A lawyer for a South Carolina hip patient told a jury Tuesday that a widely used 3M-made device that keeps patients warm during surgery caused a serious infection, while 3M’s lawyer countered that no study has shown the device contaminates wound sites.
The lawyers delivered their opening statements at the outset of a case before U.S. District Judge Joan Ericksen that could affect thousands of patients who have also sued the Maplewood-based maker of the Bair Hugger system after coming down with serious joint infections after hip or knee replacement surgery
An attorney for plaintiff Louis Gareis argued that the Bair Hugger, a forced-air heating blanket that is used in most hospitals to normalize patients’ body temperatures during surgery, was defectively designed. Gareis’ attorney, Genevieve Zimmerman, told jurors that 3M’s product disrupted the normal air flow inside the operating room where Gareis underwent hip replacement surgery in November 2010.
She added that she will present experts during the trial who will use advanced computer models to show that the Bair Hugger could have carried contaminated particles from the operating room floor into Gareis’ surgical site. Gareis developed a hip infection eight months after his surgery and ultimately had to have several surgeries, including a second hip replacement. Gareis and his wife, Lillian, were in court Tuesday.
Zimmerman showed jurors two video animations of how a forced-air blanket could theoretically move particles and smoke from underneath an operating table and into a surgical wound site. She also noted that the operating room in the Columbia, S.C., hospital where Gareis’ surgery took place had many filters, HEPA filters and germ-killing UV lights and took other precautions to prevent contamination.
She emphasized that Gareis was not blaming his medical team for the hip infection, but instead noted that the Bair Hugger device introduced an airflow disruption problem into the room that the other filtration devices could not have anticipated.
3M’s attorney Jerry Blackwell disputed Zimmerman’s argument, saying no study exists that has shown the Bair Hugger contaminates wound sites. He added that the plaintiff’s own studies don’t conclude that the Bair Hugger caused infections.
Blackwell showed jurors several studies that found that forced-air blankets reduce surgical risks and infections and cut down the common side affects associated with patient hypothermia, namely blood loss and heart attacks.
Blackwell told the jurors to use their common sense during the case. He faulted the plaintiff’s computer models, saying they did not account for protective measures taken such as the patient’s surgical gowns, drapes and taped skin.
The plaintiff’s computer models also don’t account for any other sources of air flow in the room, including the six times the operating room door was opened during Gareis’ surgery, or the movements by doctors, nurses and other equipment in the room, Blackwell said.
Lastly, he told jurors the plaintiff’s theory doesn’t take into account that the patient’s own skin can carry bacteria.
Blackwell said he will later allow jurors to feel the air coming from a Bair Hugger device. He said the air flow is so gentle that it cannot be felt 3 inches from the blanket. He disputed that the air is strong enough to cause air flow currents in a room.
Blackwell insisted Gareis could not have known for sure the source of the bacteria that infected his leg eight months after the surgery. The attorney further criticized the plaintiff’s arguments, saying none of the experts that plaintiff’s attorneys will call to the stand ever visited or took measurements of the hospital operating room where Gareis had his surgery. Most of the experts are from across the country, he said.
Plaintiff’s attorney Mike Ciresi called to the stand Tuesday two former 3M scientists who had overseen the Bair Hugger product for 3M back in 2010.
Ciresi peppered them with questions about what studies they ran or examined when determining the efficacy, safety and risks of the Bair Hugger in 2010. Ciresi also questioned whether the Bair Hugger was needed in any operating room. He insisted that a pre-surgical warming session was sufficient to warm a patient’s core body temperature for two hours of surgery. Neither scientist agreed with his assessment.
Ciresi’s legal partner Jan Conlin played jurors a video deposition of Gareis’ hip surgeon, Dr. Bradley Presnal. During the interview, which was taped Dec. 4, 2017, Presnal described his cleanliness protocols and said he had not seen studies proving that the Bair Hugger prevented surgical infections and other complications as claimed by 3M. More of Presnal’s deposition will be played Wednesday, when the trial continues for a second day.
The trial beginning this week comes after years of various claims against the Bair Hugger device, which 3M acquired when it bought Arizant in October 2010.
3M has been sued by nearly 4,000 patients who say the Bair Hugger contributed to wound site infections, a claim 3M vigorously denies. During the past two years, the lawsuits have been consolidated into federal court in Minneapolis from states around the country.
The trial that began Tuesday is the first to be tried and is considered a bellwether case. The jury ruling and other decisions that flow from this case will be used by other parties to decide if they wish to settle, continue litigation or alter strategies.
The Gareis trial is expected to last about three weeks.