Newly published papers find no evidence that 3M™ Bair Hugger™ system causes infections

Four new medical papers published this year debunk claims that forced-air warming systems cause surgical site infections.

The papers – all published in respected medical journals – reinforce the long-held contention by medical experts that the 3M™ Bair Hugger™ patient warming system does not lead to an increase in surgical site infections.

The Bair Hugger system has been used more than 200 million times in the past three decades and continues to be used thousands of times a day. Numerous scientific studies indicate that keeping patients warm before, during and after surgery can provide valuable benefits, including reduced risk of surgical site infections, fewer post-operative heart attacks, reduced blood loss and faster recovery times.

Plaintiffs’ lawyers are suing 3M, claiming that their clients developed infections during surgeries in which the Bair Hugger system was used. The lawyers cite a handful of studies that suggest the Bair Hugger systems’ use of warm air may disturb the airflow in the operating room.

Yet, no studies have ever found that the Bair Hugger system causes an increase in bacterial counts in the surgical area. Even the studies cited by plaintiffs’ lawyers acknowledge there is no proof that the Bair Hugger system leads to more bacteria.

The new papers further strengthen the existing science (and lack of a credible large-sample study), while bolstering 3M’s position that there is no merit to the claims of plaintiffs’ lawyers.  

Here is a synopsis of the papers:

• Airborne bacterial contamination during orthopedic surgery: A randomized controlled pilot trial. This study measured bacterial counts in six locations in the operating room, with a group of 80 different patients. The study found that “it was not possible to detect any higher bacterial counts on any plate in the forced-air warming group (the Bair Hugger system) versus the resistive warming group (the HotDog blanket).” Results of this well-designed study were published in the Journal of Clinical Anesthesia in February 2017. 
• Prevention of Periprosthetic Joint Infection: New Guidelines. This paper, published in the The Bone & Joint Journal in March 2017, discusses new guidelines from the World Health Organization and Center for Disease Control in preventing infections in total knee and hip replacement surgeries. On the issue of patient warming, the study notes: “Concerns regarding the use of air warming and the potential for contamination have been raised by a few authors although this has not been proven ... The guidelines agree on the importance of maintaining normothermia of the patient during surgery.’’  
• Forced-Air warmers and Surgical Site Infections in Patients Undergoing Knee or Hip Arthroplasty. This paper, published in January 2017 in the Annual Review of Nursing Research, reviewed the existing science. Its conclusion: “Current evidence does not support forced-air warmers causing surgical site infections in patients undergoing total knee or hip arthroplasty.’’ The paper called for more study of the alleged issues. 
• Normothermia in Arthroplasty. This comprehensive study was published in January 2017 the Journal of Arthroplasty. Its finding: “Based on the available evidence present at this point, there is no scientific proof that the use of forced-air warming leads to an increase in surgical site infections regardless of the type of surgical procedure and the type of operating room.’’

