Two more plaintiffs drop lawsuits against 3M

Two more plaintiffs voluntarily dismissed their lawsuits against the 3M™ Bair Hugger™ patient warming system.

In recent months, attorneys for Lucy Acosta and Randall Cantrell withdrew all claims against 3M without prejudice.  

In her complaint filed in December 2015, Acosta had alleged that she contracted an infection during knee surgery in October 2013.  She originally claimed that it was caused by the Bair Hugger warming device. Her lawsuit cited several studies that have been promoted heavily by a 3M competitor – studies that have stated specifically that they have found no actual connection between the use of Bair Hugger devices and surgical site infections. Acosta was represented by attorney Michael Goetz of Morgan & Morgan in Tampa, Fla., and by Genevieve Zimmerman, Anthony Nemo, Jason Johnston and Ashleigh Raso of the law firm of Meshbesher & Spence in Minneapolis.

In a nearly identical complaint, Cantrell also had alleged that he suffered an infection in February 2011 during knee-replacement surgery. His complaint cited the same handful of studies mentioned by Acosta. Cantrell was represented by attorney Seth Sharrock Webb of the law firm of Brown and Crouppen in St. Louis Missouri.

A third complaint was dismissed this summer by an Illinois judge at the request of plaintiff Carol Wiltshire.

The dismissals come as leading health-care experts continue to advise hospitals to use forced-air warming devices such as the Bair Hugger system.

 Both ECRI Institute, a top medical research organization, and the Duke Infection Control Outreach Network, which advises hospitals on infection control, have recommended that hospitals use the devices. A large body of research indicates the use of patient warming can reduce the risk of surgical infection.

Duke weighs in: Keep using forced-air warming devices

The Duke Infection Control Outreach Network has notified hospitals that it recommends they keep using forced-air warming devices (such as the 3M™ Bair Hugger™ warming system) during surgeries.

You can read DICON’s review here.

In the strongly worded missive, DICON said the warming devices are “the only devices proven to decrease the risk of developing a post-operative infection.’’ It noted that forced-air warming (FAW) devices have a 20-year track record of safety in more than 200 million patients.

DICON issued its memo as a result of the misinformation campaign being waged by Augustine Medical, maker of the HotDog warming blanket. The HotDog uses a different technology, called resistive polymer warming (RPW.)

DICON noted that a few investigators “have speculated that use of FAW devices disrupts laminar flow thus potentially increasing the risk of contamination of the operative site. Most studies that reached these conclusions were funded by’’ Augustine Medical. Augustine’s most-cited study is McGovern, which DICON found to “have significant limitations.’’ McGovern, by the way, is one of the key studies cited by plaintiff attorneys in their lawsuits against Bair Hugger devices. The study even admits that it “does not establish a causal basis’’ for risks of surgical site infections and forced-air warming devices like the Bair Hugger system.

DICON summed it up succinctly:

Our take:
The body of evidence describing the link between FAW and increased operative site infections is weak. To the best of our knowledge, no adequately powered, properly controlled, statistically significant, reproducible study has been published that demonstrates an increased risk of SSI due to the use of FAW warming devices. We do not believe that experimental studies using machines that emit bubbles in mock surgical procedures is a proven or standardized method to assess the risk of operative site contamination. Finally, we believe it is important and notable that no studies performed by independent investigators have been published that confirm the findings of the study by McGovern et al. Until such data are published, we believe that it is reasonable and appropriate to continue the use of FAW warming devices in patients. Indeed, our data and that collected by the NHSN suggest that approximately 99% of patients undergoing joint replacement procedures do not develop a SSI despite the fact that FAW warming devices continue to be widely and appropriately used.

Conclusions:

• We continue to believe that it is reasonable and appropriate to use FAW warming devices to maintain normothermia as these devices are the only devices proven to decrease the risk of developing a post-operative infection.
• FAW warming devices have a >20-year track record of safety in >200 million surgical patients.
• FAW devices should be regularly undergo maintenance as outlined by manufacturer’s guidelines, see attached table for recommendations.
   

Lawsuit dismissed against 3M Bair Hugger device; case misstated facts

An Illinois judge has dismissed a lawsuit against 3M Company and its Bair Hugger surgical warming device.

Madison County Circuit Judge William A. Mudge on August 25 granted the request from Carol Wiltshire to dismiss her lawsuit.

She and her husband, Jeff Wiltshire, had sued 3M in November 2015, claiming an infection she contracted after knee surgery was the result of negligence on the part of 3M, St. Anthony’s Health Center in Alton, Ill., and her physician, Dr. Bruce Vest.

Wiltshire had a total knee replacement surgery on Nov. 11, 2013 at the hospital, according to the lawsuit filed by attorney John J. Hopkins. Wiltshire said she contracted an infection that necessitated multiple follow-up surgeries, and she blamed the Bair Hugger warming system for the infection.

