FDA Will be the Least of Your Problems

If you are in the drug, medical device, or dietary supplement industries and you do not follow Good Manufacturing Practices - GMPs, you can get in big trouble with FDA.  That’s a bad place to be because FDA can:

• Send you a Warning Letter, which will be placed on fda.gov for all to see,
• Seize your product,
• Fine you or,
• Indict you

However, there is something worse. 

If your patients, investors, or competitors think that your product does not live up to your claims, they can sue you for product liability.  When that happens, the plaintiff’s lawyers will subpoena all of your GMP documentation.  They will then turn it all over to somebody like VCI, who will write an expert report on the gaps in your compliance record.  This will happen whether FDA has inspected or not.

Judges and juries hold the Food, Drug, and Cosmetic Act in high regard when it comes to establishing the standard for due diligence.  If you have complied with GMPs, your records can help you.  If not…

“Nearly 100 lawsuits have been filed by patients who claim they were injured by a da Vinci Surgery System robot.” The company was required to turn over mountains of documentation to plaitiffs’ lawyers, who are combing through the details to discover whether Intuitive Surgical, Inc. followed GMPs during the design and manufacture of the da Vinci Surgery System.

Bragar Eagel & Squire, P.C filed a class action lawsuit on behalf of the investors of Emergent BioSolutions, Inc. – EBS.  The case alleges that management misled investors by failing to disclose that the company’s Baltimore MD site mixed up ingredients for J&J and AstraZeneca vaccines forcing them to scrap 15 million doses of J&J vaccine. An FDA inspection revealed that this was not an isolated incident, but part of a history of GMP violations at the plant.

As the true facts about the data integrity breach were disclosed, EBS suffered market capitalization losses in excess of 15% over a two trading-day period, damaging investors who purchased the stock during the July 6, 2020 to March 31, 2021 class period.

In another case, Vitamins Online, Inc. sued HeartWise, Inc., a competitor, for, among other things, “falsely advertising and misrepresenting the content and characteristics of its green coffee and garcinia cambogia products”.  In other words, HeartWise had not followed GMPs when manufacturing its product.  The court awarded Vitamins Online over $9.5 million in disgorged profits plus attorney fees and costs.

Oh, one more thing:  your employees might be the initial source for the lawsuit.  The Pharmaceutical Integrity Coalition helps Pharmaceutical Whistleblowers report GMP violations.

Keep in mind that if FDA indicts you, they have to prove guilt beyond a reasonable doubt.  If you get sued for product liability, the plaintiff only has to demonstrate the preponderance of the evidence, a lower bar.

How is your Quality System working?  Are your frontline workers following 100% of your SOPs 100% of the time?  If not, you might think about Positive Compliance^TM.

How about you?  Do you have a similar story?  What has worked best for you?  Comment below.