One of us had a conversation yesterday with a lawyer (who will remain nameless because we haven’t asked otherwise) about off-label use issues in a malpractice case against a doctor who used something called a Nidek Laser in eye surgery.  We haven’t looked at any facts of any case or about the device.  We know only what our correspondent told us.

He said doctors are being sued on theories that they did something “illegal” in using an approved device with a supposedly unapproved computer program.  We offered some quick thoughts to our correspondent, whose last words were that these “interesting” issues are “popping up across the country” in similar malpractice cases involving Nidek lasers and lasik surgery.

That got us thinking.  If the plaintiff side is actually coordinating this kind of attack, maybe there are other defense side malpractice lawyers who would like to know what we had to say, since FDA-related issues of this sort (thankfully) aren’t something that’s particularly common in malpractices cases.  So here goes:

(1)  As for the purported expert claiming “illegal” activity by the doctor, move to exclude him.  Expert testimony that something was “illegal” under the Food Drug & Cosmetic Act (“FDCA”) is improper expert testimony on issues of law.  We’ve blogged about this expert issue a number of times.  See here.

(2) As for a plaintiff claiming that a doctor “illegally” violated the FDCA by using an unapproved device, that plaintiff doesn’t have standing to make that claim.  Move for summary judgment, or to dismiss.  As we’ve commented on many times previously, see here, there is no private right of action under the FDCA.  21 U.S.C. §337(a); Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).  Plaintiffs have no business claiming anything is “illegal” under the FDCA, and most states do not allow negligence per se actions based upon supposed violations of statutes that forbid private rights of action.  Our posts on negligence per se issues, found here, discuss this interplay.

(3) As for claims that off-label use is “illegal,” or “investigational” or “experimental,” it simply ain’t so.  Plaintiffs saying that are just plain hooey.  Off-label use is legal and common.  The Supreme Court confirmed that in Buckman as well.  For that proposition the court cited Bexis – really.  He wrote the earliest definitive law review article on off label use more than ten years ago, and his article also discusses the “investigational” and “experimental” points.  Here’s a link to that article.  You’ll find it cited in Buckman and almost a score of other cases for the same proposition.  The article’s somewhat dated on the legal citations (looking for what cites it is probably now more useful for case citations), but the discussion of the FDA and medical ethical issues is still pretty valuable.

We don’t generally get involved in medical malpractice cases since it’s outside our expertise, but if malpractice plaintiffs are making a concerted effort to confuse courts in such cases with bogus FDCA-related issues, such as these, then it becomes our business.  So we’ll try to help where we can.