by Aaron Johnston, WFU JD Candidate ’21
When I was just starting to move out of the “weed-out” engineering college courses—calculus, physics, circuits, and chemistry—and into the core tenets of bioengineering, one conversation with my professor has always stuck out in my mind. I had to write a final paper in the form of a National Institute of Health-style proposal. The goal was to think outside the box and attempt to put something together from the building blocks we had at the time. After one class, I wandered up to the front of the room, apparently with a half-concerned, half-perplexed look on my face.
“What’s wrong?” my Professor asked.
“Well, I wanted to run this methodology by you to see what you thought. I’m not sure it will work.” I started sketching out my revolutionary idea. I knew it wouldn’t live up to an NIH proposal, but nevertheless, I was proud of it.
“. . . and then I’ll use BMP-2 to . . .”
“Wait, BMP-2? I’d be careful about BMP-2, people have been having issues with it.”
“But I thought BMP-2 was great for stimulating bone growth in mesenchymal stem cells.”
“It is, but one thing you will eventually learn is that once people are afraid of something, research is stifled. Go take a look at Medtronic.”
I didn’t think much about that conversation at the time: it was right after new studies about BMP-2 had come to light. Four years later, however, upon entering my first torts class in law school and having our first discussion of products liability, the thought of Medtronic came to mind again. If BMP-2 was such a great, new, innovative method of stimulating bone growth, what could have possibly gone wrong? It turns out, a lot.Continue reading “Is It Time to Reevaluate Off-Label Usage?”