Fifth Circuit declines to rehear Zyla

The federal Fifth Circuit Court of Appeals has, unfortunately, denied Wells Pharma's request for an en banc hearing in its case against Zyla Life Sciences in a two-sentence document.

The background, if you haven’t been following: An April ruling by a Fifth Circuit Appeals Court judge effectively undid years of case law by ruling in Zyla’s favor in the suit the company filed against Wells Pharma. That ruling (which, to be frank, has wider political undercurrents) said that states could enforce federal laws in certain circumstances — in this case, the federal Food, Drug, and Cosmetic Act.

Wells asked that the case be heard by the entire Fifth Circuit, a so-called en banc hearing; APC submitted an amicus brief in support of this (which was accepted by the court last week), as the initial ruling could have dangerous implications for compounding. 

On Thursday, that en banc hearing was denied, not because of the merits of the case, but “Because no member of the panel or judge in regular active service requested” that en banc rehearing.

We’re obviously disappointed in this latest ruling, and we’re concerned about its implications going forward if individual states are allowed to interpret and enforce federal compounding laws and regulations. We will obviously keep you posted.

In the meantime, read a summary of the case here (PDF), and our attorneys’ analysis of the case and why it presents a threat to compounding here.