Boston Scientific settles ICD suits
This article was originally published in The Gray Sheet
Executive Summary
Implantable cardioverter defibrillator maker will pay $195 million to settle class-action litigation stemming from a series of ICD recalls by its Guidant unit in 2005 and 2006, the company says July 13. Pending "certain conditions," the settlement will resolve nearly 4,000 individual claims that had been consolidated in the U.S. District Court for the District of Minnesota. The agreement includes an undetermined number - but not all - of additional similar claims throughout the country, the company says. Pending implementation of the agreement, trials that had been scheduled to start July 30 have been suspended (1"The Gray Sheet" June 18, 2007, In Brief)...
You may also be interested in...
Boston Scientific Settles With States On Guidant ICD Investigations
Boston Scientific agreed Aug. 30 to pay $16.75 million to 35 states and the District of Columbia to settle investigations into the lack of public disclosure of certain defibrillator risks
Boston Scientific/Guidant class action
Bellwether suit in the product liability class action against Boston Scientific/ Guidant stemming from Guidant implantable defibrillator recalls in 2006 will go to a jury trial. On June 12, the U.S. District Court of Minnesota denied Boston Scientific's motions to dismiss claims by a California ICD recipient that Guidant failed to appropriately disclose information about potential device malfunctions. "This case concerns the issues of whether, how, and to whom information was shared (and to whom it should have been shared) about a device with an alleged defect and the cause of that alleged defect," Judge Donovan Frank says in his ruling. According to Boston Scientific's first-quarter 2007 report filed in May with the Securities & Exchange Commission, the firm expects the Guidant recall class actions to eventually cost $732 million (1"The Gray Sheet" July 24, 2006, p. 10)...
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.