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Law Offices of Thomas J. Lamb

October 2015 Update On Bayer’s YAZ / Yasmin Settlement Program Numbers

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We have been reporting periodically on the YAZ / Yasmin / Gianvi / Ocella / Beyaz / Safyral litigation, as we have been doing since 2009 when the first lawsuits against Bayer were filed.

The most recent Bayer information about the YAZ / Yasmin drug injury litigation was published by Bayer on July 29, 2015 in the Bayer Interim Report for the Second Quarter of 2015. From that document we get this update:

Yasmin™/YAZ™: As of July 17, 2015, the number of claimants in the pending lawsuits and claims in the United States totaled about 4,000 (excluding claims already settled). Claimants allege that they have suffered personal injuries, some of them fatal, from the use of Bayer’s drospirenone-containing oral contraceptive products such as Yasmin™ and/or YAZ™ or from the use of Ocella™ and/or Gianvi™, generic versions of Yasmin™ and YAZ™, respectively, marketed by Barr Laboratories, Inc. in the United States.

As of July 17, 2015, Bayer had reached agreements, without admission of liability, to settle approximately 9,900 claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) for a total amount of about US$1.97 billion. Bayer will continue to consider the option of settling such claims after a case-specific analysis of medical records. At present, about 590 such claims are under review…. As of July 17, 2015, about 1,200 of the 4,000 above-mentioned claimants alleged arterial thromboembolic injuries.

We expect to find updated settlement numbers in the Bayer Interim Report for the Third Quarter of 2015, which is currently scheduled to be published on October 29, 2015.

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Another Blood-Clots Warning Label Change For YAZ Coming?

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SUMMARY: In the past few years following an April 2012 YAZ label change there has emerged more medical evidence in support of the contention that birth control pills containing drospirenone (DRSP) are associated with higher rates of side effects caused by blood clots, such as deep vein thrombosis (DVT), pulmonary embolism (PE), strokes, and heart attacks.

As you may recall, the drug labels for Yasmin, YAZ, Safyral, and Beyaz were revised by Bayer and the FDA in April 2012 by adding information about the several different and conflicting (in terms of their conclusions) medical studies concerning the increased blood clot risks associated with drospirenone-containing birth control pills.

This “new” (vis-à-vis the April 2012 YAZ label change) medical evidence raises the possibility of there being another revised label for drospirenone birth control pills with a stronger and more clear, i.e., less ambivalent, warning about the increased risks of serious side effects involving blood clots.

There is a precedent for there being more than one such drug label change required by the FDA for contraceptive products like YAZ, Yasmin, Beyaz, and Safyral.

Back in 2008 we wrote this blog post, “Blood-Clot Warning On Ortho Evra Birth Control Patch Increased, Again, In January 2008”, which had as its sub-title: “Label For ‘The Patch’ No Longer Has Conflicting Information About Its Increased Risk Of Blood Clots” [emphasis added].

Given the mounting medical evidence that there is a real increased risk — not an arguable or theoretical risk — of developing a DVT, PE, stroke, or heart attack while using Beyaz, Safyral, Yasmin, or YAZ, one wonders whether DRSP birth control pills will follow the course of there being another blood-clots warning label change, as was done with the Ortho Evra patch.

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Bayer’s Numbers of YAZ / Yasmin Lawsuits and Settlements in April 2015

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SUMMARY: The most recent Bayer information about the YAZ / Yasmin litigation comes from its corporate Interim Report for First Quarter of 2015:

Yasmin™/yaz™: As of April 20, 2015, the number of claimants in the pending lawsuits and claims in the United States totaled about 4,600 (excluding claims already settled)….

As of April 20, 2015, Bayer had reached agreements, without admission of liability, to settle approximately 9,600 claims in the u.s. for venous clot injuries (deep vein thrombosis or pulmonary embolism) for a total amount of about us$1.92 billion. Bayer will continue to consider the option of settling such claims after a case-specific analysis of medical records. At present, about 1,000 such claims are under review.