Don’t believe Augustine’s latest lies; 3M™ Bair Hugger™ system is safe

• You may have seen recent advertisements or emails from Augustine Temperature Management, a 3M competitor that has worked with plaintiffs’ lawyers to attack 3M and its health-care provider partners. The advertisement continues a pattern of attacks by Augustine Temperature Management on the 3M™ Bair Hugger™ warming system.
• It is important to understand that Augustine Temperature Management is the principal architect of the litigation against 3M and the Bair Hugger system. Augustine worked with key plaintiffs’ lawyers to develop the first lawsuits against 3M, drafted a litigation guide to assist lawyers in finding prospective clients and financially supported the research now relied upon by plaintiffs’ attorneys. 
• Every lawsuit filed to date relies on studies supported by Augustine, and every one of the Augustine-promoted studies acknowledges that there is no proof the Bair Hugger system causes infections.
• In short, you should not trust communications from Augustine. His activity regarding the 3M Bair Hugger system is not rooted in facts.
• The latest advertising/email blast quotes an “expert’’ named Dr. Yadin David, who is working for plaintiffs’ lawyers. Dr. David has not even been recognized by the federal court as being competent to serve as a witness, yet Augustine is trumpeting his “findings,’’ which simply reiterate the claims made in the handful of studies promoted by Augustine. It’s noteworthy that a federal court in 2013 excluded Dr. David from testifying as an expert in another case.
• Here are important facts to remember
• A large number of studies continue to recommend patient warming, which has been shown to provide valuable benefits to surgical patients, including reducing the risk of surgical site infections, reduced mortality, fewer post-operative heart attacks, reduced blood loss and faster recovery times. A compendium of studies can be found here.
• Evidence uncovered during this litigation shows that Augustine Temperature Management attempted several times to show that use of the Bair Hugger warming system resulted in a higher level of bacteria in the surgical area. NONE of those attempts were successful; in each instance, the Bair Hugger warming system DID NOT result in higher levels of bacteria.
• Testimony in the litigation also reveals that key researchers working with Augustine continue to use the Bair Hugger warming system in their facilities.  One of those key researchers, Dr. Michael Reed, said in deposition testimony that he stopped using the Hot Dog system in early 2016. He said “we had some difficulties with them beginning to bubble and sort of melt; ‘melt’ is an over-exaggeration, but they began to bubble along the seams and we were anxious that the patient was going to get injured. So we stopped using them, we pulled them.’’
• The Bair Hugger warming system has been used more than 200 million times in the past 30 years and continues to be used thousands of times each day. Relatively speaking, these lawsuits represent an infinitesimal fraction of the people who have been treated with Bair Hugger warming therapy.
• 3M is vigorously defending the Bair Hugger system in this litigation. While the company is sympathetic to patients who experience surgical site infections, there is no proof – nor any indication – that the Bair Hugger warming system caused these infections.
• We intend to prove that in court.
• The Bair Hugger system is a safe and effective method of keeping patients warm before, during and after surgery.  

Court rules in 3M’s favor on VitaHEAT issue

Forced-air warming and conductive blankets
are different products, court says

The court overseeing the lawsuits against the 3M™ Bair Hugger™ warming device ruled that plaintiffs’ lawyers are not entitled to documents about another warming system that 3M distributes because they are not relevant to the case.

Plaintiffs’ lawyers had argued that VitaHEAT’s UB3 patient warming system, for which 3M is the exclusive distributor, is a “safer alternative” to the Bair Hugger system. In response, 3M pointed out that the two are actually completely different products. The Bair Hugger system delivers warmed air to patients through a perforated blanket to keep them warm before, during and after surgery. The VitaHEAT® UB3 system does not use air; instead, it transfers heat directly to the patient through skin contact, in a process known as “conductive’’ warming.

The court’s ruling is a victory in 3M’s ongoing defense of the 3M Bair Hugger System, which, by maintaining a patient’s normal body temperature, helps reduce complications of surgery and improve surgical outcomes.

Plaintiffs’ lawyers had hoped to suggest that 3M’s agreement to distribute the UB3 system is a concession that the UB3 is a “safer alternative” to the Bair Hugger system.

But 3M argued, and Magistrate Judge Franklin L. Noel agreed, that the UB3 system does not represent an “alternative design” with features that could be incorporated into the Bair Hugger system, given its fundamentally different approach to patient warming.

“The UB3 is a substantially different product that employs a fundamentally different technology, and the Bair Hugger system could not incorporate the UB3’s technology without itself becoming a fundamentally different product than it is,’’ 3M argued in court papers.

Last year 3M signed an agreement to distribute the VitaHeat UB3 unit to complement its warming offerings with products that allow greater mobility – while patients are being moved to and from the OR, for example.

The plaintiffs’ lawyers had argued that their requests for VitaHEAT documents were relevant to their claims that an “economically and technologically feasible and safer alternative design existed for the Bair Hugger, including but not limited to airflow-free warming technologies….’’

But Magistrate Judge Noel wrote that the UB3 system and the Bair Hugger system are “fundamentally different types of technology’’ and are “substantially different products.’’

3M also argued that the disclosure of UB3 documents would benefit one of VitaHEAT’s principal competitors, Augustine Biomedical, maker of the Hot Dog conductive warming blanket. Augustine Biomedical, led by Dr. Scott Augustine, has helped generate the litigation against the Bair Hugger system.

