FDA Declares Class I Recall for Abiomed Impella 5.5 Heart Pump with SmartAssist
In the wake of Johnson & Johnson’s recent $16.6 billion acquisition of Abiomed, certain versions of the Impella 5.5 with SmartAssist face a recall – an announcement made mere months following the hefty purchase.
On Monday, the FDA declared that Abiomed, a manufacturer of heart devices which Johnson & Johnson procured last year for a staggering $16.6 billion, is instituting a recall of select models of the Impella 5.5 heart pump equipped with the SmartAssist feature. This follows complaints regarding leakage of purge fluid from the pump’s purge sidearm.
This recall has been classified by the FDA as Class I – their most critical category – implying that without appropriate remedial action, persistent usage could result in grave injury or even loss of life.
The Impella 5.5 heart pump, augmented with the SmartAssist system, is used for up to two weeks to assist the heart’s pumping chambers in situations of continuous cardiogenic shock, which takes place within 48 hours post a severe heart attack, open-heart surgery, or when the heart’s functionality is compromised due to a disease termed cardiomyopathy, as per the FDA’s official statement.
The FDA cautions that should a purge leak transpire, “the system will encounter low purge pressures,” resulting in alarms and necessitating an evaluation. For patients in a critical state, the FDA warns that the failure of pump support could induce “further decline and exacerbation of their precarious condition, potentially leading to significant injury or death.”
Abiomed kicked off the recall process in April. As per the FDA, the company has registered 179 complaints, and three injuries, but fortunately, no fatalities tied to the recall as of this article’s publication.
“Abiomed has alerted both its customers and the FDA about this voluntary recall,” communicated Jenny Leary, the associate director of U.S. communications for the company, via email. Leary further emphasized that this recall does not impact the newest iterations of the Impella 5.5 with SmartAssist.
Filing a lawsuit for receiving monetary compensation for harm caused by a recalled product:
In instances where a product, such as the aforementioned Abiomed heart pump, causes harm, you may be entitled to file a lawsuit to receive monetary compensation for the damage incurred. This falls under the broad area of law known as product liability. This legal principle holds manufacturers, distributors, suppliers, and retailers accountable for distributing defective or dangerous products to consumers.
The first step in filing such a lawsuit is to consult with a product liability lawyer who can guide you through the process. They can help assess whether you have a valid claim based on the severity of the injury, the extent of your losses, and the link between the product and your injury. Evidence of the harm caused by the product, such as medical records, will be crucial in substantiating your claim.
In a case related to the recalled Abiomed heart pump, plaintiffs would need to prove that the device was defective and that the defect caused their injury. Given the Class I recall issued by the FDA, there may be grounds for such a lawsuit if patients experienced harm as a result of the device’s malfunctioning.
If a lawsuit proceeds successfully, compensation can cover medical expenses, lost wages due to an inability to work, and non-economic damages such as pain and suffering. In some cases, punitive damages may also be awarded to punish the defendant and discourage similar conduct in the future.
However, filing a product liability lawsuit can be a complex process. The criteria for what constitutes a defective product can vary by jurisdiction, and demonstrating the direct cause-effect relationship between the product and the injury can be challenging. This underscores the importance of seeking legal counsel with experience in product liability law.
Moreover, legal action can also lead to further product safety measures and regulations, thereby preventing similar harm from occurring to others in the future. This highlights how such lawsuits serve a compensatory function and a broader social purpose in improving product safety standards.
Should you or a loved one be affected by a defective product, it is crucial to seek legal advice promptly. A competent product liability attorney can evaluate your case, help gather necessary evidence, and guide you through the often-complex process of filing a lawsuit. Your actions could lead not only to monetary compensation for your own harm but also contribute to broader changes in product safety.
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