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A warning about FDA warning letters

By James M. Beck and Mark Herrmann

Lawyers for tort plaintiffs just love it every time the FDA issues a warning letter. To them, FDA warnings = liability (just don?t use the dirty word ?preemption?). You can book it that our opponents will use, overuse, and abuse those warnings letters at every opportunity. They will base entire parallel violation claims on FDA warning letters. They will say, citing the warning letter, that the FDA has ?found,? ?concluded,? ?held,? ?ruled,? and every equivalent in their thesaurus that the company violated the FDCA and FDA regulations.

It?s our job to put a stop to that.

Now a federal judge in Colorado, with the assistance of the FDA, has given us some good ammunition to respond to those points.

In Regenerative Sciences, Inc. v. FDA, 2010 WL 1258010 (D. Colo. March 26, 2010), the plaintiff was a company that was the target of a warning letter from the FDA about a treatment marketed by the company that used the patient?s own stem cells. Regenerative didn?t like being warned, not one little bit. So it sued the FDA and asked the court to declare that the FDA had no authority to take enforcement action concerning this treatment. The FDA moved to dismiss the complaint, arguing that the warning letter did not represent an FDA final action and that the matter therefore was not ripe for judicial review. Id. at *5.

Chief Judge Wiley Y. Daniel agreed:

[T]he July 25, 2008, FDA warning letter is not a ?final agency action,? as defined under the [Administrative Procedure Act]. Instead, it is a ?tentative or interlocutory action? which does not constitute a final agency action.

Id. at *7. The court cited two other cases that had reached the same conclusion: Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 547 F. Supp. 2d 939, 946 (E.D. Wis. 2008), and Clinical Reference Lab., Inc. v. Sullivan, 791 F. Supp. 1499, 1501, 1503-03 (D. Kan. 1992). The court therefore dismissed the complaint against the FDA. 2010 WL 1258010 at *9. Just what the FDA wanted.

But not the plaintiffs who sue our clients.

We plan to put this decision in our back pocket and pull it out whenever plaintiffs try to attach some legal significance in tort litigation to an FDA warning letter. The Regenerative Sciences decision shows that an FDA warning letter does not reflect a decision by the FDA about anything and certainly not a decision that anybody violated the FDCA. In tort litigation, the letter has no legal import. Nada. Zip. Bupkis. Zilch. As we have ranted about recently, FDA warning letters may be sent by lower-level FDA bureaucrats without clearance from any lawyer at the FDA. All an FDA warning letter means is that some person who works for the FDA ? a person who may have no legal training, no supervision, and no authority to make decisions ? wrote a letter. That?s it.

Full post as published by Drug and Device Law on April 20, 2010 (boomark / email).