Second jury affirms safety of 3M’s Bair Hugger™ technology

On Oct. 13, 2022, an Independence, Missouri, state court jury returned a verdict in favor of 3M in the second Bair Hugger trial. 3M has now successfully defended the 3M Bair Hugger™ warming system in the two cases that have gone before a jury. 

The jury, which heard evidence for two weeks, deliberated slightly more than two hours before deciding in favor of 3M.

The verdict affirms what the U.S. Food and Drug Administration and leading medical research organizations have been saying since the start of this litigation: forced-air warming does not increase the risk of surgical site infections. The Bair Hugger technology has benefitted more than 400 million patients and has been safely used globally during surgical procedures to improve post-surgical health outcomes.  

3M is encouraged that jurors continue to see past the faulty research and focus on the facts, which are:

• The U.S. Food and Drug Administration continues to recommend the use of patient-warming devices, including forced-air warming devices, for surgical procedures when clinically warranted.

• There is no reliable evidence that Bair Hugger causes or increases the risk of surgical site infections.

• Not one scientific study – not even the studies the plaintiffs’ lawyers rely upon to support these lawsuits – provides scientific evidence that the Bair Hugger system causes or contributes to surgical-site infections. In fact, the authors of those studies all explicitly acknowledge that their studies do not establish that the Bair Hugger system causes surgical site infections.

• Several studies recommend warming a patient before, during and after surgery, which has been shown to provide valuable benefits including reducing the risk of infections, reduced mortality, fewer post-operative heart attacks, reduced blood loss and faster recovery times.

This latest verdict follows a 2018 federal trial in Minnesota, at which the jury also returned a verdict completely in favor of 3M. The next trial is scheduled to begin in early December in Texas.

We are confident in our product and our case, and we look forward to continuing our successful defense in upcoming trials so that patients continue to receive the care they need.

Court of Appeals affirms jury verdict for 3M, reverses summary judgment in pending federal cases

On August 17, 2021, The Eighth Circuit Court of Appeals upheld a 2018 jury verdict in favor of 3M in Gareis – the only case involving the 3M™ Bair Hugger™ system that has gone to trial. As the Court of Appeals noted: “The jury returned a special verdict for 3M, finding that the Gareises failed to prove both that the Bair Hugger was defectively designed and that the Bair Hugger caused Louis Gareis’s PJI [periprosthetic joint infection].”

This ruling follows yesterday’s Court of Appeals’ procedural order reversing the Minnesota federal court’s dismissal of the other federal cases. In that ruling, the Court of Appeals acknowledged “weaknesses” in plaintiffs’ experts’ arguments, but held that it was wrong for the lower court to exclude them across-the-board under the Court’s permissive standard for admitting expert opinions. In Gareis, the jury heard the plaintiffs’ experts’ testimony and rejected it.

Scientific research supports the conclusion that the Bair Hugger system helps patients by maintaining normothermia, which is shown to provide valuable benefits, including reducing the risk of surgical site infections, reduced mortality, fewer post-operative heart attacks, reduced blood loss and faster recovery times. In 2017, the U.S. Food and Drug Administration sent a letter to health care providers recommending that they use patient warming devices for surgical procedures when clinically warranted. The FDA’s recommendation includes forced-air warming devices such as the Bair Hugger system.

The Bair Hugger warming system, which is used to warm patients before, during and after surgery, has been safely used more than 300 million times in the past 30 years. It continues to be used thousands of times each day in medical facilities worldwide.

3M lands major victory

Court dismisses all federal lawsuits against Bair Hugger system.

In an important win for 3M, a federal court on July 31 dismissed all of the federal lawsuits against the 3M™ Bair Hugger™ patient warming system, granting 3M’s motion that argued there is no scientific support for claims that the Bair Hugger system can cause infections. On August 1, 2019, 3M issued a press release regarding the victory.

The decision dismisses more than 5,000 lawsuits filed by plaintiffs’ attorneys from across the country. Those lawsuits were consolidated in a multidistrict litigation in federal court in Minnesota.

The federal decision also comes six months after the Minnesota Court of Appeals upheld a Minnesota state court order dismissing 61 similar cases filed by lawyers on behalf of Minnesota plaintiffs.

