Surgical Staples Lawsuit

Surgical staples are one option for closing surgical incisions — both internally and externally. These closures may be used for large or complex wounds which can’t be closed effectively with stitches or sutures. New York State limits the amount of time you have to file a lawsuit, so do not delay in reaching out to Douglas and London to discuss your claim during a free case review. Based on these serious defects in the Flex Endopath Staplers, the FDA issued a Class I recall, the most serious recall category reserved for devices that cause significant risk of bodily harm or death.

While a doctor cannot revoke your driver’s license, on their own, their report of a medical condition can set the revocation process in motion. Doctors are may be legally required to report certain medical conditions to their state’s Department of Motor Vehicles . Paragard IUD devices are known to migrate out of place, and to break upon removal, often requiring surgery and a hysterectomy. The attorneys at THL were extremely helpful with the legal aspects of setting up my small business. TorHoerman Law was responsible for handling a medical case for our family.

ethicon lawsuit staples

Manufacturers claim that they treat staplers as Class II devices, even though the FDA does not perform premarket reviews on them. The FDA has already classified implantable surgical staples as the more regulated and tested Class II devices. Filing a lawsuit is the only way to seek justice against giant companies who harm the general public. Looking at the bigger picture, victims of surgical staplers should fight for their rights in order to save other Americans from suffering the same fate as them. The more plaintiffs who will stand up, the bigger the chances of holding these companies accountable. Medtronic, which obtained Covidien in 2014, and also Johnson & Johnson subsidiary Ethicon regulate the large majority of the surgical stapler market in the USA.

A few days after the surgery, it was discovered that the staples were completely open and had misfired, leading to several hernias that adversely affected the quality of his life, and caused him regular pain and humiliation. If you feel any unexpected pain or discomfort after a surgical procedure, do not disregard it. Instead, get it checked by a doctor as soon as possible to see whether the staples that were used internally or externally during your operational procedure are intact and uninfected. If ethicon lawsuit staples the cause of your complications is determined to be a faulty surgical stapler, you may be eligible to file a claim against Ethicon or the stapler manufacturing company that made the stapler that was used in your surgery. Side Effects of the Surgical staplerThe matter was taken up by the FDA, and they ordered a recall of thousands of Ethicon’s surgical staplers. Because of their ease of application and the extra safety involved, surgical staplers started becoming popular among surgeons and doctors.

In 2007, a jury found Ethicon guilty and awarded $5 million to the family of a woman who died when the stapler failed to properly form staples, resulting in her stomach contents leaking out. Patients who have had or may undergo surgery involving staplers for internal use may be affected by this recall. If you experienced complications after a significant surgical procedure and are unsure whether a defective stapler was used, contact us today.

Another case involved a 33-year old woman who bled to death in 2013. In this case, during elective surgery, a Covidien stapler lacerated a blood vessel without sealing it. The woman began to bleed heavily and died the day of the surgery. A jury, in this case, awarded $5 million to the family of the deceased.

How Does the Ethicon Surgical Stapler Work?

According to Larry Kessler, a former FDA official, the database was created to avoid under-reporting and alleviate the time it took to review reports of similar context. The database essentially allowed adverse events, including deaths, to go unnoticed by doctors and patients alike for years. Attorneys are currently investigating if there are more stapler devices that ought to be recalled. Surgical staplers are more convenient than sutures, but it comes at the cost of having some additional risks.

The defects were reportedly caused by an issue with the manufacturing process for the staplers during the manufacturing period. When Kaiser Health News reported on the secret database in 2019, the FDA took quick steps to release the hidden reports and tighten regulations around surgical staplers. Medtronic and Ethicon products account for some of the largest surgical stapler-related recalls in recent years. The two companies combined have recalled more than 3.4 million staplers, staples and components since 2013. Damages in an Ethicon surgical stapler lawsuit can cover a wide range of losses and setbacks caused by a surgical stapler injury. Though a verdict or settlement can never really undo the tragic experiences of an injury victim, it serves the purpose of helping a victim recover and make life better moving forward.

Which Specific Staplers Were Recalled?

FDA spokesperson, Deborah Kotz, confirmed that any device manufacturer can request an exemption. The report released by Kaiser Health News prompted the FDA to release a response to the public on March 8, 2019. AV® Peer Review Rated Law Firm – An AV® certification mark is a significant rating accomplishment – a testament to the fact that a lawyer’s peers rank him or her at the highest level of professional excellence. A lawyer must be admitted to the bar for 10 years or more to receive an AV® rating. Calling this number connects you with a Drugwatch representative.

Defective Products

For a complete listing of recalled devices consisting of the Ethicon surgical staplers, visit the FDA surgical stapler recall page. These staplers are being recalled because the stapler may have a component that is out-of-specification. This could create malformed staples, causing problems in patients. As of the date of the recall, Ethicon publicly acknowledged that the recalled products had caused seven serious injuries and one death.

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