This year, infusion pumps have come under heavy fire for being defective and dangerous. That attack has been in the form of FDA recalls and through lawsuits filed by various plaintiffs alleging harm through use of such a device. Infusion pumps are medical devices that deliver drugs and other fluids into the body in specified amounts and have been used widely in hospitals, nursing homes, and in the homes of those suffering serious illnesses or disabilities. Infusion drug pumps deliver such drugs as insulin, chemotherapy drugs, antibiotics, pain medication, and more intravenously. The pump pulls fluid from a bag containing the medicine into the body and does so at a controlled rate.
In 2017, the Federal Drug Administration (FDA) identified various problems with these devices as reported to them. These problems included:
- Software errors
- Battery failures
- Alarm errors
- Defective components
- Sparks, fires, shocks, or charring
- Problems with user instructions, warnings, inadequately designed settings and alarms, and other issues involving user interface
Recalls by the FDA
Since the above problems were noted by the FDA, thousands of these devices were recalled. Drugwatch.com reports that in March of this year, the FDA had classified one such type of pump as a Class I recall which is the most serious type of recall assigned by the agency. Class 1 recalls are those that are labeled on products that could cause serious injury or death. At the time of the recall, it was reported that 55 serious injuries and one death had been associated with the device whose manufacturer is Becton, Dickinson and Company. The recall affected 774,000 of the devices sold across the country.
According to the recall, the pump’s errors could lead to over-infusing or under-infusing of a medication, delays in infusion, or an interruption in infusing. In the case of high-risk patients receiving vital and even life-sustaining drugs, these errors could lead to risk for serious harm or death.
Lawsuits of Infusion Pumps
Since the above recall, other infusion pumps have met with similar claims of defectiveness. Recently, several lawsuits have been filed against Medtronic that have been linked to overdosing of medications, underdosing, withdrawal symptoms that became life-threatening for patients, as well as some 14 fatalities. In these cases, the Medtronic infusion pumps are surgically implanted into the body of the patient near the spinal cord that then delivers the medication needed through a plastic tube. It has been used for treatment in patients with cancer, chronic pain, muscle spasm, and other serious health conditions.
In the case of patient deaths, they were caused by the person being deprived of a drug, putting them into withdrawal, or of a drug overdose.
In November of this year, a plaintiff who filed suit against Medtronic won the ability to pursue her case after a Missouri federal judge ruled in her favor. Medtronic had tried to have the woman’s lawsuit dismissed. The plaintiff’s lawsuit alleged that she was caused severe and permanent injuries when the pump malfunctioned causing her to go into a drug withdrawal of the medicine called baclofen which was used to treat her cerebral palsy and spastic quadriplegia.
Have You Been Harmed by a Defective Medical Device?
The above recalls and lawsuits are examples of the harm that can be caused by defective medical devices. If you or someone you know has sustained injuries or harm due to a dangerous or defective device, you should seek legal advice from a knowledgeable personal injury attorney. At Bertram & Graf, L.L.C., we have helped countless individuals in and around Kansas City with such cases. We invite you to put decades of legal experience on your side in seeking justice against negligent manufacturers.
We offer a free consultation to discuss your personal injury case and you pay nothing unless we win your case. Contact us at (888) 398-2277 to book your case evaluation today.