[Drug and Device Law] Res Ipsa Loquitur, or Maybe Not

Posted by Law

We haven't written much about res ipsa loquitur on the blog, and today's case doesn't really qualify as a drug or device case per se, but it's an interesting opinion and we thought it was worth sharing.  The case is Hubbard v. Mellion, No. 108461, 2013 Kan. App. LEXIS 45 (May 17, 2013), and it's an appellate decision reversing summary judgment in favor of a physician in a medical negligence case, on the basis of the appellate court's finding that the lower court should have applied the doctrine of res ipsa loquitur.  The case arose when plaintiff Hubbard underwent spinal surgery (involving various –otomies and –ectomies) to repair a herniated lumbar disc.  During the procedure, the surgeon used a device known as a pituitary rongeur, which is a forceps-type instrument that's used to remove part of the disc.  Unfortunately, during Ms. Hubbard's surgery, the tip broke off of one arm of the rongeur, and became lodged in her disc space.  Hubbard, 2013 Kan. App. LEXIS at * 6.  The surgeon tried to retrieve the tip but was unable to.  Id.  Ms. Hubbard claimed that she experienced continual pain as a result of having the fragment in her spine, and eventually underwent another surgery to remove it.  Id.  She later filed a negligence action in which she named the surgeon and the hospital, as well as the manufacturer of the rongeur, alleging that the latter was negligent for supplying a device that was in a dangerous and defective condition.  However, as we've seen plaintiffs do in other medical device cases, plaintiff later decided to pursue the surgeon alone, and backed away from her defect theory.  Really far away.  Did a 180, in fact.  Not only did plaintiff dismiss the manufacturer, her expert metallurgist authored a report in which he "ruled out the possibility that the rongeur failed due to a manufacturer's defect, ruled out the possibility that the rongeur failed because it had been improperly maintained, and ruled out the possibility that the rongeur had failed due to normal wear and tear." Id. at *11.  The plaintiff's expert's sole causation opinion was that the rongeur tip had broken off due to user error – specifically, because the surgeon had applied too much force when using the instrument.  Id. at *12. 

The surgeon moved for summary judgment on the basis that plaintiff's experts – a metallurgist, a neurosurgeon, and a quality management team leader from the rongeur manufacturer (id. at *11-12) – were not qualified to opine on the standard of care for a surgeon performing this type of procedure.  Id. at * 14-15.  The trial court agreed, and held that although these experts established that operator error had caused the rongeur to break, plaintiff had not shown that this error was outside the established standard of care.  Id. at *15.  On appeal, plaintiff argued that she was not required to present expert testimony on the standard of care because there were two exceptions to the requirement that applied in this case:  the "common knowledge" exception and/or the doctrine of res ipsa loquitur.  Id. at *20. 

The appellate court called the two doctrines "related," but noted the difference.  The common knowledge exception applies when a plaintiff presents evidence of an injury caused by a particular act or omission that is alleged to have deviated from the standard of care.  The jury then relies on its own knowledge and experience to decide whether there was a deviation from the standard, and whether that deviation caused the injury.  Id. at *19.  Application of the doctrine of res ipsa loquitur, on the other hand, requires no evidence of a standard of care or a particular act or omission; as the court noted, "the mere fact that the injury occurred raises an inference of negligence."  Id. 
The court addressed the plaintiff's "common knowledge" argument and dispatched it fairly quickly, calling it a narrow, rarely-applied exception in medical negligence cases that was inapplicable here because "[t]he proper procedure for using a rongeur during surgery is not a matter within the common knowledge and experience of the average person." Id. at *22.  It's hard to argue with that.

On the res ipsa loquitur argument, the court's analysis was more extensive, examining the three conditions that must exist in order for the doctrine to apply under Kansas law:  (1) the thing that caused the injury must have been within the exclusive control of the defendant; (2) the occurrence must be something that ordinarily does not happen in the absence of negligence; and (3) the plaintiff cannot have been contributorily negligent.  Id. at *22-23.  We can start with number three:  because the plaintiff was under general anesthesia at the time that the rongeur tip broke, not surprisingly, the court found that there could be no contributory negligence.  Id. at *32.  Element number two, a showing that the problem doesn't ordinarily occur in the absence of negligence, was handled pretty quickly by the court as well, although with a bit of sleight of hand. While the court noted that it was "inclined to believe that the prospective jurors in this case have some basis in common knowledge and experience from which they could reasonably conclude that the tip of a surgical instrument does not ordinarily break off and become lodged in a patient's disc space absent negligence on the part of the surgeon" (wait – didn't the court just reject a "common knowledge" argument?), it also found that two experts in the case had offered opinions that supported this conclusion.  Id. at *31-32.  Interestingly, the court was looking at two defense experts' opinions.  One had stated in his report that rongeurs like this one fail less than 1% of the time; the other expert stated that he had performed thousands of disc surgeries, and that in one of these surgeries, he had experienced a rongeur tip breakage like the one at issue here.  Id. at 12.  These experts were clearly trying to illustrate the point that sometimes rongeur tips can break, and sometimes for no apparent reason.  However, the court pointed to these opinions as support for a finding that the tips do not normally break off and become lodged in the patient's spine in the absence of the surgeon's negligence.  Id. at *31-32.  Considering this, and the plaintiff's expert's opinion that the surgeon's negligence was the only cause of the tip break, the court found that this part of the res ipsa test was satisfied. 
Of course, the plaintiff still had to show that the instrument was in the exclusive control of the defendant in order for res ipsa to apply.  While the court thought it was pretty clear that the surgeon who was using the instrument when it broke was in exclusive control of it (id. at *25-26), the surgeon made an argument on this point that basically involved throwing the absent manufacturer and a number of other people under the bus.  He posited that a res ipsa loquitur argument failed on the exclusive control element because "it was at least equally probable that the negligence was that of another and that such negligence occurred before Hubbard's surgery."  Id. at *26.  He argued that

he played no role in the design or manufacture of the rongeur, he was not the manufacturer of the rongeur, he did not own the rongeur, he played no role in the maintenance of the rongeur, he was not the individual charged with the responsibility to pull the rongeur from service at the end of its useful life, and the rongeur had been used by an unknown number of physicians prior to its failure in February 2008.

Id.at *26.  The appellate court was, in its own words, not persuaded.  The court first noted that the plaintiff's expert metallurgist had ruled out a manufacturing defect, improper maintenance, and normal wear as causes of the failure.  Id.  It also found that "exclusive control" had to be a flexible concept, allowing for a finding that control exists even where the defendant only shared in the control of the instrument.  Id. at *27.  The court reached back to Prosser and Keeton on this point – well, on the concept of "control" anyway, not "exclusive control," which makes us a bit uncomfortable.  And we wonder how flexible this concept is meant to be – i.e., if the only defendant in the case had been the manufacturer of the rongeur, would this court have allowed the concept to stretch far enough to find the manufacturer in "exclusive control" of the instrument at the time of injury?  And we wonder further:  in cases where both the manufacturer and surgeon are named, where does res ipsa come in?  Can the plaintiff get the inference against the manufacturer if the manufacturer chooses not to point the finger at the surgeon?  While it's true that the thing sometimes speaks for itself, sometimes it's what's not said that is troubling. 

 

 


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Posted By Melissa Wojtylak to Drug and Device Law at 5/31/2013 11:49:00 AM

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Posted by Law at 8:49 AM

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