Bayer Has Settled Less Than Half The DVT And PE Blood Clot Claims Filed Or Cases Subject To Tolling Agreements
In late October 2012 we received the Bayer Stockholders’ Newsletter which covered its third quarter financial reporting and, in particular, gave us this update about the YAZ, Yasmin, Ocella, and Gianvi products liability litigation ongoing in the U.S.:
As of October 15, 2012, the number of lawsuits pending in the United States and served upon Bayer was about 12,400. In addition, about 720 asserted claims were pending that have not been filed in court. The number of claimants in the pending lawsuits and claims totaled about 13,500 (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 October 15, 2012, Bayer had reached agreements, without admission of liability, to settle the claims of about 3,490 claimants in the U.S. for a total amount of about US$750 million. Bayer is only 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 3,800 of the pending unsettled claimants....
As regards the reference above to the claims pending but not yet filed, it is likely that most if not all those cases are the subject of an an arrangement which is generally referred to by lawyers as a "tolling agreement". Earlier in the Bayer Stockholders’ Newsletter we find this settlement-related information about this set of un-filed but recognized legal claims:
Net special items totaled minus €356 million.... Included here were €205 million [which equals approximately $265.7 million in U.S. currency as of 11/26/12] in further accounting measures taken – mainly based on additional claims asserted but not filed in court – for all cases in connection with the oral contraceptives Yasmin™/YAZ™ of which we are currently aware and which we consider to be worthy of settlement (venous clot injuries).
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Then, going back to the section of this Stockholders’ Newsletter with which we started:
Bayer has taken appropriate accounting measures for anticipated defense costs and for agreed and anticipated future settlements based on the information currently available and based on the number of pending claims alleging venous clot injuries. Bayer is insured against product liability risks to the extent customary in the industry. However, the accounting measures taken include an amount in excess of the available insurance coverage. For the accounting measures exceeding the insurance coverage, Bayer recorded expenses totaling about €0.7 billion [which equals approximately $907.4 million in U.S. currency as of 11/26/12] in the second and third quarters of 2012.
So it appears that Bayer has quite a ways to go with regard to settling the remaining, and still increasing, number of YAZ, Yasmin, Ocella, and Gianvi claims involving pulmonary embolism (PE) and/or deep vein thrombosis (DVT).
Meanwhile, in the same Stockholders’ Newsletter we learned that Bayer has a potential new drospirenone (DRSP) pill, YAZ™ Flex Plus, which is described as "oral contraception with flexible dosage regimen and folic acid supplementation". This new Bayer DRSP pill has already submitted for approval in the U.S., according to the Newsletter.
One last observation: There was not a single mention of Beyaz nor Safyral that I could find in this Bayer Stockholders’ Newsletter. Beyaz (20 mcg EE / 3 mg DRSP / 0.451 mg levomefolate calcium) and Safyral (30 mcg EE / 3 mg DRSP / 0.451 mg levomefolate calcium) are essentially YAZ and Yasmin with a form of folate or folic acid added.
In late August 2012 the FDA made available an agency staff briefing document that informed us that the Adverse Event Reporting System (AERS) database contained 467 reports for Beyaz made during the period September 2010 (when it was first approved by FDA) to May 1, 2012.
I wonder when we will start to hear from Bayer about the number of Beyaz and Safyral legal claims involving PE and/or DVT blood clot side effects.
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