The complaint wrongly claimed that the Bair Hugger device “was designed to circulate forced air around a patient’s surgical wound.’’ It also incorrectly claimed that the device circulated air “from the floor and other areas of contamination.’’

The Bair Hugger device is not designed to circulate forced air around a patient’s wound. It uses air forced through a warming blanket to keep patients warm; there is no air circulated around a wound. There is no evidence that the Bair Hugger system results in surgical site infections. In fact, clinical research studies indicate the use of patient warming actually reduces the risk of surgical site infection.

Don’t let a lawyer be your doctor

This video has a simple and sensible message. People should not depend on lawyers to diagnose medical conditions and causes – that’s better left to physicians and medical experts. We are sympathetic to patients who have experienced surgical site infections, but we’re not sympathetic when lawyers frighten patients with unsupported claims in the hope of getting a financial settlement. More than 200 million patients have been warmed successfully by 3M’s patient warming products and there is not a single confirmed incident of infection caused by the 3M™ Bair Hugger™ system. There is ample evidence that Bair Hugger warming therapy helps patients. Just ask a doctor.

Compendium outlines huge body of science supporting 3M™ Bair Hugger™ patient warming system

Guess how many scientific studies prove that the 3M™ Bair Hugger™ Patient Warming System can cause surgical site infections? Zero. None. Nada. 

Now, guess how many publications show proven benefits of patient warming? Dozens and dozens and dozens.

3M recently published an interactive compendium of scientific research conducted over the past 25+ years related to the Bair Hugger warming system.  It includes more than 200 publication summaries – the vast majority of which relate to research involving the Bair Hugger system – that demonstrate the safety and effectiveness of patient warming products, including the Bair Hugger system.

Fact: Clinical research studies show an over-60-percent REDUCTION in surgical site infections with the use of Bair Hugger therapy compared to no warming.

Fact: Clinical research studies show that the Bair Hugger system DOES NOT increase bacteria at the surgical site or in the air.

The claims against the Bair Hugger system are based on a handful of studies trumpeted by a 3M competitor.  Not one of those studies shows any proven link between the use of the Bair Hugger system and surgical site infections.  In fact, the studies specifically say they do not prove a causal link.

If you have any doubts about the safety of the Bair Hugger system, take some time to read the accompanying press release about the compendium. You can download the research compendium on the Resources page here.

Science Day showcased safety and benefits of 3M™ Bair Hugger™ patient warming system

At 3M’s request, the federal court overseeing litigation involving the Bair Hugger Patient Warming System hosted a Science Day session on May 19, designed to allow the parties an early opportunity to educate the Court on their respective views of the science.  

At Science Day, 3M’s experts outlined the safety and benefits of the Bair Hugger’s system and pointed to the lack of any scientific proof that the device causes or increases the risk of surgical site infections.  As 3M explained to the jurists, the Bair Hugger system is the most scientifically tested patient warming device in the world, and no peer-reviewed clinical study has ever concluded that the Bair Hugger system causes or increases the risk of surgical site infections.

Lawyers for the plaintiffs did not present a single scientific study that supports their claims. In their lawsuits, plaintiff attorneys have relied on a handful of studies – promoted heavily by a competitor – that purport to show the Bair Hugger system disrupts airflow in the operating room and causes bacteria to enter the surgical site.

3M experts methodically dismantled the wobbly science of those studies and the claims against the Bair Hugger system. In addition, the judges were shown key passages from each of the plaintiff lawyers’ studies that specifically acknowledge that there is no proof the Bair Hugger causes surgical site infections.

In contrast, an overwhelming number of studies and leading medical organizations continue to recommend the Bair Hugger system because it can provide valuable benefits to surgical patients, including reduced blood loss, lower chances of infection, faster recovery times and a reduced risk of surgical site infections. ECRI, a widely respected nonprofit that assesses the quality and effectiveness of medical devices, reviewed more than 180 studies about patient warming and surgical site infections. ECRI concluded that there is insufficient evidence to establish that the use of forced air warming, like the Bair Hugger system, leads to an increase in surgical site infections compared to other warming methods. Based on its review, the ECRI Institute’s recommendation was not to discontinue the use of forced air warming during surgery.

Science Day was an off-the-record session intended to educate the court about the variety of issues related to the Bair Hugger system and its technology of forced-air warming.

Recent study rebuts airflow claims; 3M™ Bair Hugger™ Patient Warming System did not disrupt operating room airflow

It’s worth reading this November 2015 study and watching the accompanying videos, available here. They do a great job of explaining how airflow works in an operating room, and use science to show that the Bair Hugger Warming System did not disrupt clean operating room airflow and did not move air from the floor to the surgical site.