In opposition to the motion, 3M lawyers wrote: “This Court is well aware of the ongoing collaborative relationship between the Kennedy Hodges firm – which issued the subpoena to VitaHEAT – and Dr. Augustine.’’

3M said it stands behind the safety and efficacy of its products, including the 3M Bair Hugger system, which has been used to safely warm more than 200 million patients over the past 30 years.

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.

3M competitor Scott Augustine admits role in manufacturing lawsuits against 3M™ Bair Hugger™ device

3M competitor Scott Augustine testified that he helped engineer the first personal injury lawsuits against the 3M™ Bair Hugger™ warming device.

Scott Augustine, CEO of Augustine Temperature Management, testified in a sworn statement to a Minnesota federal court, that he hired Houston law firm Kennedy Hodges LLP in July 2009, more than six 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.’’

The affidavit, filed in December, upholds 3M’s long-held contention that Augustine is the architect of the litigation against the Bair Hugger device. Kennedy Hodges filed the first and second lawsuits alleging that the Bair Hugger causes surgical site infections, and represent numerous plaintiffs in the current litigation.

Interestingly, Augustine’s retention of Kennedy Hodges occurred before the publication of any research suggesting that forced-air warming might increase the risk of surgical site infections.  That research, which forms the basis of the litigation against the Bair Hugger system, was funded, sponsored or connected in some way to Augustine. None of the key studies cited by plaintiff lawyers provide any verifiable link between infections and the Bair Hugger warming device.

3M – and dozens of scientific research studies – show that the Bair Hugger system is not only safe and effective, it also reduces the risks of surgical site infections.

In its court papers, 3M notes that Augustine “was the original inventor and developer of the Bair Hugger patient warming system. After being forced out of his own company, he pled guilty to Medicare fraud, developed a competing ‘HotDog’ warming system, and immediately began a prolific, sustained and often-concealed campaign to attack the Bair Hugger system. His systematic misinformation campaign about the Bair Hugger system causes and continues to drive this litigation.’’

Augustine invented the Bair Hugger system in 1987. In 2002, Augustine resigned from his position of Chief Executive Officer of Augustine Medical.  Not long after, Augustine pled guilty to Medicare fraud. 

In 2003, Augustine Medical, Inc. and Arizant Healthcare Inc. became wholly owned subsidiaries of Arizant, Inc., as part of a corporate reorganization.

In 2010, 3M acquired Arizant.

In the interim, Augustine set up his competing company and immediately launched a campaign to malign the Bair Hugger system. From 2010-2014, Augustine told 3M he would continue his campaign unless 3M either acquired his new company or acquired new patents related to the Bair Hugger system.

A federal judge overseeing the Bair Hugger litigation ordered Augustine to comply with 3M’s request for documents, which Augustine previously had failed to do. In its request to the court, 3M said “Augustine has failed to produce documents relating to his testing of the Bair Hugger system that found no evidence of the bacterial issues he claims, his involvement with other reports and studies attacking the Bair Hugger system, including supposedly ‘independent’ studies in which Augustine’s role was concealed...’’

Compendium outlines huge body of science supporting 3M™ Bair Hugger™ patient warming system

Guess how many scientific studies prove that the 3M™ Bair Hugger™ Patient Warming System can cause surgical site infections? Zero. None. Nada. 

Now, guess how many publications show proven benefits of patient warming? Dozens and dozens and dozens.

3M recently published an interactive compendium of scientific research conducted over the past 25+ years related to the Bair Hugger warming system.  It includes more than 200 publication summaries – the vast majority of which relate to research involving the Bair Hugger system – that demonstrate the safety and effectiveness of patient warming products, including the Bair Hugger system.

Fact: Clinical research studies show a significant REDUCTION in surgical site infections with the use of Bair Hugger therapy compared to no warming.

Fact: Clinical research studies show that the Bair Hugger system DOES NOT increase bacteria at the surgical site or in the air.

The claims against the Bair Hugger system are based on a handful of studies trumpeted by a 3M competitor.  Not one of those studies shows any proven link between the use of the Bair Hugger system and surgical site infections.  In fact, the studies specifically say they do not prove a causal link.

