The truth about the “science’’ behind claims against 3M™ Bair Hugger™ system: a look at Augustine connections to the research studies.

More than 1,700 medical patients have filed claims against the 3M Bair Hugger warming system. The lawsuits are part of a multi-district litigation that consolidates cases before one court in an effort to streamline the litigation.

All of the lawsuits are based on a bogus theory that the Bair Hugger system may have caused an infection during surgery. None of the lawsuits offer any conclusive proof that connects the Bair Hugger warming system with an infection. Instead, the plaintiffs’ lawyers rely on studies that suggest the Bair Hugger system disrupts air flow in the operating room and may cause bacteria to settle in a patient’s open wound.

Plaintiffs’ attorneys do not disclose, however, that every one of those studies is inextricably connected to a 3M competitor who not only invented the theory of air disruption, but also invented the Bair Hugger warming system itself. Nor do they disclose that the competitor – and the researchers he worked with – failed in multiple efforts to show the Bair Hugger system spreads bacteria.

That competitor, Scott Augustine, created and happily sold the Bair Hugger system for more than a decade before he was removed from his company while under investigation for Medicare fraud.

Then, after leaving the company, Augustine invented a competing warming product and set about trying to destroy the Bair Hugger system – all in an effort to increase sales of his competing product. The Bair Hugger system was subsequently acquired by 3M Co. in 2010.

Augustine created a “problem’’ with the Bair Hugger system, then helped create the research that attempts – but fails – to prove such a problem exists. Working with a Texas law firm, he helped develop the “research’’ to support the litigation now under way in Minnesota federal court.

Here are eight studies cited by plaintiff lawyers in the litigation against 3M, along with Augustine’s connection to each. Importantly, each of the studies notes that there is no proven link between the Bair Hugger system and surgical site infections.

As a result of the litigation, lawyers for 3M have discovered that researchers involved in at least two of the studies conducted experiments to see if the Bair Hugger system spreads bacteria in the surgical area. Their experiments showed that the Bair Hugger DID NOT spread bacteria, but the researchers never publicly disclosed those results.

Despite those facts, plaintiffs’ lawyers continue to pursue their cases against 3M.

These studies help form the foundation of the litigation by plaintiffs’ lawyers.

Study: Forced air warming, a source of airborne contamination in the operating room?

Authors: David Leaper, Robert Gauthier, Mark Albrecht

Publication: Orthopedic Review

Date: 2009

Augustine connection: Author Mark Albrecht was an employee of Augustine Temperature Management at the time of the study. David Leaper is a “consultant’’ paid £4,000 a month by Augustine. Leaper’s connection is not disclosed in the study.

Crucial caveat: “The present study did not evaluate the link between forced-air warming and surgical site infection rates.’’

Study: Forced-air warming blowers: An evaluation of filtration adequacy and airborne contamination emissions in the operating room.

Authors: Mark Albrecht, Robert L. Gauthier, Kumar Belani, Mark Litchy, David Leaper

Publication: American Journal of Infection Control

Date: 2011

Crucial caveat: “Our findings do not establish a direct link between forced-air warming and increased surgical site infection rates….’

Study: Forced-air warming and ultra-clean ventilation do not mix.

Authors: P.D. McGovern, M. Albrecht, Kumar Belani, C. Nachtsheim

Publication: Journal of Bone and Joint Surgery-British

Date: 2012

Augustine connection: Author Mark Albrecht was an employee of Augustine Temperature Management at the time of the study.

Crucial caveat: “This study does not establish a causal basis for this association.’’

Study: Effect of forced-air warming on the performance of operating-theatre laminar-flow ventilation.

Authors: K.B. Dasari, M. Albrecht, M. Harper

Publication: Anaesthesia

Date: 2012

Augustine connection: Augustine Temperature Management paid for the costs of the temperature mapping and loaned the Hot Dog warming blanket. Author Mark Albrecht was an employee of Augustine Temperature Management at the time of the study.

Crucial caveat: “Another limitation of our study is that the definitive effects of this excess heat on clinical outcomes is presently unknown.’’

Study: Do forced-air warming devices disrupt unidirectional downward airflow?

Authors: A.J. Legg, T. Cannon, A. J. Hamer

Publication: Journal of Bone and Joint Surgery-British

Date: 2012

Augustine connection: Legg had seen a video created by Augustine Temperature Management, which he decided to incorporate in his study. Augustine’s United Kingdom sales representative loaned Legg the equipment to conduct the test.

Crucial caveat: “Because of the nature of our experiment, we are unable to conclude that the use of the forced-air warming device…would actually lead to an increased risk of surgical site infection.’’

Study: Forced-air patient warming blankets disrupt unidirectional flow

Authors: A.J. Legg, A.J. Hammer

Publication: Journal of Bone and Joint Surgery

Date: March 2013

Augustine connection: Augustine employee Mark Albrecht conducted the experiment with Legg. Albrecht, who is not listed as an author, wrote an initial draft of the study. Augustine Temperature Management provided all of the equipment used in the experiment. None of this was disclosed.

Study: Maintaining intraoperative normothermia: A meta-analysis of outcomes with costs

Authors: Mike Reed, Oliver Kimberger, Paul McGovern, Mark Albrecht

Publication: American Association of Nurse Anesthetists

Date: 2013

Augustine connection: Mark Albrecht was under contract with Augustine Temperature Management to finalize and publish this study at the time of the study.

Crucial caveat: The study found a lack of correlation between blower-generated particles and internal levels of microbial colonization.

Study: Patient warming excess heat: the effects on orthopedic operating room ventilation performance

Authors: Kumar Belani, Mark Albrecht, Paul McGovern, Mike Reed, Christopher Nachtshelm

Publication: Anesthesia & Analgesia

Date: August 2013

Augustine connection: Mark Albrecht was under contract with Augustine Temperature Management to finalize and publish this study.

Crucial caveat: “Thus, we are unsure of the exact degree of ventilation disruption that might occur in a working OR during orthopedic surgery…future research is warranted to characterize the clinical conditions under which forced-air warming excess heat results in ventilation disruption during surgery.’’