Hurt by Defective Surgical Staplers or Staples? Dallas Attorneys Can Help

September 1, 2022 0 Comments

Internally, surgical staplers can be used to connect tissues inside the body, such as an organ. Surgical staplers are used to close up patients after a surgery is complete. Surgical staplers are also able to cut off excess tissue around the suture site. Unfortunately, issues withdefective medical devices are common.

ethicon lawsuit staples

People considering filing a surgical stapler lawsuit may wish to consult a lawyer who specializes in medical device cases. These types of lawsuits can be complex and involve issues of medicine, engineering and ethicon lawsuit staples manufacturing as well as product liability law. Our lawyers can help you file a Surgical Stapler Lawsuit today. Various reports of surgical stapler injury support this claim that the device is indeed faulty.

People who learn that they have been injured because of this defective medical device may be entitled to recover compensation from the company by filing a defective product lawsuit against Johnson & Johnson and Ethicon. The attorneys at The Lovely Law Firm in Myrtle Beach, South Carolina are currently reviewing claims. Surgical staplers are medical devices often used during surgery, internally or externally to close wounds. However, the FDA recalled certain surgical staplers manufactured by Ethicon Inc., a Johnson & Johnson subsidiary, due to concerns that the staplers may cause serious injuries or death. A Class I recall, the FDA’s most serious type, was issued for Ethicon’s Circular Staplers in May 2019 following reports that the devices caused patients serious harm or even death.

Tightening FDA Approval Requirements

Instead, they must be removed by a doctor after a wound has fully healed. I called Mr. Frankl and his firm about a motorcycle accident case and he helped me through the entire process. Mr. Frankl made me feel like my situation mattered to him and didn’t treatment me like just another file in a file cabinet.

What Are the Risks Associated with the Ethicon Surgical Stapler?

The agency subsequently proposed a new rule reclassifying surgical staplers as moderate-risk medical devices, which requires them to undergo greater scrutiny for premarket approval. This exemption includes the mandatory reporting of malfunctions and injuries. Therefore, non-fatal surgical stapler malfunctions are not on MAUDE. This stands for Manufacturer and User Facility Device Experience. MAUDE is a public database that tracks medical device failures.

However, these surgical staplers were on the market and used in surgical procedures for months before they were recalled. Thousands of surgeries occurred in that period, meaning that thousands of injuries could have happened in that time. The use of the affected products has been reported to cause significant injuries and even death.

This stapler may have been used in any type of gastrointestinal surgery including those for colorectal cancer, bariatric surgeries, endo related surgeries, gynecological surgeries, urological surgeries, and thoracic surgeries. Every day innocent consumers are injured and killed by dangerous drugs and medical devices. You can read about the latest surgical stapler FDA recalls on this page. Also, recommendations to surgical stapler manufacturers could be issued.

These single-user staplers were designed to be used on internal tissue during minimally invasive gynecologic, urologic, thoracic, pediatric, and general surgeries. The stapler had been disposed of following surgery, and Covidien argued that there was no proof that Strange’s death was a result of a defect in its product. Three days after Florence Kuhlmann underwent surgery in 2012, doctors found her bowel had been stapled against her rectal wall.

These kinds of lawsuits are complex, involving intricate knowledge of medicine, engineering, manufacturing and liability law. They require a legal team that specializes in standing up for the rights of patients in medical device cases and has a proven track record of success for its clients. But if a case goes to trial, plaintiffs’ attorneys would also fight for punitive damages. And punitive damages are often greater than compensatory damages. The frequency of surgical stapler misfires has been under-reported for years. Only recently the FDA made public the thousands of non-fatal incident reports.

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