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.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.