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“If it doesn’t fit, you must acquit.”  In the granddaddy of today’s reality TV shows, this buzz-phrase became synonymous with “use your head before you rely on a demonstration.”  The plaintiff in Hutson v. Covidien Holdings, Inc., et al., 2015 U.S. Dist. LEXIS 85223 (S.D. Ohio June 30, 2015), would have done well to pay heed.  As you will see, the demonstration on which his expert relied – the stuff of a high school science fair, and not in a very good school district – played a large part in ensuring that the expert’s testimony would never see the light of day.

In Hutson, plaintiff underwent a root canal.  The dentist used a needle to inject anesthesia into plaintiff’s gums, but ignored the needle box’s label, which warned not to “bend or alter needle shaft prior to use” and not to “insert the needle shaft all the way to the hub as needle breakage and possible injury may result.”  Hutson, 2015 U.S. Dist. LEXIS 85223 at *1-2.  The dentist did both – twice – and the needle broke off in plaintiff’s gum tissue.  Because no portion was sticking out, oral surgery was eventually required to remove the needle.  Id., at *2.  (Yes, we are also feeling queasy.)

Notwithstanding the warnings – and the completely predictable result of the dentist’s decision to ignore them – plaintiff chose to sue the needle’s manufacturer, alleging that a manufacturing defect caused the needle to break.  He produced the report of a “clinical engineering” expert, who described his area of expertise as “the applied application of the engineering discipline to all aspects of technology used in the clinical setting.”  Id. at *3 (citation omitted).   The expert opined that “there are four potential causes as to why the subject needle broke, three of which involve a manufacturing defect, but there is not enough data from the subject needle to rank the likelihood of causes.”  Id. at *4 (citation omitted).  We love this stuff.

The expert relied on the report of two metallurgists, neither of whom was offered as an expert himself.  The first examined the needle that was removed from plaintiff’s gum, but, according to the expert, that “analysis was substantially limited due to a foreign matter deposit on the fracture surface, making a complete analysis inconclusive.”  Id. (internal punctuation and citation omitted).  The second metallurgist demonstrated the existence of a manufacturing defect by – wait for it – placing similar needles into an empty mechanical pencil and trying to bend them.  Id.  The needles didn’t break, despite “far more intense pressure than [the dentist] had applied,” leading to the conclusion that the needle used for plaintiff’s procedure “was more than likely defective.”  Id.   Not surprisingly, defendant moved to exclude the expert’s testimony as unreliable.

First, defendant attacked the reliability of the pencil experiment, arguing that “no attempt was made to replicate what occurred in [plaintiff’s] mouth;” rather, the metallurgists, with the expert watching, “stuck exemplar needles into a mechanical pencil and bent them.”  Id. at *6.  The Court concurred, noting that “Daubert factors caution against relying on this method,” which was never “tested, published, or subject to peer review.”  Moreover, “[n]o written protocol controlled this approach.  The procedure has no known or potential error rate, and . . . [plaintiff] offers no explanation as to how this technique is generally accepted in the relevant scientific community.” Id.

The Court commented that the expert’s “lack of relevant experience similarly paints this method as unreliable.”  Though the expert stated that he had “been called upon to investigate medical device incidents involving a broad variety of medical devices,” he “highlight[ed] no experience working with needles . . . [a]nd testified that he [had] never performed a failure analysis on stainless steel.”  Id. at *7.  Moreover, he was “only vaguely aware of how a dentist performs the type of procedure that [plaintiff] underwent.”  Id. at *8.

Next, the Court emphasized that the expert’s “attempt to link the alleged manufacturing defect to the needle fracturing in [plaintiff’s] gum was based on the same unreliable method, . . . [lacking] critical points” related to the likelihood that the needle would fail in the dentist’s hands and how much force would cause such a failure.  Id. at *9.  Moreover, while three of the expert’s four potential causes of the needle’s fracture involved a manufacturing defect, he admitted that he lacked the data to rule out the fourth – “the prospect that [the dentist] overloaded the needle with pressure during the root canal.”  Id.  Thus, the expert’s “proffered testimony on the link between the alleged defect and the fracture is similarly unreliable.”  Id.

Finally, the Court commented that the expert was really only  parroting the findings of the non-testifying metallurgists.  This “regurgitation of the metallurgists’ findings” was not “responsible science,” especially where the expert conducted no tests of his own, did not witness all of the metallurgists’ tests, and lacked the qualifications and experience to assess the metallurgists’ techniques.   Id. at *10-11 (citations omitted).

And so, the expert was excluded.  In the absence of expert “defect” testimony, the Court granted defendant’s motion for summary judgment.  Lesson?  If an expert lacks “real” credentials, has no relevant experience, performs no analysis, and employs no reliable methodology, yet attempts to draw sweeping conclusions about the ultimate issues in the case, he or she should not be allowed to testify.   With our gloves on (had to figure out how to tie them back in), we commend this lesson to courts considering the testimony of a certain ubiquitous “regulatory” expert, among others.  And we thank the Hutson plaintiff for brightening our day with this silliness.