Do we say often enough how much we dislike off-label promotion theories of liability?  It has its own section on the blog and on a quick skim through you will find traditional products liability cases, qui tam False Claims Act cases (and the subsidiary First Amendment litigation), securities fraud litigation, criminal actions, and third-party payer suits.  There are probably others, but we stopped scrolling.  The point is that just about everyone who wants to sue anyone in the pharmaceutical and medical device world has at some time tried to use off-label use and promotion to get the job done.

The fact that what is and is not permissible off-label promotion remains a question doesn’t help matters.  Really, it is what drives the vast scope of off-label litigation.  And one of the primary problems is the confusion between truthful and untruthful off-label promotion. When courts, in our opinion, get it wrong is when they refuse to recognize that distinction.  Simply because something is considered off-label promotion (addresses a use or indication not on the product’s approved labeling) doesn’t make it false, misleading or untruthful.  This is where we think the court got tripped up in Hricik v. Stryker Biotech LLC, 2015 U.S. Dist LEXIS 11714 (E.D. Pa. Jan. 30, 2015).

Plaintiff brought products liability claims against the manufacturer of a spinal fusion device and two of the manufacturer’s sales representatives.  The reps are residents of Pennsylvania and therefore, their presence in the suit defeats diversity jurisdiction unless they were fraudulently joined.  The defendant manufacturer made that very argument.

The primary claims against the sales reps are for negligence and fraud.  Id. at *9.  The supporting allegations for those claims are that the reps promoted the spinal fusion device for an unapproved use.  Id. at *8.  The question for the court was whether plaintiff had stated a colorable claim against the sales reps such that the reps were not fraudulently joined and that the case should therefore be remanded to state court.  Under Pennsylvania’s “participation theory” of individual liability, the plaintiff must establish that the individual agent engaged in misfeasance rather than mere nonfeasance.  Id. at *14.  In other words, the sales reps must have engaged in affirmative bad acts.  Defendants directed the court to numerous examples of cases where the claims against the sales reps were dismissed or found not actionable (cited in the opinion), but the court chose to distinguish them on the grounds that they did not contain sufficient allegations of misfeasance as opposed to nonfeasance. Id. at *16. 

We didn’t go back and parse through all those other decisions, but we wouldn’t be surprised if the single biggest difference between them and the current case is off-label promotion.  And apparently off-label promotion, in and of itself, was enough for this court to find misfeasance.  For example, the court concluded that plaintiff’s fraud claim against the sales reps was colorable because the complaint identifies alleged misrepresentations relied on by plaintiff’s surgeon.  Id. at *18. But does the complaint actually allege a false statement?  Or does it allege that the sales reps promoted the use of the product in combination with another product and that such use is considered off-label?  Id. at *18-19.  We see off-label, but we don’t see untruthful.  And untruthful is what you need for a fraud claim.

As for plaintiff’s negligence claim against the sales reps, the court falls back on the unfortunately overly broad interpretation of negligence under Pennsylvania law (see our discussion of Lance here).  Using Lance as a springboard, the court finds that Pennsylvania would recognize a negligent off-label promotion claim:  “there is a colorable basis for a claim that sales representatives have a duty to refrain from affirmatively misrepresenting the safety and efficacy of devices for uses for which they have not been approved.”  Id. at *24.  But the court seems to be assuming that any statement about an off-label use is a misstatement and that simply is incorrect.  As many courts have recognized, off-label use can often be the medical standard of care.  A product’s approved labeling necessarily lags behind scientific developments meaning that discussions, statements or representations about the state of the science can be both off-label and completely truthful and accurate.  That’s the rub that challenges the FDA.  That’s the rub that is challenged in the First Amendment cases.  That’s the rub on preemption.  That’s the rub.