The U.S. Food and Drug Administration (FDA) announced a class I recall of the Ikaria INOmax DS Drug Delivery System because of “fretting corrosion,” which could cause such side effects as hypoxia, cardiac arrest, and organ damage.
The Rottenstein Law Group compassionately advocates for those who have suffered adverse side effects from dangerous drugs or medical devices. If you believe the Ikaria INOmax DS Drug Delivery System harmed your infant, contact RLG for a free, confidential legal consultation immediately. We will evaluate your case and remain on the lookout for Ikaria INOmax DS Drug Delivery System recalls and Ikaria INOmax DS Drug Delivery System class action lawsuits.
What Is The Ikaria INOmax DS Drug Delivery System?
INOMAX is the brand name for a gaseous form of nitric oxide (NO). Made and sold by INO Therapeutics LLC, this prescription medication is used to treat hypoxic respiratory failure associated with pulmonary hypertension (i.e., an increase in pulmonary artery blood pressure) in infants beyond the 34th week of gestation. Approved by the FDA in December 1999, the recommended dose for INOMAX is 20 parts per million.
Nitric oxide is a gaseous molecule frequently confused with nitrous oxide (N2O), popularly referred to as “laughing gas.” Actually, nitric oxide has many biological functions, including dilating capillaries in infants with pulmonary problems such as hypoxic failure, the inadequate oxygenation of a body part.
The INOmax DS Drug Delivery System is the medical device Ikaria created to deliver INOMAX to newborns. It’s a small cart with four wheels and a mounting post in the middle. Two tall cylinders of INOMAX lock into the post, and a small part bin and regulator panel attach at the top of the mounting post. The regulator allows the operator to control the amount of INOMAX that flows into the patient’s lungs.
Ikaria INOmax DS Drug Delivery System Might Cause Deadly Side Effects
On July 21, 2010, Ikaria initiated a class I INOmax DS Drug Delivery System recall. According to the FDA recall announcement, the pressure switch that helps caregivers monitor the drug supply could tear. This created the possibility that the INOMAX cylinders could deplete, leaving the infant without the drug. Side effects include:
- Hypoxemia (worsening of low blood oxygen level)
- Hypotension (low blood pressure)
- Pulmonary hypertension
Later on, in November 2010, Ikaria discovered that “fretting corrosion” at the electrical contact interface was causing “erratic nitric oxide readings.” Possible side effects include:
- Hypoxia (inadequate oxygenation)
- Bradycardia (reduced heart rate)
- Cardiac arrest
- Organ damage
- Acute respiratory distress syndrome (ARDS)
- Neurological deficits
On December 22, 2011, the FDA issued a press release stating that Ikaria has remediated the fretting corrosion by applying an anti-corrosion lubricant to the components that were at risk.
According to the FDA, “Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
RLG’s Ikaria INOmax DS Drug Delivery System Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Ikaria INOmax DS Drug Delivery System lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed your baby shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an Ikaria INOmax DS Drug Delivery System lawsuit on your child’s behalf if necessary. RLG will also keep you up to date on any Ikaria INOmax DS Drug Delivery System class action lawsuits, FDA Ikaria INOmax DS Drug Delivery System warnings, and additional Ikaria INOmax DS Drug Delivery System FDA recall announcements. If your baby was harmed by the Ikaria INOmax DS Drug Delivery System, contact RLG today.