State Court grants summary judgment to 3M, dismissing 61 lawsuits

Ruling notes Scott Augustine role in litigation

3M won a major victory on January 8, 2018, when a state court granted summary judgment in the litigation involving the 3M™ Bair Hugger™ warming system.

The ruling dismisses 61 lawsuits that had been filed by Minnesota plaintiffs who claimed the warming device had caused their infections.

In its 19-page decision, the court said that “there is no generally accepted scientific evidence – and plaintiffs offer none – that the risk of infection associated with [forced air warming] is greater than that associated with patients who are not warmed during surgery.’’ In addition, the court said there is no scientific evidence that other warming devices have a lesser infection rate than forced-air warming devices.

The court pointedly noted the role played in the litigation by 3M competitor Scott Augustine, who has waged a decade-long campaign to malign the Bair Hugger warming system by claiming it increases the risk of infection. Augustine’s company makes a competing product, the HotDog warming system.

In the ruling, the court said: “As stated at the beginning of this memorandum, Scott Augustine blatantly and unapologetically threatened Defendants with negative ‘rhetoric’ and ‘studies’ with pre-determined findings to pursue a business advantage. Perhaps in response to those threats and the litigation that has followed, the FDA reaffirmed the generally accepted science regarding warming devices in its August 2017 letter to health care providers.”

While the ruling does not affect more than 4,000 lawsuits filed in Minnesota federal court, 3M said the decision should further calm any fears provoked by Augustine.

“This ruling affirms our position that there is no generally accepted science that the 3M™ Bair Hugger™ warming system causes infections,” 3M said.

Last month, the Minnesota federal court overseeing the multi-district litigation said it would allow plaintiffs to present their evidence at trial. 3M intends to show the serious flaws in the plaintiffs’ research during the trial.

The first bellwether case is set for trial in May 2018.

Both the state and federal courts last summer denied plaintiffs’ request to seek punitive damages in the bellwether trials, noting that plaintiffs failed to provide scientific proof that the Bair Hugger system causes surgical site infections and failed to show that 3M disregarded patient safety.

In the state court ruling, District Court Judge William H. Leary III detailed a history of bad behavior by Augustine, including a conviction for Medicare fraud and repeated warnings from regulators about his marketing tactics. Judge Leary also noted that Augustine worked closely with Kennedy Hodges, the law firm that filed the first complaints against the Bair Hugger system and remains on the executive committee of plaintiffs’ counsel.

You can read the full ruling here.

Third bellwether case dismissed; just two of initial six bellwether cases remain

Another bellwether case has been voluntarily dismissed from the 3M Bair Hugger multi-district litigation.

The law firm of Brown & Crouppen, which has aired more than 2,000 advertisements seeking patients who contracted surgical site infections, agreed to dismiss a lawsuit it filed on behalf of Kurtis and Debbie Skaar against 3M.

Brown & Crouppen, claimed that Mr. Skaar developed an infection in 2014 as a result of the use of the Bair Hugger patient warming system. They dismissed the case when it was revealed that the Bair Hugger device was not used in the surgery.

Of the initial six cases chosen for the final bellwether trial pool, just two remain. Three have been voluntarily dismissed from the overall litigation; and one was de-selected as a bellwether case.

More than 4,000 lawsuits have been filed as part of the multi-district litigation. The federal court agreed to hear six initial cases.

The voluntary dismissals of the three bellwether cases – which were initially selected as representative of the group of lawsuits – lend support to the reality that multi-district litigations often attract a significant number of lawsuits with dubious, even frivolous merits.

The first bellwether trial, Gareis v. 3M, is slated for April 2018 in Minnesota federal court. Gareis is a South Carolina man who claims to have contracted an infection during a total hip replacement in 2010.

False information behind Augustine study cited by plaintiffs in lawsuits

In a recent self-published study, 3M competitor Scott Augustine used data from a New York hospital to claim that the use of his conductive warming device resulted in fewer infections during joint surgeries than the use of the market-leading 3M™ Bair Hugger™ warming system.

But there is a critical flaw in Augustine’s study: the New York hospital has testified that it never used the Bair Hugger warming system.

The Clinical Chair of the Department of Anesthesiology at South Nassau Communities Hospital in New York testified in a sworn affidavit on Sept. 29, 2017, that his hospital actually was not part of any “study’’ and that he found “multiple errors’’ in Augustine’s paper, including the fact that the hospital didn’t use the Bair Hugger system.

South Nassau is one of three medical facilities cited by Augustine in a paper he paid to publish earlier this year in an Italian journal, Orthopedic Reviews.

The other two medical facilities also have provided information that significantly undermines the study’s credibility and Augustine’s claims. Ridgeview Medical Center of Minnesota stated that there is no data to support a direct correlation to Augustine’s device and the hospital’s reduced infection rates, contrary to Augustine’s claims. Ridgeview also publicly stated that it never authorized Augustine to use its data in any study. Like the data provided by South Nassau, the data provided by the other two facilities were selectively used in a way that flatly contradicted the stated protocol. The study creates the impression that there is a difference in infection rates and this is not supported by the totality of the data.

The latest revelations are yet another setback for plaintiffs’ attorneys in their campaign against 3M and the market-leading Bair Hugger system. A key expert used by plaintiffs’ lawyers has testified that he is relying on Augustine’s paper and its findings to support his beliefs.

In the South Nassau affidavit, the chairman of anesthesiology Jonathan Singer testified that Scott Augustine’s son Garrett asked for data in September 2014 on hip and knee replacement surgery at the hospital. Garrett Augustine was the sales representative for Augustine Temperature Management, maker of the HotDog warming blanket. Singer said he provided infection data on total hip surgeries from January 2013 to June 2014, but provided no data on knee surgeries. He said Garrett Augustine never asked if any changes were made to operating room practices or antibiotic use.

Among the multiple errors cited by Singer:

  • Augustine wrote that “Only hospitals reporting that no other significant changes were made to their surgical and antibiotic prophylaxis protocols during the study qualified to be part of the study.’’ But Singer said “South Nassau Communities Hospital was not aware nor did we knowingly participate in any ‘study’; we did not seek IRB approval before releasing the data as to our knowledge we were not participating in a study; we were not asked about any variables in practice that occurred during the dates in question and as stated above, multiple protocols were changed during the timeframe when data was provided to Mr. Garrett Augustine.’’
  • Singer noted that during the so-called study period, South Nassau Communities Hospital implemented multiple initiatives to decrease the rate of infection. They included:
    • Standardizing cleansing of a patient’s skin before surgery
    • Re-educating staff on proper draping practices
    • Humidity control in the operating room
    • Standardizing post-operative dress changes
    • New wound-care instructions.

Singer was never informed that Augustine intended to use the data for a study. “At no time did Mr. Garrett Augustine inform me that he was going to use the data provided in any article or written publication nor did he ask my permission to do so.’’

 

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.