Megadyne Lawsuit Alleges 5 Year Old Burned by Recalled Electrode Pad During Tonsillectomy Surgery

Lawsuit comes after a Megadyne Electrode Pad recall was issued by the manufacturer, following reports of severe burns during surgical procedures due to design defects.

The parents of a Montana child have filed a product liability lawsuit against the makers of recalled Megadyne electrode pads, after their child suffered second- and third-degree burns during a surgical procedure to remove their tonsils.

The lawsuit was brought about five months after a Megadyne Mega Soft Pediatric Patient Return Electrodes recall was issued by the manufacturer, following reports of at least four patients suffering severe burns from the pads, which are used during some surgical procedures to conduct electrosurgical energy from target tissue in a patient and back to the surgical device.

The recalled electrode pads are supposed to prevent high current concentrations from building up during surgery, but the manufacturer sent a letter to healthcare providers urging them to stop using the products in May 2024, following reports of second- and third-degree burns among patients, which often resulted in scarring  and the need for additional surgeries.

The U.S. Food and Drug Administration (FDA) classified the letter as a class I medical device recall, suggesting that continued use of the products posed a risk of severe injury or death. An earlier recall for electrosurgery electrodes for adults and pediatric patients had also been issued by Megadyne in June 2023, after 63 patients suffered third-degree burns and other injuries that required medical treatment following the use of similar products manufactured by the same company.

This new complaint (PDF) was originally filed by Hannah and Kevin Dieterle in Montana’s Eighth Judicial District Court in November 2024, indicating that their child, Sophie Dieterle, was one of the infants burned by the recalled Megadyne electrode pads. Their lawsuit named Ethicon, Inc., Great Falls Clinic, LLC and several unnamed individuals and corporations as defendants, and it was removed (PDF) to the U.S. District Court for the District of Montana on December 19.

The Dieterles indicate that Sophie was five years old when she underwent what should have been a routine tonsillectomy at Great Falls Clinic, and Megadyne pads were used during the procedure.

“The morning after the procedure, Sophie’s mom noticed blistering on areas of her bottom. Hannah brought Sophie in to be seen by the doctor and he prescribed burn cream and referred her to wound care,” the lawsuit states. “The wound care provider documented three burn wounds on Sophie’s backside. She described two as 2nd degree and the larger one (4 x 4 cm) as 3rd degree.”

The child had to undergo mentally and physically painful wound care for three months, and will have burn scars for the rest of her life, her parents indicate in the Megadyne electrode pade lawsuit.

Their complaint points out that investigations revealed a variety of factors that led to the potential for the electrode pads to overheat, and found that infants and small children were the most at risk due to the design defects. It also notes that the pads used on Sophie were included in the Megadyne recall, and the number of burn injuries linked to the recalled electrodes has now grown to at least 99.

According to the lawsuit, both Ethicon and Great Falls Clinic blame each other for the child’s burn injuries.

The Dieterles present claims of strict product liability, breach of warranty and negligence.