Today’s guest post comes from Karl Neumann at Cozen & O’Connor.  He was on the team that won this case, and sent us such a detailed description that we invited him to write it up himself – and he was kind enough to take us up on that offer.  The title tells you what it’s about, so we simply remind everyone that our guest bloggers are 100% responsible for the contents of their posts, and deserve all the credit (and any blame).

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About this time last year, the Blog reported on a plaintiff’s attempt to obtain exemplars at a discount.  Since then, the federal court in the Middle District of Florida has dismissed the manufacturer on summary judgment for the plaintiff’s failure to demonstrate causation.  In Ramkelewan v. Globus Medical Inc., No. 5:18-cv-100, 2019 U.S. Dist. LEXIS 229357 (M.D. Fla. Dec. 10, 2019), after the plaintiff resolved separate litigation with the implanting surgeon, the surgeon’s practice, and the surgical facility, the plaintiff attempted to piece together some viable theory of liability against the manufacturer in a subsequent lawsuit.  It was transparent that the plaintiff experts’ approach was to identify anything that purportedly looked like an imperfection, call them “manufacturing defects,” and then reverse engineer causation opinions.  The court ultimately did not buy what the plaintiff and his experts were selling.

The litigation involved a cervical disc replacement device that consists of a polyethylene core and two endplates. The plaintiff underwent a C5-C6 anterior cervical discectomy where the treating surgeon implanted the device.  Two days after the procedure, the core of the device expulsed from between the two endplates.  During discovery, the surgeon admitted his post-procedure realization that the plaintiff was not an appropriate candidate for the device due to the plaintiff’s hypermobile spine and that a fusion should have been performed instead.

In the subsequent lawsuit against the manufacturer, the plaintiff alleged a host of highly speculative manufacturing defect theories.  At its core, the complaint stated the plaintiff’s damages were caused by a defectively manufactured device that did not comply with design specifications approved by the FDA.  To support that conjecture, the plaintiff retained two experts, Drs. John Jarrell and Russell Dunn – both repeat offenders for giving unsound opinions.  Both have been excluded in prior cases for providing highly speculative opinions not backed by reliable data.  In re Mirena IUD Products Liab. Litig., 169 F. Supp.3d 396, 446 (S.D.N.Y. 2016) (excluding Dr. Jarrell’s causation opinions where he could not “identify support for the proposition that a parting line mismatch in an IUD was connected to a risk of perforation”); Bolt v. Ford Motor Co., 2019 WL 1254662, at *6 (N.D. Ala. Mar. 19, 2019 (excluding Dr. Dunn because his opinion was based on nothing more than speculation despite his inspection); see also Frankum v. Bos. Sci. Corp., 2015 WL 1976952, at *16 (S.D.W. Va. May 1, 2015) (excluding Dunn and noting his “complete lack of experience with medical devices outside of litigation”).

Dr. Jarrell alleged a laundry list of unsupported defects that could be consolidated down to three theories:  a misshapen core dome, insufficient core height, and the existence of a machining burr on an endplate.  He then opined that these defects caused the core to migrate and injure the plaintiff.  However, beyond that conclusion, there was not much more to the opinion. For example, Dr. Jarrell had no idea how or at what point during the manufacturing process the alleged core defects occurred and no testing was ever performed to determine if any one purported defect, or a combination thereof, could cause enough force to expel the core from between the two endplates.  Likewise, when asked in discovery whether the defects were causally connected, he merely stated they “could or could not” be.  It was apparent Dr. Jarrell formulated his conclusion before evaluating the facts, and there was no support for his analytical leaps.

As for Dr. Dunn, he identified two different purported issues with the core:  surface roughness and oxidation. Like Dr. Jarrell, his opinions came in kitchen-sink form, which included a whopping 22 separate conclusory opinions.  Notably, his oxidation theory was a re-hash of one of his litigation go-tos where he opines that oxidation occurs during the manufacturing process.  See, e.g., Trevino v. Bos. Sci. Corp., 2016 WL 2939521, at *21 (S.D.W. Va. May 19, 2016) (excluding Dr. Dunn’s attempts to argue the medical device was defective because it underwent oxidative degeneration).

