YAZ RECALL UPDATE. YAZ RECALL vote by FDA in 2011 still in question.
In December of 2011, an FDA Advisory Committe considered the future of the entire family of DROSPIRENONE (DRSP) containing pills. Embroiled in litigation since 2009, and the subject of multiple independent studies finding higher risks of blood clots, the pills future remains in jeopardy in 2013. Whether the FDA will revisit the future of the pills and enhanced warnings added to the packaging, since the onset of over 13,000 personal injury lawsuits, is open to debate, at least in the United States.
EMA, at behest of France, revisits safety profile of YAZ, YASMIN and other pills, while countries question continued use in Europe.
Emerging reports from Europe have revealed that the European Medicines Agency (EMA), at the behest of France, is re-evaluating the use of DROSPIRENONE (DRSP) containing pills in the European Union. The French initiative coincides with an announcement that the government would not reimburse users of certain pills, including DROSPIRENONE (DRSP) containing pills, because of higher risks of blood clots and complications that essentially burden the health care system. An analysis of related news reports appearshere. As noted in this posthere, Switzerland’s largest insurer has joined a pending lawsuit to seek reimbursement for medical benefits associated with at least one victim of the new generation of birth control pills.
As noted below, BAYER has continued to evaluate and resolve certain blood clot cases over the course of almost one year. However, thousands of cases remain pending in the United States in 2013. FREE CASE EVALUATIONS and no recovery, no fee contingency fee recoveries remain an option for all victims seeking assistance. The sponsor of this site continues to offer CONFIDENTIAL NO OBLIGATION case evaluations:
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.
YAZ, YASMIN, BEYAZ & SAFYRAL SIDE EFFECTS | HIGHER RISKS
A study published in CONTRACEPTION, “Recent Combined Hormonal Cotnraceptives (CHCs) and the Risk of Thromboembolism and Other Cardiovascular Events in New Users“, confirms disturbing information about DROSPIRENONE (DRSP) containing birth control pills.
This recent study in one of several, including an FDA funded study, that have reached similar conclusions regarding DROSPIRENONE (DRSP) containing birth control pills. In evaluating the risk of a venous thromboembolic event (VTE), including Pulmonary Emboli (PE) (blood clots in the lungs) or Deep Vein Thrombosis (DVT) (blood clots in the legs) the latest study specifically found the following:
“We found that the intiation of new use of DRSP-containing” pills was “associated with a 77% increase in the risk of hospitialization for a VTE relative to the use of” a comparable group of four low-dose estrogen pills.
“[T]he growing number of studies showing an increased risk of VTE with DRSP suggests that DRSP-containing” pills “should be used cautiously for women seeking hormonal contraception“.
Given there have now been multiple studies showing increased risk of blood clots, from use of a DROSPIRENONE (DRSP) containing birth control pill, one has to wonder why any girl, woman or her prescriber would knowingly choose a DROSPIRENONE (DRSP) containing birth control pill. The history of these pills has marked by FDA WARNING LETTERS, “corrective advertising” necessitated by the manufacturer overstating the alleged benefits of the pills and over 13,000 lawsuits claiming personal injury from use of the pills or their generics.
DRSP (DROSPIRENONE) PILL FAMILY PRESENTS HIGHER RISKS OF BLOOD CLOTS.
Disturbingly, the significance of the troubled history, ongoing litigation, near market withdrawal, or recall, in December 2011, is lost among many people. Apparently, even The American College of Obstetricians & Gynecologists (ACOG) has a short lived memory and self serving interpretation of the latest study as illustrated below.
ACOG FAILS TO WARN OR DROSPIRENONE (DRSP) RISKS.
No girl or woman can have a free, or educated choice, in their contraceptive decision if they are not adequately or properly informed. The failure of the manufacturer to adequately warn of risks associated with DROSPIRENONE (DRSP) containing birth control pills resulted in over 13,000 lawsuits, as well as label changes and a near recall of the pills in December 2011. The Devil is in the Details as the illustration above indicates but ACOG has arguably forgotten many details associated with DROSPIRENONE (DRSP) containing birth control pills.
