Tuesday, April 20, 2010

A warning about FDA warning letters

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.


Kelly Lightfoot, Esq., Attorney, Fuerst Ittleman, PL said...

In Regenerative Sciences, Inc. v. FDA, the FDA did not issue a Warning Letter to Regenerative Sciences, Inc. (“RSI”). The FDA sent an Untitled Letter. As regulatory counsel, we all understand there is a significant difference between these two types of letters. You understand this distinction, as well, as you blogged about it on August 14, 2007 in your post titled “Untitled (As In “Untitled Letters”). The Untitled Letter is used by the Agency when the Agency is uncertain about an issue and when the Agency does not know if there has been an actual violation. The Warning Letter is issued for actual violations that may lead to Agency enforcement if not corrected. In the case of RSI, the Untitled Letter is merely a low-level communication expressing the Agency’s stance on the practice of medicine and use of autologous stem cells. It is not proof of any wrongdoing by RSI.

You state that RSI, based on a “warning letter,” “sued the FDA and asked the court to declare that the FDA had no authority to take enforcement action concerning this sort of treatment.” We recognized we could not sue the FDA on an Untitled Letter. We knew this type of letter was not a “final agency action.” Instead, we sued based on FDA’s claimed authority to regulate a physician’s use of autologous stem cells under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. We challenged the promulgation of the regulation as ultra vires and improperly adopted under the Administrative Procedure Act. The practice of medicine is clearly regulated by the individual states, which Congress has expressed does not fall under FDA jurisdiction. The FDA continues to infringe upon the practice of medicine and is using the Untitled Letter to do so in the case of RSI.

David Walk said...

We wrote that the FDA issued a warning letter to Regenerative Sciences because the court's opinion refers to the letter as an "FDA warning letter." 2010 WL 1258010 at *7. We only know what is in the court's opinion. We understand that other issues were raised and decided in the case, but we did not try to summarize the entire opinion; we blogged about the one aspect of the decision that caught our attention.

Sam Sniderman said...

Warning letters as I see it are a preable to some future action, if conditions are not met in the subject of the warning letter. Basically when the FDA writes such letters, they are subject to scrutiny as are all government agencies, the subject of the warning letter and the general public. If the FDA has issued such a warning letter outside of their mandate and jurisdiction they can be held accountable. In such matters the courts must decide and it is not the first time the FDA has clamped down on doctors who are not being rebellious -they are just trying to help people with modern medicine techniques such as Dr. Centeno is accomplishing at his practice. There are no violations since President Obama opened the doors to stem cell research, treatments so that China does not beat us once again at innovative and successful treatments within the USA. The FDA is thwarting all efforts to accomplish the President's goal.