As long-time readers know, this blog was founded by a couple of guys who first got to know each other defending co-defendant manufacturers in the Orthopedic Bone Screw Mass Tort.  That fact significantly colors what you read here.  A lot of the issues that we harp on – off-label use, medical device preemption, fraud on the FDA, cross-jurisdictional class action tolling, broken device cases, expert testimony on issues of (FDA) law (that’s just off the tops or our heads) – we spent close to a decade litigating in Bone Screw land.

It wasn’t a bad living. 360 (requires subscription) recently named one of our old Bone Screw cases (Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001)) as the top product liability case of the last decade. (It also stole a post idea we’d kicked around but never gotten off our duff to write up).  Even though we’ve moved on, our pet peeves haven’t.

But probably the most singularly “Bone Screw” issue was the theory that a surgeon could be liable under an “informed consent” rationale just because s/he didn’t tell a patient about the FDA regulatory status (that is to say, off-label use) of the drugs/medical devices used in the patient’s treatment. And we Bone Screwers killed that theory dead – maybe not as dead as we killed fraud on the FDA, but pretty darn close.


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