FDA: Keep using patient warming devices, including forced-air technology

The U.S. Food and Drug Administration today issued a letter reminding healthcare providers that it continues to recommend patients be warmed during surgery when clinically warranted.

The FDA specifically mentioned that its recommendation includes the continued use of forced-air warming devices. The 3M™ Bair Hugger™ warming system is the world’s leading forced-air warming product.

The FDA said it recently became aware that some providers and patients are foregoing the use of forced-air warming because of concerns about a possible increased risk of surgical site infections. Those concerns have been driven by a 3M competitor and a group of plaintiffs’ attorneys, who are promoting a theory that forced-air warming devices such as the Bair Hugger system lead to an increased risk of surgical site infections.

The FDA, which regulates medical devices, said it has thoroughly reviewed available data and “has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.”

You can read the letter here.

You can read an update from the Minneapolis Star Tribune here.

 

More than 100 lawsuits dismissed to date

Plaintiffs’ lawyers have spent millions of dollars soliticing patients who contracted infections during or after surgery, telling them that scientific evidence may suggest that their infections are related to patient warming.

In a sign of a rush to file lawsuits, more than 100 cases against the 3M™ Bair Hugger™ warming system already have been dismissed, with more expected in the coming months.

3M is vigorously challenging more than 3,300 lawsuits filed in the past 18 months, all of which rely on the same small group of studies promoted by a 3M competitor.  3M has argued in court documents that the science underlying the lawsuits is deeply flawed and has been largely generated by a 3M competitor.

Just last month, a federal court denied a motion by plaintiffs’ attorneys to allow them to add claims for punitive damages to key lawsuits in the case. The court said there was no proof that 3M disregarded the interests of patients, and it stated that the plaintiffs’ own studies failed to show that the Bair Hugger device causes infections.

The dismissals result from a variety of reasons:

  • The Bair Hugger system may not have even been used during surgery.
  • People are unwilling or unable to continue with their claims.
  • Plaintiffs failed to properly follow through on their claims.

The first trial in the Bair Hugger system multi-district litigation is set to begin Feb. 26, 2018.

 

Federal, state courts side with 3M on key damages motion

Courts deny plaintiffs’ request to add punitive damages; raise questions about science underpinning lawsuits

A federal court, as well as a Minnesota state court, have denied motions by plaintiffs’ attorneys to add claims for punitive damages to the bellwether trial pool cases and 56 cases pending in a Minnesota state court, a significant victory for 3M in its defense of the 3M™ Bair Hugger™ warming system.

Judges in the U.S. District Court for Minnesota and the Ramsey County District Court in St. Paul separately noted that plaintiffs failed to show scientific proof that the 3M Bair Hugger warming system causes surgical site infections or that 3M disregarded patient safety.

“Plaintiffs’ core contention is that the Bair Hugger system presents a high probability of injury to patients by causing surgical site infections,” the Ramsey County court wrote in its August 18 ruling. “But Plaintiffs present no evidence that any scientific study – including those studies relied upon by Plaintiffs and their experts – has ever concluded that the Bair Hugger patient warming system causes increased surgical site infections.”

In its earlier July 27 ruling, the federal court ordered attorneys for 3M and the plaintiffs to meet and propose a procedure to determine whether the federal decision in favor of 3M should apply to all of the cases in the multi-district litigation. For now, the decision only applies to the five bellwether cases that will serve as a litmus test for the overall litigation. The first of those trials is scheduled to begin in February 2018.

The court orders echoed arguments made by 3M: that the small number of research studies used by plaintiffs as the core of their cases shows no direct correlation between the Bair Hugger System and patient infections.

“Indeed,” the federal ruling noted “incorporating the studies relied on by reference in the pleadings, the Court observes that each study disclaims any direct correlation between the presence of bacteria and an increase in the risk of surgical site infections. There is no reasonable inference that could be drawn by a fact-finder that presence of bacteria in the device would result in an increased infection risk of the surgical site itself.”

The federal court concluded: “Plaintiffs have failed to plausibly allege on the face of their proposed pleading that Defendants acted with deliberate disregard for the rights and safety of others.”

