Have You Ever Heard of Semi-Secret Warnings? Neither Had the N.D.N.Y.

It is hard to imagine a less qualified expert witness than the one retained by plaintiff in Krom v. Smith & Nephew, Inc., 2024 U.S. Dist. LEXIS 121618 (N.D.N.Y Jul. 11, 2024).  And since truth is often stranger than fiction, we are just going to give it to you straight.

Plaintiff, a 73-year-old, morbidly obese man, underwent a hip replacement and six months later, the implanted device fractured.  Id. at *3-4, *8.  Plaintiff retained a mechanical engineer to opine, ostensibly, on design and manufacturing defect.  That expert’s report offered three opinions:  the device did not meet certain industry standards; defendant failed to provide adequate warnings; and defendant “deceived” the FDA.  Id. at *10. 

Starting with qualifications, the court provides a laundry list of all the ways this expert was unqualified.  We’ll offer some highlights:

• She is not a biomechanical engineer nor a medical doctor;
• She has never worked for a medical device company or the FDA – in fact she didn’t the know difference between a 510(k) clearance and PreMarket Approval;
• Her litigation consultant experience was almost completely related to lithium-ion battery failures and her only other medical device case was about the battery in a pacemaker;
• Her only warnings experience was for a technology company and not related to a medical device.

Id. at *18-22.  Leading the court to find her unqualified “by experience, knowledge, skill, training, or education to offer any opinion regarding the medical device at issue.”  Id. at *22. 

And, as if that was not enough, the expert’s opinions were also unreliable.  To the extent any methodology was described, it consisted “primarily of speculation based on her personal and non-medical device experience.”  Id. at *23. 

First, she testified at her deposition that she was not offering an opinion that the device had either a manufacturing or a design defect.  Id. at *11.    So what purpose was this engineer supposed to serve?

Her only “defect” opinion was as to warnings.  She opined that, based on her experience at a technology company, additional information should have been provided to doctors in a “kind of like semi-secret chart.”  Id.  Maybe with a decoder ring too?

Even more unbelievable, plaintiff’s expert’s opinion on what information should have been provided by the hip implant manufacturer to the implanting surgeon was based on her personal experience with her father’s heart surgery.  She believed it was “normal procedure” for surgeons to ask sales representatives for detailed information and get their recommendations on what devices to use because that is what her father’s surgeon told her he did.  Id. at *23-25.  That’s as much an “expert” opinion as Aunt Betty’s opinion that eating carrots improves your eyesight because her 65-year-old neighbor loves carrots and still has 20/20 vision.   

Plaintiff’s expert’s industry standards opinion was based on applying a set of standards that she thought maybe were used by device manufacturers and that she did not know whether they were required by the FDA.  Id. at *12.   Maybe is never good enough for expert testimony.

And, finally on misleading the FDA, plaintiff’s expert had to admit that the information she was fussing over was provided to the FDA, but maybe the FDA missed it because it was “small.”  Id. at *13-14.  We warned you–you can’t make this stuff up.

Not surprisingly, the court went on to grant defendant’s summary judgment motion.  First, plaintiff had to abandon his design and manufacturing defect claims because, after all, his expert said she wasn’t offering those opinions.  And an attempt to offer an new affidavit by the expert in response to the motion that directly contradicts her prior testimony is a sham affidavit that the court was free to ignore.  Id. at *30, n.13.

That meant that plaintiff’s negligence and strict liability claims were based only on failure to warn.  While plaintiff tried to argue that was a fact-intensive inquiry, the “facts” were that plaintiff’s surgeon testified he did not review the manufacturer’s Instructions for Use which contained numerous warnings and that he had independent knowledge of the risks, including the risk of fracture.  Id. at *33-34.   Therefore, plaintiff’s failure to warn claims fail for lack of evidence of causation.  His surgeon was a learned intermediary and he “was sufficiently warned.”  Id. at *34.  Plaintiff failed to oppose defendant’s summary judgment motion as to breach of warranty claims and so the court also considered those abandoned and dismissed them.  Id. at *35.  They likely would have been dismissed for lack of reliance even if opposition had been lodged because plaintiff admitted he had no contact with the defendant, received no information from the defendant, and was unaware of any warranty by the defendant.  Id.