March 9, 2009

The Medical Technology Learning Institute and Compliance-Alliance is offering a course to help drug and medical device companies cut down on expensive legal settlements.

The one-day $995 course, called “Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails,” is designed to educate drug and medical device company employees on how to avoid writing internal and external communications that may attract the attention of prosecutors and product liability lawyers. For example, the course teaches its students that instead of writing “We’ll meet on Thursday to destroy the documents,” it is better to say, “We’ll meet on Thursday to implement our document retention policy.”

Although the Compliance-Alliance mission statement says the course presents “the latest thinking on what it takes to achieve and maintain compliance with FDA and CMS requirements,” the class appears to do more than simply instruct corporate employees on how to keep government agencies happy. Indeed, the course program reads more like a briefing on how to avoid raising red flags with regulatory police, prosecutors, and product liability attorneys with topics like:

  • What FDA investigators look for when reviewing documents
  • How to write informative documents that don’t make you a target
  • 8 common practices that are sure to get you in trouble
  • 4 types of information never to include in documents
  • 18 words that will attract the attention of prosecutor’s or plaintiff’s lawyer

Among the healthcare companies with employees who have taken the course are Allergan Inc., Sepracor Inc., Varian Medical Systems Inc., Siemens AG, and Medtronic Inc., the medical device manufacturing giant accused of marketing its Infuse Bone Graft off-label.

Whistleblower Lawsuits

Individuals with knowledge of past or present fraud against the government, including government agencies like the FDA, can bring a civil lawsuit on the government’s behalf and collect between 15-30% of the damages recovered. These civil lawsuits, called whistleblower lawsuits, are authorized under the qui tam provisions of the U.S. Federal Claims Act, which provides for treble damages and an $11,000 penalty per violation for virtually any kind of fraud on federally funded programs.  

Contact an experienced whistleblower lawyer for a free and confidential case evaluation.

Published November 17, 2011 by