In its comprehensive ruling, the state court noted the role played by 3M competitor Scott Augustine in the litigation. “Plaintiffs cite eight studies published between 2009 and 2013,” the court wrote. “Nearly all of these studies were either co-authored by an employee of Defendants’ competitor and longtime antagonist, Scott Augustine, and/or indicate that they were sponsored by Augustine. Even so, not one of these studies concludes that the Bair Hugger system causes surgical site infections.”

Bellwether case dismissed with prejudice

Plaintiffs drop case one month after court announced trial sequence

One of the six lawsuits selected to be bellwether cases in the 3M™ Bair Hugger™ system litigation already has been dismissed.

Attorneys for Jeffrey Knuteson asked the court to dismiss their case against 3M this month. Knuteson’s attorneys agreed to dismiss the case with prejudice, which means it cannot be refiled.

The dismissal came just one month after the federal court overseeing the litigation against 3M announced the sequence of bellwether trials. The trial involving Knuteson, a Wisconsin man who claimed to have developed an infection during a total hip arthroplasty, was slated to be the fourth bellwether trial. Knuteson is represented by Lockridge Grindal Nauen of Minneapolis, which filed the original lawsuit in April 2016.

The cases against the Bair Hugger warming system are consolidated in a multi-district litigation (MDL) proceeding in Minneapolis. In an MDL, the court decides to hear one or several cases that are emblematic of the entire pool. These are known as bellwether cases. The outcomes of these cases are used to help determine how to best resolve the remaining claims.

In the Bair Hugger system litigation, attorneys for the plaintiffs and 3M each selected 16 cases, which ultimately were narrowed down to six cases.

With the Knuteson dismissal, the court now has five cases slated as bellwether trials.

Those cases are:

  • Kamke
  • Nugier
  • Walker
  • Skaar
  • Gareis

The first trial is scheduled to begin in February 2018.

Ridgeview Medical Center: a case study in Augustine mistruths about forced-air warming

The story of Ridgeview Medical Center is a classic example of the misrepresentations that form the foundation for the lawsuits against the 3M™ Bair Hugger™ system.

3M competitor Scott Augustine – the architect of the lawsuits against the Bair Hugger system – claims that Ridgeview reduced its infection rates in knee surgeries by 81% after it switched from the Bair Hugger system to his HotDog™ blanket. Augustine has told this lie to a reporter for the Minneapolis Star Tribune, broadcast it in YouTube videos, and continues to share it in professional papers, presentations at medical conferences, in and not surprisingly – in his marketing materials.

But the truth is, Augustine’s claims are not true. In internal emails and emails to the Star Tribune, Ridgeview employees repeatedly stated that the reduced infection rate could not be connected to the switch to the HotDog blanket. When the Star Tribune called Ridgeview about Augustine’s claims, BJ Buckland, director of Emergency & Surgical Services at Ridgeview, fired off a response to the hospital’s marketing director, Lisa Steinbauer

“There is no supportive data that we have or that the Surgeons would support the Hot Dog as the connection to reduced infection rates,’’ he wrote. “Our rates are lower based on the work of a number of folks and a number of different initiatives. No direct correlation to that product and I have been very clear about it with them.’’

Ridgeview’s Chief Administrative Officer also told the Star Tribune “Ridgeview Medical Center has a reputation of surgical excellence attributed to many efforts beyond the use of the Augustine Medical Hot Dog Patient Warming System. We use the Hot Dog product and are satisfied with its performance; however, there is no data to support a direct correlation to that product and our reduced infection rates.’’

Ridgeview’s data tells the same story. The hospital’s knee infection rates fell before it switched to the HotDog blanket in 2008.

The final version of the Star Tribune story is here.

You can read the Ridgeview email exchange in this court exhibit.

The hospital made it very clear: there was no data to support a direct correlation to Augustine’s product and reduced infection rates. But Scott Augustine deliberately led a newspaper reporter to believe that the hospital’s infection rate dropped as result of the HotDog blanket.

This was just one of many, many misstatements by Scott Augustine and his employees in the past decade. Don’t be fooled when he says this is about patient safety; it’s all about his business.

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 teamed up with a small group of 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
  • An overwhelming number of studies and medical organizations – after having reviewed the entire body of science on this issue – continue to recommend the Bair Hugger system because, by maintaining normal body temperature, it provides valuable benefits to surgical patients, including reduced risk of surgical site infections, reduced mortality, fewer post-operative heart attacks, reduced blood loss and faster recovery times for patients.
  • 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 bacteriaa

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...’’