Operation Room Air Flow Study with 3M™  Bair Hugger™ Warming System in Simulated Hip Replacement Surgery
John P. Abraham, Ph. D., University of St. Thomas and Jennifer A. Wagner, Ph. D., Prism Environmental Health and Safety Solutions

The Bair Hugger Warming System provides a safe and effective way to maintain normal body temperature during surgery.  When used properly the Bair Hugger Warming System lowers the risk of hypothermia and improves patient recovery and surgery outcomes (i.e. reduces risk of surgical site infection, blood loss and transfusion requirement, prolonged recovery, and fatal heart attack).  A scientific research project was undertaken to assess whether the Bair Hugger System disturbed the clean-air flow in an operating room in the vicinity of a sterile surgical site.  The investigation showed that the Bair Hugger Warming System did not disrupt the normal airflow patterns of an operating room, and did not move air from the floor to the surgical site in a simulated hip replacement procedure.

The investigation had three separate components. One part of the investigation incorporated advanced mathematical calculations based upon the fundamental laws of physics to track the paths of airflow in the operating room. The calculations demonstrated that the air from the Bair Hugger System avoided the surgical site. The air flow that emerged from the Bair Hugger System traveled away from the surgical table and migrated toward the room exhaust vents along with the air beneath the operating table– not toward the surgical site.

A second part of the investigation involved experiments performed in an operating room with flow visualization studies that purposely injected visible fog into multiple locations in the room: 1) behind the anesthesia screen where the Bair Hugger air would exit near the patient’s head; 2) underneath the surgical table; and 3) next to the surgical table, near the surgical team, and near the surgical site. This investigation found that downward clean moving air from ceiling supply ducts in an operating room inhibited air from other sources from intruding into the surgical region. The downward flow of clean air worked irrespective of whether the Bair Hugger Warming System was used or not.

The third part of the investigation included a review of the scientific literature. The best scientific work did not show any causal link between the use of a Bair Hugger Warming System and surgical site infections. Even contrary research, which was largely funded by a competitive company, failed to show any causal link. More than 170 clinical studies have utilized the Bair Hugger system, and studies have demonstrated forced-air warming’s clinical effectiveness. Studies have demonstrated perioperative temperature management with forced-air warming actually reduces the risk of surgical site infections, surgical bleeding and risk of heart attack.

The findings of the three components of this investigation mutually reinforce one another. All of these studies showed that the Bair Hugger Warming System is safe when used according to manufacturer directions, providing an effective way to maintain patient temperature.

Outpatient Surgery : Answering questions about warming and lawsuits

Of all the questions surrounding patient warming, the most burning is this: Do forced-air warmers circulate contaminants that can cause wound infections, as a spate of recent lawsuits alleges? Read on as we tackle this and other hot topics surrounding your quest to maintain normothermia.

1. Does forced-air warming cause SSIs?
Of the many proven benefits of maintaining normothermia, perhaps the greatest is that it staves off surgical wound infections. But what if the very act of forced-air warming causes SSIs? 

You've no doubt heard the claims or seen the ads from law firms trolling for clients: Besides blowing hot air, forced-air warming units stir up the germs from the floor and cause them to go airborne. The jetstream of germs, the notion goes, rises alongside the table and settles over the surface of knee or hip implants in the sterile field. The germs can take root in the wounds and cause debilitating infections, especially in patients undergoing deep joint surgery. Not everyone is buying this (Bunch of) Hot Air Theory.

"Commercially driven junk science that has no basis in reality whatsoever," says an observer.

3M's lawyers say no reputable study has proven that forced-air warmers contaminate the air when they vent their waste heat. Just the opposite is true, they say. Decades of research and clinical experience show that using forced-air to maintain normal body temperature helps reduce the risk of infections and improves surgical outcomes.

"Forced air is highly effective, easy to use, inexpensive and remarkably safe," says anesthesiologist Daniel Sessler, MD, who has researched forced-air warming extensively as chair of the department of outcomes research at the Cleveland Clinic.

Continue reading here.

3M responds to website claims on 3M Bair Hugger warming system

Top Class Actions has invited 3M to respond to recent coverage of lawsuits filed against 3M regarding its Bair Hugger Surgical Warming System.

3M believes strongly that none of these cases have merit and is eager to prove that in court. There is no valid evidence that anyone has ever contracted a surgical site infection from the Bair Hugger system. Likewise, there is no scientific study that has demonstrated a causal link between the use of Bair Hugger therapy and an increase in surgical site infections. The recent Proceedings of the International Consensus Meeting on Periprosthetic Joint Infections determined that “no studies have shown an increase in SSI related to the use of” forced-air warming devices such as Bair Hugger.

There is, however, ample evidence that Bair Hugger warming therapy helps patients. Many clinical and quality studies have shown that maintaining normal body temperature during surgery reduces the risk of surgical-site infections. Patient warming is a recommended practice by leading health care institutions and professional societies – and the Bair Hugger system is a safe, effective and efficient method of doing so.

Continue reading here.