3M warming system in hot water over allegedly causing joint infections: 5 takeaways

Written by Mackenzie Garrity | May 14, 2018 | Print  |

The Bair Hugger, 3M's warming system used at more than 80 percent of hospitals, is getting its day in court, according to the Star Tribune. The trial ruling has the potential to affect thousands of patients who suffered joint infections after surgeries involving the warming system.

Here are five takeaways.

1. 3M denies allegations its devices caused patients dating back to 2010 to develop infections. The company reiterates there is no scientific evidence the Bair Hugger causes infection by depositing bacteria-laden particles in a patient's surgical wound.

2. While the FDA has not been able to identify an association between the use of forced air and surgical site infection, the inventor of Bair Hugger, Scott Augustine, MD, said the device can cause infections. Dr. Augustine said he disclosed to 3M the device could cause infections before the company bought it for $810 million.

3. The plaintiffs argue their theory behind the cause of the infection is supported by scientific evidence. They argue because heat rises, the hot air in the blanket can cause particles and bacteria from the floor to rise, contaminating the surgical site and artificial implant.

4. This case going to trial is a bellwether case and is the first of more than 4,000 individual lawsuits against 3M. In an earlier case, the jury ruled there was not enough scientific and medical data that the device caused joint infections. This ruling threw out various allegations that accused 3M of intentionally causing harm.

5. Now only one allegation remains against 3M, strict liability for the defective design and manufacture of the Bair Hugger. The trial could last several weeks.

More articles on devices and implants:
36 orthopedic, spine devices receive FDA 510(k) clearance in April
3 things to know about Xenco Medical's SETx Technology
Globus Medical partners with the Society of Lateral Access Surgery: 3 notes

© Copyright ASC COMMUNICATIONS 2018. Interested in LINKING to or REPRINTING this content? View our policies here.

Top 40 Articles from the Past 6 Months