The federal multidistrict litigation pending before Judge Joan Ericksen in the United States District Court, District of Minnesota, for deep joint infection lawsuits involving the 3M Company’s Bair Hugger forced air warming system, continues to grow. According to a recent report issued by the United States Judicial Panel on Multidistrict Litigation (JPML), 1,343 claims are now pending in the proceeding. That represents an increase of 140 filings since February 15th, when the JPML reported 1,203 pending lawsuits (In Re: Bair Hugger Forced Air Warming Products Liability Litigation – MDL No. 2666).
On November 16, a widely anticipated Order issued in the US District Court, District of Minnesota, spelled out the latest template for the first bellwether trials expected next year, with the first Bair Hugger bellwether trial scheduled to begin November 6, 2017, which is designed to help the parties gauge the relative strengths and weaknesses of the claims, and gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.
Given the need to keep surgical theatres cool to aid in reducing the spread of bacteria and to contribute to the alertness of surgical staff, it has been determined that warming the patient during surgery aids in healing and promotes blood flow. The Bair Hugger was developed and first introduced in 1987 as a way to warm a patient’s body during surgery. The Bair Hugger, which transfers warmed ambient air from a unit on the floor through a conduit of forced air to a disposable warming blanket draped over the patient during surgery, has since been adopted by thousands of hospitals in the United States and Canada and is considered standard procedure for long surgeries. Originally manufactured and marketed by Arizant Healthcare Inc., the 3M Bair Hugger is now in the 3M stable of products after the latter acquired Arizant in 2006, and has generated over $31 billion in sales. In recent years, the Bair Hugger blanket has been used in more than 80% of all hip replacement surgical procedures, with more than 50,000 of the devices in hospitals throughout the United States.
Plaintiffs’ primary allegation is that Arizant knew or should have known that the design may cause bacteria, pathogens and other contaminants lingering at the floor level is transferred up to the patient with the warm air and risks infection, specifically at the surgical site, including deep joint infection. Various lawsuits assert that the risk of infection is worse for joint replacement procedures, such as for hips and knees. Research has also suggested that the device is linked to higher rates of hip sepsis, MRSA or other infections.
Common symptoms of infections following surgery with a 3M Bair Hugger may include:
- Warmth and Redness at Surgical Site
- Wound Drainage
- Fever and Chills
Particularly with regard to infections stemming from hip implant surgery (arthroplasty), there are several treatment options for infection:
- Two-Stage Hip Replacement Revision Surgery: The most frequently recommended joint replacement infection treatment involves removing the original implant, as well as the infected tissue and bone in a process known as debridement or irrigation. Then antibiotic-coated devices known as spacers are placed in the cavities where the tissue and hip implants were removed. Oral or intravenous antibiotics are also often employed. The spacers are left in for six to twelve weeks, leaving no hip joint and thereby resulting in a considerable loss of mobility. Once the infection is gone, the new implant is installed. This procedure has the highest success rate, but also comes with a high risk of hip infection complications, including spacer dislocation, spacers which may not contain the correct antibiotic to treat the infection, temporary loss of mobility, and, in rare cases, a risk of allergic reactions and acute renal failure.
- One-Stage Hip Replacement Revision Surgery: This technique involves having the implant removed, the infected flesh and bone debrided, and the new implant replaced in one operation. The new hip implant usually involves the use of antibiotic cement to hold the new implant in place and to prevent future infection. It is less expensive than two-stage revision and has a faster recovery time, but there is a higher risk of recurring hip joint infections. As with two-stage revision surgery, additional hospitalization, skin grafts, blood transfusions and extended home healthcare are generally required.
- Debridement/Irrigation and Hip Implant Retention: In some cases, it is necessary to leave the original implant in place. In these cases, usually used when infections are caught in their earliest stages, the infected tissue is debrided and the patient is given a long course of antibiotics. In some cases the patient takes oral or receives intravenous antibiotics for as little as six weeks, but in many cases the patient may have to take antibiotics for life. While this procedure has the fastest recovery time regarding the use of the hip, the patient may have to take harsh antibiotics for a long period of time, increasing the risk of antibiotic drug side effects. In addition, results can vary significantly.
- Suppressive Antibiotics: This is rarely used and simply involves the use of suppressive antibiotics to treat the infection. It requires long use of antibiotics and there is little data on the success rate for a hip replacement infection. The most commonly associated type of infection with hip replacement surgery is staphylococcus aureus. About 42% of infected hip replacements involve staph infections. In about 8% of cases, the infection is due to methicillin-resistant staphylococcus aureus, an antibiotic-resistant staph infection that is much more difficult to treat. The presence of staph infections increases the risk that the treatment to remove the infection will fail, according to some studies.
Amid continuing concerns about the risk of hip and knee infections from the Bair Hugger forced-air warming system, 3M Company has refuted claims that it issued a “silent” recall for the Bair Hugger replacing the forced-air warming system with an alternative product, and continues to stand behind the safety of its product. 3M indicates that its competitor, Augustine Temperature Management, sent out mass e-mails about a “silent recall of Bair Hugger” through its OrthopedicinfectionAdvisory.org website, suggesting that the false claims were made to “incite more litigation and unease” about Bair Hugger. “Augustine sells a competing product that is not widely used nor accepted in the marketplace,” according to 3M’s statement. “The company’s founder, Scott Augustine, has pursued a deliberate business strategy of disparaging and instigating litigation against the 3M Bair Hugger system in an attempt to promote his own competing product. He has a history of making false and misleading claims and has been warned by the FDA to stop.”
A few years ago, Dr. Scott Augustine, who invented the Bair Hugger in 1988, realized there was a design flaw and issued a warning about the elevated risk of patient infection that could result from use of his device. However, by that time, his company had been taken over by 3M and he had lost control over the design and marketing of his invention.