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Howard v. Zimmer is an old case. It was filed in the Northern District of Oklahoma in 2002 and got transferred to the Northern District of Ohio for the Sulzer Hip and Knee MDL. In 2010, after not participating in a class action settlement in 2003 and having plaintiff’s claims carved up on summary judgment in 2006, Howard went up the Sixth Circuit, which held in 2010 that a claim for negligence per se—if Oklahoma law recognized it—would not be preempted.

Then the case was remanded back the original Oklahoma federal court, which referred to the Oklahoma Supreme Court the question of whether Oklahoma recognized negligence per se based on an alleged violation of the FDCA. The resulting “yes” to that question in March 2013 made #3 on our list of the worst decisions of 2013.  At that point, the case went back the Northern District of Oklahoma to see if plaintiff could actually offer admissible evidence to prove his remaining claim for negligence per se based on a violation of the FDCA. Howard surfaced again last week with Daubert challenge to a fair amount of plaintiff’s expert evidence. Somewhere in the interim, plaintiff had focused his negligence per se claim on the allegation that the Defendant’s manufacturing process allowed for some residue to remain on some portion of the particular knee implant used in plaintiff’s knee replacement surgery back in 2000. Howard v. Zimmer, Inc., No. 02-CV-0564-CVE-FHM, 2014 U.S. Dist. LEXIS 28758, ** 1-2 (N.D. Okla. Mar. 6, 2014). This claim sounds an awfully lot like manufacturing defect or negligent manufacturing and not really at like negligence per se based on a violation of the FDCA, but maybe a plaintiff in a case old enough to be reserving space for its bar mitzvah party should finally be showing whether he has any admissible evidence to support any claim linked to his injury.

Compared to what we have posted on in this case before, the Daubert decision was sound and not results-driven. The weakness of plaintiff’s experts could be viewed either as a shame given the judicial resources spent on the case or as a product of the particular non-preempted claim that plaintiff was left trying to prove. Either way, with plaintiff’s experts hamstrung, we expect Howard is nearing its end, especially if Defendant gets another shot at summary judgment.

The major part of the decision focused on the reliability of gas chromatography/mass spectrometry testing of the explanted device conducted by plaintiff’s expert to show residue—basically oil—was on the device when it was implanted. We know that our readers would appreciate an explanation of how gas chromatography and mass spectrometry work. Luckily, the internet is really cool, so we are not providing the explanation ourselves. Because the challenge here was to how the testing here was performed, as opposed to whether properly performed testing can ever be a reliable basis for expert opinions, the science behind the tests does not matter too much. Id. at **7-8. Also, the alleged methodologic failures were fairly basic when cast in laymen’s terms.

First, chain of custody for the implant was only established starting when the expert’s outfit got it, leaving open questions of what might have happened to it before then, innocently or otherwise. If what got tested was not what got explanted, then the testing can hardly be said to be useful to a jury. Second, part of the testing may have involved pouring a solvent into a plastic container, which itself could have produced some or all of the chemicals (hydrocarbons) that allegedly indicated possible residue oil from manufacturing the device. It was fairly obvious that some additional testing of the container should have been done to rule it out as a source of the chemicals. Third, although plaintiff contended only one part of the device had some post-manufacturing residue on it—and instructed the expert to only test it—the testing was done on the whole device together, including a plastic part that arguably could have produced the chemicals at issue when put in contact with the solvent. Following steps to avoid false results is fairly typical of good science. Fourth, the plaintiff’s expert never tested for the specific lubricants used in manufacturing the device, but only tested some generic mineral oil, which may or may not have the same mix of hydrocarbons.

