Associate Professor Patricia Zettler quoted in Minneapolis Star Tribune discussing patient safety laws
An expert in the area of health law and a former FDA attorney, Associate Professor Patricia Zettler was recently quoted in an article by the Minneapolis Star Tribune titled, "FDA finds Hennepin Healthcare doctors violated patient safety laws in sedative studies."
"An FDA investigator who visited the hospital in 2019 discovered "objectionable conditions" on studies led by Dr. Jon Cole and Dr. Lauren Klein, both of whom ignored FDA regulations and used practices that subjected patients to "significantly increased risk," according to the letters. The hospital has since used "factually incorrect" statements to defend its research to the FDA, the letters say.
"It's quite clear that the agency's view is that there were significant violations here," said Patti Zettler, former associate chief counsel for the FDA, who now teaches at the Ohio State University Moritz College of Law. "The facts here are quite troubling."