Surgical staplers are medical instruments that are routinely used by doctors to replace sutures. They can seal wounds and incisions and are frequently utilized in minimally invasive surgery. Surgical staplers have been on the market for over 50 years and have been heavily marketed as time saves to doctors. The majority of surgical staplers are produced by Ethicon and Covidien. [1]
The FDA recently reported that between 2011-2018, there were 109,997 reports of surgical stapler malfunctions, including 11,181 serious injuries and 412 deaths. Furthermore, in May 2019, Ethicon issued a Class I recall of 92,496 units and since 2014, over 2 million units have been recalled by manufacturers. [2]
There is not currently an MDL for surgical staplers however, there have been instances where injured parties have found success in lawsuits. For example, in November 2022, a Covidien surgical stapler case, a federal judge in Massachusetts permitted claims for failure to warn and misrepresentation to proceed after concluding that the plaintiffs sufficiently alleged the manufacturer defendants underreported adverse events by abusing the FDA’s Alternative Summary Reporting (ASR) Program. [3]
Michael Brady Lynch Firm
Here at the Michael Brady Lynch firm, we handle strict product liability cases. If you or a loved one has been injured by Surgical Staples, please give us a call at 888-585-5970.
Date: Feb 20, 2023
Author: Brandon Salter
[1] https://www.drugwatcher.org/surgical-stapler-lawsuit/
[2] https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/surgical-staplers-and-staples
[3] https://minnlawyer.com/2022/12/13/medtronic-device-products-claim-survives-dismissal/
