In re Davol Inc./C.R. Bard Inc. Polypropylene Hernia Mesh Medical Device Products Liability Litigation

Introduction

In re Davol Inc./C.R. Bard Inc. Polypropylene Hernia Mesh Products Liability Litigation (MDL No. 2846) is one of the most extensive medical device mass tort proceedings in the United States. The cases are centralized in the Southern District of Ohio, where tens of thousands of plaintiffs allege that polypropylene hernia mesh devices manufactured by Bard and Davol caused complications such as chronic pain, infection, adhesions, mesh erosion, and hernia recurrence.

The litigation has become a detailed study of how biomaterials science, surgical practice, engineering principles, and FDA regulatory processes interact in large-scale product liability disputes. It also illustrates how complex discovery, expert evaluations, and judicial oversight are needed to assess long-term device performance across thousands of patients.

Major Litigation Developments in the Bard Hernia Mesh MDL

2018 – MDL Formation and Initial Organization

In August 2018, the Judicial Panel on Multidistrict Litigation created MDL No. 2846 and transferred the proceedings to Judge Edmund A. Sargus Jr. Consolidation made it possible to manage shared issues involving mesh design, materials behavior, labeling, and reported complications in a consistent manner.

Early case management orders set the framework for document production, deposition schedules, expert disclosures, and preservation of devices. These steps helped ensure a uniform process for analyzing scientific and clinical evidence.

2021 – Plaintiff and Defense Expert Disclosures for First Bellwethers

As the first bellwether trial approached, plaintiffs and defendants submitted their major expert disclosures.

During this period:

• Plaintiffs disclosed Dr. David Kessler, M.D., former FDA Commissioner, as their regulatory expert evaluating Bard’s 510(k) clearances, testing practices, and postmarket reporting.
• Dr. Jimmy Mays, Ph.D., a polymer scientist, was retained by plaintiffs to assess polypropylene degradation, oxidation, and long-term material stability.
• Dr. Ahmed El Ghannam, Ph.D., a biomaterials specialist, provided analysis on tissue response and biocompatibility.
• Dr. David Grischkan, M.D., a surgeon, offered plaintiff-side clinical interpretation of operative findings and complication patterns.
• Dr. Zachary Gleit, M.D., was disclosed as a defense surgical expert addressing clinical safety, indications, and complication interpretations.
• Dr. Kevin Gillian, M.D., provided additional surgical and causation analysis for Bard.

2021 to 2023 – Bellwether Trials and Evidence Development

From 2021 to 2023, the MDL conducted three bellwether trials to test key liability and causation themes.

Johns v. C.R. Bard was tried in 2021 and resulted in a defense verdict. Milanesi v. C.R. Bard was tried in 2022 and produced a $255,000 plaintiff verdict. Stinson v. C.R. Bard followed in 2023 and resulted in a $500,000 plaintiff verdict.

These trials featured testimony from specialists who discussed how polypropylene performs inside the body and how design features may influence outcomes. The court’s Daubert rulings during this phase clarified the standards for expert admissibility and shaped later trial strategies.

2023 – Expansion of Case Volume and Administrative Requirements

By the end of 2023, more than 20,000 cases were pending in MDL 2846. As filings increased, the court issued additional directives on Plaintiff Fact Sheets, device identification, medical record collection, and expert disclosure procedures. The expanded requirements helped maintain consistent case development as the MDL grew in complexity.

October 2024 – Announcement of a Global Settlement

In October 2024, Becton Dickinson, the parent company of Bard and Davol, announced a global settlement intended to resolve approximately 38,000 hernia mesh claims across federal and state courts. This marked a significant transition from trial preparation to settlement administration.

The agreement came after years of scientific review, expert analysis, discovery, and court rulings addressing polymer behavior, mesh design, clinical complications, and the reliability of competing expert opinions.

2025 – Settlement Administration and Remaining Active Cases

Throughout 2025, the MDL continues to oversee settlement administration. Court orders now focus on claim verification standards, lien resolution procedures, and payments through the qualified settlement fund.

