Frank Griffin, M.D., J.D., Adjunct Professor, University of Arkansas School of Law
Dangerous medical devices have been in the news, and the Institute of Medicine—upon the FDA’s request—made recommendations to make device approval pathways safer, but little has changed. Orthopaedic device companies use the pathway that the Institute of Medicine called “flawed” to gain approval of 88% of their devices—resulting in an 11.5 times higher recall rate than if a more rigorous pathway to approval were chosen. Predictably, patients are often harmed by recalled devices (and likely other devices that are not officially recalled), but harmed patients may have no choice but to suffer the “overwhelming misfortune” (envisioned in Escola) of shouldering the burden of the companies’ design choices in the current unnecessarily prejudicial legal environment.
In Daubert v. Merrell Dow Pharmaceuticals, the United States Supreme Court provided a framework for judges’ gatekeeper role in assessing the reliability and relevancy of scientific expert testimony to be heard by the jury. Unfortunately, judges may be overwhelmed and unintentionally unfair in handling a task that some judges from the beginning considered “daunting” complaining they were “no match” for the experts they face. Since Daubert, in limine challenges have increased, “primarily driven by a significant increase in the number of in limine challenges raised against plaintiff expert witnesses.”
However, there is hope for the overwhelmed judge sorting through the pretrial in limine motions regarding scientific experts in complex orthopaedic cases. As explored in depth in my recent article to allow for a fair trial, judges should place defense experts and epidemiology studies under greater scrutiny, while being more willing to admit the few experts available to plaintiffs in these often-novel cases. In addition, courts should require all experts to file conflict of interest disclosure forms under penalty of perjury similar to those used in the orthopaedic journals to assist with assessment of reliability—given that an overwhelming (>97%) majority of experts with stock options, consulting contracts, employment contracts or royalties report positive outcomes in their studies, and also considering that studies are generally reproducible only when <25% of the data comes from developers. On the plaintiffs’ side, judges should be more open to allowing experience experts and experts who do their research in preparation for trial—because in these novel cases, no other non-industry experts may exist to expose problems.
My article—“Prejudicial Interpretation of Expert Reliability on the ‘Cutting Edge’ Enables the Orthopaedic Implant Industry’s Bodily Eminent Domain Claim”—highlights information of which courts, attorneys, doctors, and patients should be aware. The article provides ways that the court may stand on equal ground with experts in these complex cases to fairly assess reliability and to do its part to create a safer and more effective medical device market that does not unnecessarily “take” Americans’ health.