Posts Tagged ‘Pharmaceutical Companies Work to Avoid Lawsuits’

Pharmaceutical companies pay $995 a pop to send employees to a course to help their employees avoid the attention of Food and Drug Administration (FDA) investigators, prosecutors, and products liabilities attorneys.  The course, entitled “Dangerous Documents: Avoiding Land Mines in your FDA Records and Emails,” is apparently offered by the Medical Technology Learning Institute and Compliance Alliance, and has been attended by Allegan, Inc., Sepracor, Inc., Varian Medical Systems, Inc., Siemens AG, and Medtronic, Inc., the manufacturer of the InFuse Bone Graft, which has been the subject of off-labeling marketing inquiries.

Nancy Singer of the Compliance Alliance developed the course while working as counsel for a device firm. “I noticed that employees at the firm did not understand how a plaintiff’s lawyer could use their emails and other documents to the firm’s detriment if the firm was ever sued in a products liability action,” she said.  The “Dangerous Documents” seminar teaches companies to avoid any written communications whenever possible, and to use vague language that cannot be connected to any potentially illegal activity that the company is conducting.  The seminar also teaches what FDA investigators search when reviewing documents, words that attract the attention of prosecutors, the kind of information that should never be included in written documents, and practices that are likely to alert the attention of investigators.  By attending the seminar, corporate drug manufacturers learn how to placate government officials, and in the process, avoid lawsuits.

One example of such a lawsuit resulting from careless documentation is the Microsoft antitrust lawsuit of 1996.  Government lawyers found a memo from an AOL executive recounting a meeting in which Bill Gates said, “How much do we need to pay you to screw Netscape.”  The memo was used in the antitrust case against the company, which Microsoft eventually lost. 

As companies become aware of the tactics of prosecutors and plaintiff’s attorneys, whistleblowers will become invaluable to uncovering corporate fraud.  If you have knowledge of corporate activity that violates an FDA policy or any governmental regulation, you could bring a civil lawsuit on behalf of the government and collect a portion of the damages.  These are called whistleblower lawsuits, and are authorized by the False Claims Act (“FCA”).  FCA whistleblower lawsuits could lead to a reward for the whistleblower of up to 15-30% of the damages awarded by a judge.