TMJ Implants Inc. and founder Robert Christensen want all 12 judges of the U.S. Court of Appeals for the 10th Circuit to review the court’s decision to uphold $340,000 in fines levied against the company and Christensen by the Food & Drug Administration.
In TMJ Implants v. United States Department of Health and Human Services, the 10th Circuit court upheld the FDA’s imposition of civil money penalties against Christensen and his company. The case stems from a 2004 warning letter sent to the firm concerning 22 adverse events related to its temporo-mandibular joint 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, or surgically removed, 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.
After an administrative law judge concluded that the FDA penalties were proper, TMJI and Christensen petitioned the 10th Circuit for review. Three judges on that court upheld the decision, prompting TMJI to file an en banc petition that all 12 of the courts judges review the case.
Specifically, the en banc petition claims that TMJI was denied due process by the FDA and that the agency failed to adhere to its own requirements in levying the fines. The petition also claims that the 10th Circuits ruling “conflicts with and ignores the prior recent decision in this Circuit of the federal district court for the State of Utah in US v. Utah Medical Products … that was involved with the issue of how broad a latitude FDA should be given” in mandating how companies achieve compliance with its regulations, according to court documents.
Another contention in the petition concerns procedural breakdowns within the agency, which then-commissioner Andrew von Eschenbach admitted to in a letter to members of Congress
“In evaluating the due process issue in this case the indisputable facts of record, ignored completely by the [10th Circuit] Panel, are that FDA conspired to file this CMP before, not after a ruling on interpretation by the FDA Commissioner,” according to court documents. “Also it cannot be over emphasized that Andrew C. von Eschenbach, FDA Commissioner at the time of filing appeal of the CMP to this Court admitted in writing in his letter to two ranking members of the U.S. House of Representatives’ FDA oversight committee, the Committee on Energy and Commerce, that is part of this record that there had been a “process failure” within FDA in the handling Petitioners’ TMJI dispute.”
That “process failure” meant that TMJI’s appeal to von Eschenbach languished for eight months while the agency prepared to levy the civil money penalties.
“FDA has never came [sic] forward in this case with any good faith rationale for ‘trapping’ Petitioners into a no win CMP before responding to TMJI’s appeal. Petitioners thus have had to spend huge amounts of money to defend themselves at the administrative level, conservatively amounting to triple the amount of money penalties sought in the CMP,” according to the petition. “FDA knows this and uses this as leverage to force a company to settle a CMP on its terms knowing that the potential mounting cost of defense to go forward at this level will far exceed the cost of settlement and admission of guilt on terms dictated by it, regardless of the merits of the company’s cause.”
And FDA failed to meet its own burden-of-proof requirements for the CMP process, a fact that the 10th Circuit panel ignored, the petition claims. In nine of the adverse event reports, the agency redacted information that would identify the devices at issue, making it impossible to establish the “preponderance of evidence” required by the agency’s own rules.
“Petitioners contend that nowhere in the underlying statute or in the MDR regulations is there legal justification for the interpretation by the Panel that in such situations MDRs are required even though the device was not the ’cause in fact’ or even though there is not enough evidence to support a conclusion that the device caused or contributed to a serious injury,” according to court documents.
“As the guy who invented this technique and is known as the father of this surgery, I have a pretty good idea of device-related situations,” Christensen told MassDevice. “I was going by not only by my experience, but by the fact that we had done 100 or more tests on this thing for the [FDA’s pre-market approval process]. … It was punitive from Day One.
“Of these event reports, nine of them were so redacted that we had no idea if anybody had anything put in, or if our devices were involved. So there was no way to evaluate those.”
Five or six of the remaining MDRs concerned cases concerned the ongoing progression of TMJ disease, Christensen said.
“It isn’t the device that’s causing it, it’s just the progression of the disease,” he said. “They’ve said in disease progression you don’t need to file an MDR.”
Asked about the implications for his company should the case not go his way (or should the 10th Circuit decline the en banc petition), Christensen was loathe to speculate.
“I have exhausted about all my resources to keep the company going. I don’t know. If they slap that on me, it would be very interesting what might have to happen. I don’t even want to state it,” he said.