for Unapproved Use

Jennifer Williams — Mon, 21 Nov 2011 20:08:00 GMT

An article out today on Bloomberg.com states that units of Bayer AG, Germany's largest drug maker, may have promoted its birth control pills, Yasmin and Yaz, for unapproved uses. The article also indicates Bayer may have misled women about the health risks the drugs pose.

According to the article, certain documents, including company e-mails, show Bayer employees discussing promoting Yaz for PMS when the drug has not been approved for treatment of PMS, but rather the more serious form of the disorder called PMDD (premenstrual dysphoric disorder). Yasmin on the otherhand has not been approved for any uses other than as a contraceptive.

Bayer was previously ordered by the FDA to correct misleading claims about Yaz in its television ads in 2008. Now, the FDA has scheduled hearings on the risks that Yaz/Yasmin (drospirenone-containing birth control pills) pose to women, specifically the potential increased risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism). The full-day hearing with independent scientists is scheduled for December 8, 2011. Representatives from our offices plan to monitor the hearings and will provide updates shortly thereafter.

New Study of Irsaeli Women Reveals Increased Risk of DVT and Pulmonary Embolism in Yaz/Yasmin Users

Jennifer Williams — Tue, 08 Nov 2011 19:42:00 GMT

A new study published November 6, 2011 in the Canadian Medical Association Jounral links oral contraceptives containing drospirenone (Yaz, Yasmin, Ocella, Beyaz) with a higher risk of venous thrombosis (DVT and pulmonary embolism) compared to both second and third generation birth control pills.

The study followed Israeli women aged 12 to 50 years old who were prescribed combined oral contraceptives from 2002 through 2008. The population-based cohort study used computerized records of the largest health care provider in Israel.

The article's authors concluded that "[u]se of dropsirenone-containing oral contraceptives was associated with an increased risk of deep vein thrombosis and pulmonary embolism... relative to second- and third-generation combined oral contraceptives." The study did not find an increased risk of arterial thromboic events in users of drospierenone-containing oral contraceptives.

Over ten thousand law suits have been filed by women who suffered serious injuries, including deep vein thrombosis and pulmonary embolism, after taking drospirenone-containing birth control pills such as Yaz, Yasmin, Ocella and Beyaz made by Bayer Healthcare. The first bellwether trials for women who suffered pulmonary embolism are slated to begin in January 2012.

Report from FDA-funded study confirms increased risk of VTEs in users of Yasmin and Yaz

Jennifer Williams — Thu, 27 Oct 2011 19:29:00 GMT

The FDA released the report today from its study of the relative risks of various combined hormonal contraceptives (CHCs). The study compared recently marketed CHCs including Yasmin/Yaz, Ortho Evra and NuvaRing to four older CHCs. The study found a "significantly higher risk of VTE [venous thromboembolic event] relative to low-estrogen comparators.

The study followed 835,826 women ages 10-55 years from January 1, 2001 to December 31, 2007. The FDA considered four primary study endpoints, arterial thrombotic events (which includes arterial myocardial infarction and ischemic stroke), venous thrombolic events, cardiovascular disease mortality and total mortality.

After adjusting for various confounders (such as traditional cardiovascular risk factors as hypertension, hyperlipidemia and diabetes), birth control pills containing drosperinone (including Yasmin and Yaz) were associated with a significantly higher risk of VTE compared to other birth control pills. Further, new users of Yasmin and Yaz were at an even higher risk of both arterial thrombotic events and venous thrombotic events than indviduals who had used other birth control pills previously.

The FDA concluded that the "positive finding regarding VTE risk in this study adds to what is becoming an increasingly clear picture" of the relative risk of VTE in users of Yasmin/Yaz compared to users of other oral contraceptives.

New Danish Study Confirms Increased Risk of Venous Thromboembolism in Yaz / Yasmin Users

Allen Law Firm — Thu, 27 Oct 2011 02:25:00 GMT

A new study published in the British Medical Journal today confirms previous studies that concluded users of Yaz and Yasmin are at least at twice the risk of venous thromboembolism compared with users of oral contraceptives with levonorgestrel.

The study's objective was to assess the risk of venous thromboembolism (deep vein thrombosis, pulmonary embolism, stroke) from use of combined oral contraceptives according to progestin type and estrogen use. The study included women who were aged 15-49 with no prior history of thrombolic event. The participants were followed from January 2001 to December 2009.

This is the seventh study completed on the relative risk of venous thrombotic events in women using drosperinone-containing birth control pills (Yasmin, Yaz, Ocella) and birth control pills containing other progestins and the fifth study confirming an increased risk (approximately two-fold) in users of Yaz, Yasmin compared to users of birth control pills containing levongestrel (a 2nd generation progestin).

FDA to Convene Panel to Weigh Risks of Yasmin and Yaz

Jennifer Williams — Tue, 27 Sep 2011 18:40:00 GMT

On September 26, 2011 the FDA issued a Drug Safety Communication regarding its safety review of drospirenone-containing oral contraceptives such as Yasmin and Yaz. The FDA bulletin states that while the FDA has not reached a definitive conclusion, it "remains concerned about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills".

The FDA has reviewed two 2011 studies that evaluated the risk of blood clots for women taking Yasmin/Yaz and is also continuing to review a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products. Preliminary results of the FDA-funded study show an approximately 1.5-fold increase in the risk ofvenous thromboembolism for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.

Because there is some conflict in the findings of the six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study, the FDA has planned a joint meeting of the Reproductive Health DRugs Advisory Comittee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss "the risks and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills."

