The week of April 10, 2012 marked a week of monumental developments in ongoing litigation over DROSPIRENONE (DRSP) containing birth control pills. FDA announced revisions in the label for the entire brand warning of the potential for 3x higher blood clot risk from use of the pills. The manufacturer, BAYER HEALTHCARE PHARMACEUTICALS, issued related public relations information that diminished the significance of these new and revised warnings after profiting for over a decade from the higher risk oral contraceptives.
APRIL 13, 2012: YAZ, YASMIN, BEYAZ, SAFYRAL & GENERICS TO GET NEW UPGRADED WARNING LABEL - APRIL 2012.
Following the announcement, BLOOMBERG reported on a select number of DROSPIRENONE LAWSUIT, DRSP LAWSUIT, YAZ LAWSUIT OR YAZ CLAIMS settlements discussed here. The settlements involve blood clot and complications from debilitating injuries. The confidential sources cited by BLOOMBERG estimate $110 Million U.S. Dollars in settlements of a minority of pending lawsuits that exceed 11,000.
APRIL 13,2012: DROSPIRENONE (DRSP) SETTLEMENTS-Bayer Said to Pay $110 Million in Yaz Birth-Control Cases - Bloomberg
While the DROSPIRENONE (DRSP) containing family of contraceptives continue for sale, despite FDA’s own study confirming a 74% higher risk of blood clots, the sponsor of this site continues to evaluate potential DROSPIRENONE SETTLEMENTS and YAZ LAWSUITS.
In late July 2012, BAYER announced that it had agreed to settle 1,877 blood clot lawsuits involving DROSPIRENONE (DRSP) containing birth control pills. BLOOMBERG disclosed related information in “BAYER’S YASMIN SETTLEMENTS RISE TO $402.6M“.This includes cases involving personal injuries from Pulmonary Emboli or Deep Vein Thrombosis. Nearly 13,000 lawsuits were filed claiming a variety of injuries and complications from use of the oral contraceptives. As of July 19, 2012, YAZ LAWSUIT SETTLEMENTS reportedly totaled $402 Million U.S. Dollars with total settlements expected to reach exponentially higher figures as catastrophic cases involving death or permanent disability are resolved.
YAZ LAWSUITS SETTLEMENTS JULY 2012 UPDATE.
YAZ SETTLEMENTS UPDATE INFORMATION 2012
FREE DROSPIRENONE SETTLEMENT CASE EVALUATIONS ARE AVAILABLE THROUGH USE OF THE CONTACT FORM BELOW.
With over 11,300 YAZ CLAIMS pending as of February 2012, as discussed here, this is the first report of a meaningful settlement of some blood clot cases. There is no discussion of gallbladder cases despite there being a plethora of these cases among pending lawsuits. The BLOOMBERG story notes that an FDA funded study released in October 2011 found that DRSP (DROSPIRENONE) containing birth control pills were 74% more likely to suffer blood clots in comparison to other pills.
This report comes on the heels of the FDA’s announcement this week that the DRSP (DROSPIRENONE) family of contraceptives would carry a revised warning label warning of increased risks of blood clots that may be up to 3x higher in comparison to other pills. The manufacturer has continued to claim otherwise despite multiple studies emerging since 2009, including the FDA’s own study, that confirm a higher risk. FDA’s revised label was announced this past week and raises questions explored below.
YAZ LAWSUITS or YAZ CLAIMS continue to be evaluated and filed. FREE CASE EVALUATIONS are available through the sponsor of this site.
YAZ Updated Warning Labels (Again) in April 2012 as YAZ CLAIM Settlements Announced.
FDA SPOTLIGHT ON YAZ CONTINUES 90 DAYS AFTER RECALL VOTE
FDA SPOTLIGHT REMAINS ON YAZ DRSP (DROSPIRENONE) PILLS.
90 DAYS AFTER FDA ADVISORY COMMITTEE VOTE & SETTLEMENT UPDATES
FDA AD COMM VOTE WAS 12.8.11 - ACTION PENDING.