In comparison, from Bayer’s 2014 Annual Report:

• As of January 31, 2015, the number of claimants in the pending lawsuits and claims in the United States totaled about 5,000 (excluding claims already settled).
• As of January 31, 2015, Bayer had reached agreements, without admission of liability, to settle approximately 9,500 claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) for a total amount of about US$1.9 billion.
• At present, about 2,000 such claims are under review….

We will continue to report periodically on the entire Beyaz / Safyral / YAZ / Yasmin / Gianvi / Ocella drug injury litigation, as we have been doing since 2009 when the first lawsuits against Bayer were filed.

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Beyaz / Safyral / YAZ / Yasmin: These Drospirenone Containing Birth Control Pills Have A Higher Risk Of Blood Clot Side Effects Than Older Options

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New Medical Journal Article Presents “Compelling Evidence” That These Newer Oral Contraceptives Are Associated With More Venous Thromboembolism Events

 
SUMMARY: From an Editorial piece published May 26, 2015 by the medical journal BMJ, “Fresh evidence confirms links between newer contraceptive pills and higher risk of venous thromboembolism”, we get this commentary from Susan S. Jick, of Boston University School of Public Health):

Notably, Vinogradova and colleagues also looked at the newer oral contraceptives, such as those containing desogestrel, gestodene, and cyproterone, as well as the newest pill containing drospirenone, where data have been limited and the magnitude of effects on the risks of venous thromboembolism remains controversial…. Vinogradova’s comprehensive study addresses important questions about the risk of venous thromboembolism in women taking oral contraceptives, concluding that the risk associated with newer pills is around twofold higher than the risk associated with older contraceptives.

The important new medical study that Dr. Jick is alluding to above is the subject of this article, “Use of combined oral contraceptives and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases”, published in the same edition of the BMJ medical journal.

Beyaz, Safyral, YAZ, and Yasmin are birth control pills which contain ethinyl estradiol (EE) and the progestin drospirenone (DRSP). These DRSP oral contraceptives have been associated with several different adverse side effects such as:

• Blood Clots
• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism (PE)
• Stroke or Cerebrovascular Accidents (CVA)
• Heart Attack or Myocardial Infarction

We will continue to watch for legal, medical, and regulatory developments as regards Beyaz, Safyral, YAZ, and Yasmin, as well as other DRSP birth control pills such as Gianvi and Ocella.

[Read this article in full at original source]

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YAZ / Yasmin Litigation Update For March 2015: According To Bayer’s 2014 Annual Report, “Additional lawsuits are anticipated.”

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Bayer Claims It Settled About 300 Of These Cases While Another 1300 Lawsuits Were Filed From Mid-October 2014 To The End Of January 2015

 
SUMMARY: From this earlier article, “December 2014 YAZ / Yasmin Litigation Update: Still Over 2000 DVT And/Or PE Cases Not Settled According To Bayer’s Most Recent Financial Report”, we get these previous numbers:

  • As of October 13, 2014, the number of claimants in the pending lawsuits and claims in the United States totaled about 4,000 (excluding claims already settled).
  • As of October 13, 2014, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 9,200 claimants in the U.S. for a total amount of about US$1.8 billion.

And from the PRODUCT-RELATED LITIGATION part of Bayer’s Annual Report 2014, we get these more recent numbers:

  • As of January 31, 2015, the number of claimants in the pending lawsuits and claims in the United States totaled about 5,000 (excluding claims already settled).
  • As of January 31, 2015, Bayer had reached agreements, without admission of liability, to settle approximately 9,500 claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) for a total amount of about US$1.9 billion.

While the Bayer DRSP birth control pills Beyaz and Safyral are not mentioned in this part of the Annual Report, we know lawsuits for women who developed blood clots, including some who died, have been filed against the drug company in addition to YAZ, Yasmin, Gianvi, and Ocella cases involving DVT and/or PE side effects.

[Read this article in full at original source]

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December 2014 YAZ / Yasmin Litigation Update: Still Over 2000 DVT And/Or PE Cases Not Settled According To Bayer’s Most Recent Financial Report

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And New Blood Clot Side Effect Lawsuits, Including Some Involving The Lesser-Known Safyral And Beyaz DRSP Pills, Are Still Being Filed Against Bayer

 
SUMMARY: From Bayer’s Stockholders’ Newsletter Financial Report as of September 30, 2014, published on October 30, 2014:

As of October 13, 2014, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 9,200 claimants in the U.S. for a total amount of about US$1.8 billion. Bayer has only been 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 a rolling basis. Such injuries are alleged by about 2,100 of the pending unsettled claimants. Bayer will continue to consider the option of settling such individual lawsuits in the U.S. on a case-by-case basis.

