Friday, May 18, 2012

No, That's Not Justifiable Reliance

Sometimes we feel like pulling our hair out − those of us who still have some, anyway.  One things that gets us in that mood is the other side claiming that the prescribing physician (who went to med school and typically has loads of experience with the relevant product) would have treated as gospel this or that piece of information, if only s/he had been told about by the sales rep (no med school, no clinical experience).  It just doesn’t work that way.  Most doctors think quite highly of their own abilities and knowledge and aren’t about to listen to a sales rep on a medical question.

But try finding a decision anywhere that makes this rather obvious point.

We found one.

There’s a new case, Hall v. Horn Medical, L.L.C., 2012 U.S. Dist. Lexis 68482 (E.D. La. May 16, 2012), that makes this point − in a case with a rare prescriber willing (or desparate enough) to say what the plaintiff wanted.

As you might guess, Hall was a medical malpractice case, or at least had a strong medmal component.  The product was a spinal fusion device, and the surgeon who implanted it ignored an explicit statement in the package insert only to use the device with bone grafting material.  The doc didn’t and guess what?  The fusion failed.

When asked why he ignored the manufacturer's warning, the doctor said that he performed the procedure the way he did because the sales rep told him that the device was OK for this particular “off-label use.” 2012 U.S. Dist. Lexis 68482, at *9-10 (prescriber “emphasized that he ‘would not use it without bone graft unless the rep said that it could be used without bone graft’”).

The sales rep, of course, flatly denied ever recommending the device for a use that was not only off-label, but positively contraindicated by the aforementioned warning.  Id. at *9.  For one thing, promotion of off-label use is a major regulatory sin for which the FDA can, and has, prosecuted sales reps.

For his part, the plaintiff sued the sales rep for negligent misrepresentation.  Justifiable reliance is an element of that tort.

The rep moved for summary judgment.

But, there’s a he-said-she-said conflict here that prevents summary judgment, innit?  One says yes; the other no.  Classic credibility dispute, right?


The court held that a physician cannot justifiably rely on anything a sales rep might have said with respect to a medical issue:

Even if [the rep] told [the doctor] a that he could use the [product] without a bone graft, the Court finds that any reliance by [the doctor] on that statement to be unreasonable as a matter of law. These representations . . . addressed what type of spinal procedure [the doctor] should perform on [plaintiff]. As a seasoned neurosurgeon, it is patently unreasonable for [the doctor] to rely on a sales representative's opinion about the type of procedure that should be employed in operating on a patient’s spine.

2012 U.S. Dist. Lexis 68482, at *10 (emphasis added).

Sw, while it’s not 100% on point, since a product liability claim was not involved in the litigation, this excerpt from Hall is as good a statement as we’ve seen for the proposition that doctors do not − and legally cannot − rely on sales reps for medical information.