Supreme Court sets pre-emption case date
This article was originally published in The Gray Sheet
Executive Summary
The U.S. Supreme Court will hear Riegel v. Medtronic on Dec. 4 in what could be the last word on the issue of federal PMA preemption. Charles and Donna Riegel sued Medtronic for alleged negligence in the design, testing, labeling and manufacturing of the Evergreen balloon catheter after the balloon burst while Mr. Riegel was undergoing an angioplasty procedure. The plaintiffs claim that Medtronic should be liable for resulting complications, while the company counters that the product was in compliance with FDA regulations for labeling, manufacturing and design, among other requirements, and thus is not vulnerable to state suits (1"The Gray Sheet" Oct. 8, 2007, p. 11)
You may also be interested in...
Supreme Court To Hear Medtronic Pre-emption Case, Despite Irregularities
The U.S. Supreme Court reaffirmed Oct. 1 that it will hear a case against Medtronic this session that could settle the long-standing issue of whether FDA premarket approval protects device manufacturers from liability in patient lawsuits
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.