Dietary Supplements — Litigating Unregulated "Drugs"
I am asked quite frequently to evaluate supplements cases and thought I would share some information that I have found to be helpful and provide some things to consider.
The following supplements can be very dangerous and I recommend they be avoided. Supplements, which combine these and other ingredients into multi-ingredient supplements, are even worse.
- Bitter Orange
- Collodial Silver
- Country Mallow
- Greater Celandine
From a litigation perspective, the insurance companies for manufacturers of these compounds are likely to have meticulously excluded cases involving the supplements contained on this list from coverage. Pursuing shell companies without insurance coverage does not, in any way, benefit a client injured by these products.
Being successful in these cases requires very diligent work and insight into these very specialized products is needed. The research is very time consuming when done by even the most knowledgeable people.
The FDA warning to manufacturers relating to misbranding is much like pursuing Al Capone for tax evasion in order to put him in prison for much worse things. A misbranding announcement is the “siren call” for much bigger problems in most cases.
Plaintiffs were fortunate in the “Total Body Mega” formula cases, for example, because they were negligently made with excess selenium that causes a variety of problems. From the FDA misbranding letter to resolution it took two years to resolve 222 cases, which is an excellent result with these types of cases.
FDA warnings on misbranding and other false claims are an excellent indication that further research may very well allow you to discover the real problems with a product or one of its ingredients. These are not regulated drugs, so recalls or outright bans tend to be very rare.
Plaintiffs also need to be wary of Daubert issues. Studies and research to substantiate causation in these types of cases can be difficult because they tend to not be areas for “notable” research and there are no federal requirements for clinical trials. This puts the defendants in the position to argue that their own negligence in failing to conduct meaningful product evaluation has created a vacuum for reliable research about the product. Given the rulings by some federal judges dismissing claims on a Daubert basis, an opening may be seen by some manufacturers that if there are no clinical trials and no research, some judges may be persuaded to dismiss claims. At the least, defendants are hopeful to convince judges to require the plaintiff to perform what will be a full blown clinical trial simply to sustain their case because the defendants did not research to determine if their product was safe before they put it on the market.
Supplements are a billion dollar business and the stakes are very high for each manufacturer. These cases require experienced teams who are skilled in navigating these highly specialized waters.