Over the last six years, lawsuits against 3M have been slowly making their way through the legal system and 3M has been rigorously defending their product, the Bair Hugger. The lawsuits claim that 3M’s patient warming system, the Bair Hugger, causes post-surgical infections. The judge tossed out the lawsuits because as 3M stated originally when the lawsuits were filed, the Bair Hugger is a perfectly safe for patients used them during a surgery.
The legal victory was announced on Thursday. In a statement released by 3M, the general manager of 3M Medical Solutions Business, Dr. Todd Fruchterman, says that this victory is a win for not only 3M but for patients, hospitals and doctors everywhere who use Bair Hugger. The benefits of using Bair Hugger on patients who have to undergo surgery are numerous and the lawsuits continue to prove Bair Hugger provides a critical component to an operating room.
The plaintiffs claimed in their lawsuits that the Bair Hugger could increase the risk of infection in a few different ways. One claim was that the blower could be colonized with bacteria and has the capabilities to blow bacteria in the air above a surgical wound. Another claim is that the blower can suck up bacteria particles from the floor and blow those particles over the surgical wound. The lawsuit also claimed that the Bair Hugger could disrupt the ceiling to floor airflow that is designed to remove skin particles from the operating room. U.S. District Judge Joan Erickson in Minneapolis ruled that none of the plaintiff’s experts could prove the above claims.
Dr. Fruchterman said in the statement, “There is no legitimate scientific support for the plaintiffs’ theory. We are pleased that the court has dismissed all of the cases in the multidistrict litigation. “ He concluded with, “Most importantly, we want physicians and patients to understand that the practice of patient warming is supported by leading health care institutions, professional societies and the U.S. Food and Drug Administration. Our industry-leading 3M Bair Hugger system has been proven to be a safe, effective and efficient method of delivering patient warming therapy.”
The Bair Hugger was invented by an anesthesiologist from Minnesota named Dr. Scott Augustine in 1987. He pioneered the idea of using a warming blanket to keep patients warm during a critical time during surgery. He invented the Bair Hugger as a means to warm a patient’s body before, during, and after surgery to help prevent perioperative hypothermia. During surgery, the body is not clothed and operating room temperatures are kept cold keep the staff comfortable during a stressful time. These two factors were known to cause hypothermia in patients. Other benefits of warming a patient during surgery include less bleeding and a fast recovery post surgery.
After the invention of the Bair Hugger, the device was used in hospitals all over the country. The Bair Hugger also made Dr. Augustine a lot of money. For decades, the device was used with no complaints or issues until Dr. Augustine had a very public falling out with the board of his company.
The company that sold the Bair Hugger warming device was Arizant Inc. and in 2002, he resigned as chairman and CEO. There as a disagreement and he decided to resign but the reason was never made clear. Shortly after, Dr. Augustine and Arizant settled in court over Medicare fraud concerning a different device that he had invented. In 20014, he pled guilty to a single misdemeanor charge stemming from the Medicare fraud investigation. He then sued Arizant claiming that they owed him the $2 million fine from the fraud charge and under a settlement he received $5 million. Arizant during this time was purchased by 3M. The product then became the 3M Bair Hugger.
Once the lawsuits were settled, Dr. Augustine did not stop there. He then rallied against 3M and the Bair Hugger, his old invention, claiming that his old invention was faulty. He said that the Bair Hugger poses a danger to surgical patients receiving implant devices such as heart valves and joints by spreading bacteria via the forced air. The bacteria can then potentially cause infections that have life threatening consequences.
All these claims sound very alarming but the one thing that Dr. Augustine did not have was proof of his claim. Also, his defamatory statements came a very coincidental time for Dr. Augustine. He had just launched a competitive product to the Bair Hugger and it was believed by individuals who were familiar with the technology that these statements were designed to drive interest to his new product.
He went so far as to speak out about the Bair Hugger and professional medical meetings and had studies underwritten on his behalf to try and prove that the Bair Hugger was responsible for spreading bacteria throughout the operating room. He put videos on his new website that suggested that his device was superior and safer than the Bair Hugger.
Professionals and specialist in the medical field found his claims to be unsubstantiated however, the legal community saw an opportunity. A false rumor spread that the Bair Hugger was responsible for post surgical infections and the lawsuits soon followed. However, these Bair Hugger lawsuits are proving to be built on baseless accusations. This dismissal is a huge win for 3M but there are still two similar cases pending that were filed in Texas and Missouri. This legal victory for 3M sets the tone for the rest of the lawsuits moving forward. Experts believe that these other lawsuits are also just as baseless and believe that they too will be dismissed.