Ninety (90) Days ago, on December 8, 2011, the U.S. Food & Drug Administration, convened a joint panel of experts to discuss emerging studies that linked DRSP (DROSPIRENONE) containing birth control pills to the increased risk of blood clots. Since 2009, multiple studies, including an FDA funded study have reached the very same conclusion: DRSP (DROSPIRENONE) containing birth control pills increase the risk of blood clots exponentially in comparison to other pills. The manufacturer, BAYER HEALTHCARE PHARMACEUTICALS, has repeatedly disputed these findings and pointed to studies, with close ties to them or the industry, for support of their defense.
The December 8, 2011, Advisory Committee voted, 21-5, that the WARNING LABELS communicating risks to users, or consumers, as well as prescribing physicians needed to include findings from FDA’s study, and other independent studies, that were released during October 2011 that show an increased risk of blood clots from use of DRSP (DROSPIRENONE) containing birth control. Only days before FDA released it’s findings an independent study also released in October 2011 once again found DRSP (DROSPIRENONE) containing birth control pills increased the risk of blood clots in comparison to other pills.
11,000 YAZ LAWSUITS PENDING – BAYER’S ANNUAL REPORT
BAYER 2011 ANNUAL REPORT CONFIRMS OVER 11,000 YAZ LAWSUITS.
As of February 1, 2012,11,300 YAZ LAWSUITS alleging personal injuries from use of a DRSP (DROSPIRENONE) containing birth control remain pending. More are anticipated as DRSP (DROSPIRENONE) birth control pills remain on the market with WARNING LABELS already determined to not reflect information and knowledge about the elevated risks of Blood Clots, Strokes, Myocardial Infarcts, Heart Attacks, Pulmonary Emboli, Deep Vein Thrombosis, Arterial Clots and related complications and potential injuries, or death.
BAYER REPORTS 11,000 YAZ LAWSUITS PENDING in 2012.
Civil Jury Trials were scheduled to commence in January 2012 but were delayed by Judges overseeing the litigation in multiple venues to encourage the parties to explore potential settlements or alternative dispute resolution on a case by case basis. While this is arguably a positive development for litigants it has not changed the “business as usual” promotion of DRSP (DROSPIRENONE) pills. The manufacturer has continued to claim that the pills are both safe and effective when used as directed despite the 21-5 vote recommending FDA upgrade or enhance the WARNING LABEL to better communicate risks to users and prescribers.
After over a decade on the U.S. market the DRSP (DROSPIRENONE) family of contraception pills has continued to expand. There are now four trademarked brands: YASMIN, YAZ, BEYAZ and SAFYRAL and multiple generics. Given the experts vote, it can be argued that DRSP (DROSPIRENONE) containing birth control pills have not fully informed users of increased risks for years, or quite possibly from the time they were launched in the U.S. market. Without fully knowing risks associated with a product, how can someone make an informed choice about using the product? This question is one of many at the heart of YAZ LAWSUITS and any pending YAZ SETTLEMENTS.
Recently published reports have pointed to progress in ongoing YAZ SETTLEMENT negotiations with claims of seventy (70) settlements having occurred as of February 13, 2012.
BAYER REPORTS SETTLEMENTS in 2012.
This information and graphic above is taken from BAYER’s ANNUAL REPORT which is available on line.
YAZ RECALL VOTE RAISES CONFLICT OF INTEREST ? 11,000 YAZ LAWSUITS PENDING. FREE CASE EVALUATIONS.
To date, no official FDA action on either the 15-11, or 21-5, vote nor calls by public interest group for a re-vote over the December 8, 2011 hearings. We will update this site with any public reports of information.
FREE YAZ LAWSUIT CASE EVALUATIONS are available from the sponsor of this site.
Gabriel F. Zambrano, P.A., by using the contact forms above or below. Gabriel F. Zambrano, represents several of the 1st 100 Girls and Women to file YAZ LAWSUITS throughout the United States and has been at the forefront of claims regarding DRSP (DROSPIRENONE) containing birth control pills since before 2009.