Investigational Device

We’ve heard about a new plaintiffs’ informed consent theory that’s making the rounds.  It’s similar to, if even goofier than, the FDA regulatory status (that is, off-label use) theory that the plaintiffs tried with notable lack of success in the Bone Screw litigation (which we’ve discussed here and here).

As with all informed consent

In Burgos v. Satiety, Inc., 2010 U.S. Dist. Lexis 125924 (E.D.N.Y. Nov. 30, 2010), the court held earlier in the week that all claims (negligence, strict liability, warranty) were preempted where plaintiff received the device in question (some sort of gastric stapling system) as part of an investigational device clinical trial.  The entire discussion

One of the questions we’ve been asking – but not finding answers – is where exactly do investigational medical devices (IDE) fit in to the preemption rubric after Riegel. Investigational devices, after all, are PMA, only their applications haven’t been approved yet. Since IDE devices are subject to the same regulations as PMA devices,

We got your attention with that title on this blog, didn’t we?

So let’s cut to the chase: There are no loopholes in Riegel.

(Neutral observers sometimes ask why we aren’t more even-handed in our blog posts. We can’t be even-handed because we and our law firms defend pharmaceutical and medical device companies in

The “Great Divide” in medical device preemption law is well known and reasonably well established – pending possible United States Supreme Court review (in the pending certiorari petition from Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006), the high court recently requested a brief from the FDA). In all circuits save one,