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Here’s a guest blogpost, this time from Jaclyn Setili, an associate in Reed Smith’s San Francisco office.  As always with guest posts, our posters deserve all the credit, and shoulder any blame, for what follows.  Take it away, Jaclyn:


Here at the DDL Blog, there are few things we enjoy more than a defense-friendly Daubert ruling – one of those things being, of course, our regular Sunday night HBO date with Game of Thrones.  The “Hardhome” episode two Sundays ago finally provided the action-packed relief the show had been somewhat lacking thus far this season, culminating in an adrenaline-charged showdown between the Wildlings (and Crows) at Hardhome and the zombie-like army led by the White Walkers (speaking of which, we would gladly take a losing Daubert ruling over facing even one of those child wights any day).

Always thinking of our DDL readers, we were naturally struck with the comparisons one might draw between Daubert practice and this particular GoT storyline.  First, the standard for expert testimony draws some parallels to the constant challenges to Jon Snow’s recent promotion as Lord Commander of the Night’s Watch.  As we know, Federal Rule of Evidence 702 governs the admissibility of expert testimony.  The test requires that (1) the expert be qualified to testify competently regarding the matters he or she intends to address, (2) the methodology the expert uses to reach his or her conclusions is sufficiently reliable under the inquiry set forth in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), and (3) the testimony assists the trier of fact through the application of scientific, technical, or other specialized expertise.

Likewise, Jon Snow is regularly subjected to Daubert-like inquiry in his dealings at Castle Black and elsewhere.  Is he truly qualified to lead the Night’s Watch?  After all, he certainly is young, and has not had many opportunities to successfully wield his Valyrian steel to victory.  Are his decisions sufficiently reliable – for instance, journeying to Hardhome in the first place to forge an unlikely alliance with a centuries-old adversary of those living south of the Wall?  Finally, can Jon truly assist the “trier of fact” – in this case, the inhabitants of Hardhome – with his “specialized expertise”?  For poor Jon, doubts abound, and leaving that bag of Dragonglass behind when he and his cohorts made their escape by boat at the episode’s climax is not helping his case.

Second, constructing arguments for exclusion in a Daubert motion truly is a Game of Unknowns.  Parties are likely tempted to throw any argument but the kitchen sink at a potential testifying expert at the hopes of an exclusion order, and are often rewarded only with a “grant in part, deny in part” ruling.  In other words, as Jon Snow well knows, you can’t win them all (or as the dearly-missed Ygritte might observe, “You know nothing Jon Snow”).

This Game of Unknowns was on full display in a recent decision from the Middle District of Florida, Ocasio v. C.R. Bard, Inc., 2015 U.S. Dist. LEXIS 58163 (M.D. Fla. May 4, 2015), where it was plaintiffs’ experts who were on the chopping block.  Plaintiff claimed injuries from an allegedly defective inferior vena cava (“IVC”) filter.  Plaintiffs sought to disclose a number of expert opinions, including those of Drs. Hyman and Begley and Ritchie, regarding the alleged defects of the filter. Defendants challenged the various opinions of all three experts, aiming their sword strokes at any or all of the Daubert elements.  Ultimately, the battle was a toss-up, with the court granting in part and denying in part Bard’s motions.  The rulings we like, and the rulings we don’t, are summarized below.

The Good

Lack of Qualifications

First, several of the experts’ opinions were struck down due to lack of relevant qualifications.  In excluding Hyman’s opinions regarding the filter’s labeling, the court found relevant his testimony that he had never drafted the  IFU (“Instructions for Use”) for any medical device, and that he had only had input or commented on pieces of “a few” unspecified IFUs.  Further, as Hyman was not a medical doctor, he had “never personally relied upon an IFU” in making a medical decision.  Id. at *9.  With no prior expertise, on either the giving or receiving end, out those opinions went.

Similarly, the court excluded Begley’s opinions on the adequacy of the defendants’ manufacturing process and quality control for the filter.  While Begley’s doctorate degree in Mechanical Engineering might sometimes be enough, the court found that plaintiffs “set forth no evidence that Begley [had] any training or professional experience in manufacturing techniques or manufacturing control measures.”  Id. at *16.  Significantly, the court noted that Begley’s background in mechanical processes and his testimony on manufacturing processes were “not so closely related that such expertise in one would
necessarily establish expertise in the other.” Id. at *16-*17.

Opinions Not Supported by Sufficient Data or Reliable Methodology

Next, a failure of reliable methodology convinced the court to knock out a number of other opinions.  As to Hyman’s opinions regarding the design and testing of the filter, the court disagreed with Bard, and found Hyman qualified.  While Hyman “lack[ed] training specifically in regard to implantable medical devices, such as IVC filters,” the court found that his thirty-plus year career in the design, testing and regulation of other medical devices rendered him “clearly qualified” to opine on design and testing (making this part of the ruling more properly assigned to “The Bad”).  Id. at *5-*6.  However, the court still excluded these opinions on the grounds that they were not the product of reliable principles and methods.  Specifically, Hyman “failed to test or examine the [product] or any other type of IVC filter”; indeed, he had “never even seen in person or touched” any IVC filter at all.  Id. at *7.  Rather, Hyman’s only opinions on design and testing were “gleaned from documents selected by Plaintiffs’ counsel,” and completely lacked “any independent verification of the data or testing of the device.”  Id. 