In its ruling, the federal court granted 3M’s request to exclude the plaintiffs’ general causation experts, leaving the plaintiffs with no scientific support for their claims.

The plaintiffs’ infection theory was invented by 3M competitor Augustine Temperature Management and its founder Dr. Scott Augustine. Dr. Augustine has waged a decade-long campaign to malign the Bair Hugger system as part of an effort to market his own competing product. Plaintiffs’ lawyers have spent millions of dollars on advertising to solicit patients who contracted infections during surgery.

In August 2017, the U.S. Food and Drug Administration sent a letter to health care providers stating that it continues to recommend the use of patient warming devices, including forced-air warming devices, for surgical procedures when clinically warranted.

The 3M Bair Hugger system, which is used to warm patients before, during and after surgery, has been safely used more than 300 million times in the past 30 years. It continues to be used thousands of times each day in medical facilities worldwide.

Bair Hugger System Litigation Update: Case Dismissals Continue

Here is the latest update on the status of the multi-district litigation involving the 3M™ Bair Hugger™ warming system.

Of the 14 bellwether cases selected thus far in this litigation:

• One case went to trial and 3M won.

• Nine have been withdrawn by plaintiffs before ever reaching trial.

• One was dismissed by a federal district court.

• Another was dismissed by a Minnesota state court.

• One was deselected and returned to the broader pool of cases.

• One has been postponed.

Some background: In multi-district litigation involving a large number of lawsuits, courts try “bellwether’’ cases, which are nominated by plaintiffs and defendants and supposed to be representative of the entire pool of lawsuits.

The idea is that courts will hold trials of the bellwether cases and the outcomes of those trials will help determine the fate of the larger pool of lawsuits.

To date, 14 lawsuits have been selected as bellwether cases. Of those, only one trial has occurred, one case was dismissed by a federal district court, one case was dismissed by a Minnesota state court, another case has been postponed, and ten cases either have been withdrawn or pulled from the pool.

Meanwhile, more than 590 lawsuits in the larger pool of cases have been dismissed, either by plaintiffs or by court order.

Bottom line: Five years into the litigation involving the Bair Hugger warming system, 3M has not lost a single case. Nor does it expect to.

Every one of the lawsuits is based on bad science orchestrated by a 3M competitor with a track record of misrepresenting facts and an actual conviction for fraud. There is no proof the Bair Hugger system causes infections.

In fact, in August 2017, the U.S. Food and Drug Administration recommended that healthcare providers continue using warming devices, including forced-air devices such as the Bair Hugger system, for surgery when clinically warranted. Fortunately, most medical providers have taken the time to understand the facts and thousands of patients each day are continuing to be warmed with the Bair Hugger system.

The case dismissals are not entirely surprising. In a 2015 paper, attorneys from law firm Skadden, Arps, Slate, Meagher & Flom noted that multi-district litigations tend to become magnets for lawsuits.

“Through aggressive advertising and highly sophisticated recruitment strategies, plaintiffs’ counsel have been able to use the existence of multidistrict proceedings to attract claims of dubious merit. And because multidistrict proceedings by design have tended to prioritize global issues over individual ones, plaintiffs’ counsel have successfully warehoused meritless claims and shielded them from judicial scrutiny in a way they never could have if all the cases were being tried individually.’’

As the bellwether record shows, the plaintiffs’ cases in this litigation have not survived scrutiny.

3M wins Minnesota state cases

State Supreme Court denies plaintiffs’ request to review rulings

3M scored another victory in the Bair Hugger litigation on March 27, 2019, when the Minnesota Supreme Court denied a request to reconsider the dismissal of 61 cases that improperly blamed the Bair Hugger patient warming system for surgical site infections.

The Supreme Court refused to hear an appeal from the decision of the Ramsey County District Court, affirmed by the Minnesota Court of Appeals, granting summary judgment to 3M in the 61 cases filed in the State of Minnesota. No reason was given for the denial.

The court’s decision effectively ends the Minnesota state court litigation for those plaintiffs who sued 3M in those cases.

