knowingly false statement of regulatory compliance may be actionable

Dental Recycling North America, Inc. v. Stoma Ventures, LLC, 2023 WL 6389071, No. 4:23 CV 670 CDP (E.D. Mo. Oct. 2, 2023)

The parties compete in the market for amalgam capture devices, which remove fillings (or pieces thereof) from dental office wastewater. This is required by the EPA because fillings can contain toxic mercury. EPA regs say that dental offices may comply by using amalgam capture devices, “separators” and removal devices “other than separators.” Both options require at least 95% removal efficiency; the former must use ANSI testing, while the latter must use sampling averages. There’s no premarket approval.

Plaintiff alleged that Stoma falsely advertised that its Capt-all device, which fits onto the end of a high volume evacuator valve, is an amalgam separator and EPA compliant. However, it allegedly only treats amalgam process wastewater that passes through its device, rather than all potential sources of amalgam process wastewater in a dental office, which is insufficient.

Stoma argued that representations about legality/legal compliance were inactionable opinion. Prior cases have so found, unless there was a clear statement to the contrary from a relevant authority (including a very clear statute), or unless there was no good-faith belief in the statement about legality.

Here, the plaintiff alleged that Stoma made/caused others to make false statements that the Capt-all was tested and found to be an amalgam separator when it knew that Capt-all did not meet the regulatory definition of an amalgam separator. Stoma conceded that the Capt-all is not an amalgam separator; the knowing falsity exception could apply, even if statements about Capt-all being “compliant” with EPA regulations may not be actionable.