Icy Hot Patches Are Overhyped by Sanofi, Sorrento Lawsuit Claims


French drugmaker Sanofi was accused in a lawsuit of misleading consumers about the effectiveness and safety of its “Icy Hot” pain patches backed by ex-National Basketball Association star Shaquille O’Neal.

A unit of Sorrento Therapeutics Inc. alleges subsidiaries of Paris-based Sanofi and Japan’s Hisamitsu Pharmaceutical Co. are deceptively marketing their over-the-counter pain patches, which rely on the same lidocaine medicine used in Sorrento’s ZTlido product that has approval from the U.S. Food & Drug Administration.

The companies’ ads -- featuring the ex-Los Angeles Lakers all-star center and Bob Arnot, a former medical correspondent for NBC News and CBS News -- dupe consumers into believing their products are more effective than Sorrento’s and offer “the maximum amount of lidocaine available in patch form,” according to the complaint, filed Tuesday in federal court in San Francisco.

“By making such false and misleading advertising claims through various channels -— including online content, social media, and television advertisements —- defendants achieved their goal of increasing sales and profits by deceiving consumers regarding the characteristics and efficacy” of their lidocaine patches, lawyers for Sorrento’s Scilex Pharmaceuticals Inc. unit said in the complaint.

Ashleigh Koss, a U.S.-based Sanofi spokeswoman, declined to comment on the suit. Representatives of Saga, Japan-based Hisamitsu couldn’t immediately be reached for comment.

Sorrento’s ZTlido has FDA clearance for use in relieving some nerve pain. It’s a non-opioid patch that relies on lidocaine to relive burning pain caused by shingles infections. Sorrento added ZTlido as part of its 2016 acquisition of a majority stake in closely held Scilex.

Icy Hot was the country’s top-selling external analgesic rub brand in 2019 with U.S. sales of more than $155 million, according to the web site Statista. Hisamitsu’s Salonpas patch ranked second with in more than $121 million in sales.

Sorrento officials contend while their patch is only approved for pain tied to shingles infections, doctors often prescribe in a so-called “off-label” manner for back and spinal pain. The company contends ZTlido offers the highest dosage of lidocaine available in a patch.

While federal law prevents companies from marketing prescription drugs for ailments other than those approved by FDA regulators, doctors’ can prescribe any drug if they think it will be an effective treatment for a particular medical issue.

Sorrento executives contend their lidocaine-patch rivals are unfairly diverting possible ZTlido sales through false and misleading claims about Icy Hot and Salonpas patches. The pharma company wants a judge to bar Sanofi and Hisamitsu from continuing to deceive consumers about their over-the-counter products, run corrective ads and pay damages.

The case is Scilex Pharmaceuticals Inc. v. Sanofi-Aventis U.S. LLC, 21-cv-1280, U.S. District Court, Northern District of California (San Francisco).

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