Johnson & Johnson is issuing a recall for a surgical stapler after reports that seven patients were seriously injured and one died. According to news reports, the medical device, manufactured by Johnson & Johnson’s Ethicon unit, is used to simultaneously cut and staple tissue back together during surgery. However, problems with a part led to staples failing to properly close incisions, the U.S. Food and Drug Administration (FDA) said.
Risk of Serious Injury and Death
The FDA classified this as a Class I recall, the most serious category declared only when there is a risk of serious injury or death. The staplers have been linked to one death and seven injuries before Ethicon began recalling them on Oct. 3. The agency’s notice states that if a problem with the staple line is not recognized or not properly addressed, there is a potential risk of prolonged surgery, postoperative connection leak, hemorrhage, hemorrhagic shock, additional surgical intervention or death.
The recalled devices were distributed from Aug. 1 through Sept. 26. People who have had open or lightly invasive surgeries in the last two months or will be having surgery soon, should ask their doctors what types of staplers were or will be used. The recall includes four different kinds of Echelon Flex Endopath staplers. In April, Ethicon had to recall 92,486 curved staplers used in gastrointestinal surgeries for “insufficient firing and failure to completely form staples.”
Last March, the FDA sent a letter to health care providers after finding more than 41,000 medical device reports that describe adverse events and deaths associated with the use of surgical staplers and staples for internal use between Jan. 1, 2011 and March 31, 2018. In April, FDA proposed to reclassify surgical staplers from class I (general controls) into class II (special controls) and Medtronic and J&J offered support for that reclassification.
Liability Issues
Medical device manufacturers have a duty and an obligation to make devices that are safe for consumer use. When they make defective devices, consumers who receive those devices are not only put in extreme danger, but may also need to surgically extract the device from their bodies. This leads to additional pain and suffering, and costs associated with surgery, hospitalization and so on.
Injured victims of defective medical devices can seek compensation by filing a product liability lawsuit against the manufacturer. They may be able to seek damages such as medical expenses, loss of wages, hospitalization, permanent injuries, disabilities, pain and suffering and emotional distress. An experienced product defect lawyer will be able to advise them regarding their legal rights and options.
Sources: https://www.miamiherald.com/news/health-care/article236856873.html
https://www.bloomberg.com/news/articles/2019-10-31/j-j-recalls-surgical-tool-after-patient-death-serious-injuries