Dr. Dunn posited the oxidation theory despite his concession that – prior to formulating his opinion for the case – he had never researched the issue of potential oxidation of medical-grade polyethylene.  Nor did he conduct any independent testing to conclude the subject core suffered oxidation during the manufacturing process.  Tellingly, Dr. Dunn conceded in discovery that oxidation could occur at room temperature and the core had been outside of the plaintiff’s body for three years and eight months by the time he inspected it.  Only then is when he allegedly discovered “some evidence” of oxidation on the core’s surface.  Like Dr. Jarrell, it was apparent that Dunn was taking a result-oriented approach to his opinions like he had done in the past.  See Bolt, 2019 WL 1254662, at *5 (excluding Dunn where he did not test his purported opinion).

During the litigation, the parties filed extensive Daubert cross-motions along with the manufacturer’s Motion for Summary Judgment.  Despite the plaintiff’s attempts to muster up some defect and causation theory, the court recognized the experts’ opinions were conclusory at best:

Dr. Jarrell’s report offers little more than a conclusion when it comes to his causation opinions. Dr. Jarrell opines, “The . . . failure was caused by the device[’]s defective condition and Globus’s improper manufacture and inspection of the device prior to distribution.” (Doc. 95-2, p. 6). Dr. Jarrell also opines, “In the absence of a manufacturing defect and Globus’s improper production . . . the implant would not have failed as it did in this case.” (Doc. 95-2, p. 14). Finally, Dr. Jarrell opines, “A properly manufactured core would not have experienced expulsion/migration during patient use as occurred in this case.” (Doc. 95-2, p. 16). While Dr. Jarrell offers these opinions, he fails to explain how he reached these conclusions, which appear to be little more than ipse dixit—especially since Dr. Jarrell did no independent testing to confirm such defects could cause the core to expel from the endplates. 

Ramkelawan v. Globus Med. Inc., No. 5:18-cv-100, 2019 WL 8267231, at *9 (M.D. Fla. Dec. 10, 2019) (emphasis added).

The court ultimately precluded Dr. Jarrell from providing any causation opinions because they were not based on sound scientific methodology.  Id.  The court reached a similar result with Dr. Dunn:

The Court agrees with Globus that Dr. Dunn’s opinions should be excluded. First, despite Dr. Dunn’s opinion that the core was oxidized and not to specification in regard to surface roughness, he fails to point to any FDA-approved specification with which these observations are inconsistent. Further, Dr. Dunn does not point to any manufacturing process with which Globus did not comply. And contrary to the [plaintiff’s] assertions, there does not appear to be any correlation between Dr. Dunn’s testimony regarding oxidation and surface roughness, and the resulting failure of the subject . . . core. So even assuming the core was defectively manufactured such that there was oxidation and an issue with the core’s surface roughness, neither Dr. Dunn nor any other expert has opined these defects caused the . . . core to explant and injure [the plaintiff].

Id. at *11.  Hours after the Daubert Order was released, the Court granted summary judgment because the Plaintiff could not “prove that any manufacturing defect caused the injury to [the plaintiff].”  Ramkelawan, 2019 U.S. Dist. LEXIS 229357, at *6.  In the opinion, the Court reiterated its concern with the expert’s reverse engineering, noting that “Dr. Jarrell admitted he had not performed testing to confirm his opinions and did not explain what caused him to conclude the defects could result in the core expelling.” Id.

Too often in medical device cases, courts permit experts to get away with this result-oriented approach–that is, large gaps between the expert opinions proffered and the underlying data. Many times, the issue is left for counsel to handle during cross examination at trial even though the opinions are not grounded in the facts.  So it is refreshing to see a court exercise its gatekeeping function and prevent such opinions from being presented to a jury in the first place.

Ending on one last positive note, there was no appeal.