Bair Hugger Litigation: MDL 2666 Status and Court Record

The Bair Hugger litigation is a group of federal product liability cases about forced-air patient warming devices and surgical site infections. The cases were consolidated in December 2015 as MDL 2666 in the U.S. District Court for the District of Minnesota before Judge Joan N. Ericksen. The Judicial Panel on Multidistrict Litigation counted 8,424 actions pending in the proceeding as of October 1, 2026, out of 10,828 filed over its life. A jury has rejected one plaintiff’s design-defect claim, the Eighth Circuit has reversed the MDL-wide summary judgment that once ended the litigation, and no court decision reviewed for this article has found that the device caused any patient’s infection.

What the device is

A Bair Hugger system warms a patient during surgery. The Eighth Circuit described a central heating unit, a hose and a disposable perforated blanket placed over the patient. The unit draws air through a filter, warms it, and blows it into the blanket, and the air leaves through perforations to keep the patient warm (Amador v. 3M, Aug. 16, 2021).

The FDA’s device database records a premarket notification for the Bair Hugger Patient Warming System, number K873745, cleared on November 6, 1987, with Augustine Medical as the applicant (FDA 510(k) record). A 510(k) clearance is a substantial-equivalence determination, not a finding that a device is safe in every use.

What is established vs. what is alleged

Established by the court record

• The consolidation exists. The JPML transfer order dated December 11, 2015 centralized 14 actions and noted 51 additional related federal actions. It assigned the proceeding to Judge Ericksen in Minnesota, where 3M and Arizant are headquartered (transfer order).
• The case count is published. The panel’s October 1, 2026 report lists 8,424 actions now pending and 10,828 total actions for MDL 2666 (JPML report).
• The district court once ended the MDL. In July 2019 the court excluded the plaintiffs’ general-causation medical experts and one engineering expert, then granted summary judgment for 3M on all claims and entered an MDL-wide final judgment (Amador).
• The Eighth Circuit reversed those rulings. On August 16, 2021 it reversed in full the exclusion of the general-causation experts, reversed in part the exclusion of the engineering expert, and reversed the summary judgment. It affirmed the challenged discovery and sealing decisions (Amador).
• One jury rejected a design-defect claim. In Gareis, the district court granted summary judgment for 3M on a failure-to-warn claim under South Carolina law, and a jury returned a verdict for 3M on the design-defect claim. The Eighth Circuit affirmed on August 17, 2021, noting the jury found the device was not unreasonably dangerous for its intended use, that no reasonable safer alternative design was proven, and that the infection would have occurred without the device (Gareis).
• The docket is still active. In October 2026, 3M moved to exclude testimony from Dr. Yoav Golan and moved for judgment on the pleadings in three cases; the court also issued orders in individual cases (MDL docket).

Alleged in the complaints

The transfer order summarized the plaintiffs’ theory as two alleged defects: the device “affects airflow in the operating room, causing bacteria from the operating room floor to be deposited into the surgical site,” and the internal airflow paths of the blower “can become contaminated with pathogens that can then be expelled into the operating room.” Plaintiffs alleged that they developed serious infections during orthopedic surgery because of those conditions (transfer order).

Those are allegations. The 2021 rulings addressed expert admissibility and summary judgment, not whether the device is defective or caused any infection.

Where the claims stand procedurally

MDL 2666 remains on the panel’s pending list. An MDL is not a trial and not a class action: it consolidates pretrial proceedings, mainly discovery and expert challenges, before one judge, while individual plaintiffs keep their own cases. The difference is explained in MDL versus class action.

After the 2021 reversal, the cases returned to pretrial litigation in Minnesota. The 2026 docket shows repeated defense motions to dismiss individual cases for failure to comply with pretrial orders or for failure to prosecute, including the eighteenth, nineteenth and twentieth such motions between August and September 2026, along with new expert and pleading motions in October.

The 8,424 figure is a docket count of actions not yet closed or remanded. It does not measure how many claims are being actively litigated or how many have merit. The same report lists 10,828 actions filed since 2015, so roughly 2,400 have been closed or otherwise removed from the pending count.

FDA recalls and the infection question

The FDA’s enforcement database contains Class II recalls for Bair Hugger components, but none reviewed for this article gives surgical site infection as the reason.

