False Advertising by Smith & Nephew Can Put Patients At Risk of Pressure Ulcers, Mölnlycke Lawsuit Alleges
NORCROSS, GA, Monday, October 16, 2017 – Patients could face increased risk of pressure ulcers due to false and misleading advertising and promotional activity by Smith & Nephew, according to new allegations in a pending lawsuit filed by Mölnlycke, a world-leading medical solutions company.
The suit asserts that Smith & Nephew’s claims about the ability of its Allevyn® Life wound dressings to prevent pressure ulcers mislead healthcare decision makers into purchasing a product that lacks clinical evidence.
“Misrepresentation of facts about medical devices can expose patients to an increased risk of unnecessary pain and suffering. With a recent randomized clinical trial (RCT) demonstrating an 88 percent reduction in pressure ulcers,
The lawsuit alleges that: “Each year more than 2.5 million people in the U.S. develop pressure ulcers, resulting in 60,000 patient deaths.
The lawsuit further alleges that, “A latecomer in the area, Smith & Nephew has made false, misleading, and unsubstantiated advertising claims, including those which compare its Allevyn Life dressings to Mölnlycke’s Mepilex Border dressings.” Mölnlycke alleges that “these advertisements injure it, but more importantly, put patients at risk of unnecessary suffering and death. Mölnlycke pursues this action to stop Smith & Nephew’s false, misleading, and unsubstantiated advertising.”
The suit outlines several instances of misleading claims by Smith & Nephew through advertisements, news releases, websites, brochure and trade shows. As detailed in the filing, Smith & Nephew has:
• Claimed a 2013 publication in the International Wound Journal
• Asserted that a 2016 study
• Made false, misleading, and unsubstantiated claims that its products delivered greater pressure ulcer protection than Mepilex Border based on laboratory pressure redistribution studies, including one that simply positions a steel ball on a dressing that has been placed on a pressure mapping pad, despite no evidence that the tests correlate to protection in humans. Indeed, Smith & Nephew's steel ball test is criticized in published literature.
The new allegations were filed in the U.S. District Court for the Northern District of Georgia. The action expands on a lawsuit originally submitted by Mölnlycke in April 2017.
About Pressure Ulcers
For further information about Pressure Ulcers please visit the National Pressure Ulcer Advisory Panel website.
Mölnlycke is a provider of high-quality solutions for customers, healthcare professionals, organizations and patients worldwide. We develop and bring to market innovative wound care and surgical solutions along the entire continuum of care from prevention to post-acute settings. Our solutions provide both clinical and financial value, supported by clinical and health economic evidence. www.molnlycke.com.