Hyman’s methodology itself was also concerning:  he simply reviewed the facts of the case, the known failure modes of the device, and relevant medical literature; he then compared his impression of the defendants’ approach to “what he believed a prudent product manufacturer would have done.” Id. at *8.  According to the court,


[I]t appears that Hyman arrived at his opinions based solely upon a comparison of the underlying facts to his own subjective idea of what a prudent manufacturer would have done.

Hyman has failed to articulate any scientific or regulatory bases for his methodology.  He has not developed any test protocols that he believes should have been performed on the device.  There is no objective standard that could be employed to evaluate Hyman’s design and testing opinions.

Id.  Thus, these opinions were excluded.

The court also noted that Begley’s opinions on manufacturing and quality control would be excluded under this ground as well, given that his opinions appeared “to rest solely on other experts’ observations of variability between the filters and [Begley’s] observations of” the defendants’ “internal documents.”  Id. at *17.  Like Hyman, Begley did not conduct any tests of his own, and could not even recall if he had ever reviewed the manufacturing specifications for the this product.  Id.

As to Ritchie, he opined that certain factors known to result in filter fracture also caused the perforation of plaintiff’s filter.  The court held that this opinion was not the product of reliable scientific methodology.  The court concluded that “Ritchie offers nothing more than his own ipse dixit to conclude that these conditions [leading to fracture] also cause tilt, migration, and perforation. . . . As the Eleventh Circuit has cautioned, courts must be wary of leaping from an accepted scientific premise to an unsupported one.”  Id. at *15.

Opinions That Would Not Assist the Trier of Fact

The last bit of helpful rulings precluded opinions the court determined would not be helpful to the trier of fact.  These involved the all-too-common transgressions of plaintiff-side experts. For one, the court rightly excluded Hyman’s opinions summarizing the defendants’ internal documents, finding that such testimony both “invades the province of the jury,” which does not need expert aid to interpret corporate documents, and is improper, because “[a]n expert cannot be presented to the jury for the purpose of constructing a factual narrative based upon record evidence.”  Id. at *11-*12.

The court also excluded much of Begley’s chosen vocabulary in characterizing the defendants’ conduct.  The court agreed with Bard that terms such as “negligent” and “reckless” have a “specialized meaning in the law,” and precluded Begley from using these words, as it is “well-established that a testifying expert may not offer legal conclusions.”  Id. at *20.  Begley was also prevented from using the word “unethical,” finding that it was “founded only upon his own subjective ideas on how a medical device company should act.”  Id. at *22.

The Bad

And now, for the fatalities.  First, while Begley was prohibited from using certain words, the court ruled that he could be allowed to use other unflattering terms when characterizing the defendants’ conduct.  “Incompetent” passed muster, given that the word carries no distinct legal definition and would supposedly assist the trier of fact in evaluating the defendants’ “duty of care.”  Id. at *21.  Begley’s use of the word “misleading” also squeaked through for the same reasons.  Id. at *22-*23.

Other opinions were deemed helpful to the trier of fact.  Hyman’s opinions on the FDA regulatory process, for example.  As a
slight consolation, the court limited Hyman’s opinions on this topic by precluding him from opining on whether the defendants “should have done more than was required by FDA regulations.”  Id. at *10-*11.

Ritchie’s opinions regarding causes of fracture of the filter were similarly permitted.  Defendants attempted to argue that, because plaintiff’s filter did not fracture, Ritchie’s opinions did not “fit” the facts of the case.  Instead, the court found that Ritchie’s opinion that perforation (which plaintiff did experience) could “increase the risk” of fracture would be helpful to the trier of fact, and “[t]he fact that Ritchie was unable to establish the increase in likelihood of fracture due to perforation to a reasonable degree of engineering certainty does not warrant the exclusion” of such opinions.  Id. at *13.  Since when has “increase in risk” even been a product liability theory?  The court did, thankfully, leave open the possibility that such opinions could be subject to a motion in limine or objection at trial due to the risk of unfair prejudice.

Finally, the court ruled to allow Begley’s opinions regarding a stress/strain analysis and the adequacy of product testing, finding both would assist the jury.  As to the adequacy of testing specifically, defendants argued that Begley could not point to any specific defect that caused plaintiff’s filter to perforate.  The court was not persuaded, noting that there is “no requirement that Plaintiffs or their experts establish that any one specific defect caused [plaintiff’s] filter to perforate.”  Id. at *19.  The Court found that opinions on the adequacy of testing would assist the jury in determining whether the filter was defective and whether the warnings were sufficient.  Id.

Ultimately, we think the message of Ocasio is that, while you may swing your sword widely in commencing a Daubert attack, only some blows will stick.  Fortunately, this case provides enough satisfactory rulings that it may just stick around long enough (parts of it anyway) to be cited in the next Eleventh Circuit Daubert battle.