An Open Letter to the Orthodontic Community:
On behalf of all of us at OrthoAccel Technologies, I feel it is important to address recent misinformation about our company that has been shared and distributed online. We are currently litigating a case against an unethical competitor.
We regret it if any orthodontists or industry professionals have the impression that we are getting between them and their suppliers. We are not. Any claims otherwise are patently false. I have reached out personally to dozens of doctors to put this rumor to bed.
We are pursuing this action to protect the reputation and credibility of our company and this industry. You and your patients deserve to be confident that your partners are adhering to the highest industry standards.
The fact is, our legal dispute is with a competitor who disobeyed legal statutes and made advertising and marketing claims about patient benefits that are not backed by proven clinical evidence. These unsupported claims are documented and include such language as, “bone growth,” and, “better retention.” We are deeply concerned that good practitioners believe these highly unethical sales claims.
In the course of defending our business and pressing this legitimate case, we are obliged to do two things: 1) address the competitor’s false advertisements, and 2) prove the effects of their false advertising. The legal precedent in this area is very well established. It was the unethical tactics used by this competitor that drew a few doctors into this case. We welcome fair competition over litigation any day.
A single doctor claimed to be disturbed by a process server carrying out his legal duties. If we could e-mail a subpoena, we would gladly do so. But, the law requires that the specified recipient be presented in person. The service was for a request to produce documents, nothing more. This process is normally no more disruptive than a FedEx delivery. This instance aside, we have no reason to believe, or any evidence that shows that the highly professional process server was anything but courteous, discreet, and efficient.
Importantly, the competitor uses the same legal tools.
OrthoAccel is a small business with a highly innovative product. Our goal is and always has been to support orthodontists and the industry. We have a long and verifiable track record of doing so. Our mission is to provide technology and solutions that increase patient satisfaction and your success.
We have always operated according to the highest ethical principles demanded by the orthodontic community. These principles are why we cannot stand by while a competitor deceived the professional community and promoted its product as an FDA-registered or FDA-cleared medical device for several months in early 2016.
To be clear, the competitor’s product was neither registered nor cleared during this period. This example, along with other patterns of ignoring legal statutes as well as the ethical and clinical standards of our industry, are why, based on advice from legal counsel, we felt we had no option but to take action.
Our products are supported by strong clinical evidence that we have always made publicly available. For example, we submitted to a rigorous 510(k) review in order to demonstrate safety and efficacy, and obtained clearance from the FDA to market and sell AcceleDent as a Class II medical device. We invite you to review our substantial portfolio of clinical evidence and patient cases.
Thank you for your time and consideration.
Michael K. Lowe
CEO, OrthoAccel Technologies, Inc.