Bair Hugger System

  • Bair Hugger System

The Bair Hugger system is a surgical warming blanket that treats, prevents, and monitors unintended hypothermia and its associated problems in surgical patients. It is marketed under the 3M Bair Hugger brand name. It was approved by the U.S Food and Drug Administration (FDA) in 1988 as the first surgical blanket that worked on a forced air system. The company offers 25 Bair Hugger blankets in various styles and sizes offering a warming tool for any surgical procedure.

It works on a system devised by Dr. Scott D. Augustine and consists of a portable heater/blower connected by a flexible hose to a blanket that blows warm air around the patient’s body to help maintain his body temperature during a surgery. Faster recovery time and less bleeding are a few of the benefits that have been revealed by a study performed in patients who were kept warm during a surgery.

Serious Alleged Injuries may include:

  • Bair Hugger Complications Potential treatments that may be needed to address the deep joint infections caused by a Bair Hugger hospital blanket warmers may include: Hospitalization Physical therapy Surgery Removal of implant Amputation of the affected lim

FDA Safety Warnings:

2017: Safety Alert

FDA Safety alert said: FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process. The letter said:  The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.

The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.

Legal Updates:

A number of MRSA lawsuits have been filed post Dr. Augustine’s warning about the MRSA infection and other acquired infections over the use of Bair Hugger blanket. Patients who developed infections after surgeries involving Bair Hugger temperature management systems filed ‘3M lawsuits’ claiming the device's manufacturer, 3M, was negligent as it failed to warn the doctors and patients of the Bair Hugger infection risk and misrepresented its products as safe to use.

Dr. Scott D. Augustine is, however, campaigning against his own discovery since his resignation as chairman and chief executive of Arizant Healthcare Inc., in 2002. He claims the Bair Hugger therapy can cause infectious bacteria to spread during an orthopedic surgery. During the procedure, air is also released under the surgical table at the same time. This released air under the table can cause germs and bacteria to spread throughout the room, landing on a patient's surgical incision site. Infections such as sepsis and Methicillin-resistant Staphylococcus aureus (MRSA) in the patient’s hip or knee can occur. Deep joint infections, adverse health complications, and other hospital-acquired infections have a higher probability of occurrence. Subsequent treatments become very difficult if they occur deep in the joints.

Centralization of the existing lawsuits against 3M Bair Hugger system took place in December 2015, in the federal court, Minnesota.

Multidistrict litigation 2666  (In Re: Bair Hugger Forced Air Warming Devices Products Liability Litigation, MDL No. 2666) was established with product liability Personal Injury cases filed, and additional cases are expected to be filed in or transferred to this Court.

January 2016, witnessed a filing of at least 112 individual 3M Lawsuits.

2018: At least 2,000 3M Bair Hugger lawsuits are pending in the U.S. District Court, District of Minnesota.

August 2019: 5000 Plus Bair Hugger Lawsuits Tossed: U.S. District Judge Joan Erickson of the District of Minnesota granted summary judgment against more than 5,000 lawsuits over 3M’s surgical warming blankets that sought to exclude the plaintiffs’ general causation experts.

Presiding Judges:

United States District Judge Joan N. Ericksen

Magistrate Judge Franklin L. Noel

The first Bair Hugger trial is scheduled for February 26, 2018.

Important Time-Lines

August 2019: 5000 Plus Bair Hugger Lawsuits Tossed: U.S. District Judge Joan Erickson of the District of Minnesota granted summary judgment against more than 5,000 lawsuits over 3M’s surgical warming blankets that sought to exclude the plaintiffs’ general causation experts. The lawsuits coordinated in the MDL alleged that the defendant’s forced-air warming system increased the risk of infection. Todd Fruchterman, General Manager of 3M Medical Solutions Business, stated that there is no legitimate scientific support for the plaintiffs’ theory. He also stated that they want physicians and patients to understand that the practice of patient warming is supported by leading health care institutions, professional societies, and the U.S. Food and Drug Administration.

In the first bellwether trial, the defendant won the verdict as a federal jury sided with them. After trial, the defendant filed a motion for the judge to reconsider a 2017 summary judgment. In the renewed motion filed on January 24, they cited newly released scientific research that refuted claims from plaintiffs’ attorney that Bair Hugger disrupted protective “forcefield” around patients during surgery, an idea that plaintiffs’ own expert called “absolute rubbish” and “silly” during the first bellwether trial.

December 2018: 3M managed to get two bellwether cases dismissed this December linked to lawsuits filed by patients who claimed they got severe infections due to the company's Bair Hugger warming system. So far, eight bellwether cases that were considered as representative of the entire pool of cases were dismissed voluntarily by plaintiffs' attorneys. The only bellwether case that went to trial was ruled in favor of 3M in less than two hours of deliberation. The first bellwether trial was dismissed in June 2018, and the appeal for a new trial was rejected in September 2018. On October 30, 2018, Lawyer Seth Webb voluntarily excluded two more cases, which were scheduled for December 3, 2018 - the bellwether case of another plaintiff was dropped from the court's list after most of her claims made were dismissed by the Minnesota federal court in September 2018. The case has not been formally dismissed yet.

Overall, more than 550 Bair Hugger lawsuits filed against 3M have been dismissed. The cases were dismissed based on a variety of reasons: plaintiffs failed to support their claims; voluntary dismissal by the plaintiff's attorney; no proven use of Bair Hugger system during surgery; plaintiffs failed to comply with the court orders.

June 2018: The two-week trial for 3M Bair Hugger System ended in favor of the defendant as the Minneapolis federal jury announced on May 30 that the plaintiff failed to provide adequate evidence to affirm the Bair Hugger System caused the surgical site infection. This was the first bellwether trial in a series of lawsuits lined up against the air warming blanket maker. The plaintiff from South Carolina suffered a deep joint infection in 2010 after he underwent a total right knee replacement surgery during which the 3M Bair Hugger warming blanket was used. In the allegation, the plaintiff states that the defective design of the warming blanket was the reason for him to undergo the antibiotic treatments, intravenous injections, and revision surgery for the removal of his knee implant. A second 3M Bair Hugger System trial is expected to be trial-ready by December 2018, involving claims by a couple of Idaho.

April 2018: Two 3M Bair Hugger System cases were selected for the upcoming trial to begin on or after April 30, on the basis that the plaintiffs involved allegedly suffered infections caused by 3M’s Bair Hugger warming blankets used during their total knee replacement surgeries. Claims made by both the cases are similar that defendants 3M Company and its Arizant Healthcare subsidiary sold a dangerous and defectively designed product that caused severe and debilitating deep joint infections. The selected cases were filed by a plaintiff from South Carolina and a couple from Idaho. In October 2017, Judge Joan N. Ericksen, presiding over the centralized litigation, MDL No: 2666, in the District of Minnesota, released an order for the case-specific discovery and disposition motions of these cases to be trial-ready by April 30, 2018. This month, Judge Ericksen denied a defense motion seeking to dismiss a design defect claim made by a plaintiff and also denied the defense request to exclude the plaintiff’s expert witness testimonies. The judge did grant the defense motion to dismiss the plaintiff’s failure to warn claims.

Evidence:

  • Anesthesia records of the surgery
  • Perioperative temperature management records
  • Surgical Care Improvement Project Data (SCIP)
  • Operative report to treat postoperative infections.

Medical Record Review and claim validation of Bair Hugger System case should take approximately 2 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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