February 20, 2014 -- The federal case against a person convicted of counterfeiting dental materials highlights the need for dental practitioners to be aware that the materials you purchase might not be all that meets the eye.
Court records indicated Luu was a former employee of Kerr Dental. He established the company Tri Dental for the purpose of sales and distribution of counterfeit Kerr Dental products, including Revolution, Premise, Maxcem Elite, Nexus, NX3, OptiBond, Herculite, Herculite XR, Prodigy, and Unidose. Luu even went to the extent of generating printed material that exactly replicated Kerr's Directions for Use to deceive dentist consumers.
The counterfeit dental materials were sold to at least two unauthorized dealers, DC Dental Supply (Baltimore) and Kings Two Dental Supply (City of Industry, CA). The dollar amount of counterfeit sales that could be accounted for exceeded $8 million. These criminal actions were initiated in 2006 after Luu was terminated from employment with Kerr Dental. The court awarded Kerr Dental treble damages (more than $24 million) for violations to the Lanham (Trademark) Act. As Luu was represented by a public defender, it may be doubtful if Kerr Dental will recover any court-awarded financial damages.
Concurrently, the U.S. Food and Drug Administration (FDA) went forth with a grand jury indictment of Luu in U.S. District Court in September 2013 for activities from his sales and distribution of counterfeit dental materials. Luu is facing the very possible future of a federal prison sentence.
What does this all mean for the dental profession?
If a dental materials counterfeiter could fool experts who run dental supply companies, they can certainly fool dental practitioners. For patients' best interest, one is optimally served by only trading with authorized distributors (Kerr Dental lists these on its website). Most dental products manufacturers have similar links.
While the sales and distribution of "gray-market" dental materials (dental materials intended for foreign sales, but repackaged at a reduced fee for U.S. sales) may be legal, these products are difficult to distinguish from potential counterfeits. Cost savings may seem attractive, but there are potentially serious risks to patients. I don't need to list the possible clinical sequelae of a single resin bond failure.
One makes a huge leap of faith assuming gray-market dental products exactly match those materials intended for U.S. and Canadian markets. In a private discussion with a dental manufacturer chemist, I was told about chemical reformulations in a resin bonding system that were not reflected in changes to the product name, or represented in product information material. One may reasonably assume the enhanced formulation was intended for distribution solely to U.S. and Canadian markets. Any older unsold lots of product may have been distributed to offshore markets. Which dental material do you want for your patients?
Luu's counterfeiting activities, legally disclosed, involved $8 million in sales to two reported distributors. Representatives from Kerr Dental, who were kind enough to communicate with me, did not release any other names of dental suppliers involved. Either these were the only two or this is the tip of an iceberg. Regardless, $8 million represents a lot of dental products at the wholesale level. That harms many doctors and many patients. I suspect the damage was far greater than the information that was publicly released.
Michael W. Davis, DDS, maintains a private general dental practice in Santa Fe, NM. He serves as chairperson for the Santa Fe District Dental Society Peer Review. He is also active in expert witness legal services.
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