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North Carolina Appeals Court Medication Decision – FDA Shocker(?)


North Carolina Appeals Court Says RX OK Even If Not FDA Approved

A North Carolina Appeals Court rendered a very interesting decision earlier this month that was a shocker..  I am not saying whether or not I agree with the decision.  Those kinds of decisions are best left to the courts.

FDA Logo North Carolina Appeals Court
(c) FDA.gov

The case was  Davis v. Craven County ABC Board, No. COA17-908, 04/17/2018.   The complete decision can be found here. 

It is a small PDF file.  You will need a PDF reader such as Adobe Acrobat.

One of the bedrock decisions in North Carolina (I was the claims adjuster on this one) was Simon v. Triangle Materials.   The Simon decision brought “effect a cure and give relief” to light and strengthened the phrase in our HQ state.

Davis’s claim was accepted as compensable.  The treating physician prescribed a non-FDA-approved cream for the injured employee to use. The carrier denied the prescription.  The North Carolina Industrial Commission approved its use by Davis at both Deputy Commissioner and Full Commission levels.

The insurance carrier once again appealed it now to the NC Court of Appeals.   The North Carolina Appeals Court summarized their decision very well in one paragraph:

As explained below, we reject Defendants’ argument that non-FDA-approved drugs should be categorically excluded from medical compensation under the workers’ compensation system. The text of the Workers’ Compensation Act does not limit drug treatment solely to FDA-approved drugs. Defendants assert a number of persuasive policy arguments concerning the risks of non-FDA-approved drugs, but
this Court has no authority to rewrite the law on policy grounds. That is a task for the legislative branch.

Take notice of that last bolded sentence – very interesting.

The Rx North Carolina Appeals Court Icon
commons.wikimedia.org by Nevit Dilmen

I was involved in an offshore captive insurer’s decision to deny a cream that contained Fentanyl.   The treating physician in Florida changed the cream from a Fentanyl-based to a non-FDA approved cream.  I provided the captive with a large amount of documentation on Fentanyl.  The non-FDA approved cream was OK’ed by the captive owners as a better alternative than what was considered a dangerous drug a few years ago (2011).

Why did I write up this article?   Many workers comp adjusters, not only in North Carolina, need to know when an unusual decision or circumstance occurs in Work Comp.  Even if you do not have claims in the Tarheel State, this type of decision may be coming to or already has happened in your state.

The reach of a decision sometimes is much longer than this North Carolina Appeals Court decision.

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James J Moore - Workers Comp Expert

Raleigh, NC, United States

About The Author...

James founded a Workers’ Compensation consulting firm, J&L Risk Management Consultants, Inc. in 1996. J&L’s mission is to reduce our clients’ Workers Compensation premiums by using time-tested techniques. J&L’s claims, premium, reserve and Experience Mod reviews have saved employers over $9.8 million in earned premiums over the last three years. J&L has saved numerous companies from bankruptcy proceedings as a result of insurance overpayments.

James has over 27 years of experience in insurance claims, audit, and underwriting, specializing in Workers’ Compensation. He has supervised, and managed the administration of Workers’ Compensation claims, and underwriting in over 45 states. His professional experience includes being the Director of Risk Management for the North Carolina School Boards Association. He created a very successful Workers’ Compensation Injury Rehabilitation Unit for school personnel.

James’s educational background, which centered on computer technology, culminated in earning a Masters of Business Administration (MBA); an Associate in Claims designation (AIC); and an Associate in Risk Management designation (ARM). He is a Chartered Financial Consultant (ChFC) and a licensed financial advisor. The NC Department of Insurance has certified him as an insurance instructor. He also possesses a Bachelors’ Degree in Actuarial Science.

LexisNexis has twice recognized his blog as one of the Top 25 Blogs on Workers’ Compensation. J&L has been listed in AM Best’s Preferred Providers Directory for Insurance Experts – Workers Compensation for over eight years. He recently won the prestigious Baucom Shine Lifetime Achievement Award for his volunteer contributions to the area of risk management and safety. James was recently named as an instructor for the prestigious Insurance Academy.

James is on the Board of Directors and Treasurer of the North Carolina Mid-State Safety Council. He has published two manuals on Workers’ Compensation and three different claims processing manuals. He has also written and has been quoted in numerous articles on reducing Workers’ Compensation costs for public and private employers. James publishes a weekly newsletter with 7,000 readers.

He currently possess press credentials and am invited to various national Workers Compensation conferences as a reporter.

James’s articles or interviews on Workers’ Compensation have appeared in the following publications or websites:

  • Risk and Insurance Management Society (RIMS)
  • Entrepreneur Magazine
  • Bloomberg Business News
  • WorkCompCentral.com
  • Claims Magazine
  • Risk & Insurance Magazine
  • Insurance Journal
  • Workers Compensation.com
  • LinkedIn, Twitter, Facebook and other social media sites
  • Various trade publications


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