A subset of plaintiffs who declined settlement participation continue with individualized litigation. These cases involve targeted discovery or focused negotiations as the MDL approaches its final administrative stages.

Expert Witnesses in Polypropylene Hernia Mesh Medical Device Products Liability Litigation

1. Regulatory and FDA Compliance Expert Witness (Plaintiff) In this MDL, plaintiffs relied on regulatory specialists such as Dr. David Kessler, M.D., a former FDA Commissioner. His evaluations focused on premarket submissions, testing practices, product labeling, and postmarket reporting expectations.
2. Polymer Science and Materials Engineering Expert Witness (Plaintiff) Polymer scientists, including Dr. Jimmy Mays, Ph.D., evaluated oxidative degradation, polymer chemistry, and the long-term stability of polypropylene after implantation. Their work contributed to understanding how environmental conditions inside the body may affect mesh durability.
3. Biomaterials and Tissue Response Expert Witness (Plaintiff) Experts in biomaterials, such as Dr. Ahmed El Ghannam, Ph.D., examined how tissue interacts with polypropylene and how inflammatory processes may contribute to complications. Their analyses supported broader discussions about biocompatibility and degradation.
4. Hernia Surgery and Clinical Outcomes Expert Witness (Plaintiff) Plaintiffs also retained clinicians such as Dr. David Grischkan, M.D., who reviewed operative technique, postoperative findings, revision surgery indications, and patterns that may relate to mesh performance. Courts evaluated whether his methods supported his opinions under Rule 702.
5. Hernia Surgery and Clinical Outcomes Expert Witness (Defense) Defense teams engaged surgeons such as Dr. Zachary Gleit, M.D., and Dr. Kevin Gillian, M.D., who provided perspectives on device safety, accepted surgical practices, warnings in the Instructions for Use, and interpretations of adverse events. Their analyses were also examined through the MDL’s evidentiary rulings.
6. Medical Devices Expert Witness A medical device expert witness is a specialist in biomedical engineering, product safety, or FDA regulatory compliance who analyzes how medical devices are designed, manufactured, and used in clinical settings. In U.S. litigation, they help determine whether a device functioned properly, met industry standards, or contributed to a patient’s injury. Their testimony supports product liability, implant failure, and surgical equipment cases across federal and state courts nationwide.

Useful Information for Lawyers and Litigators

• Device Model Verification and Product Differences Accurately identifying the specific Bard mesh model used in each case is essential. Variations in pore size, coatings, fixation features, and intended surgical applications can influence biological response and complication patterns. Clear identification strengthens causation analysis.
• Importance of Comprehensive Medical Documentation Operative notes, imaging, symptom histories, and revision surgery records are key components of clinical evaluation. These materials help determine whether reported symptoms align with device behavior, patient-specific factors, or surgical conditions.
• Expert Evaluations as Core Evidence Because polypropylene mesh cases involve engineering, materials chemistry, surgical technique, and biocompatibility, expert evaluations play a central role in both plaintiff and defense strategies. Their assessments help explain how devices perform over time and whether alleged injuries align with known device characteristics.
• Understanding FDA 510(k) Regulatory Context Many Bard mesh products entered the market through the 510(k) process. Regulatory specialists help clarify how substantial equivalence, risk reporting, labeling requirements, and postmarket duties relate to the issues presented in each case.
• Influence of Bellwether Trials on Settlement Strategy The outcomes in Johns, Milanesi, and Stinson provide insight into how juries may weigh scientific disputes and competing expert opinions. The court’s Daubert rulings also set important precedent for evaluating expert reliability in remaining or future mesh cases.

Conclusion

The Davol and C.R. Bard hernia mesh litigation remains one of the most significant medical device mass torts in the United States. While the global settlement resolved many claims, the MDL continues to manage ongoing administration and remaining active cases.

This litigation underscores the importance of multidisciplinary expert review, complete medical documentation, and structured case management when evaluating implantable medical devices. As final stages proceed, the MDL continues to offer important guidance for attorneys handling large-scale product liability disputes.