BAYER YAZ LAWSUIT SETTLEMENTS CONTINUE | YAZ LAWSUIT SETTLEMENTS UPDATE OCTOBER 2012
BAYER, the manufacturer of the original DROSPIRENONE (DRSP) containing birth control pills has released information today, October 30, 2012, confirming settlements of blood clot case as of October 15, 2012, totaling $750 Million U.S. Dollars.
As illustrated above, BAYER has confirmed, and provided the following YAZ SETTLEMENTS UPDATE for OCTOBER 2012:
It has agreed to settle approximately 3,490 blood clot cases for a total of $750 Million U.S. Dollars.
As of October 15, 2012, the number of related lawsuits pending and served upon BAYER totaled 12,400.
Pending unsettled cases include 3,800 blood clot cases.
There are an additional 720 cases were claims have been asserted but not filed as lawsuits.
Excluding claims already settled there were an additional 13,500 cases filed.
Cases are being settled on a case by case basis after a case specific analysis and presentation of medical records on a rolling basis.
Based upon the above, it appears that there are at least another $800 Million U.S. Dollars in blood clot settlements, or YAZ SETTLEMENTS, pending in the 3,800 cases identified as unsettled. Other types of cases remain pending and potentially viable despite the manufacturer not agreeing to consider their settlement as of this writing.
As note below, a number of studies have been published since 2009 that confirm that DROSPIRENONE (DRSP) containing birth control pills present higher risks of blood clots to users. The higher risks and failure to warn were at the heart of related blood clot lawsuits for injuries and complications from Deep Vein Thrombosis or Pulmonary Emboli that became known as YAZ SIDE EFFECTS.
FREE CASE EVALUATIONS remain available through the sponsor of this site by submission of the contact form below. This is a no obligation evaluation of your YAZ BLOOD CLOT CLAIM.
In a recently released publication, BAYER has confirmed that as of July 19, 2012, it had agreed in principle to settle approximately 1,877 blood clot cases. As a result, it reported $402M in settlements had been reached in the pending litigation. These cases involve blood clots, which include Pulmonary Emboli, Deep Vein Thrombosis and related complications. This report is a follow up to prior reports of ongoing settlement negotiations.
Reported settlements do not translate into payments or money having exchanged hands as of this time. Rather, these are agreements to resolve cases, on a case by case basis following extensive litigation, commenced in 2009, and the evaluation of claimed injuries. The parties have been engaged in meaningful settlement negotiations – as reported below – since January 2012. Cases involving gallbladder removal or surgery are not considered part of these settlements as indicated in the insert above.
FREE CASE EVALUATIONS ARE AVAILABLE THROUGH USE OF THE CONTACT FORM BELOW.
NEJM STUDY FINDS RISK OF THROMBOTIC STROKE & MYOCARDIAL INFARCTION WITH HORMONAL PILLS CONTAINING EE ESTROGEN IN YAZ,YASMIN, BEYAZ & SAFYRAL PILLS
NEW NEJM STUDY FINDS STROKE & HEART ATTACK RISK LINKED TO ESTROGEN IN YAZ, YASMIN, BEYAZ & SAFYRAL.
In “THROMBOTIC STROKE AND MYOCARDIAL INFARCTION WITH HORMONAL CONTRACEPTION“, an Abstract in the prestigious New England Journal of Medicine (NEJM) evaluates 15 years of data to address the risk of thrombotic stroke and heart attacks, or myocardial infarction, in birth control pills that contain ETHINYL ESTRADIOL (EE) as an estrogen. Until now, most of the focus and risks associated with the trademarked YASMIN, YAZ, BEYAZ & SAFYRAL pills centered on their containing the protesting DROSPIRENONE (DRSP). As noted in other posts, independent studies, and an FDA funded study have confirmed they present a higher risk of blood clots in comparison to other pills. This “new” study followed women from the ages of 15-49 with no prior history of heart disease or cancer. The data analyzed involved 1.6 Million women and compared certain types of available hormonal contraceptives and the risks associated with the for thrombotic strokes and heart attacks. The authors concluded that there was a link between those pills that contain .02 micrograms of ETHINYL ESTRADIOL (EE), as well as those that varied from .03 micrograms to .04 micrograms. The risk was increased by a factor of 0.9-1.7 in those with .02 micrograms and 1.3-2.3 for those with .03-.04 micrograms of ETHINYL ESTRADIOL (EE). The only difference between YASMIN & YAZ is the difference in the amount of ETHINYL ESTRADIOL, as well as the length of dosing. Similarly, the difference between BEYAZ & SAFYRAL is the addition of folate. Basically, all DROSPIRENONE (DRSP) containing birth control pills fall within either of these higher risk ranges. The point is not how low the probability of an adverse event is, but whether or not consumers are being properly warned by the manufacturer before they choose their pills.