FREE YAZ LAWSUIT CASE EVALUATIONS ARE AVAILABLE THROUGH USE OF THE CONTACT FORM BELOW.
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.
FDA’s MEDWATCH UPDATE APRIL 2012 ON YASMIN, YAZ, BEYAZ, SAFYRAL, GIANVI, OCELLA AND OTHER DROSPIRENONE (DRSP) CONTAINING BIRTH CONTROL PILLS AND GENERIC VARIATIONS
FDA MEDWATCH SAFETY ALERT APRIL 2012.
During April 2012, the FDA announced that all DROSPIRENONE (DRSP) containing birth control pills would carry and new upgraded warning of increased risks of blood clots. (Discussed here) In “FDA’S MEDWATCH SAFETY ALERTS: APRIL 2012“, represented above, provides as summary of FDA action and alerts during April 2012 here. The text raises questions and arguably “waters down” what the FDA announced on April 10, 2012. Since 2009 multiple independent studies have concluded that DROSPIRENONE (DRSP) containing birth control pills present higher risks to users than comparable pills. In October 2011, FDA released findings of an FDA funded study that also found the pills presented higher risks – 75% higher risk in comparison to other pills – and unexplained risks in the 35-55 age group of Arterial Thromoembolic Events. However, the MEDWATCH ALERT UPDATE FOR 2012 makes no mention of FDA’s own study. Why?
FDA's Consumer Update on MEDWATCH SAFETY ALERT APRIL 2012.
Sadly, this is another missed opportunity for the FDA to raise awareness of the risks of DROSPIRENONE (DRSP) containing birth control pills but they have failed to seize it and make a difference. Ironically, it is National Women’s Health Week this week and the upgraded warnings on the family of pills are barely a month old. Reports of monetary settlements have overshadowed, to some extent, the fact that after over a decade on the market, DROSPIRENONE (DRSP) containing birth control pills will now carry another revised warning over blood clot risks. The arguably troubled history of the pills is outlined here. In the end, with little attention having been brought to recent FDA action on the pills a new post-April 2012 Generation of DROSPIRENONE (DRSP) containing birth control users remains at risk.
We are continuing to evaluated potential blood clot cases from the use of any DROSPIRENONE (DRSP) containing birth control pill. FREE CASE EVALUATIONS are available through use of the contact form below.
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.
DRSP (DROSPIRENONE) PILL FAMILY TO GET NEW LABELS PER FDA.
As explained in this announcement, FDA “has completed its review of recent observational studies (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin containing pills”. In October 2011, FDA released results from an FDA-funded study of the blood clot risk and this announcement indicates that “revised drug labels” will include a summary of their results.
What does this mean? Granted the FDA’s announcement couches the revised labels in terms of “may be associated with a higher risk for blood clots” it is clearly a step in the right direction in terms of warning potential users and prescribers of the higher risk of blood clots presented by DROSPIRENONE (DRSP) containing birth control pills. For many girls and women, the warning is too late and they have suffered debilitating injuries or complications from blood clots. Those girls and women are pursuing YAZ CLAIMS or their individual YAZ CLAIM for related injuries given that they were never fully warned of the potential consequences and higher risk the pills presented. Since 2009, the manufacturer has continued to resist scientific findings of increased risk and defend the Blockbuster $1 Billion in Annual sales products associated with DROSPIRENONE (DRSP). However, FDA’s own study noted that the picture was literally becoming clearer with regard to the higher risk these pills pose to users despite the manufacturers defense to the contrary.
Civil Jury Trial remain pending, with settlement discussions ongoing regarding YAZ CLAIMS, FDA’s action may provide a needed catalyst to promote awareness of the risks associated with these pills, outside of the litigation context and claimed defenses of the manufacturer.
FREE YAZ CLAIM EVALUATIONS are available through the sponsor of this site by using the contact form below.
YAZ, YASMIN, BEYAZ, SAFYRAL & GENERICS TO GET NEW UPGRADED WARNING LABEL - APRIL 2012.
