As medical innovation evolves, someone is the first person to do a procedure. If the results are great – wonderful. What happens if the results are great most of the time, but one patient out of 100 has a horrible complication? If that patient sues for malpractice, he will argue you were not following the standard of care, and that failure caused damages. That is the hallmark of a medical negligence suit.

Well, if you are the only person doing this procedure- paving the way for others to follow- it’s true. You are NOT following the standard of care. The standard of care is what a majority or respectable minority in the field would do in same or similar circumstances. If you’re the only person in the US doing the procedure, then even though you may be respectable, a respectable minority implies N>1. So, you run the risk of being sued for medical negligence even if you are on the cusp of a changing paradigm.


Of course, some doctors practice outside the mainstream “standard of care.” That, in it of itself, is not a showstopper. Otherwise, how would innovation or progress ever occur? In the 1980s, gastric ulcers were universally believed to be caused by excess gastric acid secretion. Decrease the acid and the ulcer would disappear. One innovative Australian proposed the heretical hypothesis that such ulcers were really caused by bacteria. He was laughed off as a quack. Most know the story. He discovered that helicobacter, a bacterium, causes many ulcers. Antibiotics are the correct treatment. Barry Marshall and Robin Warren won the Nobel Prize in Physiology and Medicine in 2005. Not all innovations have this happy ending. Some innovations are wrong. But, this issue is no less a problem with mainstream medicine.


To pre-empt being accused of failing to follow the standard of care – either in a medical negligence case, or Board of Medicine complaint, consider receiving an Institutional Review Board (“IRB”) approval for your innovation. There are private groups that will set the physician up with IRB approval, such as Copernicus ( They will do two things. Look at the general safety of the protocol relative to the perceived benefit. There is flexibility as long as the protocols are not intrinsically dangerous. Next, the IRB will evaluate the informed consent form.


If the Board of Medicine investigates, and the protocol being addressed is under cover of IRB approval, it is more likely the Board will accept that as reasonable. Private IRB evaluations are reasonably priced – and certainly far less expensive than defending against a Board investigation. If the practitioner does a large number of a few protocols, consider obtaining IRB for those high volume protocols.


Likewise, if you are sued for medical negligence, you would be arguing that the procedure is innovative, and has been reviewed by IRB. As long as you do not deviate from the protocol; implement the protocol ineptly; or fail to obtain proper consent, you should be able to successfully defend.


Finally, a couple of details. If you are performing the procedure under cover of IRB, it might not be reimbursed by health insurance. Many health insurance carriers exclude payment for investigational procedures. Also, check with your medical malpractice carrier to make sure they will defend you if the innovative procedure is approved by IRB. They may need to add a rider to address boilerplate exclusions.


Innovation is great for doctors and patients. But, dot the i’s and cross the t’s before there’s a potential problem. Not all innovation proceeds as expected.