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Boston Scientific said in a recent SEC filing that it is facing numerous lawsuits, including more than 1,000 cases related to its acquisition of heart-device maker Guidant and a series of patent infringement cases with rival devicemakers.
In a letter published in the Feb. 15 issue of the New England Journal of Medicine, molecular pathologist and attorney Roger Klein of the Yale University School of Medicine questioned the validity of patents used to prevent clinical laboratories from performing certain genetic tests.
When deciding which type of FDA marketing application to submit, device firms should consider the possibility they may have to defend themselves against civil, or "tort," lawsuits if their products are linked with patient injury, legal experts told attendees at an FDAnews audioconference last month.
The Washington Legal Foundation (WLF) is supporting a former regulatory affairs official’s appeal of a recent court ruling that he conspired to sell a device that had not been approved by the FDA.
Orthopedic devicemaker Endotec said it will challenge an FDA complaint in court and argue that the agency lacked adequate information when it sought a permanent injunction against the company.
The briefs and evidence kept secret in a case involving heart devicemaker Guidant must be unsealed, Public Citizen said in a motion filed Aug. 8 in the U.S. District Court for the District of Minnesota.
The Department of Justice (DOJ) and Medtronic announced July 18 the firm will pay the government $40 million to settle a civil suit alleging that the firm's Sofamor Danek division paid kickbacks to healthcare professionals to induce them to use Medtronic's spinal products.
A World Health Organization (WHO) initiative to loosen diagnostics and drug intellectual property (IP) laws in developing countries could lead diagnostics manufacturers to consider patent restrictions for their products and dampen their financial incentive to develop tests for diseases that are prevalent in poorer nations, an industry consultant suggests.