Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in The Wall Street Journal, in “How FDA Approved Hysterectomy Tools It Now Disfavors,” by Jon Kamp and Thomas M. Burton.
Following is an excerpt:
“With a mechanical instrument, the idea was that you can predict the effects on health with some certainty,” says Bradley Merrill Thompson, a medical-device lawyer in Washington, “whereas a drug permeates your body and is harder to predict.” ...
Any individual report might not have been enough to raise alarms, and it took years for scientific evidence to accumulate. Companies and the FDA aren’t required, under the 510(k) system, to scour scientific literature for studies on a tool’s potential risks, says Mr. Thompson, the device lawyer.
