If anyone is still shocked that medical device manufacturers’ sales representatives are present during surgery – don’t be.  It’s a common practice.  If you don’t believe us, see our posts here and here.  Surgeons believe manufacturers’ representatives have an important role to play in making sure the surgical instruments and the surgical team are fully prepared. That means that reps are in the OR to stay. 

With that comes the very real possibility of sales representatives being sued by plaintiffs who believe something went wrong during surgery or the possibility of manufacturers being sued for the alleged acts/omissions of their representatives during surgery.  Our earlier posts cover both situations and today we’ve stumbled upon another example of the latter -- McCartney v. U.S., No. 2:13-CV-1118 TS, slip op. (D. Utah Jul. 16, 2014).  Plaintiff underwent multiple surgeries involving implantation of defendant’s spinal cord stimulator.  One or more of defendant’s representatives was present during plaintiff’s surgeries. McCartney, slip op. at 1-2.  During one of the procedures, one of these reps called the plaintiff’s wife to ask about the location of the plaintiff’s pain.  Plaintiff’s wife didn’t know which leg was afflicted.  Id. at 2.

Plaintiff brought two negligence claims against the manufacturer based on its representatives being present during his surgery.  The first claim is premised on an alleged general duty of care owed by manufacturers to ensure that their devices are properly implanted.  Id. at 4.  In support, plaintiff alleged that the manufacturer’s representatives “instructed” his surgeon as to how to implant the stimulator (an act) and failed to ensure that the device was properly implanted (an omission).  Id. at 6.  The difference between an act and an omission was critical to the court’s decision on whether there was a duty.  “Acts of misfeasance typically carry a duty of care while nonfeasance generally implicates a duty only in cases of special legal relationships.”  Id.  

In this case, however, neither portion of plaintiff’s claim survived.  While the complaint alleged that the defendant’s reps instructed the surgeon – it contained no facts to back that up. So, on misfeasance, plaintiff’s claim didn’t meet the TwIgbalstandards.  Id. at 7.  As to nonfeasance, the court concluded “that there is no special relationship between medical device manufacturers and patients such that medical device manufacturers owe a duty of care for their nonfeasance during a physician’s surgery.”  In other words, the mere presence of a sales rep in an operating or treatment room does not create a duty. 

But what about something beyond simply being present? That was plaintiff’s second cause of action – that defendant voluntarily undertook a duty to make sure the device was properly implanted when its sales rep called plaintiff’s wife during the surgery.   Plaintiff argued that by placing this call, the defendant (via its rep) “involved itself in medical-decision making in some affirmative way.”  Id. at 8.  Given that plaintiff’s wife’s response was “I don’t know” – we think common sense alone negates plaintiff’s argument.  Fortunately, the court also had a strong legal basis for rejecting the argument.  Relying on Restatement (Second) of Torts § 324A regarding a voluntary undertaking, the court found that plaintiff didn’t allege any facts that defendant acted unreasonably in its undertaking or that anyone relied on defendant’s undertaking.  What was there to rely on?  Without supported allegations that defendant’s representative supplied misinformation or that plaintiff’s surgeon relied on said misinformation, plaintiff hasn’t stated a claim for liability for a voluntary undertaking.  But the court did give plaintiff a little wiggle room here and dismissed the claim without prejudice in case evidence about reliance or misinformation is revealed during discovery. 

While this case worked out okay for defendants, the role of manufacturer’s representatives in the operating room is anything but plain and simple.  Like we’ve seen with other cases, this is a very fact sensitive issue.  And the lines between duty and no duty; reasonable and unreasonable; breach and no breach are very blurry.  We know the answer is not removing the reps from all treatment situations, they provide a valuable service.  The only partial answer we do have is training, restraint and caution.  That doesn’t solve all of the problems, but it’s a start.