Late last year, TMJ Implants Inc. and founder Robert Christensen were fighting an ultimately losing battle against the Food & Drug Administration, seeking to overturn $340,000 in fines levied against the company and Christensen.
After a federal appeals court denied the move, TMJ and Christensen asked for an en banc review of the case by all 12 judges of the U.S. Court of Appeals for the 10th Circuit. That request was denied Dec. 22, 2009, according to court documents.
That left Christensen and the company he founded, which makes temporo-mandibular implants, on the hook for the fines. Back in December, he told MassDevice.com that TMJ’s fortunes hinged on having the fines pulled back.
"I have exhausted about all my resources to keep the company going. I don’t know. If they slap [the fines] on me, it would be very interesting what might have to happen. I don’t even want to state it," Christensen said at the time.
Those fears were realized after the appeals court denied a review. TMJ Implants filed for Chapter 7 bankruptcy in May, reportedly after a March FDA order to pay $170,000 immediately and $17,000 a month plus 7.5 percent interest thereafter. Christensen, who could not be reached for comment, told MD+DI in May that he sank TMJ Implants resources and his own personal savings into his fight against the FDA and faced losing his home over the debacle.
Now a venture capital firm has acquired TMJ Implants for an undisclosed amount. Crocker Ventures, based in Salt Lake City, said it plans to build a new production facility in Golden, Colo., slated to be complete this fall. The new facility will house the production plant, while sales, marketing and administrative functions will be run out of Salt Lake City, according to a press release.
Crocker vice president Jared Crocker told MassDevice.com that his firm bought the name and assets of TMJ Implants, which was dissolved in the bankruptcy, calling the acquisition "a new company and a clean turning of the page."
The battle with the FDA stemmed from a 2004 warning letter sent to the firm concerning 22 adverse events related to the implants. The FDA can require device manufacturers, importers, distributors and user facilities to file medical device reports "whenever the manufacturer … receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices may have caused or contributed to a death or serious injury." But device makers are not required to submit MDRs if there is reasonable evidence that the device did not cause or contribute to a serious injury.
TMJI and Christensen argued that they had a reasonable belief that MDRs were not required, even though some of the devices had to be explanted and infections in other patients required treatment with antibiotics. They argued that the explants were due to a natural progression of TMJ disease and that there was little evidence that the infections were caused by the implants. TMJI appealed the judgment through the FDA’s internal forum, but FDA rejected the appeal without review because the civil money penalties case was concurrently being pursued.
Crocker told us that his firm is not inheriting any of those issues with its acquisition of TMJ and that regulatory compliance is of the highest priority for the company’s new management.
"The company was dissolved, so the company we have started is, in all important senses of the word, a new company in terms of complications from the past that they were dealing with — legal, financial and regulatory," he said. "If we had actually acquired that corporate entity then it would have remained an issue, but since that company became no more and we started a new company it’s not a problem."
TMJ Implants was an attractive target because of the product’s decades-long record of safety and effectiveness, Crocker said.
"From a product standpoint, the implant TMJ offered is just a solid product for a lot of the instances of TMJ syndrome as they become more severe. We took a hard look at the background of the disease and the products and their history," he said. "This particular product just has an outstanding safety profile."
Asked about the apparent conflict between the FDA’s stance on the MDRs and his firm’s high opinion of the device’s safety, Crocker said the evidence points toward a very safe and effective device.
"[Christensen] invented it decades ago. He’s been implanting it since the ’60s and ’70s/ We’re talking about 15 to 20 instances that required MRDs, versus hundreds and even thousands of these procedures that have statistically demonstrated their effectiveness in reducing pain and successfully treating this disease," he said. "If it had been that this device typically or even very frequently was leading to a lot of problems that would be one thing, but we found from a statistical standpoint that not only is there not usually an MDR, it actually has an outstanding record of success."
Another attractive aspect was the production team in Golden, Crocker added, all of whom will be kept on board.
"What the company really specialized in and was really good at was delivering a quality product in cases were an implant was needed. The personnel had just become expert at delivering the right product for each case," he said. "We determined that if there was a good way to get past all the complications and the bankruptcy, those elements of the company were really valuable."