This just in: The West Virginia Supreme Court of Appeals today reversed that scary trial court decision that held a drug manufacturer to be bound by, and incapable of disputing, FDA-DDMAC “false and misleading” violation claims in warning letters. Here’s a copy of the opinion, encaptioned, West Virginia v. Johnson & Johnson, No. 35500, slip op. (W. Va. Nov. 18, 2010).
The court held that FDA warning letters were insufficiently final to be a basis for collateral estoppel:
The Appellants contend that the circuit court erred by giving preclusive effect to DDMAC’s determination that their [drug related] statements were false and misleading. They point out that, pursuant to the FDA’s own guidelines, warning letters are merely “informal and advisory” and do not constitute a final judgment of the FDA. The Appellants further assert that, despite the circuit court’s finding to the contrary, they did not have the ability to administratively appeal the allegations contained in those warning letters and, thus, were never afforded the opportunity to defend against the FDA’s informal determinations. This Court agrees
Slip op. at 20. And again:
Here, no preclusive effect can be given to the FDA’s determination that the statements and omissions in the [defendant’s statements] are false and misleading, because the FDA did not render a “final adjudication on the merits” on this issue, nor did the Appellants have an opportunity to fully and fairly litigate the question.
Slip op. at 21. And yet again:
Clearly, in issuing warning letters, the FDA is not acting pursuant to any adjudicatory authority, nor does it employ any due process procedures similar to those accorded defendants in courts of law. Rather, in issuing a warning letter, the FDA, acting pursuant to its regulatory authority, attempts to remedy a perceived violation through informal means. No hearing is provided prior to the issuance of the letters, nor is the recipient notified of the alleged violations. Indeed, the purpose of the warning letters is to provide such preliminary notification, thereby giving the alleged violator an opportunity to resolve the problem in an informal manner before actual adjudication takes place. Accordingly, the warning letters cannot be considered quasi-judicial determinations by the FDA and, thus, are not subject to collateral estoppel under West Virginia law.
Slip op. at 24.
The trial court decision in this matter was one of the scariest – and most downright wrong – decisions of recent years. We on the defense side can breathe a little easier tonight.
Thanks to Phil Combs at Allen, Guthrie for passing this along to us.