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.
At this time, reports of any settlements represent a very small minority of the 11,000 plus pending YAZ LAWSUITS. The troubled history of DRSP (DROSPIRENONE) containing birth control pills is expected to continue with FDA action still pending on a ‘evolving’ warning label that has already changed twice in the past 24 months and is still not properly or effectively communicating risks to users. When, and how, will FDA handle expert recommendations remains to be seen.
SHOULD EXPERTS HAVE VOTED FOR A YAZ RECALL ? WILL THEY RE-VOTE?
No discussion of the December 8, 2011 vote should ignore the 15-11 vote that determined the pills were effective in preventing pregnancy, and the risks of pregnancy, thus somehow justifying their continued availability. This slim margin, and narrow vote, may have helped DRSP (DROSPIRENONE) containing birth control pills in avoiding a ‘market withdrawal’ or ‘recall’ but is ignited a new and troubling revelation. In January 2012, reports emerged that several members of the December 8, 2011, joint panel of experts had past financial ties to BAYER. Sound familiar? The only studies claiming the DRSP (DROSPIRENONE) containing birth control pills presented no increased risk have also been found to have past financial ties to BAYER.
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.
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