We are just going to dive right into it today.  Because in a world where the rules and the situation are in such a state of flux and unknown, a little taste of something familiar is reassuring.  Such as – no causation, no case.  That’s tried and true.  Music to our ears every time.  So, if you are feeling a little overwhelmed or just a little lost, here’s a little bit of normal.

Plaintiff brought design defect and failure to warn claims against the manufacturer of a robotic device used to assist doctors in laparoscopic surgeries.  Pierre v. Intuitive Surgical, Inc., 2020 U.S. Dist. LEXIS 41474 (S.F. Fla. Mar. 6, 2020).  While undergoing a hysterectomy, she sustained a thermal burn to her bowel.  Id. at *1.  Plaintiff alleged that the device was prone to microcracks that allowed electrosurgical energy to leak to tissue and potentially cause thermal injury, a risk known as arcing.  Id. at *4.

The court began its analysis with plaintiff’s design defect claim.  The first thing to explain is that in Florida, the definition of design defect “is in a state of flux.”  Id. at *13.  While most courts use one of the three design defect tests – consumer expectations, risk utility, or reasonable alternative design – Florida hasn’t picked one yet.  So the court used all three.

On consumer expectations, defendant rightly argued that it should not apply to a complex device such as a robotic surgical device.  The court didn’t find the argument meritless.  After all, medical devices are intended for use by physicians and trained medical professionals, not the ordinary consumer.  Id. at *15-16.  However, the court was more persuaded by the Florida Supreme Court’s general philosophy that the burden should be on the manufacturer, not the injured consumer and therefore, consumer expectations had to come into play.  Id. at *16.   In this case, however, plaintiff failed to establish that the device did not perform to her or her surgeon’s expectations because there was no admissible evidence that the risk, arcing, actually occurred during plaintiff’s surgery.  Plaintiff’s surgeon didn’t notice it, he only assumed it occurred because of the inadmissible hearsay of another physician who watched the recording of the surgery.  So, applying consumer expectations, there was no design defect.  Id.

On risk-utility, plaintiff relied on adverse event reports showing microcracks and that was sufficient to raise a question of fact on whether there was an unreasonable risk associated with the design of the product.  Id. at *18.   So too on alternative design plaintiff was able to present evidence of a safety feature utilized on other products that she alleges should have been used on defendant’s product, id. at *20, despite it not being industry-required.  See id. at *4.  But, while plaintiff may have raised a factual issue for trial as to whether the device was defectively designed, her claims failed for lack of causation.

Plaintiff’s only causation expert was her surgeon.  Because he was not a retained expert, he was not required to submit an expert report – so long as his opinions were formed during and because of his treatment of plaintiff.  Id. at *25.  “However, if a treating physician’s opinion is based on information outside of his or her personal observations, the treating physician’s opinion is inadmissible unless the physician provides a written report in compliance with Rule 26(a)(20(B).”  Id.   Plaintiff’s surgeon’s testimony regarding what he observed directly contradicted his litigation-driven causation opinion.  He did not see any defect in the instrument or witness arcing during the surgery and the injury was more likely related to other pieces of equipment in use at the time.  Id. at *26.  Because his causation opinion was not made based on his personal observations during treatment, it was inadmissible without a written report.  Id. at *26-27.

Plaintiff’s surgeon’s causation opinion was also based on hearsay statements made by a colleague.  He asked the other doctor to review the videotape of the surgery and according to plaintiff’s surgeon, that doctor concluded the injury was due to arcing.  However, the other doctor is now-deceased.  The court found no hearsay exception applied and therefore, plaintiff’s surgeon could not base his opinion on inadmissible hearsay.  Id. at *27-29.  And, as if that wasn’t enough, plaintiff was using her surgeon’s testimony and other circumstantial evidence to attempt to prove causation via differential diagnosis.  Differential diagnosis alone is insufficient to prove causation.  Id. at *29.  Without causation evidence, plaintiff’s design defect claims failed – both strict liability and negligence.

Plaintiff’s failure to warn claim didn’t fare any better.  First, plaintiff had no expert testimony regarding the adequacy of the warnings and with a complex medical device that is a requirement.  Id. at *33-34.  Second, the device’s instructions for use contained warnings about the risk in question.  Id. at *34.  But, even if the court hadn’t concluded that the warnings were adequate as a matter of law, plaintiff’s failure to warn claim also failed for lack of causation.  To establish causation, plaintiff had to show that her surgeon would not have used the device if adequate warnings had been provided.  Id. at *36.  Here, the testimony was that her surgeon not only knew of this exact risk but also warned plaintiff of the risk via a signed informed consent form.  Id. at *37.  Again, no causation, no claim.

Complete summary judgment for this defendant.  Completely satisfying for defendants everywhere.