A 3M competitor once again is spreading inaccurate and malicious information about the market-leading 3M™ Bair Hugger™ patient warming system.
Scott Augustine, maker of the HotDog warming blanket, has sent emails to medical providers stating that 3M is doing a “silent recall’’ by “quietly replacing Bair Hugger with an alternative device.’’ The emails are from Orthopedic Infection Advisory and StopSurgicalInfections.org, shell organizations supported by Augustine Temperature Management.
That is absolutely false. 3M is not replacing the Bair Hugger warming system. This is another attempt by Augustine to spread confusion and concern in the medical community.
Augustine, who pled guilty to Medicare fraud in 2004, has waged a decade-long campaign to malign the Bair Hugger warming system, a device he invented and then lost control of when he was ousted from his company during the criminal investigation.
Augustine has a history of such behavior. In 1992, a federal court ordered Augustine to stop disparaging a competing product. In 2009, a German court ordered Augustine to stop making false claims. In 2012, the FDA ordered Augustine to stop making false statements.
In a sworn statement, Augustine recently said that, in 2009, he contacted the Kennedy Hodges law firm to encourage them to pursue litigation against the Bair Hugger System. Kennedy Hodges filed the first two lawsuits against the Bair Hugger System.
The FDA is aware of Augustine and his activity regarding the Bair Hugger system. In fact, in the first week of December 2016, the Food and Drug Administration’s Minneapolis District conducted an inspection at 3M regarding the Bair Hugger warming system. That inspection was triggered by a complaint from Augustine about 3M not complying with medical device adverse event reporting regulations. 3M has been very transparent with the agency regarding Bair Hugger system litigation and 3M’s medical device adverse event reporting process. After visiting 3M and reviewing its processes and the scientific evidence that the Bair Hugger System does not cause or contribute to infection, the FDA affirmed that 3M is in compliance with regulations and found no deficiencies.
The Bair Hugger warming system has been used more than 200 million times during the past 30 years. It is safe and effective.
Do not be alarmed or misguided by Scott Augustine and his campaign of lies.
