Researchers failed in multiple efforts to prove 3M™ Bair Hugger™ system spread bacteria

Competitor who engineered lawsuits couldn’t prove his own theory

Newly discovered documents and testimony reveal that medical researchers bankrolled by 3M competitor Scott Augustine tried and failed in efforts to show that the Bair Hugger warming system increased the amount of bacteria around an operating table.

The blockbuster evidence once again confirms what 3M and its legal team have been arguing: There is no proof that the Bair Hugger warming system increases the risk of bacterial infection at surgical sites. But there is ample research showing that forced-air warming reduces the risk of surgical site infections.

The revelations are just the latest in the litigation involving 3M’s market-leading patient warming system. That litigation was spawned by Augustine, who recently testified that he helped engineer the first personal injury lawsuits against the Bair Hugger warming device.

As outlined in an earlier story here, Augustine, CEO of Augustine Medical, testified in a sworn statement to a Minnesota federal court, that he hired Houston law firm Kennedy Hodges LLP in July 2009, more than three years before the first lawsuits were filed against 3M. Augustine acknowledged that he wanted to find ways to generate personal-injury lawsuits against 3M and the Bair Hugger system.

“The purposes of the representation were multiple,’’ Augustine said in the court affidavit. “First, we wanted to learn about product liability litigation – how cases were analyzed, what evidence was required, etc…Second, we wanted to understand why personal injury firms virtually never filed cases on behalf of patients injured by surgical infections. Finally, we wanted to educate Kennedy Hodges about the research regarding the risks of forced-air warming, receive analysis and reactions from them, and understand their concerns and objections, if any.’’

Plaintiffs’ lawyers in those cases now are relying on a handful of studies by researchers connected to Augustine. Those studies suggest that forced-air warming technology may disturb air movement in the surgical field. They further suggest that such air movement may deliver more bacteria to the surgical area. (Augustine has repeated the fact that “hot air rises,’’ somehow suggesting that forced-air warming results in more surgical site infections.)

But the new evidence uncovered as part of the litigation shows that researchers funded by Augustine were unable to find higher levels of bacteria when the Bair Hugger system was in use. They even detached the hose from the Bair Hugger device and blew air directly onto bacterial plates and failed to find any bacteria.

Rather than attempt to publish their findings, the researchers shelved them.

In 2009, for example, researchers that included that Dr. Paul McGovern conducted a study at Wansbeck Hospital in England entitled “Do Forced-Air Warming Devices Increase Bacterial Contamination of Operative Field?’’

The researchers wrote that “It was hypothesized that turning on the Bair Hugger blanket would create warm air currents, that, despite the influence of laminar air flow, would contaminate the operating field with particles, possibly including pathogenic bacteria.’’

But the hypothesis turned out to be untrue. Among the written findings:

* “However, there is no suggestion from these results that turning on the Bair Hugger makes any difference to operative field particle counts under controlled conditions.’’

* “Settle plates, air sampling, wound sampling, and swabbing Bair Huggers showed there was only very low numbers of skin bacteria found within various areas of the operating theater during the operating procedure if correct procedures are carried out.’’

A surgeon involved in the study – who received £5,000 from Augustine to help conduct the study – wrote in an email after viewing the findings that the Bair Hugger system did not increase bacteria in the operating area: “Isn’t this surprising, and very valuable. I’m not sure whether it is reassured (I’ve been using them for years) or disappointed.’’

In another study, in 2011, a British researcher – also working alongside employees of Augustine Temperature Management – placed bacteria-gathering plates in a surgical area while the Bair Hugger device was on. Once again, the level of bacteria found on the plates was within acceptable ranges. (In deposition testimony, the researcher acknowledged that the bacteria plates were used routinely to measure bacteria levels in operating rooms.)

The researcher, Andrew Legg, said he decided not to include that information in the final results of his study. The final study also did not include any disclosure that Augustine provided equipment and personnel to assist in the study, including authoring the initial draft of the results.