Pharmaceutical and medical device companies who want to protect themselves against litigation can now take a course offered by a former U.S. prosecutor.
According to a report on Reuters, Nancy Singer – founder of the Medical Technology Learning Institute and Compliance-Alliance – is offering a course on how to avoid "land mines in your FDA records and emails."
Central to the course’s ethos is the idea that external and internal communications should be closely controlled to avoid raising red flags with regulators or litigators.
Singer told the news provider that the class is not intended to promote the cover-up of illegal practices or concealment of negative data.
"To survive in our litigious society, organizations need to have the right communications culture," she explained.
For example, she advises never to use words such as "illegal" or "negligent" but instead phrase sentiments more like "it could be argued that that doesn’t comply with requirements."
Singer also recommends monitoring employee emails and discouraging people from putting their concerns in writing to protect themselves, as these memos will only be used against the company in a lawsuit.
Companies including Merck have found themselves in court confronting leaked internal documents that indicate they were aware their products could cause harm.