Bair Hugger Litigation Update and Resources

Bair Hugger®/3M (Forced-air Warming) Litigation Update

Editors note: this page is a resource for healthcare providers looking for information about the Multi-District mass-tort litigation (MDL 15-2666) against 3M, the manufacturer of Bair Hugger® forced-air patient warming systems, for allegedly causing devastating implant infections. All of the information shared on this page is publicly available. It can be accessed via the government’s Pacer system https://www.pacer.gov. It requires registration and small payments to access the records. In order to make it easier for you, we have assembled and summarized the information.

Over 2,000 lawsuits have been lodged against 3M (May 2017). General discovery has closed, and bellwether cases have been scheduled for trial in February 2018.

A series of reports from the plaintiffs’ experts recently became public. The experts analyzed existing data, 3M’s internal communications, and sworn deposition testimony of 3M employees and ex-employees. In some cases they have done their own original research.

Summary abstracts as well as the full reports are available below:

Hazard Analysis Report: Bair Hugger Patient Warming System

Expert Report of Yadin David, Ed.D., P.E., C.C.E.

Dr. David presently serves as Chairman of the Medical Device Good Manufacturing Practice Advisory Committee of the Food and Drug Administration (FDA). He serves on the FDA’s Medical Device Advisory Panel. He has been awarded the FDA Commissioner’s Special Citation.
Abstract PDF:
Full Report PDF:

 

Risk of Patient Safety Posed by Bair Hugger® Patient Warming System

Expert Report of Dr. William Jarvis

Dr. Jarvis worked in various leadership roles at the CDC in Atlanta, GA for 23 years, focusing on the investigation and prevention of infectious diseases. He received the CDC’s Lifetime Scientific Achievement Award. Currently he is the chairman of the Food and Drug Administration’s (FDA’s) General Hospital and Personal Use Committee.
Abstract PDF:
Full Report PDF:

 

Does Use of Bair Hugger® During Hip and Knee Joint Replacement Surgeries Increase Risk for Deep Joint Infections?

Expert Report of Jonathan M. Samet, MD, MS

Dr Jonathan M. Samet MD, a pulmonary physician and epidemiologist, is professor of Medicine at the University of Southern California and director, USC Institute for Global Health. He is chair of several committees of the National Academies of Science, Engineering and Medicine. Dr. Samet is chair of the Clean Air Scientific Advisory committee of the EPA.
Abstract PDF:
Full Report PDF:

 

Effect of Heated-Air Blanket on the Dispersion of Squames in an Operating Room

Expert Report of Said Elghobashi

Professor Elghobashi is an expert in highly sophisticated Computational Flow Dynamics (CFD) computer modeling. He is a distinguished professor of Mechanical and Aerospace Engineering at the University of California, Irvine.
Abstract PDF:
Full Report PDF:

 

Testing of Bair Hugger Warming Systems For Particle Emissions

Expert Report of Michael W. Buck

Michael W. Buck is an Environmental Health and Safety Compliance Specialist at the University of Minnesota.
Abstract PDF:
Full Report PDF:

 

Full Report PDF:

Plaintiffs’ MEMORANDUM OF LAW in support of motion for leave to amend master long form and short form complaints to add claim for punitive damages

 

 

Need to understand the plaintiffs’ position?
Click here to view an example of a full copy of a petition to the Court.

Downloadable PDF