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Q&A With Covington's Gerald Masoudi

June 25, 2012, Law360

Gerald Masoudi is featured in a Q&A with Law360 discussing the trends from food and drug matters and the recent updates from the FDA.

In the first question, “What is the most challenging case you have worked on and what made it challenging?,” Mr. Masoudi says:

“While I was chief counsel at FDA, I was involved in cases raising the question of whether failure-to-warn claims under state law brought against drug manufacturers are preempted by federal law governing labeling of drugs. FDA carefully considers labeling of drugs and approves a package insert that contains only those statements (including warnings) that FDA believes are supported by evidence.”

Later in the article, he was asked, “What is a mistake you made early in your career and what did you learn from it?” He responded by saying:

“As a young litigator, I was responsible for preparing and submitting responses to requests for admission in one of my first cases. The schedule set by the court counted all deadlines backward from the trial date, and responses to requests to admit were due some number of days before trial. Because of the duration of the period, holidays did not count toward the calculation, and there was a holiday between the deadline and the trial date. Ordinarily, having a holiday in the calculation means more time, but in this case it meant less. I discovered the miscalculation late on the afternoon of the actual due date and was not in a position to submit the responses on time. I immediately went to the partner in charge who fixed the problem by calling the other side and announcing, ‘We’re going to be serving our responses tomorrow. Would you like them by email or fax?’ The other side was never the wiser, and the problem went away. What I learned: (1) always triple-check deadlines; (2) if you make a mistake, own up right away and get help; and (3) a little chutzpah can go a long way.”

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