To find out more about the Bayer Group’s legal risks, please see Note 32 to the consolidated financial statements in the Bayer Annual Report 2014, which can be downloaded free of charge at www.bayer.com. Since the Bayer Annual Report 2014, the following significant changes have occurred in respect of the legal risks:
Yasmin™ / YAZ™: As of October 16, 2015, the number of claimants in the pending lawsuits and claims in the United States totaled about 3,400 (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 16, 2015, Bayer had reached agreements, without admission of liability, to settle approximately 10,000 claims in the U.S. for venous clot injuries (primarily deep vein thrombosis or pulmonary embolism) for a total amount of about US$2 billion. Bayer will continue to consider the option of settling such claims after a case-specific analysis of medical records. At present, about 600 such claims are under review.
In August 2015, Bayer reached an agreement to settle, without admission of liability, lawsuits and claims in which plaintiffs allege an arterial thromboembolic injury (primarily strokes and heart attacks) for a total maximum aggregate amount of US$56.9 million. Bayer may withdraw from the settlement if fewer than 97.5% of those who are eligible, and / or fewer than 96% of those who are eligible and allege death or catastrophic injuries, choose to participate. As of October 16, 2015, about 1,200 of the 3,400 above-mentioned claimants alleged arterial thromboembolic injuries.
In August 2015, the U.S. multidistrict and state coordinating courts overseeing the litigation issued case management orders governing all cases before them (regardless of alleged injury), imposing strict threshold requirements for litigating the remaining unsettled cases as well as the filing of new cases, failing which they will be dismissed.
Mirena™: As of October 16, 2015, lawsuits from approximately 3,500 users of Mirena™, an intrauterine system providing long-term contraception, had been served upon Bayer in the U.S. Additional lawsuits are anticipated. Plaintiffs allege personal injuries resulting from the use of Mirena™, including perforation of the uterus, ectopic pregnancy, or idiopathic intracranial hypertension, and seek compensatory and punitive damages. As of October 16, 2015, five lawsuits relating to Mirena™ seeking class action certification had been served upon Bayer in Canada.
Xarelto™: As of October 16, 2015, lawsuits of approximately 2,500 recipients of Xarelto™, an oral anticoagulant for the treatment and prevention of blood clots, had been served upon Bayer in the U.S. Plaintiffs allege personal injuries from the use of Xarelto™, including cerebral, gastrointestinal or other bleeding and death, and seek compensatory and punitive damages. Additional lawsuits are anticipated. As of October 16, 2015, six lawsuits relating to Xarelto™ seeking class action certification had been served upon Bayer in Canada.
Competition law proceedings
Phillips’ Colon Health / Department of Justice: In September 2015, a New Jersey federal court ruled that the United States failed to discharge its burden of proving that Bayer failed to possess competent and reliable scientific evidence to substantiate its claims made about some of its dietary supplements. Thus, the court found that Bayer did not violate a 2007 consent decree. In 2014, the United States Department of Justice, representing the United States Federal Trade Commission (FTC), had filed a motion in the New Jersey federal court. The FTC can appeal.
Beyaz™ / Safyral™: In September 2015, the U.S. federal court ruled in favor of Bayer regarding both the validity of its patent and the infringement thereof by Watson Laboratories, Inc. Watson appealed the decision. In May and October 2015, Bayer filed two suits against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (together “Lupin”) in U.S. federal court for infringement of the same patent. In April and September 2015, Bayer had received two notices of an abbreviated new drug application (ANDA) by Lupin seeking approval to market generic versions of Safyral™ and Beyaz™, Bayer’s oral contraceptives containing folate, in the United States.
Finacea™: In July 2015, a U.S. federal court found that Bayer’s patent relating to Finacea™ topical gel is valid and infringed by Glenmark Generics Ltd. Glenmark appealed the decision.
Staxyn™: In Bayer’s patent infringement suit in a U.S. federal court against Watson Laboratories, Inc., the court ruled in April 2015 that both of Bayer’s compound patents are valid and infringed. Watson may appeal. Bayer’s erectile dysfunction treatment Staxyn™ is an orodispersible (orally disintegrating) formulation of Levitra™. Both drug products contain the same active ingredient, which is protected in the U.S. by the compound patents upheld by the court.
Xarelto™: In October 2015, Bayer and Janssen Pharmaceuticals, Inc. filed a patent infringement suit in a U.S. federal court against Aurobindo Pharma Limited, Aurobindo Pharma USA, Inc. (together “Aurobindo”), Breckenridge Pharmaceutical Inc. (“Breckenridge”), Micro Labs Ltd., Micro Labs USA Inc. (together “Micro Labs”), Mylan Pharmaceuticals Inc., Mylan Inc. (together “Mylan”), Prinston Pharmaceutical Inc. (“Prinston”), Sigmapharm Laboratories, LLC (“Sigmapharm”), Torrent Pharmaceuticals, Limited and Torrent Pharma Inc. (together “Torrent”). In September 2015, Bayer had received notices of an ANDA by Aurobindo, Breckenridge, Micro Labs, Mylan, Prinston, Sigmapharm and Torrent, each seeking approval to market a generic version of Xarelto™, an oral anticoagulant for the treatment and prevention of blood clots, in the United States.
Further legal proceedings
Bayer Pharma AG former shareholder litigation: In August 2015, the special court proceedings initiated by former minority stockholders of Bayer Pharma AG (formerly named Bayer Schering Pharma AG), Berlin, were resolved by way of settlement agreements. All applicants in both proceedings have agreed to the settlement. The settlements provide for an increase of the compensation in both proceedings to a uniform amount which is covered by the accounting measures that had been taken before.