The 3M Bair Hugger forced air warming (FAW) blanket, a medical device used to warm patients during orthopedic surgeries, has been linked to an increased risk of MRSA, sepsis and deep joint infections.
Update: Bair Hugger MDL Court Orders 2 New Bellwether Trials
November 2, 2017 – The federal court overseeing MDL No. 2666 in Minnesota has ordered 2 knee replacement infection lawsuits to be prepared for bellwether trials, which are scheduled to begin in Sept. 2018. Case discovery for the complaints started on Sept. 26, and is expected to be completed by Dec. 8, according to an Order issued by the court on Thursday. Initial expert reports and disclosures are expected to be exchanged before the Thanksgiving break, with all rebuttals completed by December 15.
What is the Bair Hugger?
The Bair Hugger system uses forced, warm air to prevent and treat hypothermia in surgical patients. The device, which was created by Dr. Scott Augustine and approved by the U.S. Food & Drug Administration (FDA) in 1998, consists of a warming unit and disposable blanket that distributes warm air across the patient before, during and/or after surgery. Studies have shown that keeping a patient warm during surgery helps regulate their body temperature and prevents hypothermia, which results in less bleeding and faster recovery time.
What’s the Problem?
Even though he invented the device, Dr. Augustine now wants hospitals to stop using the Bair Hugger because it poses a danger to patients, according to The New York Times.
Specifically, Augustine asserts that his invention is a danger to patients receiving implant devices like artificial heart valves and joints because the forced air can spread bacteria associated with hospital-acquired infections. Heat generated by the Bair Hugger can redirect circulation in rooms where joint implant surgeries are performed, which can change air flow and bring airborne contaminants into contact with patients, according to Augustine.
“I am very proud of the old technology,” he said. “But I am also proud to spread the word that there is a problem.”
Manufacturer Accused of Hiding Problems with Bair Hugger
Augustine has also accused the company that sells the Bair Hugger, Arizant Healthcare Inc., of covering up problems with the device.
“The question for you to answer is the following; is Bair Hugger going to be replaced quickly and catastrophically by a mandatory recall, or do you survive a voluntary recall and live to fight another day?” Augustine wrote.
Arizant has filed a lawsuit against the inventor’s new company, Augustine Biomedical and Design, alleging that it distributed information that falsely disparages the Bair Hugger. Arizant was acquired by 3M for $810 million in Fall 2010.
Forced-Air Warming Studies
- October 2009 – Study titled “Forced-Air Warming: A Source of Contamination in the Operating Room?” finds that forced-air-warming (FAW) devices like the Bair Hugger have the potential to generate and mobilize airborne contamination in the operating room. The authors recommended that manufacturers should redesign their products to ensure compliance with mandates for internal decontamination, and warned clinicians that FAW blowers emit more than just hot air.
- November 2010 – Study published in the American Journal of Infection Control concludes that forced-air warming filters are inadequate to prevent airborne contamination emissions or protect the internal air path from microbial contamination buildup.
- May 2011 – Journal Bone and Joint Surgery study compares the effects of forced-air and conductive fabric on operating theatre ventilation during simulated hip replacement and lumbar spinal procedures. The authors found a significant increase in deep joint infections with FAW devices and recommended air-free warming for orthopedic procedures.
- March 2012 – Study in Anesthesia finds that forced-air warming generates convection current activity around the surgical site. The authors believe these currents may disrupt ventilation airflows intended to clear airborne contaminants from the surgical site.
- August 2013 – Article published in Anesthesia and Analgesia determined that warming devices like the Bair Hugger could present a potential risk for infection in prolonged vascular and hip surgery. The authors stated that forced-air warming “was found to establish convection currents that mobilized resident air from non-sterile areas (under the anesthesia drape) upward and into the surgical site.”
