LexisNexis Torts Law Center Staff

Sometimes, I feel like I’m back in my newspaper days, covering the police and courthouse beats, writing about arrests, trials and sentencings. In the current issue of Mealey’s Emerging Drugs & Devices, I report on the indictment of the former CEO of MedImmune for allegedly directing the off-label marketing of Actimmune.

Once again, I typed an all-too-familiar subject heading: “Criminal Prosecution” or “Criminal Enforcement” in a newsletter that covers drug and medical device civil liability for personal injuries.  The criminal stories all relate to drugs/devices that are involved in the product liability cases.  How many times had I written about drug or device companies or employees getting prosecuted by the government for civil or criminal claims? I looked back through 2006. I’d written about criminal or civil prosecutions 10 times in 2006, 11 times in 2007 and four times just in the first 3 ½ months of 2008. That's close to one a month.

Companies paid tens of millions or hundreds of millions to settle prosecutions. Three executives from one company — including a medical doctor and a general counsel — pleaded guilty to misdemeanors. A former FDA commissioner pleaded guilty to failing to report his interests in a company regulated by the FDA. One company faces criminal charges in Africa for an incident that took place more than 10 years ago.

In another case, government scientists failed to report that they were paid consultants of a drug company. A lot of cases involved companies paying kickbacks to doctors to get them to prescribe or promote their products. Incredibly, a 2006 story was about the government prosecution of MedImmune. And here I am two years later, reporting that a MedImmune exec is indicted in the same investigation.

I didn’t go back over all the drug and device publications I’ve edited in 13 years to see just how frequently drug companies and their managers get “booked,” but I can’t recall having had to type the word “criminal” back in the mid-to-late 90s. A lot is written today about “activist” state attorney generals, but the majority of criminal actions comes from the federal government since they involve violations of federal law. And that’s in an administration that is perceived as being business friendly and where some U.S. attorneys got tossed during what was seen as a political housecleaning. If federal criminal and civil prosecutions of drug and device companies and their employees have, indeed, increased, what’s changed to make it so?