Whenever you read about some high profile drug company trial where the smoking gun is some incriminating email, do you shake your head and wonder, “How could they have written that in an email?” There are two ways for a drug company to protect itself from being nailed by these kinds of emails. The best is not to do things that if written anywhere would incriminate them. The other way is to teach your employees not to leave documentary evidence of your company’s misdeeds. Guess which route the drug companies are taking?
Want to avoid those embarrassing internal emails containing concerns that an important product may be harmful, or documents that could attract the attention of an ambitious prosecutor?
The Medical Technology Learning Institute and Compliance-Alliance is offering: “Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails” — a course tailor-made for the drug industry and medical device company executive anxious to cut down on pesky multimillion-dollar legal settlements.
Dangerous Documents offers such helpful tips as: Instead of writing, “We’ll meet on Thursday to destroy the documents,” it’s better to say, “We’ll meet on Thursday to implement our document retention policy.” (Bill Berkrot, Reuters)
Sounds like a grand course. At least it cost a grand (well, $995) to take it, but you’ll be learning from an expert, Nancy Singer, a former prosecutor who litigated on behalf of the FDA. Now she’s working the other side, teaching the minions of Big Pharma “the latest thinking on what it takes to achieve and maintain compliance with FDA and CMS requirements.” Or, if you don’t, how not to get caught. From the syllabus:
- Who can be held criminally liable under the Federal Food, Drug and Cosmetic Act
- 18 words that will attract the attention of prosecutors or plaintiffs’ lawyers
- 8 common practices that are sure to get you in trouble
- The dangers in not monitoring employee emails
Never use words like illegal or negligent when you can instead say, “It could be argued that that doesn’t comply with requirements” or “perhaps we haven’t been as careful as we should be,” Singer said.
Don’t ever say something is illegal or negligent. Even if it’s true.
A common problem is what Singer calls the Cover Your Ass memo, where the employee writes a memo to the file as evidence they raised the issue. Possibly good for the employee. Bad for the company. Singer teaches the employee it won’t protect them (I’m not sure this is true, but it’s good for the companies that hire her). Engaging in questionable activity won’t protect them either, nor will lying about it.
If caught. The whole point of this course seems to be, don’t get caught. What a way to make a living.