The FDA advises health care providers to inform their patients of the potential risk for blood clots of drospirenone-containing birth control pills such as Yasmin, Yaz and Ocella.

Judge Says He Will Push Settlement Negotiations Following Bellwether Trials

Jennifer Williams — Fri, 26 Aug 2011 19:08:00 GMT

In Order handed down on August 18, 2011, Judge Herndon, presiding Judge of the Yaz/Yasmin federal court litigation, indicated that he is working on a plan to "engage the parties in settlement discussions following the bellwether trials in a meaningful way." The court acknowledged that "[t]his comes as a surprise to the parties since the Court has not, until this moment, revealed this plan to the parties." However, the judge assured "all concerned that when the time is appropriate each party will be given input in the process."

This statement was made in the context of an order regarding how the bellwether trial plan should proceed. The Judge refused Plaintiffs request to consolidate plaintiffs for bellwether trials 2 and 3 currently scheduled for mid-late 2012. The Court did not rule out consolidating plaintiffs for trials after this first round of bellwether trials is completed. However, if the Court's settlement plan is effective, there may be no need for further trials following the initial bellwether trials.

The first bellwether trial in the Yaz litigation is still slated to begin in January 2012. The first trial involves a young woman who suffered a pulmonary embolism while using Yaz.

Bellwether Trial Schedule Set for New Jersey Litigation

Jennifer Williams — Thu, 04 Aug 2011 18:41:00 GMT

The New Jersey court in charge of the Yaz/Yasmin consolidated litigation in that state has recently issued a bellwether trial schedule. The plan laid out in Case Management Order 25 sets the first trial for September 2012.

The court has requested the parties select 18 cases to undergo further discovery. Nine cases will be chosed by plaintiffs and nine will be chosen by defendants. Discovery in these cases will begin this month and continue through November 2011.

The parties will be allowed to select the first case(s) for trial. However, if an agreement cannot be reached, the court will select the first case to be tried.

There are upwards of 1,000 cases filed in New Jersey currently. There are thousands more Yaz/Yasmin cases on file in the federal court MDL and state courts in California and Pennsylvania. The first bellwether trials in the federal MDL and Pennsylvania state court are slated to begin in January 2012.

MDL Bellwether Trial Schedule Set

Jennifer Williams, Esq. — Tue, 14 Jun 2011 18:14:00 GMT

On June 9, 2011, Judge Herndon set the bellwether trial schedule for the Yaz / Yasmin litigation in the federal court multidistrict litigation (MDL). The first case set for trial involves a young woman who suffered a pulmonary emobolism after taking Yaz. Her case is set to begin on January 9, 2012.

Following the pulmonary embolism trial in January, the court is scheduled to begin the first case involving a gallbladder injury on April 2, 2012. Judge Herndon has yet to select a case for this trial. The third case is slated to begin on June 25, 2012 and will involve a venous thromboembolic injury.

The Court's order also included dates for the bellwether trials in the Pennsylvania consolidated litigation involving Yaz and Yasmin. The first bellwether case in Pennsylvania will being January 23, 2012 and will also involve a pulmonary embolism and the case will be selected by Plaintiffs. The next case to be tried will be a pulmonary embolism case selected by Defendants and will begin on February 21, 2012. The Pennsylvania court will then hear gallabladder cases on April 23, 2012 and May 21, 2012 and venous thromboembolism cases on July 23, 2012 and August 20, 2012.

FDA Warns of Increased Risk of Blood Clots with Yaz and Yasmin

Jackson Allen Williams, LLP — Wed, 01 Jun 2011 16:25:00 GMT

On May 31, 2011 the FDA issued a safety alert warning of a possible increased risk of blood clots associated with birth control pills containing drospirenone. Drospirenone is a hormone found in the birth control pills Yaz, Yasmin, and their generics.

The British Medical Journal recently included two reports that found a twofold to threefold greater risk of venous thromboembolism (VTE) in women taking pills like Yaz or Yasmin. The studies focused on whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. Expects said doctors and patients should watch for symptoms of blood clots, such as leg or chest pain.

Currently, the FDA is evaluating the results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. The FDA has commissioned an 800,000 person study to examine the risks, which it expects will be completed later this summer.

Two New Articles Confirm Increased Risk of Venous Thromboembolism in Yaz & Yasmin Users

Jackson Allen Williams, LLP — Mon, 25 Apr 2011 15:07:00 GMT

April 25, 2011 - Two articles published in British Medical Journal over the weekend confirm previous studies that show an increased risk of venous thromboembolic events including stroke, pulmonary embolism and deep vein thrombosis in women who use Yaz, Yasmin, Ocella, Gianvi, Zarah and Beyaz.

One article reports on a nested case-control study using data from the UK General Practice Research Database. This article reported a 3.3 times greater risk of non-fatal venous thromboembolism including pulmonary embolism, stroke, and deep vein thrombosis in women who use drosperinone-containing oral birth control pills including the brand names manufactured by Bayer including Yasmin, Yaz and Beyaz and the generic versions of these drugs Ocella, Gianvi and Zarah, with those using OCPs containing levonorgestrel.

The second article written by Susan Jick, director and senior epidemiologist at Boston Collaborative Surveillance Program and Boston University School of Medicine, reported on a nested case-control study and cohort study using information from PharMetrics, a United States-based company. This article found a 2.3-2.8 times greater risk of VTE (pulmonary embolism, deep vein thrombosis, stroke) in users of drosperinone-containing oral birth control pills (Yaz, Yasmin, Ocella, Gianvi, Zarah and Beyaz) with those using OCPs containing levonorgestrel.