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Thursday, October 29, 2009
FDA Wins Court Case Against TMJ Implants, Inc. — Manufacturer to Pay $340,000 in Civil Money Penalties
On October 27, 2009 the United States Court of Appeals Tenth Circuit ruled in favor of the FDA in a civil money penalties case against TMJ implant device manufacturer, TMJ Implants, Inc. and President, Dr. Robert W. Christensen, for failure to submit 17 medical device reports.Click here to read the article that appeared in FDA Law Blog.
The following information is taken from the October 27, 2009 United States Court of Appeals document:
"FDA has explained the purpose of the reporting requirement and its broad scope: To carry out its responsibilities, the agency needs to be informed whenever a manufacturer or importer receives or otherwise becomes aware of information about device problems. Only if FDA is provided with such information will it be able to evaluate the risk, if any, associated with a device and take whatever action is necessary to reduce or eliminate the public's exposure to this risk" (pg. 4).
"Dr. Christensen contended that in each of the disputed events TMJI's devices were not explanted because of any inherent problem with the device iteself; rather, natural progression fo the TMJ disease necessitated removal of the device" (pg. 9).
"Dr. Christensen and his colleagues also expressed concern that filing MDRs wuld expose TMJI to civil lawsuits and provide their competitors wih an unfair advantage" (pg. 10).
Dr. Christensen offered to file the required MDRs if FDA promised to drop the Civil Money Penalties of $340,000. The judges state:
"offering to abide by the law only after being punished for not doing so does not mitigate the culcability of the initial unlawful conduct..." (pg.26).
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