What does this add to the risks associated with the use of a DROSPIRENONE (DRSP) containing birth control? Another factor for all prescribers, girls, their Mothers and adult women to consider when choosing their hormonal contraceptive. Why would any DROSPIRENONE (DRSP) birth control pill be the 1st choice for any 1st time user, or why would any woman switch from an established hormonal contraceptive to a DROSPIRENONE (DRSP) containing birth control pill if they are properly and adequately informed of available data and risks? Arguably, they would not.
Unfortunately, many girls, their Mothers, adult women and their prescribers did not know any better prior to 2009. Mounting evidence appears to confirm that DROSPIRENONE (DRSP) containing birth control pills present higher risks that outweigh their effectiveness and that the FDA or manufacturer should consider a market withdrawal or recall.
FREE CASE EVALAUTIONS are available through use of the contact form below from the sponsor of this site. We will evaluate and consider cases from the time that DROSPIRENONE (DRSP) containing birth controls pills, and their generic equivalents were launched until such time that they are ultimately recalled, if ever.
DRSP (DROSPIRENONE) PILL FAMILY TO GET NEW LABELS PER FDA.
BLOOMBERG REPORTS: BAYER YASMIN YAZ BEYAZ SAFYRAL SETTLEMENTS CLIMB OVER $142 MILLION OVER BLOOD CLOT LAWSUITS INVOLVING BIRTH CONTROL
Bayer YAZ Yasmin BEYAZ SAFYRAL Lawsuit Settlements Climb to $142 Million - Bloomberg
Today, April 26, 2012, BLOOMBERG provided an update on the ongoing YAZ LAWSUITS involving DRSP (DROSPIRENONE) containing birth control pills. In, “BAYER YASMIN LAWSUIT SETTLEMENTS CLIMB TO $142 MILLION“, reporters Jef Feely & Margaret Cronin Fisk, cite to Financial Reports, and BAYER’s Stockholders Newsletter for the First Quarter of 2012, in identifying settlements totaling $142 Million U.S. Dollars. Previously, BLOOMBERG had reported settlements of $110 Million U.S. Dollars only 13 days ago.
FDA study confirms DROSPIRENONE pills higher risk.
This news comes only 15 days after the FDA announced that the entire family of DRSP (DROSPIRENONE) containing birth control pills would be required to carry a revised label warning users and prescribers of the potential for increased risk of blood clots. Estimates vary on the increased risk from 3x more likely in comparison to other pills or 74% higher risk in comparison as confirmed in an FDA funded study. The contraceptives narrowly escaped a market withdrawal or “recall” on December 8, 2012 in a 15-11 vote of experts.
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.
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.
12.8.11 has been circled in the calendars of DRSP (DROSPIRENONE) survivors, watchdog groups, advocates on behalf girls and women that suffered YAZ BLOOD CLOTS or YAZ SIDE EFFECTS, because this day marks the meeting of two expert panels expected to evaluate the increased risk of blood clots and emerging scientific evidence that examine this risk.
BMJ studies repeatedly confirm increased blood clot risk of DRSP since 2009.
In May 2011, the European Medicines Agency (EMA) announced that it was requiring an updated label for DRSP (DROSPIRENONE) containing birth control pills. The EMA did not have the benefit of FDA’s study, which found an elevated risk of 75%, or 1.74x, in comparison to other hormonal contraceptives. FDA’s study was publicly released in late October 2011. Most recently, on December 5, 2011, HEALTH CANADA, announced that it had concluded a “safety review” of medical literature and concluded, consistent with prior studies, that DRSP (DROSPIRENONE) birth control pills present a 1.5x -3.0x risk of blood clots.
FDA is reportedly weighing stricter, or stronger, warning labels on DRSP (DROSPIRENONE) containing birth control pills as reported by REUTERS in “FDA Eyes Stronger Warning on Popular Birth Control” by Alina Selyuk.
Will simply adding additional verbiage to the fine print change the status quo or really impact the behavior of prescribers or consumers of these pills? The label has already been changed twice in the past 18 months, however the initial change literally challenged the results of studies in the context of the printed label and fine print, that have now arguably been embraced by FDA, EMA and HEALTH CANADA. From 2009 through the present, the manufacturer, BAYER HEALTHCARE PHARMACEUTICALS, continues to dispute new science, challenge methodologies and cry ‘error’ to oppose mounting scrutiny. Are the FDA, EMA, HEALTH CANADA all wrong in their similar interpretations of recent studies? Given the conflicting messaging from the manufacturer to FDA, prescribers and consumers how can FDA counter balance a decade of conditioning through television advertising, social media and internet campaigns, promoting DRSP (DROSPIRENONE) as scientifically superior and beneficial? The message that has reached the average person has consistently touted the benefits of these pills, cloaked with FDA’s stamp of approval, called critics, as well as victims of personal injuries, into question through the clever use of statistics and the convenient ability to claim recent science is inadequate or flawed.
