FDA Warning Letter with a Class Action Chaser

An FDA Warning Letter is just what it sounds like: A letter from FDA warning you they think you're doing something wrong. The "warning" part of the letter is the fact that if you don't stop what you're doing, FDA is warning you something bad is going to happen. FDA's success rate on these "warnings" is about 99.95% (they might be perfect except for when they've crossed paths with us).

Our client received an FDA Warning Letter telling them to stop making a profitable product. We looked at the Warning Letter and told the client to keep making the product. FDA was wrong on the science and wrong on the law. But while the client was jumping with joy, I had to tell him that even if FDA was wrong, it's their policy to publish Warning Letters on their website which plaintiff's class action attorneys monitor. If the Warning Letter's subject was grounds for a class action (this one was), a plaintiff's attorney will immediately file a class action, sometimes in less than 24 hours. So we had to move past FDA and focus on the larger issue -- -- class action risk. We executed a two prong approach:

First: We had to prepare a powerful response to FDA before they published the Warning Letter. We used an obscure FDA regulation that forced them to publish our response together with their Warning Letter on their website. We wanted to get our story out with theirs -- -- not in a later press release.

Second: We wrote our response to three distinct audiences: FDA, the public and the plaintiffs' class action attorneys. Reaching the attorneys was important because we wanted them to know that if they filed a class action, they'd be grabbing the blade end of the sword. Our strategy was to persuade them that suing someone other than us would be easier and cheaper.

The strategy worked: FDA published their Warning Letter and our response. FDA eventually gave up trying to halt production of our client's product. No one filed a class action against our client.

Sometimes the best defense to a class action is a pre-emptive strike.


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