Federal Court to Select Pool of Bellwether Cases in Bair Hugger MDL

bair-hugger-infectionUS District Judge Joan N. Ericksen said she will randomly select 150 cases for bellwether trials from the 809 actions filed in In Re: Bair Hugger Forced Air Warming Products Liability Litigation – MDL No. 2666 in Minnesota.

Pretrial Order No. 15, issued on November 16, states that the cases will be designated on Dec. 23 from those that were filed in, removed to, or transferred to MDL No. 15-2666 (JNE/FLN) on or before Dec. 19, 2016.

After the parties submit relevant characteristics or categories to be considered, they will each select 16 cases from the pool of 150 for consideration for bellwether trials. Cases can be drawn from those filed in Ramsey County, Minnesota state court.

Deep joint infections

Bellwether nominations must be made by Jan. 20, 2017. Between then are March 1, 2017 the parties may conduct case-specific discovery, including collecting records from third parties. By March 1 the court will select up to eight of the Bair Hugger lawsuits for the final trial pool, with the first trial commencing on Nov. 6.

The 3M Bair Hugger is used during surgical procedures to regulate a patient’s body temperature. During an operation, a portable heater/blower takes in and warms ambient air, which is then gently forced through a flexible plastic hose into a single-use, disposable blanket.

Plaintiffs include patients who developed hip and knee infections following joint replacement surgery that involved use of the forced air warmer system. They assert that the Bair Hugger has a design defect that may cause the surgical site to come into contact with bacteria and other contaminants from the operating room floor. They further charge that the 3M Company has been aware of this risk for years, yet failed to make design changes or issue any warnings to the medical community.

The Bair Hugger system was developed by Arizant Healthcare, Inc., which was acquired by the 3M Company in 2006. Since its introduction in 1987, the apparatus has been adopted as the standard surgical warming system in thousands of hospitals throughout the U.S.

For more information see Court Approves Bair Hugger Plaintiff Fact Sheet and Medical Form.

Read More

Pretrial Conference Set for 800+ Bair Hugger Product Liability Cases

bair-hugger-infectionUS District Judge Joan N. Ericksen set November 17 as the date for the Initial Pretrial Conference in Bair Hugger Forced Air Warming Devices Products Liability Litigation consolidated in MDL 2666 in Minneapolis.

Since the Judicial Panel on Multidistrict Litigation (“JPML”) created the multi-district litigation docket on December 11, 2015 in the District of Minnesota, the caseload has ballooned from 200 lawsuits to 809 today.

These cases involve the Bair Hugger Surgical Warming products, which are medical devices used to maintain patients’ normal body temperature and prevent hypothermia during surgery.

Increased risk of infection

Plaintiffs’ counsel argue that peer-reviewed medical literature in international journals such as the Journal of Bone & Joint Surgery reveal problems with forced-air warming devices in general, and demonstrate an increased risk of infection with the Bair Hugger device specifically. The plaintiffs allege they developed infections as a result of the use of the Bair Hugger products and allege causes of action relating to the product’s design, development, manufacture, testing, regulatory approval process, and marketing. Plaintiffs further allege 3M Company and Arizant Healthcare, Inc. have fraudulently and intentionally concealed knowledge about the dangers associated with

The plaintiffs allege they developed infections as a result of the use of the Bair Hugger products and allege causes of action relating to the product’s design, development, manufacture, testing, regulatory approval process, and marketing. Plaintiffs further allege 3M Company and Arizant Healthcare, Inc. have fraudulently and intentionally concealed knowledge about the dangers associated with

The plaintiffs allege they developed infections as a result of the use of the Bair Hugger products and allege causes of action relating to the product’s design, development, manufacture, testing, regulatory approval process, and marketing. Plaintiffs further allege 3M Company and Arizant Healthcare, Inc. have fraudulently and intentionally concealed knowledge about the dangers associated with use of these products.

Defendants contend that plaintiffs will never be able to prove that their surgical site infections were caused by the Bair Hugger warming system. Defendants contend that, in each of the studies upon which plaintiffs’ lawyers rely, the authors themselves explicitly acknowledge that their studies do not establish that the Bair Hugger warming system causes surgical site infections. Defendants further respond that, to the contrary, the body of peer-reviewed scientific literature proves that the Bair Hugger warming system is safe and effective in maintaining normal body temperature during surgery. Defendants assert that since the Bair Hugger warming system’s entry into the market more than 25 years ago, it has safely warmed more than 200 million surgical patients.

For more information see Court Approves Bair Hugger Plaintiff Fact Sheet and Medical Form.

Read More

700 Cases Filed in Bair Hugger Surgery Blanket Product Liability Litigation

bair-hugger-infectionThe US Judicial Panel on Multidistrict Litigation reported that 700 product liability lawsuits have been filed as of Sept. 15 in federal court in Minnesota against 3M Company involving its Bair Hugger forced-air warming blanket used in hip or knee surgery.

The docket is In Re: Bair Hugger Forced Air Warming Products Liability Litigation – MDL No. 2666. It was created in December 2015 when there were only 14 cases pending.

The actions share factual issues arising from allegations that plaintiffs developed serious infections during their orthopedic surgeries due to the introduction of contaminants into their open wounds as a result of the use of a Bair Hugger system.

The plaintiffs allege that the device is defective in two respects:

  1. The device affects airflow in the operating room, causing bacteria from the operating room floor to be deposited into the surgical site.
  2. The internal airflow paths of the device’s blower can become contaminated with pathogens that can then be expelled into the operating room.

Deep joint infection

The actions present common issues concerning the development, manufacture, testing, regulatory approval process, and marketing of the Bair Hugger blanket. The plaintiffs developed a deep joint infection after hip or knee implant surgery. 3M is accused of ignoring the flaw for years, and of failing to make design changes or provide appropriate safety warnings to the medical community.

The Bair Hugger surgical warming system was brought to market in 1987 by Arizant Healthcare, Inc., which was acquired by the 3M Company in 2008. For further information, see Study: Contamination Increased 2000x With Bair Hugger Warming Blanket.

In pretrial order No. 13 on Sept. 9 the court set out an amended scheduling order governing discovery, proposals for short form complaints and plaintiff fact sheets, and setting the first bellwether trial for November 6, 2017. The next status conference will be held on October 13, 2016. Starting in November 2016, the regularly scheduled status conferences shall be held on the third Thursday of each month.

Read More