United States: Passive "Gatekeeping" In Biomet Hip Implant Daubert Decision

Last Updated: August 12 2019
Article by Rachel B. Weil

A couple of years ago, we were overjoyed to learn that our very favorite old-fashioned Broadway musical was being revived. The lead role – a famously brassy female character – was being played by a famously brassy singer and sometime-actress we believed was perfectly cast.   We bought tickets the day they went on sale, and we saw the show nearly as soon as it opened.   We could feel our excitement building at the swell of the first chords of the overture and at our first view of the Candy Land colors of the old-school set and costumes.   There was no place in the world we'd rather have been at that moment . . . and we were sorely disappointed. We thought the lead actress – notoriously bawdy and broad – played the role in much too "small" a fashion. The male lead was completely miscast. Inexplicable cuts had trimmed the best finale ever written to a mere footnote. And, once again, we were reminded that too-high expectation expectations beg to be dashed.

As they were in today's case.  We really liked the first half of In re Biomet M2a Magnum Hip Implant Prods. Liab. Litig., 2017 WL 10845178 (N.D. Ind. Dec. 21. 2017), an older decision that inexplicably just appeared in our weekly search.  The judge in the metal-on-metal hip implant litigation was asked to decide Daubert motions filed by both sides.  He started with the plaintiffs' motions to exclude five of the defendants' experts.   First, the plaintiffs moved to exclude the opinions of the defendants' mechanical engineering expert, a mechanical engineer and professor of tribology (the science of friction, wear, and lubrication – who knew??) related to the "reasonableness" of the defendant's "design and safety decision-making," Biomet, 2017 WL 10845178 at *2.   The court denied the motion, explaining that the expert's opinions were based on his review of "a large design file," which met "Rule 702's threshold requirement that an opinion be based on sufficient facts or data." Id. at *3. The defendant argued that the expert's "reasonableness" opinions were based on his review of "relevant literature, depositions, and [the defendant's] design files for the devices at issue in this case." Id. at *3. The court held that the files the expert reviewed met "Rule 702's threshold requirement that an opinion be based on sufficient facts or data," id. at *4, and that questions about other documents he could have considered were appropriately left for cross-examination.

Second, the judge considered the plaintiffs' motion to exclude two categories of opinions of the defendant's biomaterials expert. The judge held that the expert was not qualified to offer "sweeping" opinions about regulatory compliance but that he could offer opinions about the defendants' compliance with regulatory requirements to the extent that such compliance played a role in the development of the devices at issue. The judge denied the motion to exclude the expert's general opinions about factors surgeons consider in selecting a hip implant device.

Third, the plaintiffs moved to exclude the testimony of the defendant's regulatory expert on issues related to the 510(k) clearance process. The plaintiffs argued that: 1) they did not contend that the defendant violated the 510(k) process and regulatory compliance was a question of law an expert could not resolve; 2) the expert's opinion that the 510(k) process considers safety and effectiveness in addition to "substantial compliance: was contrary to FDA statutory and regulatory authority; and 3) evidence of 510(k) clearance was more prejudicial than probative.   Id. at *5. The court explained the split of authority on the admission of testimony about 510(k) clearance, then held that it would be premature for the court to rule on the admissibility of the expert's testimony on a litigation-wide basis at the MDL level.   Instead, the court held, resolution of the motion fell into the category of state-law determinations that should be made on remand to transferor courts.

Fourth, the Plaintiffs moved to exclude the testimony of the defendant's orthopedic surgeon/joint replacement specialist. The defendant offered the expert to testify about, "among other things, the rationale for second generation metal-on-metal devices." Id. at *8. The plaintiffs moved to exclude the expert's opinions on tribology, offering that he was unqualified to offer them. The court explained that the expert's opinions on "allegedly improved tribological characteristics of the second-generation metal-on-metal implants" were admissible to the extent that "they [were] the type on which an orthopedic surgeon would commonly rely." Id.   But, the court emphasized, the expert couldn't "take the place of a tribology expert and offer opinions beyond those on which an orthopedic surgeon would commonly rely." Id. As such, the court granted the motion to the extent that the expert was attempting to testify as a tribology expert and denied it to the extent that an orthopedic surgeon would reasonably rely on the opinions.

