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From Products Liability Law Daily, August 5, 2015

Bayer establishes $56.9 million fund to settle drospirenone-related thromboembolism claims

By John W. Scanlan, J.D.

A $56.9 million fund established by Bayer HealthCare Pharmaceuticals to settle patients’ claims alleging an arterial thromboembolism (ATE) resulted from use of drospirenone-containing oral contraceptives (DCOCs) has been approved by the U.S. District Court for the Southern District of Illinois. The settlement is intended to resolve claims brought in that court as part of MDL No. 2100; state court litigation in California, New Jersey, and Pennsylvania; and any other federal and state proceedings (In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices, and Products Liability Litigation, August 3, 2015, Herndon, D.).

Settlement terms. The master settlement agreement provides for Bayer to pay $56.9 million into a qualified settlement fund, with $46.9 million attributed to “Phase One” payments going to most claimants, and another $10 million to “Phase Two” payments for claims involving severe injury, death, documented medical expenses exceeding $100,000, or other extraordinary injury. Phase One damage awards will be based on a point system involving six initial allocation levels based on the level of the injury, the age of the patient, and whether hospitalization is required, with various risk factor deductions such as patient BMI, tobacco use, illegal drug use, and discontinued DCOC use, along with risk factor enhancements such as lengthy hospitalization stays, post-injury anticoagulation use, surgical procedures due to injury, and post-injury rehabilitation required. A Special Master will make a determination for each Phase Two claim as to whether a supplemental award is justified for that claim.

Deadlines. Eligible claimants who wish to participate in the settlement must file an irrevocable Notice of Intent to Opt-In by September 12, 2015. Program participants then must file within 30 days of the Notice of Enrollment Status (or decision by the Special Master on the participant’s enrollment status) a Claim Package containing various documents, including an executed Release of rights, a signed medical authorization, pharmacy and medical records, hospitalization and treatment records, a declaration as to whether a Phase Two claim is being made, and others. Within 30 days of receipt of a Claims Package, the administrator will have 30 days to notify a Participant of any deficiency, and the Participant will have 30 days to remedy it subject to dismissal with prejudice. Within 15 days of a determination that a Claims Package is complete, the administrator will make a determination of allocation levels and apply risk factor enhancements and deductions in calculating the points used in making the award. The Participant may appeal this calculation within 5 days, and one of two Special Masters appointed by the court will make a binding and final ruling on the appeal within 5 days. Any remaining funds after all Phase One and Two payments made will be distributed pro rata to Participants based upon their Phase One awards.

Right to Withdraw. Bayer will have the option to walk away from the settlement up to 45 days after receipt of the last Claim Package pursuant to any deadlines and extensions unless at least 97.5 percent of all eligible claimants and 96 percent of death and severe injury claimants enroll in the settlement, along with all eligible claimants in federal or state court in which a date for trial or jury selection has been identified.

The case is No. 3:09-md-02100-DRH-PMF (MDL No. 2100).

Attorneys: Mark R. Niemeyer (Niemeyer, Grebel & Kruse LLC), Michael S. Burg (Burg Simpson Eldredge Hersh & Jardine, PC), and Michael A. London (Douglas & London PC) for Plaintiffs. Adam L. Hoeflich (Bartlit, Beck, Herman, Palenchar & Scott, LLP), and John E. Galvin (Fox Galvin LLC) for Bayer Corp., Bayer HealthCare Pharmaceuticals, Inc., Bayer HealthCare LLC, Walgreen Co., Bayer AG, Bayer Pharmaceuticals Corp., Bayer Schering Pharma AG, Berlex Laboratories, Inc., and Berlex, Inc.

Companies: Bayer Corp.; Bayer HealthCare Pharmaceuticals, Inc.; Bayer HealthCare LLC; Walgreen Co.; Bayer AG; Bayer Pharmaceuticals Corp.; Bayer Schering Pharma AG; Berlex Laboratories, Inc.; Berlex, Inc.

MainStory: TopStory ClassActLitigationNews DrugsNews

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