Bair Hugger Infections
Treatment to control and repair Bair Hugger infections may include:
- Insertion of antibiotic spacers into affected joint(s)
- IV antibiotic / physical therapy
- Revision / removal of implant
- Permanent Disability
3M Sued Over Bair Hugger Injuries
In 2013, a civil lawsuit was filed in the U.S. District Court, Southern District of Texas, on behalf of a 70-year-old man who allegedly developed a serious deep-joint infection following a surgery in which a Bair Hugger forced air warming blanket was used. Following the March 2011 procedure, the plaintiff required 15 additional surgeries, including one to remove his artificial hip due to the infection, according to the lawsuit.
The complaint alleges that the Bair Hugger pulled in contaminated air from under the surgical table, which then re-circulated into the hip replacement device that was being implanted. Defendants named in the complaint included 3M, Arizant, and a sales representative who works for 3M and Arizant. The lawsuit is: Case No. 4:13-cv-01164.
Another lawsuit currently pending in the U.S. District Court, District of Kansas, alleges that the Bair Hugger system caused a patient’s MRSA infection following knee replacement surgery. According to the complaint, the warming blanket allowed hot air to accumulate under the surgical drape and escape below the surgical table. The air allegedly created warm, rising airflow currents that transported bacteria from the floor into the surgical site. As a result of his MRSA infection, the plaintiff had to have his leg amputated. The lawsuit is: Case No. Case 2:14-cv-02044.
The Bair Hugger is not the only patient warming device to be linked to severe injuries. In October 2015, the FDA issued a warning about life-threatening Nontuberculous Mycobacteria (NTM) infections associated with heater-cooler systems used during open-heart surgery and other medical procedures. At least 6 patient deaths and dozens of microbial infections have been associated with the devices, according to CNN.
Bair Hugger Blanket Linked to Death of 6-Year-Old Boy
August 25, 2017 – Penn State Hershey Medical Center has been cited in the death of a 6-year-old boy whose temperature soared to 107 degrees while being covered with a Bair Hugger warming blanket. The hospital acknowledged that a review of his chart revealed his temperature had not been recorded once over a 10-hour period after he was admitted to the hospital for a low body temperature.
Joint Infection Lawsuits Selected for Bellwether Trials
April 21, 2017 – The court overseeing the federal Bair Hugger MDL is moving forward with plans to convene bellwether trials for joint infection lawsuits early next year. According to a Brief filed earlier this month, more than 30 such complaints have been nominated as potential bellwether trial candidates, all of which will be subject to limited case-specific discovery pending selection of a Final Bellwether Trial pool.
Bair Hugger MDL Tops 1300 Cases
March 17, 2017 – The federal multidistrict litigation (MDL NO. 2666) established in the U.S. District Court, District of Minnesota, for deep joint infection lawsuits involving the 3M Bair Hugger forced air warming system has grown to at least 1,343 cases, according to a report (PDF) issued Wednesday by the JPML. This number represents an increase of 140 filings since February 15, when the JPML reported 1,203 lawsuits pending in the MDL.
Woman Claims Bair Hugger Caused Burns
November 14, 2016 – A woman is suing Rush University Medical Center in Chicago, the 3M Company and Arizant Healthcare Inc., alleging that she was severely burned after undergoing surgery with a Bair Hugger warming blanket. Plaintiff Diane Shannon is seeking judgement against the defendants in excess of $50,000 plus court costs, claiming they failed to safeguard her care. The case is: Cook County Circuit Court Case number 16L010954.
Nearly 700 Lawsuits Consolidated in Bair Hugger MDL
September 27, 2016 – The Bair Hugger multidistrict litigation (MDL 15-2666) has grown significantly over the past month, with Arizant Healthcare and 3M now facing nearly 700 lawsuits alleging that they failed to warn about the risks associated with the device. According to an update by the U.S. Judicial Panel on Multidistrict Litigation (JPML), from August 15 to September 15, the MDL increased by 147 filings – bringing the current total to 693. It is likely the litigation will break 700 before the end of the month.