The Supreme Court denial comes two months after the Minnesota Court of Appeals upheld the ruling from the Ramsey County District Court. In that decision, the appeals court noted that the trial court had reviewed documents which “clearly demonstrate that the relevant scientific community has not accepted the novel scientific opinion that [forced air warming devices] cause an increased risk of [surgical site infections].”

The court further concluded, “that there is no demonstrated causal relationship between [forced-air warming devices] and increased risk of [surgical-site infections.]

In its decision, the appeals court also detailed the role played in the litigation by 3M competitor, Scott Augustine. The court noted Augustine’s history involving the Bair Hugger system and his role in funding a medical study against the Bair Hugger system. The court also noted Augustine’s 2004 guilty plea to Medicare fraud and highlighted warnings from U.S. and German regulators for Augustine to stop making false claims related to patient warming.

The Supreme Court decision continues 3M’s record of victories in defending the safety of the industry-leading warming system.

In the only trial to date involving the Bair Hugger system and infection claims, a jury deliberated less than two hours before finding fully in 3M’s favor. Over 600 cases also have been dismissed, including most of the bellwether cases that have been selected as representative of the multidistrict litigation.

The federal court overseeing the litigation has postponed a trial that was scheduled for May for the only active bellwether case remaining, Trombley v. 3M. No other trials are pending.

3M wins appellate decision

Court upholds dismissal of 61 Minnesota cases

Ruling extends 3M’s string of victories in 3M™ Bair Hugger™ system litigation

3M won another significant legal victory on Jan. 14, 2019, when the Minnesota Court of Appeals upheld a lower court’s dismissal of 61 cases that inappropriately blamed the Bair Hugger patient warming system for surgical site infections.

The appeals court affirmed a decision by a Ramsey County District Court to grant summary judgment to 3M in all 61 cases filed in the state of Minnesota.

The appeals court noted that the lower court reviewed documents which “clearly demonstrate that the relevant scientific community has not accepted the novel scientific opinion that [forced air warming devices] cause an increased risk of [surgical site infections].”

The court further stated, “We … conclude that there is no demonstrated causal relationship between [forced-air warming devices] and increased risk of [surgical-site infections.]

The appeals court also affirmed the lower court’s decision preventing plaintiffs’ attorneys from seeking punitive damages, noting the lower court found that the plaintiffs’ arguments “lacked any support, much less clear and convincing evidence.’’

The decision affects 61 cases filed by plaintiffs in Minnesota. All of those cases are dismissed in 3M’s favor. The decision does not affect cases pending in federal court.

The appeals court also detailed the role played in the litigation by 3M competitor, Scott Augustine. The court noted Augustine’s history involving the Bair Hugger system and his role in funding a medical study against the Bair Hugger system. The court also noted Augustine’s 2004 guilty plea to Medicare fraud and highlighted warnings from U.S. and German regulators for Augustine to stop making false claims.

The appellate ruling continued 3M’s record of victories in defending the safety of the industry-leading warming system.

In the only trial to date involving the Bair Hugger system and infection claims, a jury deliberated less than two hours before finding fully in 3M’s favor. Nearly 600 cases also have been dismissed, including most of the cases selected as representative of the multidistrict litigation.

You can read the appeals court order here.

Federal court dismisses bellwether case

3M continued its string of victories in the litigation involving the 3M™ Bair Hugger™ warming system, when a federal district court dismissed a bellwether case, Axline v. 3M, on December 21.

As a result, plaintiffs’ attorneys now have withdrawn, or courts have dismissed, a total of ten bellwether cases, which initially were selected to be representative of the other cases in the multidistrict litigation (MDL).

Indeed, over the five years since Bair Hugger lawsuits were first filed, 3M has not lost a single case. More than 580 lawsuits brought against the Bair Hugger warming system have been dismissed so far. The only case to make it to trial resulted in a swift jury verdict for 3M.

Every one of these lawsuits is based on a campaign orchestrated by a 3M competitor with a track record of misrepresenting facts and an actual conviction for fraud. There is no proof the Bair Hugger system causes infections. In August 2017, the U.S. Food and Drug Administration recommended that healthcare providers continue using warming devices, including forced-air devices such as the Bair Hugger system, for surgery when clinically warranted.

The Bair Hugger system has been safely used more than 300 million times in the past 30 years and continues to be used on thousands of patients each day.

