The PharmaCertify™ Team

Friggatriskaidekaphobia is running rampant today because it is Friday the 13th! (Cue the bloodcurdling scream). We promise you the News Week in Review is not written under a ladder and nowhere near a black cat. So there’s no bad luck here. However, with it being Friday the 13th, we’ll understand if you want to keep a four-leafed clover or a horseshoe nearby as you enjoy this week’s News Week in Review.

Federal prosecutors haven’t had the best of luck lately with FCPA cases. Gaffes in several recent cases may encourage those finding themselves accused of violating the bribery law to take the fight to the courtroom rather than settle. Over the last several months, federal prosecutors have been called to task for misconduct, have had charges dismissed due to lack of evidence and had one high profile trial end in a mistrial. When convictions have occurred, judges have not necessarily been inclined to levy the penalties the prosecution recommends. In one case, the judge cited the defendants “good works” when passing a lighter sentence than what was recommended by the prosecution.

The Medical College of Georgia doesn’t want any bad juju from the relationship between doctors at the college and pharma companies; therefore it placed a limit of $25 on gifts doctors may accept from the industry. The College joins a growing number of med schools attempting to eliminate conflicts of interest between staff and the industry.

532 proved to be the lucky number for whistleblowers during 2011. Up $140 million over the previous year, whistleblowers took home $532 million for their efforts in bringing False Claims suits during the 2011 fiscal year. The percentage of whistleblower cases opened during the year increased from 75% in 2010 to 84% in 2011.

In other False Claims Act news, Iowa’s revised False Claims Act was given the thumbs up by the OIG for meeting requirements under section 1909 of the Social Security Act. The state will now be allowed to receive an increased share of recoveries from False Claims suits brought by the federal government.

Criminal proceedings began in Boston against Stryker Biotech, over marketing practices of two of its bone products. Prosecutors argue the company and its sales force marketed an unapproved mixture of two of its bone growth products. They say the mixture was unsafe and led to adverse events in patients. Defense lawyers say the company did not mislead surgeons, and they claim the government has even conceded there is no evidence that the reported adverse events could be attributed to the mixture of the products. In related news, the judge in the case granted the motion of Stryker Biotech’s former president to sever charges against him. With the motion granted, he’ll be able to use communications between himself and company lawyers in his defense.

The latest anti-bribery writing on the wall is not superstitious, but it is Portuguese. The Brazilian Congress is considering a bill that would strengthen the country’s foreign bribery law. The bill will penalize domestic bribery and the bribery of foreign government officials. It also establishes civil liability of corporations for bribing foreign officials, and holds them liable for the actions of executives and officers.

Whew, we made it! No ill-timed carpal tunnel spasms or computer crashes. And hey, this may just turn out to be your lucky day! If you’re considering attending CBI’s Pharmaceutical Compliance Congress, we can save you a few bucks on your registration with a discount voucher. If interested, drop Sean Murphy an e-mail at smurphy@pharmacertify.com. Once you’re at the Congress, come on by the PharmaCertify booth, and take a look at some of our mobile learning apps. Compliance information is just a tap away!

Even it is the 13th, it is Friday, and we’re headed to the weekend! We hope yours is a good one!