Finally, the defendant offered a biomedical engineer to testify about its testing of the hip implant device. The plaintiffs sought to exclude the expert's conclusion that: 1) the defendant's postmarket surveillance and use of the information it obtained were appropriate; and 2) the defendant "reviewed information in peer-reviewed journals concerning clinical experience with [its] devices and appropriately applied any new knowledge that was acquired" in assessing the products' long-term safety and efficacy.   Id. at *9. The plaintiffs argued that the expert lacked the specialized training or experience that would qualify him to offer these opinions, including training or experience with FDA regulatory procedures, that the expert did not employ a sound methodology, and that the defendant did not need an expert to testify to the fact of post-market surveillance. The court disagreed, noting that the expert's field was hip device wear testing and holding that his qualifications in analyzing data form those tests qualified him to analyze data from post-market testing and reports. The court rejected the "unreliable methodology" argument, holding that the expert's opinions were admissible because they were "reasoned, use[d] the methods of [his] discipline, and [were] founded on data."   Id.   The court excluded a single opinion offered by the expert – the opinion that metal-on-metal revision rates might be artificially high because of heightened scrutiny of the devices, finding that the theory was not supported by any of Daubert's indicia of scientific reliability – the theory was not tested, peer-reviewed, evaluated for error rates, or accepted within the scientific community.

The Defendant's Motions to Exclude the Plaintiff's Experts

By this point in the decision, we hoped that the judge's denial of the vast majority of the plaintiffs' motions signaled a pro-defense approach that would translate into exclusion of the plaintiffs' experts. By and large, this was not to be.

The court first considered the defendant's motion to exclude the plaintiffs' biomedical engineering expert, who offered the opinions that: 1) the defendant's products were defective; 2) metal-on-polyethylene implants were a safer, feasible alternative design; 3) the defendant's testing of its devices was inadequate; 4) the defendant's warnings were inadequate; 5) the defendant downplayed the risks of the devices; and 6) excessive metal ions produced by metal-on-metal devices cause clinical effects in patients.   The defendant moved to exclude all of the opinions.

First, the defendant argued that the expert was not qualified to offer the opinion that all metal-on-metal devices are defectively designed. The court denied the motion, holding that the expert's experience as an engineer qualified her to opine on the design issues even though her degrees were in mechanical engineering and not tribology. Next, the court held that the expert could testify to her proposed "alternative design," and that omissions in the information she considered were appropriately reserved for cross-examination. The court found that the expert was qualified to opine about the adequacy of the defendant's testing, notwithstanding her lack of training in tribology, and that she employed a reliable methodology in formulating those opinions when she "examined the testing [the defendant] conducted and pointed to other testing employed in peer-reviewed studies."

With respect to the expert's "inadequate warnings" opinions, the court held that the expert's experience "developing and reviewing warnings for orthopedic products" qualified her to offer the opinions, notwithstanding the fact that she was not an orthopedic surgeon and had no medical training. The court also held that the expert employed a reliable methodology when she "compared [the defendant's] warnings with relevant research on the alleged risks associated with metal-on-metal devices and opined on what additional warnings were necessary based on the deficiencies she found," even though she did not "explain whether and how additional warnings would have affected a surgeon's decisions" and did not "test her theories through studies or other mechanisms." Id. at *13.

Finally, the court held that the expert could not testify "as an expert on the clinical effects of metal ions" but could "permissibly rely on other experts' opinions that metal ions cause clinical effects to support her opinion that metal-on-metal devices [were] unreasonably dangerous." Id. at *15.

The plaintiffs' second expert was an orthopedic surgeon specializing in joint replacement. Like the first expert, he offered opinions that the defendant's devices, and metal-on-metal devices generally, were defectively designed and that the defendant's testing and instructions for use were inadequate.

The defendant argued that the expert was not qualified to offer his design opinions because he had no training in tribology. The court rejected this argument, explaining, "While [the expert] discusses issues that arguably fall within the field of tribology, . . . Rule 703 allows an orthopedic surgeon to reasonably rely on the opinions of other experts." Id. at *16. The court held that the expert permissibly relied on the expertise of others when his opinions required knowledge outside of his own field of expertise, and that that he employed reliable methodology in arriving at his general opinions about metal-on-metal devices. The court did exclude the expert's specific opinions about the design of the defendant's devices, holding that he had not considered sufficient device-specific data in developing these opinions. The court also excluded the expert's opinion that the defendant's testing of its devices was inadequate because he had not conducted a sufficient review of the relevant testing data.   But the expert was permitted to testify about the adequacy of the defendant's instructions for use because he "compared the facts in evidence with the content shown" in the instructions for use.   Id. at *18.

So while the judge excluded an opinion here and there, he admitted most of the plaintiffs' experts' opinions.  Call us biased, but we thought that the judge's analysis of the defendant's experts' opinions was mostly quite strong but that he stretched too far in allowing the plaintiffs' experts to testify far outside of their fields of expertise and to offer opinions that were the products of questionable methodologies.  No great surprise there.  But hope springs eternal, and we will continue to watch for the "good" while we report on the "bad" and the "ugly."

This article is presented for informational purposes only and is not intended to constitute legal advice.

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