Company Forced to Recall Products by FTC

This case takes place in Ohio and involves a pharmaceutical company that was ordered to remove products from retail outlets in a nationwide recall. The plaintiff filed a complaint alleging that the defendants had violated multiple sections of the FTC act by making false and unsubstantiated claims in connection with their advertising and sale of various over-the-counter medications. The FTC contended that the defendants had made revised statements about four products that are not substantiated by competent or reliable scientific evidence. The court concluded that the defendants violated the order by making unsubstantiated advertising claims for their products and by failing to include a required health-risk warning for those products. The defendants were ordered to recall all products with alleged violating product packaging and labels from retail stores. They were required to submit a report to the court within 30 days of that order on the status of the product recalls. These products have already been sold at several stores, and it has been nearly impossible to track how much had been purchased by consumers.

Question(s) For Expert Witness

1. What kind of knowledge do you have of nationwide recalls - the proper protocols and the amount of time that should be given to ensure products are removed?

2. What kind of experience do you have serving as an expert witness in a FTC nationwide recall case?

3. Please explain your experience with FTC/FDA nationwide recalls involving regulatory affairs.

Expert Witness Response E-008942

I have worked since 1974 on FDA Drug and related issues, and I have been personally involved with approximately 40 product recalls. The U.S. Supreme Court once quoted my FDA treatises with the words, "The experts have written. . . ” My books on FDA issues are the standard reference works. My familiarity with FTC procedure led to a paid assignment advising the FTC Chair on improving the processes of the FTC. I co-chair the American Bar's FDA Committee and have taught in this area of law since 1980. I have been an expert witness in drug, medical device, food and radiological product cases and I have extensive hands-on expertise. Further, I was co-director of what was then the world's largest product recall, the 2 billion unit recall of Rely tampons in 1980-1981.