This Medical Device Company Had to Fight for Its Rights

In 1997, a small manufacturer of orthodontic muscle monitors faced unfair treatment by FDA, which ended up costing the company several million dollars in canceled sales and legal expenses.

It all began with an Oct. 20, 1997, FDA warning letter to Kent, WA-based Myotronics. The company's label claims existed before the effective date of the Medical Device Amendments of 1976 and were thus grandfathered and legal. However, that did not stop FDA reviewers from alleging that the devices were misbranded, nor did it stop the agency from seizing the company's product.

Dental clinicians use a neuromuscular stimulator device called the Myo-monitor to set and determine a patient's bite and jaw position. Image credit: ViDi Studio / iStock via Getty Images

According to a former MD+DI reporter's account of the Myotronics story, the same FDA reviewers "staged an advisory committee meeting in October 1994 that was loaded with academic opponents of Myotronics."

After exhausting all other FDA remedies and appealing to the agency's ombudsman, the company's founder, Roland Jankelson, took the fight to Capitol Hill.

The subsequent investigation's findings were prepared in a report by the Office of the Inspector General (OIG) in FDA's parent Department of Health and Human Services. The OIG report found that a former CDRH general and restorative devices reviewer concealed documents proving that, with one exception, Myotronics' label claims existed before the effective date of the Medical Device Amendments of 1976 and were thus grandfathered and legal. The OIG investigation also found that a second FDA employee, a former dental products advisory panel executive secretary, was unable to explain how confidential Myotronics materials came to be distributed to panel members. As a result of that leak, the panel voted to up-classify the device.

Myotronics' vigorous complaints caused Susan Alpert, then director of the CDRH Office of Device Evaluation, to later officially vacate the panel's recommendation, a first in FDA history.

Based on Myotronics' allegations and the OIG findings, Alpert also secured the voluntary resignation of the advisory panel chair, who had been a former competitor of Myotronics and had brought an unsuccessful lawsuit against the company over the very products the panel was reviewing. Alpert also declined to renew the appointment of a nonvoting advisory panel consultant whom Myotronics identified as a well-known opponent of its technology. In a deferred sequel to these actions, Alpert also revoked the impanelment of two new panel members after Jankelson identified them as possible opponents of his company, as well.