Breaking News: Legislative Reaction to a Tragic Death in Florida IV Hydration Therapy Industry

The IV hydration industry has been flourishing.?Flooded largely by nurses fleeing crushing institutional healthcare environments, the IV hydration industry is in fact one of the most vibrant and unlikely industry leaders in healthcare.?Many experts have pressed providers in the early-stage industry to self-regulate before they fall victim to the typical legislative reaction to a terrible event (which was inevitable).?We’ve seen it in other states; and now Florida is facing that axe.

Stefanie Balais was a 26-year-old, very loved nurse in South Florida who tragically died in 2020 in connection with IV hydration provided by her employer.?According to the Miami products liability case filed against the compound pharmacy, the IV included an overdose of selenium which killed her, but it’s not clear in the pleadings if the selenium overdose was attributable to the pharmacy or the employer. ?No other cases were filed against the pharmacy related to the IV bag batch.?The case was settled with no admission of liability (which is typical of such settlements).

One of the key inspirations for legislation in the healthcare field is a “bad case,” where someone is injured or dies.?That understandably inspires legislators and governmental agencies to go into public protection mode.?The Balais case is the sole stated reason for the proposed legislation, PCS for House Bill 725.?

???????????The proposed law:

?Defines “intravenous vitamin treatment” for the first time;

?Targets M.D., D.O.s and nurses for specific regulation;

?Requires the targeted professionals to—

?Obtain a self-screening assessment from a patient before administering IV treatment;

????????????Provide the patient information related to potential side effects????????

?Provide the patient a visit summary??????

????????????Notify the patients designated physician that IV treatment was provided;?

?Have a written plan for emergency care to be kept at the IV treatment location, which has to include (i) the name and address of a hospital closest tot eh IV treatment location, and (ii) reasons for which emergency treatment may be required, and (iii) medical services to be used in the event of a health emergency.

The proposed law authorizes the Boards for Medicine, Osteopathic Medicine and Nursing to promulgate rules.

???????????“What problem are we trying to fix?” is a great question any legislator or piece of legislation should clearly answer.?Looking at the proposed law, one can assume that the legislation seeks to address several issues:

1.???Florida M.D.s, D.O.s and nurses are providing IV hydration in their offices; and

2.???They don’t know how to properly and safely provide it.

Is that true??Is it true that physicians and nurses are providing these services in their offices??Is it true that the provision of “vitamin bags” are, of themselves, in need to more regulatory scrutiny and oversight than what already governs these professionals??Is it true that existing regulations and professional liability law falls short for the IV hydration industry??Are there any instances at all where vitamin bags are used as a medium for any other things that physicians or nurses use to treat patients??Even assuming problems do exist in the IV hydration industry and exist to the level that new laws are needed to fix them, will these new regulations fix them??What are the actual problems??And how does the proposed law fix them????

???????????The Balais case is a products liability case, meaning the plaintiff’s lawyer thought that a product caused Ms. Balais to die.?Yet there is nothing related to product safety in the proposed law.?Maybe because Chapters 795 and 797 of the United States Pharmacopeia (USP) are already extremely specific and designed to ensure product safety.?But those regulations are aimed at the pharmacies that produce the IV hydration products, not the professionals who administer them.?Is there a problem in the Florida IV hydration market with quality control? ?????

???????????What about the fact that many IV hydration providers provide these services on a mobile basis for patient convenience??How will they comply with the proposed law??They can’t!?And what about the fact that M.D.s and D.O.s rarely even provide IV hydration services, but other healthcare professionals (not mentioned in the proposed law) often do?

???????????“There are two things in Life you don’t want to see being made” the joke goes.?“One is sausage and the other is law.”?Laws are made too often that don’t accurately define a problem or seek to fix it in the most effective way.?Even more concerning is that laws are often made without the needed input of the people and industries that have the greatest practical insight and value to bring to the conversation.

???????????Public safety is no joke.?Which is why, if the legislature and our elected officials suspect there is a problem, why not study it thoroughly and then have all those involved in the issue sit at the table and identify any problems and discuss how to best fix them?