The U.S. attorney in Minneapolis settled a kickback case with device maker Medtronic yesterday, with the company agreeing to pay $23.5 million without admitting it paid doctors $1,000 to $2,000 for choosing its brand of defibrillator. What is so galling about this and other cases like it is that the physicians were being asked to enroll patients in post-marketing clinical trials and registries that would determine if the company’s latest heart-shocker worked as well as advertised given the limited trials conducted prior to Food and Drug Administration approval.
Stop and think about that for a minute. The FDA or perhaps the Center for Medicare and Medicaid Services asks a company to conduct trials or register patients in a database so their outcomes can be looked at later to measure efficacy. The company allegedly (Medtronic didn’t admit guilt) pays the physicians to use their particular brand of device before enrolling them in the trial, which undoubtedly costs Medicare and other payers significantly more than previous iterations or other brands of the device, since it is the latest one on the market. Hasn’t that payment introduced a huge element of bias into the patient selection for those trials and registries? Hasn’t that undermined the validity of the studies?
Medtronic may not have admitted guilt in paying bribes. But its tacit admission that it made payments (it agreed to a $23.5 million settlement) was a crime against science. The latter, it seems to me, is far worse for a company that purports to be science-based.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The author, Merrill Goozner, is an award-winning journalist and author of “The $800 Million Pill: The Truth Behind the Cost of New Drugs” who writes regularly at Gooznews.com.
