Update: Court of Appeals Upholds Lower Court’s Ruling in HiFi’s Reclassification Petition Denial Case

December 22, 2009

By Carmelina G. Allis

Earlier this month, the United States Court of Appeals for the Second Circuit rendered a summary order affirming the District Court’s judgment for dismissal of the case.  We previously reported that FDA had moved to dismiss HiFi DNA Tech, LLC’s (“HiFi’s”) lawsuit alleging that FDA had improperly denied the company’s petition for reclassification of an HPV nested DNA polymerase chain reaction detection device from Class III to Class II.  The U.S. District Court for the District of Connecticut granted FDA’s motion to dismiss the case. 

HiFi appealed the lower court’s ruling and argued that the District Court had erred by not allowing HiFi to introduce evidence outside the administrative record and by concluding that FDA had not acted arbitrarily and capricious when it denied HiFi’s reclassification petition.  The Court of Appeals held that HiFi waived its argument regarding the introduction of evidence outside of the administrative record because the Plaintiff never requested to do so in the District Court.  In addition, the introduction of such evidence is generally appropriate under certain circumstances, such as when the agency acts on bad faith.  In this case, HiFi appears not to have alleged any facts to support such a finding.

The Court of Appeals also determined that HiFi’s arbitrary and capricious argument also failed.  HiFi alleged that FDA acted arbitrarily and capricious when it reviewed its product as a cancer-detection device instead of a virus-detection device.  The court found, however, that based on the intended use for the device as defined by HiFi in its FDA application, the agency reasonably determined that the device’s intended use was to assess a woman’s risk of developing cancer.  Other arbitrary and capricious arguments raised by HiFi were also dismissed for a lack of merit.

The Court of Appeals affirmed the lower court’s judgment.

Categories: Medical Devices