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U.S. FDA Issues Ethicon Stapler Recall

Empty Medical Stapler on Blue Surgical Cloth

Ethicon surgical stapler lawsuit TV commercials have alerted consumers to the legal actions which victims of defective medical devices have already taken. However, some would ask whether, in the face of the risk posed by malfunctioning Ethicon staplers, government agencies have taken steps to mitigate additional incidents.

The government agency involved with such matters would be the U.S. FDA - the Food & Drug Administration. And, in fact, the FDA has already issued recalls on Ethicon devices in the past.

Ethicon Surgical Stapler Recall 2019

In 2019, the FDA issued a Class I recall on specific Ethicon staplers, Class I denoting this as the "most serious type of recall" given that the device can cause serious injury or death. The warning listed multiple stapler models and specific production date ranges.

The recalled models shared the same purpose: they are sterile endoscopic staplers. They also had the same issue - staples could become malformed by a potentially faulty component in the "jaw" of the staplers. It's worth noting these devices may serve not only as staplers but also as cutting devices.

Along with the recall were sent letters to any facilities possessing the device. They were instructed to ship back any of the recalled models if present in their inventory. After shipping the faulty models back to the manufacturers, the inventory would be replaced with non-faulty equivalents. The number of devices was estimated at nearly 100,00 units.

By the time the official FDA surgical stapler recall was issued, it is believed that Ethicon was made aware of at least 7 grave injury cases resulting from the faulty devices. Additionally, at least one death was reported to have been caused by complications from surgical staples which were likely to have been malformed upon application.

Increased Regulations

As a result of the seemingly widespread issues encountered with surgical staplers, an FDA advisory panel voted to improve their supervision of internal staplers. Moving forward, such devices will require extensive review and approval before making it to market.

Naturally, such increased supervision and review is expected to reduce the number of internal staple complications that arise moving forward.

Does A Recall Mean That A Lawsuit Can Be Filed?

The sheer number of recalled units is quite concerning as it points to the fact that many may have these defective staples inside them right now. Some may have already suffered due to the defective staples and may have been left without answers in the past.

With the tangible damages that many patients have suffered due to the faulty devices, does it mean that all claims against the manufacturer will be successful? This could not be further from the truth.

The fact of the matter is that Ethicon stapler lawsuits are no simple legal case. Such defective product litigation, particularly due to the fact that it is medical in nature, can be a drawn-out process. Moreover, a case will likely require input from expert witnesses, including medical doctors.

The legal team you chose to represent you in court will be the ones drafting your legal strategy, and so they will have a direct impact on the outcome. Make sure you're represented by a law firm experienced in the specific nature of your case. Unsure whether you're eligible? Contact our 24/7 helpline now for a free legal consultation.
Continue Reading: Ethicon Class-Action Lawsuit Due To Malfunctioning Surgical Staplers

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Laurence Banville
Date Published: December 1, 2020
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