Federal judges have questioned sufficiency of Justice Department pharmaceutical and medical device manufacturers. First, in 2009, the pharmaceutical giant Pfizer paid over $2 billion to settle the largest health care fraud settlement in history. Half of this payment was to cover the largest criminal fine ever imposed in the United States. However, in signing off on this settlement, US District Court of Massachusetts Judge Douglas Woodlock raised concerns that no individual was going to serve prison time for corporate conduct involving the illegal promotion of various pharmaceutical drugs, including Bextra and Lipitor.

Then, recently, fellow-Federal District of Massachusetts Judge William Young rejected a plea agreement under which medical device maker Orthofix Inc. would pay nearly $42 million in criminal and civil penalties arising from its off-label promotion of bone growth stimulators. Foreshadowing this decision, Judge Young had earlier told the parties that the company’s conduct may have been egregious enough to warrant a sentence that deprived the company of its patents for the products involved. With a trial date now set for March 2013, all eyes are now on Boston.

More information for whistleblowers is located at the Nolan Auerbach website.