Statistics Expert References International Data In Hip Implant MDL

ByZach Barreto

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Updated onJuly 22, 2019

Court: United States District Court for the Northern District of Texas, Dallas DivisionJurisdiction: FederalCase Name: Re DePuy Orthopaedics, Inc.Citation: 2016 U.S. Dist. LEXIS 194777

This case involves multidistrict litigation (MDL) against defendant device manufacturer, DePuy Orthopaedics, Inc. regarding the design, development, manufacture, and distribution of the Pinnacle Acetabular Cup System hip implants (Pinnacle device). The device, which was used to replace diseased hip joints, intended to remedy conditions such as osteoarthritis, rheumatoid arthritis, avascular necrosis, or fractures, and provide patients with pain-free natural motion over a longer period of time than other hip replacement devices.

There were 8,000+ cases in this MDL involving Pinnacle devices lined with metal, ceramic, or polyethylene in their sockets. The plaintiffs acted through a large group of plaintiffs’ lawyers that formed the Plaintiffs’ Steering Committee, which in turn was headed by the Plaintiffs’ Executive Committee, a small group from the Plaintiffs’ Steering Committee appointed by this Court to conduct discovery and other pretrial proceedings and identify common issues in the MDL.

On July 15, 2016, the court entered a scheduling order providing that 6 cases involving California plaintiffs Andrews, Davis, Metzler, Rodriguez, Standerfer, and Weiser be set for a third bellwether trial.

The plaintiffs retained an expert in statistics and biostatistics to offer opinions regarding the relative performance of artificial hip implants with different bearing surfaces. The expert opined that data from the National Joint Registry for England, Wales, and Northern Ireland suggested a Pinnacle metal-on-metal revision rate of 41% at 15 years post initial surgery. He further stated that combined data from an internal DePuy registry and its clinical studies suggested a Pinnacle metal-on-metal revision rate of 64% at 15 years post initial surgery.

DePuy Orthopaedics moved to exclude the opinions of the plaintiffs’ statistical expert witness. The defendant contended that the expert’s opinions were based on statistical extrapolations of existing data into future years versus an analysis of the actual revision rate at 15 years post primary surgery, for which no data was available. The defendant argued that the court’s previous review of this issue misunderstood the defendants to contest the accuracy of the statistics expert’s analysis, rather than the methodology. To the contrary, this court found in the previous bellwether, and affirmed here, that the plaintiff expert’s statistical methodology, the application of a fitted quadratic model to observed hazard rate data, was a common and well-accepted statistical method that can be subjected to testing, verification, and cross-examination.

In was held that the defendant’s position was more appropriately an attack made on the weight of the testimony at trial rather than its admissibility. Thus, the defendant’s motion to partially exclude the opinions and testimony of the plaintiffs’ statistics expert was denied.

About the author

Zach Barreto

Zach Barreto

Zach Barreto is a distinguished professional in the legal industry, currently serving as the Senior Vice President of Research at the Expert Institute. With a deep understanding of a broad range of legal practice areas, Zach's expertise encompasses personal injury, medical malpractice, mass torts, defective products, and many other sectors. His skills are particularly evident in handling complex litigation matters, including high-profile cases like the Opioids litigation, NFL Concussion Litigation, California Wildfires, 3M earplugs, Elmiron, Transvaginal Mesh, NFL Concussion Litigation, Roundup, Camp Lejeune, Hernia Mesh, IVC filters, Paraquat, Paragard, Talcum Powder, Zantac, and many others.

Under his leadership, the Expert Institute’s research team has expanded impressively from a single member to a robust team of 100 professionals over the last decade. This growth reflects his ability to navigate the intricate and demanding landscape of legal research and expert recruitment effectively. Zach has been instrumental in working on nationally significant litigation matters, including cases involving pharmaceuticals, medical devices, toxic chemical exposure, and wrongful death, among others.

At the Expert Institute, Zach is responsible for managing all aspects of the research department and developing strategic institutional relationships. He plays a key role in equipping attorneys for success through expert consulting, case management, strategic research, and expert due diligence provided by the Institute’s cloud-based legal services platform, Expert iQ.

Educationally, Zach holds a Bachelor's degree in Political Science and European History from Vanderbilt University.

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