Mallinckrodt Initiates a Recall of Its Respiratory Valves Categorized as Class I by FDA
Mallinckrodt Manufacturing has initiated an urgent recall of its One-Way Valve 22F x 22M devices after discovering that the valves were malfunctioning. The United States Food and Drug Administration (FDA) has categorized this recall as Class I, indicating that continued use of these devices poses a risk of severe health consequences, including death.
The company has pulled back a total of 1,799 valve devices distributed in packs of five, affecting units that have been on the market in the U.S. from January 2022 to July 2023. These valves are key components in Mallinckrodt’s INOmax Delivery System, which is designed to administer nitric oxide therapy gas. The valves are positioned between the patient’s breathing circuit and the ventilator to prevent nitric oxide from flowing back toward the patient. Without this safeguard, elevated levels of nitric oxide could potentially be inhaled by the patient.
The FDA issued a recall alert stating that the malfunction in these valves could impede the proper flow of air or oxygen, which may lead to severe health implications. Specifically, any disruption in the ventilation process could postpone the delivery of nitric oxide gas. Such delays could result in insufficient levels of oxygen in the blood, leading to respiratory failure and even death. The risk is particularly acute for neonatal and pediatric patients, in whom a delay could additionally cause a slowdown in heart rate, or bradycardia.
Only two complaints related to these malfunctioning valves have been reported to Mallinckrodt Manufacturing so far. The company has instructed customers to return the affected devices unless they are currently part of a functioning breathing circuit and are operating as expected.
Initiating a Civil Lawsuit Over Mallinckrodt Manufacturing’s Defective Valve
If you or a loved one have been adversely affected by Mallinckrodt Manufacturing’s recently recalled respiratory valves, you may be contemplating taking legal action. The process can be intricate, and it’s essential to understand the steps involved.
Here’s a general guide to kickstart a civil lawsuit related to this issue.
Consult Our Legal Experts – First, consult an attorney who specializes in product liability or medical malpractice to evaluate your case’s strength. Provide all necessary documentation, such as medical records and any correspondence with Mallinckrodt or medical providers.
Collect Evidence – Gather all relevant evidence, including medical reports, invoices, pictures of the faulty device, or any other documentation that supports your claim. This will help your attorney assess your case more effectively.
Send a Demand Letter – Before filing the lawsuit, you may need to send a “demand letter” to Mallinckrodt Manufacturing, detailing your complaints and the compensation you seek. This step is often a prerequisite in civil cases and can sometimes lead to an out-of-court settlement.
File a Complaint – If the demand letter does not lead to a resolution, the next step is to officially file a lawsuit by submitting a complaint to the appropriate court. This legal document outlines your grievances and the damages you seek. Your attorney will guide you through this process.
Service of Process – After the complaint is filed, it must be formally delivered (“served”) to the defendant, in this case, Mallinckrodt Manufacturing. This gives them official notice that a lawsuit has been filed against them.
Discovery Process – Once both parties are aware of the pending lawsuit, the “discovery” phase begins. This involves the exchange of evidence and information between the plaintiff and defendant. Both sides evaluate the data to prepare their cases.
Pre-Trial and Settlement Negotiations – Before the case goes to trial, both parties usually engage in settlement discussions. These discussions can result in an agreed-upon compensation amount, effectively ending the lawsuit without going to court.
Trial – If a settlement is not reached, the case will go to trial. Your attorney will present your case, and Mallinckrodt will defend itself. The judge or jury will then determine the outcome.
Appeal – Either party has the option to appeal the court’s decision. If you’re unsatisfied with the outcome, consult your attorney about the feasibility and process of an appeal.
Compensation – If you win the case, the court will determine the amount of compensation you’re entitled to, based on factors like medical expenses, loss of income, emotional distress, and other relevant considerations.
If you or a loved one has been affected by the recent Mallinckrodt Manufacturing valve recall, don’t navigate these complex legal waters alone. Call the national law firm of Parker Waichman LLP for personalized legal advice and potential representation. Simply call 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation and get the justice you deserve.
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