If you have any doubts about the safety of the Bair Hugger system, take some time to read the accompanying press release about the compendium. You can download the research compendium on the Resources page here.

Know the truth: the CDC, FDA and forced-air warming

Once again, a 3M competitor is bending the truth in an effort to incite more litigation and unease about the market-leading Bair Hugger patient warming device.

Augustine Temperature Management is claiming that the FDA and CDC have warned against allowing anything in an operating room that blows air, including the Bair Hugger device (goodbye, surgeons!). The FDA and CDC have had recent discussions about medical devices and surgical site infections, but those discussions have focused largely on heater-cooler units used in cardiac surgery. Neither the FDA nor the CDC have ever stated that the Bair Hugger system should not be allowed in operating rooms.

Augustine, who has been warned by the FDA about making spurious claims and who pled guilty to Medicare fraud, has made a series of claims in presentations and written materials, attempting to link the heater-cooler units to the Bair Hugger device.

These facts provide the truth:

• The Centers for Disease Control and FDA have not issued warnings about forced-air patient warming devices in operating rooms.
• The Bair Hugger warming system is safe and effective. Dozens of scientific studies show that forced-air warming devices effectively warm patients before, during and after surgery and can reduce the risk of surgical site infections.
• A 3M competitor has published erroneous claims that the CDC and FDA have warned people to avoid the use of forced-air warming devices such as the Bair Hugger. The CDC and FDA have done no such thing.
• This is not the first time that the competitor, Scott Augustine (CEO of Augustine Temperature Management), has made blatantly false claims.
• Augustine sells a competing product that is neither widely used nor accepted in the marketplace. Scott Augustine, has a history of making erroneous claims and has been warned by the FDA to stop doing so.
• Augustine has selectively highlighted phrases from CDC and FDA meetings and publications, with the intent of maligning forced-air warming devices.
• For example, he has highlighted a line from CDC discussion of heater-cooler devices that noted “nothing that blows air should blows air should be in an operating theater, if possible.’’ The discussion was focused entirely on Heater-Cooler Units, which have water tanks that have been identified as a source of a very rare water-borne infections in cardiothoracic surgery. Those units use a completely different technology than forced-air warming devices.
• In fact, an article in a CDC journal about airborne contaminants specifically noted that “there appears to be no definite link for surgical site infections’’ from forced-air warming devices.
• When an FDA official was asked whether the prohibitions on heater-cooler units would extend to forced-air devices, she responded that the issue was specific to heater-cooler devices. Of course, Augustine fails to note that fact in his materials.

Scott Augustine Strikes Again with False Claims

• A 3M competitor once again is spreading inaccurate and malicious information about the market-leading 3M™ Bair Hugger™ patient warming system.
• Scott Augustine, maker of the HotDog warming blanket, has sent emails to medical providers stating that 3M is doing a “silent recall’’ by “quietly replacing Bair Hugger with an alternative device.’’ The emails are from Orthopedic Infection Advisory and StopSurgicalInfections.org, shell organizations supported by Augustine Temperature Management.
• That is absolutely false. 3M is not replacing the Bair Hugger warming system. This is another attempt by Augustine to spread confusion and concern in the medical community.
• Augustine, who pled guilty to Medicare fraud in 2004, has waged a decade-long campaign to malign the Bair Hugger warming system, a device he invented and then lost control of when he was ousted from his company during the criminal investigation.
• Augustine has a history of such behavior. In 1992, a federal court ordered Augustine to stop disparaging a competing product. In 2009, a German court ordered Augustine to stop making false claims. In 2012, the FDA ordered Augustine to stop making false statements.
• In a sworn statement, Augustine recently said that, in 2009, he contacted the Kennedy Hodges law firm to encourage them to pursue litigation against the Bair Hugger System. Kennedy Hodges filed the first two lawsuits against the Bair Hugger System.
• The FDA is aware of Augustine and his activity regarding the Bair Hugger system. In fact, in the first week of December 2016, the Food and Drug Administration’s Minneapolis District conducted an inspection at 3M regarding the Bair Hugger warming system. That inspection was triggered by a complaint from Augustine about 3M not complying with medical device adverse event reporting regulations. 3M has been very transparent with the agency regarding Bair Hugger system litigation and 3M’s medical device adverse event reporting process. After visiting 3M and reviewing its processes and the scientific evidence that the Bair Hugger System does not cause or contribute to infection, the FDA affirmed that 3M is in compliance with regulations and found no deficiencies.
• The Bair Hugger warming system has been used more than 200 million times during the past 30 years. It is safe and effective.
• Do not be alarmed or misguided by Scott Augustine and his campaign of lies.