FDA WARNING LETTER on Current Good Manufacturing Practices.
Or, does the FDA need to weigh all options and consider stronger action? Recent reports quoting former FDA Commissioner David Kessler raise red flags that indicate FDA will not consider relevant, important and potential outcome altering information during these hearings. What difference that information would have will not be known. Yet, the history of DRSP (DROSPIRENONE) from 2000-2011is now a matter of record. FDA has issued multiple FDA WARNING LETTERS, SAFETY COMMUNICATIONS, cited the manufacturing facility for failure to follow current good manufacturing processes (CGMP), monitored a little publicized recall for the failure to follow CGMP, overseen the need for ‘corrective advertising’, approved two label changes in less than a 14 month period and now had to convene a joint meeting of committees to engage in further debate over the higher blood clot risk DRSP (DROSPIRENONE) containing birth control pills present to consumers under the FDA’s seal of approval.
FDA WARNING LETTER - October 2008 on YAZ
The time for FDA to silence the conflicting message fostered by claims of debatable conclusions, or flawed methodologies, has come. The past decade illustrates the need to consider a YAZ RECALL or implementation of warnings that significantly curtail, or limit the use of DRSP (DROSPIRENONE) containing birth control pills. FDA’s study arguably supports the idea that no DRSP (DROSPIRENONE) birth control pill should be any girl or woman’s first choice when they choose a form of hormonal birth control. As a result, few if any young women, based upon available science, should consider any DRSP (DROSPIRENONE) pill as their initiation into the use of hormonal birth control. Similarly, women that are in between different types of pills need to carefully consider, and be properly warned, about risks associated with their age before considering DRSP (DROSPIRENONE) containing birth control pills. This is consistent with the findings in FDA’s own study prior to any debate or hearings on the subject. In the end, the potential group of consumers for which a DRSP (DROSPIRENONE) containing birth control pill is appropriate appears to be very limited. Studies indicate all hormonal contraceptives have some benefit in treating acne and thus these pills have not been proven to be superior. With regard to any claimed benefit for PMDD, the initial studies were short term and there should now be 10 years, or more, worth of studies to prove whether they are effective or superior to other recognized methods for treating PMDD. Again, there appears to be little proof that PMDD should be treated, either initially, or exclusively, with a DRSP (DROSPIRENONE) containing birth control pill.
DRSP (DROSPIRENONE) pills - Bayer HealthCare AG
As a result, in the final analysis, DRSP (DROSPIRENONE) birth control pills are arguably not safer or more effective in any FDA approved category or indication. If so, what role do the pills have in being an option to girls or women seeking a form of hormonal birth control after 12.8.11? Whether the advisory committee meetings will result in additional and continued ‘evolving warnings’ on DRSP (DROSPIRENONE) containing birth control or other action remains to be seen. We will monitor and report on any developments as they are disclosed or reported.
As noted in prior posts, FDA has scheduled a public hearing of two (2) joint panels of experts to discuss industry backed studies and emerging scientific literature, including an FDA funded study, that confirm an increase risk of blood clots from birth control pills containing DRSP (DROSPIRENONE). FDA’s analysis of related data confirmed a significantly higher risk of potentially life threatening blood clots, or venous thromboembolism (VTE) which can manifest themselves as pulmonary emboli (PE) in the lungs, or deep vein thrombosis (DVT) in the legs.
However, given that FDA’s own studies confirmed a significantly higher risk of blood clots in comparison to other pills, as well as multiple FDA WARNING LETTERS, a prior YAZ RECALL and label changes in April 2010 , it is possible that a past history of action and violations will lead to some assertive action by FDA. While women are undertaking some risk in choosing any form of birth control, to accept any risk they must be fully and adequately informed before they can evaluate the safety and effectiveness of any given product. Historically, the DRSP (DROSPIRENONE) family of birth control focused on hype, which resulted in Four (4) FDA WARNING LETTERS, corrective advertising, a failed inspection of manufacturing facilities and notable deficiencies in good current manufacturing practices, before the April 2010 change in the label. Only after achieving and maintaining a Blockbuster status – over $1Billion in annual sales – did information begin to emerge about the higher risk of blood clots from these pills. Could there be more victims, or survivors of DRSP (DROSPIRENONE) than those 10,000 that have come forward and filed lawsuits? Most likely, yes and time will tell whether they will come forward and connect the dots that have taken so long to materialize since these pills came to market.
