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 kill ratio 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 plaintiffs’ 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 big ticket landmine – – 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 and use 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 if they filed a class action, they’d be grabbing the blade end of the sword. The strategy was to push them to sue someone other than us because it 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.