The U.S. Food and Drug Administration announced earlier this month that Hospira Inc. would recall its Gemstar Docking Station due to a problem that has the potential to adversely affect the user of the Gemstar infusion pump. The FDA categorized it as the highest and most urgent level of recall because of the safety concern.
There is a problem on two levels: one involving the use of a certain infusion pump while it is connected to a docking station and the other involving the use of certain pump models and the docking station along with an external battery pack.
Apparently, when the docking station is used in connection with a certain model of infusion pump, the pump potentially can fail to power up while it is connected to the docking station. Further, while using these devices in conjunction with a battery pack, the pump potentially can detect what seems to be excessive voltage and can stop the infusion.
The manufacturer admits that a delay or interruption of therapy has the worst-case potential to result in “significant injury or death.”
There is no need to return the docking station at this time, according to the FDA’s safety communication, which alludes to the alternative of using a pump that works better with the other equipment. In the meantime, according to the FDA’s report, there are recommendations for patients and for health care professionals.
“Healthcare professionals,” the FDA wrote, “are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Customers should consider the use of an alternative pump, particularly in patients in which a delay/interruption in/of therapy could result in serious injury or death.”
Time will tell whether Gemstar injuries lead to litigation. For now, the courts are adjudicating cases in which other medical devices allegedly have posed unreasonable risks that resulted in serious injury. Cases involving the transvaginal mesh, metal-on-metal hip implants, the Mirena IUD, and the GranuFlo compound in the dialysis process come to mind.
In any case, one can count on the specialized skill and expertise of the experienced product liability attorneys at Reich & Binstock in the pursuit of compensation.