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.

Two more plaintiffs drop lawsuits against 3M

Two more plaintiffs voluntarily dismissed their lawsuits against the 3M™ Bair Hugger™ patient warming system.

In recent months, attorneys for Lucy Acosta and Randall Cantrell withdrew all claims against 3M without prejudice.  

In her complaint filed in December 2015, Acosta had alleged that she contracted an infection during knee surgery in October 2013.  She originally claimed that it was caused by the Bair Hugger warming device. Her lawsuit cited several studies that have been promoted heavily by a 3M competitor – studies that have stated specifically that they have found no actual connection between the use of Bair Hugger devices and surgical site infections. Acosta was represented by attorney Michael Goetz of Morgan & Morgan in Tampa, Fla., and by Genevieve Zimmerman, Anthony Nemo, Jason Johnston and Ashleigh Raso of the law firm of Meshbesher & Spence in Minneapolis.

In a nearly identical complaint, Cantrell also had alleged that he suffered an infection in February 2011 during knee-replacement surgery. His complaint cited the same handful of studies mentioned by Acosta. Cantrell was represented by attorney Seth Sharrock Webb of the law firm of Brown and Crouppen in St. Louis Missouri.

A third complaint was dismissed this summer by an Illinois judge at the request of plaintiff Carol Wiltshire.

The dismissals come as leading health-care experts continue to advise hospitals to use forced-air warming devices such as the Bair Hugger system.

 Both ECRI Institute, a top medical research organization, and the Duke Infection Control Outreach Network, which advises hospitals on infection control, have recommended that hospitals use the devices. A large body of research indicates the use of patient warming can reduce the risk of surgical infection.

Duke weighs in: Keep using forced-air warming devices

The Duke Infection Control Outreach Network has notified hospitals that it recommends they keep using forced-air warming devices (such as the 3M™ Bair Hugger™ warming system) during surgeries.

You can read DICON’s review here.

In the strongly worded missive, DICON said the warming devices are “the only devices proven to decrease the risk of developing a post-operative infection.’’ It noted that forced-air warming (FAW) devices have a 20-year track record of safety in more than 200 million patients.

DICON issued its memo as a result of the misinformation campaign being waged by Augustine Medical, maker of the HotDog warming blanket. The HotDog uses a different technology, called resistive polymer warming (RPW.)

DICON noted that a few investigators “have speculated that use of FAW devices disrupts laminar flow thus potentially increasing the risk of contamination of the operative site. Most studies that reached these conclusions were funded by’’ Augustine Medical. Augustine’s most-cited study is McGovern, which DICON found to “have significant limitations.’’ McGovern, by the way, is one of the key studies cited by plaintiff attorneys in their lawsuits against Bair Hugger devices. The study even admits that it “does not establish a causal basis’’ for risks of surgical site infections and forced-air warming devices like the Bair Hugger system.

DICON summed it up succinctly:

Our take:
The body of evidence describing the link between FAW and increased operative site infections is weak. To the best of our knowledge, no adequately powered, properly controlled, statistically significant, reproducible study has been published that demonstrates an increased risk of SSI due to the use of FAW warming devices. We do not believe that experimental studies using machines that emit bubbles in mock surgical procedures is a proven or standardized method to assess the risk of operative site contamination. Finally, we believe it is important and notable that no studies performed by independent investigators have been published that confirm the findings of the study by McGovern et al. Until such data are published, we believe that it is reasonable and appropriate to continue the use of FAW warming devices in patients. Indeed, our data and that collected by the NHSN suggest that approximately 99% of patients undergoing joint replacement procedures do not develop a SSI despite the fact that FAW warming devices continue to be widely and appropriately used.

Conclusions:

• We continue to believe that it is reasonable and appropriate to use FAW warming devices to maintain normothermia as these devices are the only devices proven to decrease the risk of developing a post-operative infection.
• FAW warming devices have a >20-year track record of safety in >200 million surgical patients.
• FAW devices should be regularly undergo maintenance as outlined by manufacturer’s guidelines, see attached table for recommendations.
   