Illinois Couple Sues 3M, Arizant Over Bair Hugger Infection
May 9, 2016 – A man and woman from Illinois has filed a products liability lawsuit against 3M and Arizant over injuries allegedly caused by the Bair Hugger forced-air warming blanket. According to the lawsuit, plaintiff Jill Schlueter underwent knee replacement surgery with a Bair Hugger blanket on February 19, 2013. Schlueter subsequently developed an MRSA infection which she claims was caused by the device blowing airborne contaminants onto her open wound.
Veteran Alleges Leg Amputation from Bair Hugger Infection
March 29, 2016 – A veteran of the New Orleans Police Department and Vietnam War has filed a product liability lawsuit against 3M Co. and Arizant Healthcare alleging that a defect in the Bair Hugger blanket caused the amputation of his left leg. Plaintiff Lee Edward Peyton claims the Bair Hugger blew airborne bacteria onto his open knee wound, resulting in a severe MRSA infection in his left knee that required additional medical procedures to treat including 6 more surgeries, the removal of his knee joint, and ultimately the amputation of his left leg just below the hip.
Louisiana Man Sues 3M Over Bair Hugger Knee Infection
February 17, 2016 – A Louisiana man has filed a product liability lawsuit against 3M and Arizant Healthcare Inc. over a severe infection he allegedly developed after undergoing knee surgery with the Bair Hugger blanket. According to plaintiff Richard Smith, the infection was caused by a design defect in the Bair Hugger that caused bacteria to be blown into his surgical wound. Smith claims to have suffered permanent personal injury including reduced mobility, medical expenses, economic loss, emotional distress, loss of enjoyment of life and pain.
Conference Scheduled in Bair Hugger MDL
February 11, 2016 – An Initial Pretrial Conference has been scheduled for Thursday, Feb. 18 at 9:30 a.m. CST, according to a Pretrial Order (PDF) issued earlier this week. The Order further states that a number of issues may be addressed during the conference, including the structure of plaintiffs’ leadership and the status of state court proceedings.
Bair Hugger Lawsuits Consolidated in Minnesota
December 18, 2015 – About 70 federally-filed lawsuits alleging injuries from the Bair Hugger blanket have been centralized in a multidistrict litigation (MDL) before Judge Joan Ericksen in the U.S. District Court for the District of Minnesota. The complaints allege that the Bair Hugger disrupts air ventilation in the operation room, causing infections which have led to multiple surgeries and even amputation of affected limbs. The litigation is: In Re: Bair Hugger Forced Air Warming Products Liability Litigation; MDL No. 2666; Case MN/0:15-cv-03328.
Texan Says Knee Replacement Infection Led to Amputation
December 15, 2015 – A woman from Texas who allegedly suffered an infection which required the amputation of her leg after undergoing knee replacement surgery with a Bair Hugger warming blanket has filed a lawsuit against 3M and other defendants in the District Court of Harris County, Texas. In addition to suing 3M, plaintiff names as defendants Arizant Healthcare, the doctor who allegedly performed the knee replacement, and the medical center where the procedure took place. The lawsuit is: Ruth E. Childers v. 3M Company et al., case number 2015-73957.
Has There Been a Recall?
Despite being linked to severe infections and other adverse complications, the Bair Hugger has not been recalled and it does not appear that the FDA will remove the device from market anytime soon. However, you may still pursue a lawsuit against the manufacturers if you were injured. If our lawyers determine that you have a valid claim, compensation may be available to you to assist with medical expenses, lost wages, pain and suffering, and other damages.
Complaints filed against 3M allege the company:
- Knew about the risks associated with use of the Bair Hugger
- Failed to redesign the device to make it safer
- Neglected to warn doctors and patients about the potential for developing deep joint infections and other complications from using the Bair Hugger during hip and knee replacement surgery
- Attempted to hide and/or discredit any scientific data that found problems with the warming system