U.S. Food and Drug Administration (FDA) regulates staplers as Class I medical devices. These types of devices are devices that should have minimal potential harm and their designs are simple. For example, latex gloves, bedpans, and tongue depressors are all examples of Class I medical devices. Class I devices are exempt from many of the FDA regulations surrounding medical devices and are exempt from the reporting of malfunctions and injuries. Non-fatal surgical stapler malfunctions and injures are not reported on the Manufacturer and User Facility Device Experiences (MAUDE), a public database that tracks medical device failures. The only data on MAUDE concerning surgical staplers involved fatalities, a small percentage of the total number of incidents. Reports for non-fatal incidents went to the Alternative Summary Reporting Program (ASRP). This is an FDA database that did not become available to the public until June 2019.
Surgical Staplers are used to close wounds and surgical openings and operate much like home, office, or construction staplers that many are familiar with. Along with similar operation, surgical staplers also come with many problems often associated with home and construction staplers including jamming, misfiring, and failure to close the staples. The consequences of these defects can be devastating, especially when these issues occur near sensitive tissue or organs. Complications arising from the use of surgical staplers include sepsis, internal bleeding, damage to internal organs, additional surgeries, life-long nutritional and digestive issues, and death.
Between 2011 – 2018, the FDA reported that there were 109,997 reports of surgical stapler malfunctions. These malfunctions included 11,181 serious injuries and 412 deaths. This equates to 4 serious injuries a day and roughly one death per week. In May 2019, Ethicon issued a Class I recall of 92, 496 units, with over 2 million units being subject to a recall across all manufacturers. Between January 1, 2011, and March 31, 2018, the FDA reviewed 41,000 medical device reports and discovered that the medical devices were linked to serious complications including death, serious injuries, and malfunctions.
The surgical stapler lawsuit is a mass tort claim by victims against the device manufacturer. These lawsuits allege that a design defect caused these staplers to misfire resulting in organ damage along with other complications. To bring a defective design claim against a surgical stapler manufacture, a Plaintiff would need to prove the device’s defective design posed a foreseeable risk, and the device was manufactured and used as it was supposed to be. So far no class actions or multi-district litigation (MDL) have formed.
If you believe that you have been injured during surgery due to a stapler malfunction, contact Oliver Law Office for a free consultation.