Lawsuit dismissed against 3M Bair Hugger device; case misstated facts

An Illinois judge has dismissed a lawsuit against 3M Company and its Bair Hugger surgical warming device.

Madison County Circuit Judge William A. Mudge on August 25 granted the request from Carol Wiltshire to dismiss her lawsuit.

She and her husband, Jeff Wiltshire, had sued 3M in November 2015, claiming an infection she contracted after knee surgery was the result of negligence on the part of 3M, St. Anthony’s Health Center in Alton, Ill., and her physician, Dr. Bruce Vest.

Wiltshire had a total knee replacement surgery on Nov. 11, 2013 at the hospital, according to the lawsuit filed by attorney John J. Hopkins. Wiltshire said she contracted an infection that necessitated multiple follow-up surgeries, and she blamed the Bair Hugger warming system for the infection.

The complaint wrongly claimed that the Bair Hugger device “was designed to circulate forced air around a patient’s surgical wound.’’ It also incorrectly claimed that the device circulated air “from the floor and other areas of contamination.’’

The Bair Hugger device is not designed to circulate forced air around a patient’s wound. It uses air forced through a warming blanket to keep patients warm; there is no air circulated around a wound. There is no evidence that the Bair Hugger system results in surgical site infections. In fact, clinical research studies indicate the use of patient warming actually reduces the risk of surgical site infection.

Don’t let a lawyer be your doctor

This video has a simple and sensible message. People should not depend on lawyers to diagnose medical conditions and causes – that’s better left to physicians and medical experts. We are sympathetic to patients who have experienced surgical site infections, but we’re not sympathetic when lawyers frighten patients with unsupported claims in the hope of getting a financial settlement. More than 200 million patients have been warmed successfully by 3M’s patient warming products and there is not a single confirmed incident of infection caused by the 3M™ Bair Hugger™ system. There is ample evidence that Bair Hugger warming therapy helps patients. Just ask a doctor.

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 an over-60-percent 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.

Science Day showcased safety and benefits of 3M™ Bair Hugger™ patient warming system

At 3M’s request, the federal court overseeing litigation involving the Bair Hugger Patient Warming System hosted a Science Day session on May 19, designed to allow the parties an early opportunity to educate the Court on their respective views of the science.  

At Science Day, 3M’s experts outlined the safety and benefits of the Bair Hugger’s system and pointed to the lack of any scientific proof that the device causes or increases the risk of surgical site infections.  As 3M explained to the jurists, the Bair Hugger system is the most scientifically tested patient warming device in the world, and no peer-reviewed clinical study has ever concluded that the Bair Hugger system causes or increases the risk of surgical site infections.

Lawyers for the plaintiffs did not present a single scientific study that supports their claims. In their lawsuits, plaintiff attorneys have relied on a handful of studies – promoted heavily by a competitor – that purport to show the Bair Hugger system disrupts airflow in the operating room and causes bacteria to enter the surgical site.

3M experts methodically dismantled the wobbly science of those studies and the claims against the Bair Hugger system. In addition, the judges were shown key passages from each of the plaintiff lawyers’ studies that specifically acknowledge that there is no proof the Bair Hugger causes surgical site infections.

In contrast, an overwhelming number of studies and leading medical organizations continue to recommend the Bair Hugger system because it can provide valuable benefits to surgical patients, including reduced blood loss, lower chances of infection, faster recovery times and a reduced risk of surgical site infections. ECRI, a widely respected nonprofit that assesses the quality and effectiveness of medical devices, reviewed more than 180 studies about patient warming and surgical site infections. ECRI concluded that there is insufficient evidence to establish that the use of forced air warming, like the Bair Hugger system, leads to an increase in surgical site infections compared to other warming methods. Based on its review, the ECRI Institute’s recommendation was not to discontinue the use of forced air warming during surgery.

Science Day was an off-the-record session intended to educate the court about the variety of issues related to the Bair Hugger system and its technology of forced-air warming.