02-December-2007

In the St. Paul Pioneer Press article titled “High-Stakes Decision,” Ralph Hall, counsel with Baker & Daniels and an advisor with B&D; Consulting, was interviewed. The article previewed an upcoming U.S. Supreme Court case on injured patients suing medical device makers. The prospect of jury judgments involving the design and labeling of PMA products presents obvious problems, Hall said. “The manufacturer cannot comply with both standards — they are contradictory,” he said. “Every device, every drug has risks inherent with it. What (the industry is) saying is that as a matter of policy the FDA — not a jury — is the one that decides that balancing point” in the risks and benefits of a device.