In an (unfortunately) not-for-publication opinion, the 9th Circuit affirmed a defense summary judgment in Carson v. Depuy Spine, Inc., No. 08-56698, slip op. (9th Cir. Feb. 16, 2010). There’s nothing particularly interesting about the affirmance as to the manufacturing defect claim. But what the court had to say about plaintiff’s allegations concerning off-label promotion is music to our ears. First, there’s nothing improper about off-label (more…)

We don’t routinely follow qui tam litigation involving our clients. It’s not something that we, personally, defend against. It’s not our sandbox; qui tam trolls are the responsibility of other defense counsel.

But we are interested in off-label use. Thus Hopper v. Solvay Pharmaceuticals, No. 08-15810, slip op. (11th Cir. Dec. 4, 2009), caught our eye. It’s one of these cases where a supposed relator (almost invariably a disgruntled (more…)

We have been frequent critics of the FDA’s efforts to prohibit truthful promotion of off-label uses. We’ve arguedthat these restrictions contrary to the public health because they limit the ability of the most knowledgeable party (the drug manufacturer) to communicate with the medical community about the risks and benefits of cutting edge medical therapy. Actually, even the FDA (sometimes) admits this:

FDA does recognize, however, (more…)