ExeGi/Visbiome prevails in false advertising lawsuit against ‘generic’ probiotic

In a recent ruling, Judge J.P. Stadtmueller found that Wisconsin-based Brookfield Pharmaceuticals, LLC was liable for false advertising under the Lanham Act, which governs false advertising and unfair competition in commerce.

The case focused on allegations that Brookfield’s High Potency Probiotic (HPP) was being advertised as a generic equivalent of ExeGi’s Visbiome, a medical food for the dietary management of dysbiosis associated with IBS, antibiotic-associated diarrhea, ulcerative colitis, pouchitis, and hepatic encephalopathy.

The court ruled that Brookfield could not claim its HPP product is a generic equivalent of Visbiome. Judge Stadtmueller also ruled that its HPP product does not contain the same strains and probiotic bacteria as Visbiome.

“ExeGi Pharma welcomes the court's decision, which reinforces consumer protections related to accurate and truthful information in marketing,” said Marc Tewey, CEO of ExeGi Pharma. “As a manufacturer committed to producing high-quality probiotics, it is critical we ensure that our patients get medical products appropriate for their conditions."

“We urge consumers to use caution when considering probiotic products that claim to be 'generic equivalents' especially those without clinical data to back up those assertions.”

A spokesperson for Brookfield Pharmaceuticals confirmed the company will be appealing the judgement, but said it is unable to comment further since this is an ongoing case.

Attorney: “This case will most likely continue to evolve”​

Commenting independently on the case, Kevin Bell, Partner at Arnall Golden Gregory LLP, told us that ExeGi achieved, “partial victory on summary judgment.  They successfully obtained injunctive relief precluding Brookfield from using three advertising phrases that ExeGi asserted were harmful to their business and creating confusion for consumers." 

“To obtain a permanent injunction, a party has sufficiently demonstrated the following four factors: (1) success . . . on the merits; (2) irreparable harm; (3) that the benefits of granting the injunction outweigh the injury to the defendant; and (4) that the public interest will not be harmed by the relief requested,” explained Bell.

“Brookfield was also ordered to send out ‘corrective’ letters,” he noted. “The last time I recall that occurring was when Kaneka was ordered to send out ‘corrective’ letters regarding its yet unproven assertions of patent infringement on CoQ10. 

“This is a very good decision in ExeGi’s favor,” added Bell, “but it’s not a ‘landmark’ ruling, and my reading of the opinion shows that there are still issues to litigate and that ExeGi did not prevail on other claims which were dismissed. 

“Also, Brookfield has filed a motion to stay the Court’s injunction, arguing in part that the specific language used by the Court in its injunction is not completely accurate and that some of the ‘corrective’ statements ordered by the Court would be false and misleading to consumers if disseminated.

“I think you have to stay tuned on this case. It will most likely continue to evolve.”