To put all of this into context, the YAZ / Yasmin litigation began back in mid-2009 when the first lawsuits against Bayer were filed. In January 2012 Bayer decided to begin to attempt to negotiate settlements for YAZ / Yasmin / Ocella / Gianvi blood clot lawsuits, e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE), on a case-by-case basis. And new lawsuits, including some cases involving Safyral and Beyaz, are still being filed against Bayer to date.

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Summer 2014 Update YAZ / Yasmin / Ocella / Gianvi Litigation: Bayer Reports On Total Settlements And Number Of Pending Claims

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Perhaps The Slow-Going Over Past Year Will Be Changed By Upcoming Mediations With Two Special Masters Appointed Recently By Judge Herndon

 
SUMMARY: For the YAZ / Yasmin / Ocella / Gianvi litigation as of July 2, 2014:

•  Settlements with about 8,900 claimants for total of $1.8 billion;
•  The number of pending claims with deep vein thrombosis (DVT) and/or pulmonary embolism (PE) — the “venous clot injuries” — is approximately 2400; and,
•  There are an estimated 2,600 claims with other alleged drospirenone (DRSP) related injuries, such as arterial clots.

So where do things stand in comparison to our last article about the Bayer DRSP birth control pills litigation? More new blood clot cases have been filed than there have been older cases settled, using Bayer’s numbers.

One hopes that the two special masters appointed by Judge Herndon “for the purpose of mediating settlement” will serve to move cases to settlement at a faster pace than has been the experience of this past year.

[Read this article in full at original source]

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About 2000 YAZ / Yasmin / Ocella / Gianvi Blood Clot Cases Are Still Not Settled More Than Two Years After Bayer Began Settlement Mediations

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Bayer Reports That As Of April 8, 2014 Settlement Negotiations Have Resolved “approximately 8,560 claimants in the U.S. for a total amount of about US$1.74 billion”

 
SUMMARY: As of early April 2014 there were about 2000 unresolved YAZ / Yasmin / Ocella / Gianvi claims according to the Bayer Stockholders’ Newsletter First Quarter 2014.

Our previous article about this litigation was “YAZ / Yasmin Products Liability Litigation: February 2014 Bayer Information About The Number Of Claims, Lawsuits, And Settlements”, which included Bayer’s report that as of February 10, 2014 venous clot injuries (deep vein thrombosis or pulmonary embolism) were alleged by about 1,950 of the pending unsettled claimants.

The litigation update article before that was titled “During 2013 Bayer Has Had More Than 2000 YAZ / Yasmin Lawsuits For Blood Clots That Are Not Settled”.

In re-reading those articles again, now, it seems that Bayer’s settlement efforts have slowed down over the past year, for whatever reason(s).

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YAZ / Yasmin Products Liability Litigation: February 2014 Bayer Information About The Number Of Claims, Lawsuits, And Settlements

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While 2013 Annual Report Includes Gianvi And Ocella Drug Injury Cases, The Only Mention Of Beyaz And Safyral Legal Cases Is Regarding Patent Disputes

 
SUMMARY: From the Bayer 2013 Annual Report which was issued recently:

•  As of February 10, 2014, the number of claimants in the pending lawsuits and claims in the United States totaled about 4,600 (excluding claims already settled)….
•  As of February 10, 2014, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 8,250 claimants in the U.S. for a total amount of about US$1.69 billion. Bayer has only been settling claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism)….
•  Such injuries are alleged by about 1,950 of the pending unsettled claimants.

We will continue to monitor the YAZ / Yasmin litigation, including the status of filed and unfiled Beyaz and Safyral cases involving blood clot side effects like deep vein thrombosis (DVT) and pulmonary embolism (PE).

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Law Offices of Thomas J. Lamb, P.A.
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