Stuart M. Gerson and Bradley Merrill Thompson, Members of the Firm, were quoted in the Bloomberg BNA Medical Devices Law & Industry Report, in “Bipartisan House Bills Take Aim at Unsafe Medical Devices,” by Bronwyn Mixter. (Read the full version – subscription required.)
Following is an excerpt:
Stuart Gerson, a health-care attorney at previous Epstein Becker & Green PC in Washington, told Bloomberg BNAMay 5 the issue with H.R. 2164 is whether a particular state should be able to supersede the FDA.
“It seems to me the better answer, especially in dealing with a company that is marketing a device nationally and is being used everywhere, is to have the FDA do its job,” Gerson said. “If the FDA has done its job adequately, which is what we ought to insist on as citizens and participants in the marketplace, and then approves the device, that should be sufficient.”
On H.R. 2163, Bradley Merrill Thompson, also an attorney with Epstein Becker & Green PC, told Bloomberg BNAin an email the bill adds physicians and physician offices to the list of entities required to do user reporting. User reporting is required when a user receives or otherwise becomes aware of information that reasonably suggests that a device has or may have caused or contributed to the death, serious illness or injury of a patient.
“In theory adding physicians individually and physician offices to the list of organizations that must report sounds good. But the issue is one of resources. Patients die or get seriously injured all the time. Investigating and figuring out whether a medical device played a role in that death can be pretty time-consuming,” Thompson said.
Thompson said this reporting requirement will take up time that physicians don’t have. He also said it may have little benefit because hospitals are already required to report and high-risk procedures aren’t often done in a physician’s office. Thompson is a Bloomberg BNAadvisory board member.