Photo of Michelle Yeary

If you are one of our readers who fall into the over 50 demographic, we are going to assume that in your head you read the title of today’s post in John Houseman’s voice and you tagged it with “they earned it.”  That’s because you were alive in the early 1980s when if you wanted to watch TV, you had to watch commercials.  And John Houseman’s Smith Barney commercial is a classic.  If you are also asking who John Houseman is, then we have to assume you have never seen the Paper Chase and to that we say, “you come here with a skull full of mush.”  (again, in Houseman’s voice).

But we digress as we sometimes do.    Instead, we will recite the facts of Kendrick v. Wright Medical Technology, 2021 WL 3526663 (E.D. Ark. Aug. 10, 2021) and try to “fill the room with [our] intelligence.”  Defendant manufactures a knee replacement system.  It is a multi-component system that also involves the use of cement.  Id. at *1.  In the ten years the system has been on the market, defendant was aware of only two incidents where the femoral components broke after implant.  Mr. Kendrick’s was one of them.  Kendrick underwent knee replacement surgery using defendant’s device in 2011.  Approximately four years later plaintiff began experiencing pain which led to a revision surgery at which time the broken femoral component was discovered.  Id.  The surgery also revealed osteolysis behind the femoral component.  All experts in the case agree that osteolysis is a phenomenon that causes “empty spaces” at the bone-implant interface.  In this case, defendant’s expert opined that those empty spaces were caused by poor cement penetration which caused the cement to crack and eventually lead to the osteolysis.  Defendant’s experts also opined that the osteolysis is what in turn caused the femoral component to suffer a fatigue fracture.  Id. at *2.   Defendant also presented expert evidence that the device “met all manufacturing specifications” and was not designed or manufactured in a defective manner.  Id.  Plaintiff’s expert for the most part agreed with the defense experts.  Id.   Finally, the device was accompanied by Instructions for Use (“IFU”) that included a warning of the risk of “osteolysis and component fracture.”  Id. at *3.  Plaintiff’s surgeon testified that he never read the IFU, but that osteolysis is a general risk known to him.  Id.

On plaintiff’s manufacturing and design defect claims, it was undisputed that the device failed “but that doesn’t get Mr. Kendrick over the summary judgment hill.”  Id. at *4.  To prove a defect, plaintiff needs evidence “tending to show that the defect existed before the accident.”  Id. Plaintiff “has not even suggested” the presence of a defect or what the defect might be.  Id. Therefore, plaintiff’s only other recourse is to rely on res ipsa loquitur – asking the jury to infer a defect from the failure of the device.  However, under this theory plaintiff must “negate other possible causes of the failure of the product not attributable to the defendant.”  Id.  But it was undisputed that the osteolysis left the femoral component unsupported and therefore was a possible cause of the fracture.  Instead of negating that cause, plaintiff argued “a rational juror could reasonably infer . . .  that a knee implant which effectively destroys itself . . . is a defective condition.”  Id. at *5.  But there is no record evidence to support plaintiff’s conclusion that the device “destroyed itself” which is what “set[s] off the speculative chain of events [plaintiff] suggests.”  Id.  Since “speculation falls far short of dispelling other causes,” defendant was entitled to summary judgment on manufacturing and design defect.

As to failure to warn, first the court ruled that the Arkansas Supreme Court would apply the learned intermediary doctrine to prescription medical devices for all the reasons it adopted it for prescription drugs.  Id. at *6.  Therefore, defendant’s duty to provide an adequate warning of the risks ran to plaintiff’s surgeon.  Because defendant’s IFU warned of the very risks plaintiff encountered, defendant’s warnings were adequate as a matter of law.  Id. at *7.  But even if the court found the warnings deficient in some way, plaintiff’s claim would still fail for lack of proximate causation.  Plaintiff’s surgeon never read the warnings, so any inadequacy in the warning could not have been the cause of plaintiff’s injury.  Further, his surgeon testified he was independently aware of the risks which also cuts off any causal link.

Finally, plaintiff’s implied warranty claim also required proof of a product defect and therefore failed for the same reasons the manufacturing and design claims failed.  Id.  And, plaintiff’s negligence claims failed because defendant presented expert evidence that it manufactured a “well-functioning” device that was appropriately evaluated for safety and effectiveness and in compliance with FDA regulations.  Id. at *8.  Plaintiff’s experts did not refute this evidence; therefore, plaintiff did not raise a triable issue on negligence.  Relying on the device failure alone was again insufficient to sustain his claim.  Id.

Now, if you weren’t with us in our opening pop culture reference, maybe you’ll like this one better.  Plaintiff’s first name was Billy Ray.  Since we were already thinking of the financial market with Smith Barney, Billy Ray led us directly to Trading Places.  They may not have made their money the old-fashioned way, but they did it with style.