A Class I recall basically means that there is a “reasonable probability” that the use of such a product will cause serious injuries, adverse health consequences, or death. Class I devices are not heavily tested or regulated and do not undergo premarket review, and include things like cotton swabs and crutches. Class II devices must undergo a premarket review by the FDA before being approved for use. Total additional medical expenses were in the hundreds of thousands, never mind the pain and suffering. Mr. Frankl was such an asset to have on my team while I picked up the pieces following an accident.
There were 8.256 linear surgical staplers affected by the recall that could have caused severe injury to patients or even caused their deaths. There have been seven major injuries reported to the FDA and to Ethicon as well as a death. This recall in October of 2019 followed Ethicon’s earlier recall of 92,000 circular surgical staplers for similar reasons. Medical device manufacturers are required to report serious injuries and deaths related to the use of their products to the U.S. The FDA maintains a public database of reported medical devices problems.
In April 2019, David Bakos from Los Angeles County underwent a gastrointestinal surgery in which the surgeons had used an Ethicon stapler. A few days later, Mr. David started experiencing high fever and abnormal abdominal pain. He had to undergo other surgeries to correct an anastomotic leak that had occurred due to the staples not staying in place.
By World War II, Ethicon’s share of the surgical closure device market was up to 70% across the world. In the United States, Ethicon’s market share is currently about 80%, making it one of the most purchased-from surgical closure device manufacturers in the country. The Ethicon Echelon circular stapler is a surgical stapler designed to close internal wounds on organs that are circular in nature. A husband in Illinois was awarded $5.5 million in a settlement over the death of his wife due to a surgical stapler injury. The other factor driving new public awareness of the risk these staplers and sutures pose have been massive recalls – with more than 3.4 million units and components from the two major manufacturers alone recalled since 2013.
How much Money can I get in a Surgical Stapler Settlement?
Our attorneys have access to the resources needed to thoroughly investigate your situation to determine if you were affected and eligible to file a surgical stapler lawsuit. There have been numerous recalls of surgical staplers over the years, proving just how risky they are to use. In May 2013, Ethicon, a subdivision of drug giant ethicon lawsuit staples Johnson & Johnson, issued a Class-II recall for surgical staples sold under the name Echelon. Echelon staples were used in a number of different types of surgery, including stomach stapling surgery. The recall states that Echelon staples used in stomach stapling had been reported to misfire and break, risking serious complications.
Contact an Ethicon Recall Lawyer Today
But the only data on MAUDE for surgical staplers involve fatalities. A surgical stapler lawsuit is a mass tort claim by a victim against the device manufacturers. In these lawsuits, plaintiffs allege that a design defect caused the staplers to misfire.
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The two companies produce 4 out of 5 surgical staplers used in American hospitals. The information on Drugwatch.com has been medically and legally reviewed by more than 30 expert contributors, including doctors, pharmacists, lawyers, patient advocates and other health care professionals. Johnson & Johnson has issued a recall of its Echelon Flex Endopath Staplers. This surgical stapler, which is manufactured by Johnson & Johnson’s Ethicon division, was developed to cut and staple internal tissue together simultaneously during procedures. Affected patients may include anyone who has received surgical staples in connection with gastrointestinal surgeries, such as bariatric patients and those with colorectal cancer. The October 2019 recall from the FDA is disturbing, but it is sadly not new for Ethicon.
Please read our disclaimer for more information about our website. While studies indicate that the procedure can promote weight loss and reduce the risk of complications from obesity, it is a major procedure with serious risks. Surgical staples are only meant to remain in the patient for a specific period of time. After the appropriate time determined by the surgeon or doctor, they will remove the staples.