• Temperature sensors, 2017. 3M recalled 3,825 Model 360 sensors because a programming error could produce a readout lower than the patient’s actual temperature. The recall began October 17, 2017 and is listed as terminated (FDA report Z-0114-2018).
• Underbody blankets, 2018. 3M recalled Full Access Underbody Warming Blankets, models 63500 and 63700, because a design change could cause unintended airflow occlusion and partial inflation. The recall began January 23, 2018 and is listed as terminated (FDA report Z-0598-2018).

Neither reason mentions infection or operating-room airflow contamination. A recall record is not a finding that a device caused any injury.

Key dates

• November 6, 1987: The FDA clears K873745, the Bair Hugger Patient Warming System, for Augustine Medical.
• December 11, 2015: The JPML creates MDL 2666 and assigns it to Judge Ericksen.
• October 17, 2017 and January 23, 2018: 3M begins the sensor and blanket recalls.
• July 2019: The district court excludes the plaintiffs’ causation experts, grants summary judgment for 3M, and enters an MDL-wide final judgment.
• August 16 and 17, 2021: The Eighth Circuit reverses the expert exclusions and summary judgment in Amador, and affirms the defense verdict in Gareis.
• October 1, 2026: The JPML reports 8,424 actions pending and 10,828 filed.

What this does not establish

The record reviewed here contains no judicial finding that a Bair Hugger device caused any patient’s surgical site infection. One jury rejected that claim in Gareis, and the Eighth Circuit affirmed. The Amador reversal concerned expert admissibility and summary judgment, not a finding that the device is dangerous. The 510(k) clearance is a substantial-equivalence determination, not a safety finding for every patient. The recalls concern temperature readings and blanket inflation. The pending count does not show that any claim is strong or that payment is available. No global settlement or court-approved resolution of MDL 2666 appears in the documents reviewed.

Frequently asked questions

Is the Bair Hugger litigation a class action?

No. It is a multidistrict proceeding in which individual plaintiffs keep separate cases consolidated for pretrial purposes. See MDL versus class action.

Has a court found that Bair Hugger causes infection?

Not in the documents reviewed here. A jury found for 3M on the design-defect claim in Gareis, and no later decision cited here makes a contrary causation finding. The 2021 reversal reopened the remaining claims; it did not decide them.

Did the FDA recall Bair Hugger over infections?

The enforcement records reviewed list Class II recalls for temperature sensors and underbody blankets. Neither reason mentions infection.

Can new Bair Hugger cases still be filed?

MDL 2666 remains on the JPML’s pending list as of October 1, 2026, and the docket shows active pretrial proceedings. Whether a particular person can file depends on state law and the facts; statute of limitations rules for injury claims explains the general framework. This article does not evaluate anyone’s claim.

Sources

1. United States Judicial Panel on Multidistrict Litigation: “MDL Statistics Report - Distribution of Pending MDL Dockets by District” (link, accessed 2026-10-18)
2. United States Judicial Panel on Multidistrict Litigation: “Transfer Order, In re Bair Hugger Forced Air Warming Devices Products Liability Litigation, MDL No. 2666” (link, accessed 2026-10-18)
3. United States Court of Appeals for the Eighth Circuit: “Amador v. 3M Company, No. 19-2899 (8th Cir. Aug. 16, 2021)” (link, accessed 2026-10-18)
4. United States Court of Appeals for the Eighth Circuit: “Gareis v. 3M Company, No. 18-3553 (8th Cir. Aug. 17, 2021)” (link, accessed 2026-10-18)
5. Free Law Project, RECAP archive of the U.S. District Court for the District of Minnesota: “Docket, In re Bair Hugger Forced Air Warming Devices Products Liability Litigation, No. 0:15-md-02666 (D. Minn.)” (link, accessed 2026-10-18)
6. U.S. Food and Drug Administration: “510(k) Premarket Notification K873745, Bair Hugger Patient Warming System” (link, accessed 2026-10-18)
7. U.S. Food and Drug Administration: “Device Enforcement Report Z-0114-2018, Bair Hugger Temperature Monitoring System Sensors” (link, accessed 2026-10-18)
8. U.S. Food and Drug Administration: “Device Enforcement Report Z-0598-2018, Bair Hugger Full Access Underbody Warming Blanket” (link, accessed 2026-10-18)

CollectiveClaim.us publishes general legal information. This article is not legal advice and does not create an attorney–client relationship. Court records and agency actions change; verify current status with the court or agency before relying on it.