Infusion provider settles; 'faulty' tubing costs Baxter $18 million
Attorney says could be worse for home infusion providers
Baxter Healthcare Corporation in Deerfield, IL, was recently hit with an $18 million judgment in a lawsuit brought by the estate and plaintiff of an individual who suffered permanent injury as the result of an IV tubing mishap. According to an attorney for the plaintiffs, the award was not surprising and likely would have been higher if the situation had occurred in the home. The hospital that provided the infusion was also sued, along with a nurse; they settled out of court.
In 1991, Andrina Hansen underwent successful ulcer surgery and was receiving fluids and medications through a central venous catheter. Her surgeon had already assured Hansen's husband and three sons that the surgery was a success and that the patient would recover fully. The cannula was connected to Baxter's Continu-Flo Solution Set IV tubing, which was made with a non-locking connection that Baxter called a "luer slip."
The tubing disconnected while a hospital nurse was assisting Hansen from her bed, allowing air to travel through the opening to her heart and into her brain.
"The IV line separated from her central venous catheter, and it came apart at the connection," notes John C. Erb, an attorney with the law office of Paul B. Episcope Ltd. in Chicago. Erb assisted Episcope in trying the case against Baxter.
"She was sitting up at the time, and the nurse was getting her out of bed to walk, and because of her position, when she breathed in, the pressure inside sucked air into the central venous catheter, into her heart, and ultimately, into her brain. She had a grand mal seizure, and a CT scan showed she had air in her brain and massive brain damage on the left side of her brain and brain stem."
Erb points out that it is unclear exactly how the set disconnected, as the nurse with Hansen at the time did not see the tubing disconnect.
After several months of rehabilitation following the incident, Hansen was unable to walk, speak full sentences, or care for herself. She died in a nursing facility four years later.
The lawsuit initially named the nurse and hospital as defendants. It wasn't until four years later that Baxter was added to the lawsuit. When all other involved parties settled out of court, Baxter was left as the lone defendant in the lawsuit.
"After the hospital settled out of court, we fought it all the way," a Baxter spokesperson told Home Infusion Therapy Management. "We didn't see why we were even included in the lawsuit to begin with."
Erb says there was a simple reason Baxter was named. If a safer alternative is available to patients and customers, it should be used.
"At the time, Baxter made two kinds of IV sets," he says. "One was a [luer] slip-fit or friction fit that slides in male to female, and the other had a luer lock that screws on and cannot come apart. Baxter was selling the slip fits to this particular hospital rather than the luer locks, even though Baxter had a patent on a good design going back to 1982.
"One of the key points is that they had a better product, and for some reason, they weren't promoting it to the customer," adds Erb.
However, such an assumption brings up an interesting point, says Elizabeth Hogue, JD, a health care attorney in Burtonsville, MD.
"You can't force them to buy something because it's safer," she says. "And somewhere along the line, someone at the hospital made the decision to use this product in that type of line."
Erb says there was a second area that was critical in the jury reaching its decision.
"It was very important to the jury that Baxter didn't warn their customers of this kind of complication for this kind of slip friction fit IV set."
Erb notes that Baxter had no warnings on its packages or any of its mailings, the company never sent any alerts out to customers, and it didn't provide inservices at the hospitals noting what situation the lines were appropriate for.
"While it may be fine to use one in a peripheral line, they should never be using the slip fits in a critical line like a central venous catheter or an arterial line, and Baxter knew it, but they weren't telling anybody," says Erb.
Hogue says there is a gray area in the law regarding where responsibility should fall or if the responsibility should be split between manufacturer and user.
"One of the questions is can you force a health care provider to properly use a product?" she says.
However, Baxter maintains its innocence and says the tubing is not faulty in design.
"This particular product is an IV administration set and has been used for decades on millions of patients worldwide without an incident, so it was clearly not a case of product failure," according to the company spokesperson. "Other than that, we can't comment any further because we have filed a post trial motion, so litigation is continuing."
Erb says his firm was confident going into the case in large part because the issue was a simple one for a jury.
"This was not a complex issue," he says. "Baxter had a product that would have worked just fine, and by their own admissions, if that product had been in use, this incident would have never occurred."
It's important to note that although the Intravenous Nursing Society standards recommend using locking IV sets, the choice ultimately is made by the infusion provider. And such locking IV sets are often more expensive than the friction fit IV sets.
But even with lower cost, you might want to reconsider the use of such friction sets. Erb says that home infusion providers would be held even more accountable for any such mishap.
"It would be worse if this happened in the home because people in the home have very little experience with these IV sets and would not in any way appreciate the danger of it pulling apart," he says. "So for home use, it would be practically criminal to sell non-locking IV sets."
The demand for settlement as the trial began was that Baxter change its design and/or publish a warning to all health care providers of the likelihood of the connection separating accidentally so that it not ever be used in central lines.