Two more bellwether cases dismissed by plaintiffs; case initially slated for December trial also to be dismissed

3M scored two more victories this week when plaintiffs’ attorneys dismissed two more bellwether cases in the multidistrict litigation involving the 3M™ Bair Hugger™ warming system.

The latest dismissals came on December 3, 2018, when plaintiffs’ lawyers voluntarily dropped Ruth and Douglas Goodpaster v. 3M and Terry Arnold v. 3M.

So far, plaintiffs’ attorneys have voluntarily dismissed eight bellwether cases, which were considered representative of the entire pool of cases. In the only bellwether case that has gone to trial, a jury deliberated less than two hours before finding in favor of 3M.

Also, a trial that was slated to begin on December 3 – the bellwether case of Nancy Axline v. 3M – has been removed from the court’s calendar after most of the plaintiff’s claims were dismissed by the court. That case has not been formally dismissed yet.

Overall, more than 550 lawsuits filed against the Bair Hugger warming system have been dismissed. No cases have been resolved in favor of a plaintiff.

3M contends that the entire litigation against the Bair Hugger warming system is based upon faulty science orchestrated by a 3M competitor, who has conspired with plaintiffs’ lawyers to attack the reputation of the market-leading warming system.

The Bair Hugger system has been safely used more than 300 million times in the past 30 years and continues to be used on thousands of patients each day.

Two more bellwether cases dismissed by plaintiffs

3M secured two more pivotal victories in the multidistrict litigation involving the 3M™ Bair Hugger™ warming system as plaintiffs’ attorneys dismissed another two bellwether cases.

The two dismissals now bring the number of bellwether cases dismissed by plaintiffs’ attorneys to six.

Lawyer Seth Webb of the law firm of Brown & Crouppen voluntarily dismissed David Henderson v. 3M and Julio & Maria Ramirez v. 3M on Oct. 30, 2018.

Both cases had been selected as bellwether cases – which are supposed to be representative of the pool of cases against the 3M Bair Hugger system.

Overall, more than 500 lawsuits against the Bair Hugger warming system have been resolved in 3M’s favor, including a jury verdict in the only case to go to trial.

500 Cases Dismissed - All in Favor of 3M

More than 500 lawsuits now have been dismissed - all in favor of 3M - in the litigation involving the 3M™ Bair Hugger™ warming system.

The large number of dismissals result from a variety of reasons:

• Plaintiffs are unable to substantiate their claims.

• Plaintiff’s attorneys have voluntarily dismissed cases, including bellwether cases they nominated for trial.

• The Bair Hugger system may not have been used during surgery.

• Plaintiffs did not comply with orders of the court.

Just one case filed in the past three years actually has made it to trial. On May 30, 2018, a federal jury deliberated for less than two hours in the first bellwether case involving the Bair Hugger system before reaching its verdict. The jury determined that the patient warming device is not defectively designed and did not cause the plaintiff’s infection.

Bellwether cases are selected to be representative of the entire pool of cases. Of the first six bellwether cases, four have been dismissed by plaintiffs’ attorneys, one was removed from the bellwether pool and the other resulted in the recent verdict. Another group of six bellwether cases were selected this year and, already, one has been dismissed.

Large numbers of lawsuits are an unfortunate characteristic of the multi-district litigation process, which is designed to streamline the legal process by concentrating multiple lawsuits on the same subject into one court.

In a 2015 report, the U.S. Chamber Institute for Legal Reform discussed the negative side effects of MDL practice.

“Through aggressive advertising and highly sophisticated client-recruitment strategies, plaintiffs’ counsel have been able to use the existence of multidistrict proceedings to attract claims of dubious merit. And because multidistrict proceedings by design have tended to prioritize global issues over individual ones, plaintiffs’ counsel have successfully warehoused claims and shielded them from judicial scrutiny in a way they never could if all the cases were being tried individually.

The litigation against the Bair Hugger system is emblematic of that issue. More than 5,000 cases have been filed, but none have been shown to have merit.

While 3M is sympathetic to patients who experience surgical site infections, there is absolutely no conclusive evidence that Bair Hugger warming therapy causes or increases the risk of surgical site infections.

In fact, the U.S. Food and Drug Administration and 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.