Rather than resolving these questions or determining that success on any one challenge would have been sufficient to knock out the testing, the court held that “it is clear that the combination of the four errors is sufficient” to find the testing unreliable. Id. at ** 13-14. We might have preferred if the court had stated this as a failure of plaintiff to establish the reliability of the testing, as it was clearly plaintiff’s burden to do. The court had indirectly quoted Paoli for “any step that renders the analysis unreliable . . . renders the expert’s testimony inadmissible. This is true whether the step completely changes a reliable methodology or merely misapplies that methodology.” Id. at * 13 (quoting Mitchell v. Gencorp Inc., 165 F.3d 778, 783 (10th Cir. 1999)). Then the court found it “unclear” if the hydrocarbons found in the testing could have come from the lubricants used to manufacture the part at issue, as opposed to from the container, another part, or some post-explant contamination. Id. at * 14. So, this really does sound like the plaintiff not carrying his burden and we are content.

We were also pleased that all opinions based on the unreliable testing were excluded without any particular analysis. The tidy decision to exclude regulatory opinions from the expert who did the testing was also good. He denied expertise in FDA’s regulation of medical devices, but got a “general idea of what needs to be done” from internet research. Not enough. Id. at ** 16-17. Just like conducting the internet research we advocated above would not confer expertise in gas chromatography. Unfortunately, this expert did offer some opinions based neither on the testing or his non-existent regulatory expertise, so he was not excluded entirely.

That was not the case for Dr. Fred Hetzel, whom we have mentioned before. In addition to opinions based on the unreliable testing, he tried to offer legal conclusions about the meaning of FDA regulations on Good Manufacturing Practice regulations and speculation that metallic residue also could have been on the device when it was implanted. As to the first part, it was apparently “law of the case” from way back when the case was back in the MDL that Hetzel was “not competent to testify to legal conclusions about what the GMPs require.” Id. at * 18. This is an interesting limit to have in a case where the plaintiff was trying to proceed on the theory that the violation of those regulations constituted negligence per se. As to the second part, Hetzel basically admitted that he had no evidence of any metallic residue on plaintiff’s device, in part because relevant evaluating and testing was not performed. Id. at ** 18-19. This made it easy for the court to find opinions on metallic particulates unreliable—and obviously irrelevant.

The last part of the decision concerned the attempt of a treating opinion to ascribe the failure of plaintiff’s knee replacement surgery to an issue with the manufacture of the device based on his experience that he saw a similar course with another patient with the same device. Opinions based on “clinical experience” often get offered by plaintiff and defense experts, particularly surgeons, and it can be hard to sort out when an opinion is simply based on what amounts to a comparison to the expert’s own unpublished case report or on something more substantial. The court’s analysis was direct and logical, so we will just insert it:

There is no evidence that any further scientific inquiry was conducted to determine the extent of the similarities between [plaintiff’s] experiences and those of the other patient. The sole basis for Dr. Robertson[‘s] opinion appears to be that both [plaintiff] and the other patient had aseptic loosening and that both patients’ implants were easier to remove than anticipated. Plaintiffs have failed to establish that this comparison is reliable. Plaintiffs have not provided evidence that this comparison has been subject to peer review and publication, that there is an established rate of error for this comparison, or that this comparison has general acceptance. See Bitler v. A.O. Smith Corp., 400 F.3d 1227, 1233 (10th Cir. 2005). Dr. Robertson’s methodology for reaching the conclusion that [plaintiff] and his other patient’s experiences were substantially identical is insufficiently rigorous, and, as a result, his opinion should be excluded. See Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (1999) (“[The objective of Daubert’s gatekeeping requirement] is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.

Id. at * 22-23 (record cite omitted). That is dead on and even introduced the burden issue we harped about above. As its parting shot, the court dismissed the argument that cases providing for the admissibility of prior accidents (or ADEs or MDRs for our typical cases) do not support an expert’s reliance on a single prior patient for a causation opinion. Id. at ** 23-24.

We hope that we are nearing the end of Howard, as it seems to have been a long and expensive exposition of a principle we find self-evident: not every failed surgery with a medical device gives rise to a viable cause of action against the device’s manufacturer. With close to twelve years of litigating, including a bad preemption decision by the Sixth Circuit and a really bad negligence per se decision by the Oklahoma Supreme Court, it may be that the case was an exercise in futility from the start, because there was never anything wrong with the device. (And, much like Howards End, movies where Antony Hopkins does not play a psychopath can run a little long.)