Ethicon Endo-Surgery Inc., a division of Johnson & Johnson, marketed and sold several brands of surgical staplers which have since been recalled after the staplers malfunctioned, causing severe physical injuries to patients who had been treated with the Ethicon staplers. The Ethicon staplers – which included the Proximate HCS Hemorrhoidal Circular Stapler and Accessories, the Proximate PPH Hemorrhoidal Circular Stapler and Accessories, and the TRANSTAR Circular Stapler and Accessories – were used in the surgical treatment of prolapse and hemorrhoids and surgical treatment of anorectal wall defects and obstructed defecation syndrome.
The staplers malfunctioned when used in surgical treatments and failed to fire properly, resulting in incomplete firing stroke and incomplete staple formation and causing severe injuries to the patients on whom the staplers were utilized. The FDA has warned that the effects of use of the Ethicon staplers could cause serious adverse health consequences, including death. According to the FDA, these failures to complete the firing stroke of the stapler could lead to the following conditions in patients undergoing procedures involving the Ethicon staplers: “…severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal…poor staple formation, dehiscence (a bursting or splitting open) of the rectal wall staple line and bleeding.”
Manufacturer product safety recalls came too late for many
The Ethicon staplers known to cause these serious health consequences were manufactured and distributed between April 2011 and July 2012. Ethicon Endo-Surgery Inc. issued a recall of the Ethicon staplers in August 2012, but numerous individuals were already severely injured by the defective staplers as of that time. The August 2012 recall was classified by the FDA as a Class 1 recall, which is the most serious type of recall, and is issued when there is a reasonable probability that use of the defective products, here the Ethicon staplers, will cause serious adverse health consequences or death.
The August 2012 recall resulted in 157,000 of the Ethicon staplers being recalled. At the time of the recall, Ethicon’s parent company Johnson & Johnson had “grappled with a series of product recalls and supply disruptions in connection with manufacturing-quality lapses over the past three years, ” according to the Wall Street Journal.
Lawsuits abound for a number of injuries caused by product defects
Ethicon Endo-Surgery Inc., the makers of the Ethicon staplers, has faced litigation from many plaintiffs injured by use of the staplers, including plaintiffs who have suffered gangrene, closure of the rectum, sepsis, and other severe injuries, causing severe physical and mental pain and requiring extensive corrective surgeries. These injuries have also resulted in injuries to the spouses of patients who have been treated with the Ethicon staplers, as the patients’ injuries have resulted in the inability to perform spousal functions. Ethicon Endo-Surgery has been forced to pay out millions of dollars in damages over the years to plaintiffs injured by its defective products, and further litigation will continue for injuries that have been caused by the Ethicon staplers recalled by the company in August 2012.
You may be entitled to compensation for Ethicon stapler injuries
If you believe that you or someone in your family has undergone procedures involving the use of the Ethicon staplers (including the Proximate HCS Hemorrhoidal Circular Stapler, the Proximate PPH Hemorrhoidal Circular Stapler, and the TRANSTAR Circular Stapler) and experienced the symptoms described here or other adverse health effects from the use of the Ethicon staplers, please contact New York personal injury lawyer Leandros A. Vrionedes for a confidential consultation with a skilled and knowledgeable attorney in the field of personal injury and pharmaceutical products liability.