The Bair Hugger system includes blankets, warming units and accessories and has been used on more than 180 million patients in more than 80 percent of the hospitals in the United States.

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50 cases dismissed against 3M™ Bair Hugger™ system

Dozens of plaintiffs drop claims before key deadline

Dozens of plaintiffs are dropping their lawsuits against 3M™ and its Bair Hugger™ warming device in advance of a deadline that requires them to provide facts about their claims.

To date, 50 plaintiffs with claims in the federal MDL have voluntarily asked to dismiss their cases.

Throughout the prolonged smear campaign against its Bair Hugger system, 3M has been adamant that:

• There is no evidence linking the Bair Hugger device to surgical site infections.
• To the contrary, there is ample evidence that the Bair Hugger system reduces the risk of such infections.

The latest batch of dismissals came as plaintiffs and their attorneys faced a late December deadline to provide a host of facts about their claimed injury. The Minnesota federal court overseeing the multi-district litigation required plaintiffs with cases pending as of late September 2016 to complete a 22-page Plaintiff Fact Sheet by December 26. The fact sheet required plaintiffs to provide:

• Basic personal information
• Facts about their surgery
• General medical/health information
• Insurance coverage
• Any possible economic and other damages

Given the absence of any proof that the Bair Hugger device causes surgical site infections, it is not surprising that many plaintiffs and their lawyers decided to drop their cases.

None of the lawsuits against 3M provides any proof that the plaintiffs’ surgical site infections are connected to the Bair Hugger device. Instead, all of the lawsuits rely on the same six studies touted by a 3M competitor who has waged a misinformation campaign about the warming system.

Plaintiffs’ lawyers have embraced the claims of that competitor – Dr. Scott Augustine -- even though the authors of studies touted by Augustine all explicitly acknowledge that their studies do not establish that the Bair Hugger system causes surgical site infections.

That has not stopped plaintiffs lawyers from aggressively soliciting people who contracted infections after surgery, and convincing them that their infections may be linked to the Bair Hugger device.

The U.S. Centers for Disease Control notes that any surgery that causes a break in the skin can lead to a post-operative infection. About one of every 100 patients undergoing a joint arthroplasty, for example, develops an infection after surgery. The CDC also notes that the majority of surgical site infections come from bacteria in the patient’s own body.

Many factors are known to increase the risk of surgical site infections, including having other medical conditions such as diabetes, high blood pressure or heart disease, being elderly or overweight, and smoking.

3M is confident the science will show that there is no evidence the Bair Hugger warming device causes surgical site infections.

Doctor admits FDA complaint about 3M™ Bair Hugger™ system was authored by 3M competitor

An anesthesiologist who supposedly authored a complaint to the FDA about the 3M™ Bair Hugger™ warming system in 2010 acknowledged in a recent deposition that he didn’t write the report, nor did he file it with the FDA.

Under questioning, Dr. Robert Gauthier admitted that the letter he signed actually was written by executives of Augustine Temperature Management, a 3M competitor. Scott Augustine, the company’s founder, and its general counsel, Randy Benham, drafted the letter, Gauthier said.

“They wrote it, I edited it,’’ Gauthier testified. “I toned it down, if you will.’’

Augustine claimed that the FDA complaint was filed by Dr. Gauthier, an “independent anesthesiologist,” but Gauthier testified otherwise. Gauthier’s revelation is further proof of the smear campaign waged by Augustine. It’s also another piece of the mounting evidence showing Augustine’s involvement in the “science’’ underpinning the lawsuits against the Bair Hugger warming system.