Legal Risks

To find out more about the Bayer Group’s legal risks, please see Note “Legal Risks” to the consolidated financial statements in the Bayer Annual Report 2016, which can be downloaded free of charge at www.bayer.com. Since the Bayer Annual Report 2016, the following significant changes have occurred in respect of the legal risks:

Yasmin™/YAZ™: Most of the lawsuits and claims concerning Bayer’s drospirenone-containing oral contraceptives in the United States have been resolved. Claimants allege that users have suffered personal injuries, some of them fatal, from the use of Yasmin™ and / or YAZ™ or their generic versions, and seek compensatory and punitive damages, claiming, in particular, that Bayer had not adequately warned of the alleged risks. As of October 12, 2017, lawsuits and claims of approximately 40 claimants remain pending against Bayer in the U.S. Without admission of liability, Bayer is considering three of the lawsuits and claims for possible settlement after a case-specific analysis of medical records. The two motions for certification of a class action that are pending in Israel have been dismissed by the competent court. The plaintiffs can file an appeal with the Supreme Court in Jerusalem.

Bayer believes the risks remaining in this litigation are no longer material.

Mirena™: As of October 12, 2017, lawsuits from approximately 3,000 users of Mirena™, an intrauterine system providing long-term contraception, had been served upon Bayer in the United States. 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. Additional lawsuits are anticipated. In April 2017, most of the cases pending in U.S. federal courts in which plaintiffs allege idiopathic intracranial hypertension were consolidated in a second multidistrict litigation proceeding for common pre-trial management. The first multidistrict litigation proceeding concerns perforation cases. In August, 2017, Bayer reached an agreement in principle with plaintiffs’ counsel leadership for global settlement of the perforation litigation, for a total amount of USD12.2 million. As of October 12, 2017, a total of approximately 4,000 cases would be included in the settlement. The idiopathic intracranial hypertension multidistrict litigation proceeding is not included in the settlement.

Xarelto™: As of October 12, 2017, U.S. lawsuits from approximately 20,500 recipients of Xarelto™, an oral anticoagulant for the treatment and prevention of blood clots, had been served upon Bayer. Plaintiffs allege that users have suffered 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. In May, June and August 2017, the first three federal multidistrict litigation trials resulted in complete defense verdicts. One additional trial has been scheduled this year in a Pennsylvania state court and further trials are currently scheduled for the first quarter of 2018. Bayer anticipates that additional trials will be scheduled. As of October 12, 2017, ten Canadian lawsuits relating to Xarelto™ seeking class action certification had been served upon Bayer.

Essure™: As of October 12, 2017, U.S. lawsuits from approximately 10,600 users of Essure™, a medical device offering permanent birth control with a nonsurgical procedure, had been served upon Bayer. Plaintiffs allege personal injuries from the use of Essure™, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy, and seek compensatory and punitive damages. Additional lawsuits are anticipated. As of October 12, 2017, two Canadian lawsuits relating to Essure™ seeking class action certification had been served upon Bayer.

Damoctocog alfa pegol (BAY 94-9027, long-acting rFVIII): In August 2017, Bayer filed a lawsuit in a U.S. federal court against Nektar Therapeutics (“Nektar”), Baxalta Incorporated and Baxalta U.S., Inc. (together “Baxalta”) seeking a declaration by the court that a patent by Nektar is invalid and not infringed by Bayer’s drug candidate BAY 94-9027 for the treatment of hemophilia A. In September 2017, Baxalta and Nektar filed a complaint in a different U.S. federal court against Bayer alleging that BAY 94-9027 infringes seven other patents by Nektar. Regarding the complaint by Bayer, Nektar and Baxalta gave Bayer a covenant not to make any claims against Bayer for infringement of that patent. Bayer amended the complaint to now seek a declaration by the court that the seven other patents by Nektar are not infringed by BAY 94-9027. The patents are part of the same patent family registered in the name of Nektar which further comprises European patent applications at issue in the lawsuit Bayer filed against Nektar in 2013 in the district court of Munich, Germany. Bayer continues to believe that the patent family does not include any valid patent claim relevant for BAY 94-9027.