Drug pumps, more commonly known as pain pumps, administer low doses of pain medications on a consistent basis to relieve chronic and severe pain. Recent lawsuits against Medtronic, a manufacturer of pain pumps, show just how dangerous these devices can be when a company fails to maintain adequate quality control during manufacturing.
Medtronic Eyed by FDA Regulators
FDA inspectors were already displeased with the way Medtronic failed to handle a 2008 recall, leaving pain pumps on the market for two years after Medtronic learned of dangerous defects. Then, in the summer of 2009, the FDA issued warning letters regarding two specific pain pump models, the SynchroMed and the MiniMed pain pumps. The FDA found that poor quality control at Medtronic’s Puerto Rico plant had caused defects in the products.
Lawsuit Filed Against Medtronic
Recently, an Illinois woman filed a legal complaint against Medtronic in Madison County Circuit Court, under case no. 10-L-1267. Susan Daniels alleges that her husband Tony received a fatal dose of Fentanyl because of a defective pain pump and improperly trained medical staff. The drug is a synthetic opiate pain medication, more potent than morphine. Doctors prescribe the medicine for severe and chronic pain resulting from injury or disease.
In her complaint, the woman alleges that caregivers at the Piasa Pain Center used a SynchroMed II device in 2009 to deliver pain medication to Mr. Daniels. The caregivers used a far higher amount of the drug than necessary. This caused an overdose that severely damaged Mr. Daniels’ lungs and brain. Immediately after the overdose, Daniels was taken to Alton Memorial Hospital. The suit names the hospital as a defendant, listing it as owner of the Piasa Pain Center and as a medical caregiver for failing to administer timely treatment. Tony Daniels died from complications of the overdose November 19, 2010.
Problems with Infusion Pumps
The device in question, sometimes called an infusion device, delivers medication at a steady rate over time, infusing medication into the blood. Over the past five years, the FDA has received more than 56,000 reports of problems with infusion pain pumps. Of those, 500 resulted in death. Many problems can cause injuries to patients using pain pumps. They include confusing usage instructions from the manufacturer, software glitches, and mechanical failures such as dead batteries or power outages.
FDA Working to Make Pain Pumps Safer
In April of 2010, the FDA began researching the risks associated with pain pumps and has provided safety recommendations to physicians. They have also put tougher guidelines for manufacturers for approving new devices. It is hoped that these changes will save lives, protecting patients from defective pumps.
Please contact us if you or someone you care about was injured because of a dangerous drug like Fentanyl, or suffered any other injury because of a defective pain pump. Our experienced attorneys are ready to talk and provide you with free legal advice. We will help you decide if you should file a pain pump lawsuit to secure compensation for your injuries.