• Cytori Case Decision Upholds FDA’s Not Substantially Equivalent Determination
  • March 27, 2013 | Author: Jeffrey K. Shapiro
  • Law Firm: Hyman, Phelps & McNamara, P.C. - Washington Office
  • The U.S. Court of Appeals for the D.C. Circuit (appeal no. 11-1268) issued a decision last Friday backing up FDA’s denial of 510(k) clearance to two of Cytori’s products, the Celution 700 and the StemSource 900, which are intended to harvest cells from adipose (fat) tissue.  Cytori argued that the “not substantially equivalent” (NSE) determination was arbitrary and capricious under the Administrative Procedure Act (APA).  The appeals court rejected this argument. 

    The first issue the appeals court decided was whether an NSE determination is the type of decision that can obtain direct review in the Court of Appeals without first going through the trial court.  The court answered “yes” because it is an “order” under the APA’s definition, and there is a provision in the Food, Drug, and Cosmetic Act (FDCA) allowing direct review by an appellate court of FDA’s orders.

    The second issue decided was whether FDA’s NSE determination was arbitrary and capricious.  Cytori argued its devices are substantially equivalent to devices already cleared for harvesting cells from blood and bone marrow.  FDA concluded that these two intended uses (harvesting cells from fat versus blood) are different, precluding a finding of substantial equivalence.  In addition, FDA also concluded that the enzyme used to separate cells out of fat tissue posed new safety questions, again defeating substantial equivalence.  Cytori had provided data from 12 donors to show equivalence.  FDA found that this study was too small.

    The appeals court did not do much heavy lifting.  It simply deferred to FDA’s “scientific” determination that removing cells from fat is too different from blood, that the enzyme raises new safety questions, and that the 12 donor study was insufficient to establish equivalent safety.  QED.

    Said the court (p. 10):  “A court is ill equipped to second guess that kind of agency scientific judgment under the guise of the APA’s arbitrary and capricious standard.”

    Hence, the court expends very little effort in even describing the scientific analysis and reasoning underlying FDA’s judgment.  The court seemed to have essentially reviewed the administrative record to ensure that FDA had provided a reasonable sounding explanation.

    This decision is a reminder why there have been so few challenges to FDA’s NSE determinations.  The courts are so deferential under the arbitrary and capricious standard that is very hard to win a case like this one.