IRB Letters Cited as Evidence Woman Was Enrolled in Trial Without Consent

LOS ANGELES—Attorneys for a woman who sued Pomona Valley Hospital Medical Center and two medical device makers after she sustained serious injuries during back surgery said July 24 that documents obtained during discovery suggest the hospital enrolled patients without their consent in an experimental research project.

The documents, three letters from institutional review board members, were included as attachments in a June 29 response by the woman’s attorneys to a filing by PVHMC seeking a stay of a court order to produce IRB records (Pomona Valley Hospital Medical Center v. Superior Court of the County of Los Angeles response ...