Juvederm Lawsuit Claims AbbVie Failed To Disclose Granuloma Risk Associated With Injections

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A proposed class action lawsuit alleges that AbbVie failed to warn consumers and healthcare providers that its Juvederm hyaluronic acid dermal fillers can cause delayed-onset granulomas, leaving patients at risk of permanent facial disfigurement and serious health complications.

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The 26-page complaint contends that AbbVie has long omitted any warning about the development of granulomas—hard masses of immune cells and inflammation that form around infections and foreign objects in the body, even months or years after injections—from Juvederm’s labeling, marketing materials and patient information, despite being aware of the risks through its own testing and medical literature.

According to the class action lawsuit, Juvederm is a line of dermal fillers that comes in four varieties, including Juvederm Ultra, Juvederm Ultra Plus and their lidocaine-containing counterparts. The injections are marketed as a way to smooth facial wrinkles and restore skin volume through the injection of hyaluronic acid, a naturally occurring substance in the body, the suit states.

The case says that delayed-onset granulomas can create hard, painful lumps, discoloration and swelling at injection sites that may require medical treatment and could cause permanent scarring or disfigurement. The suit adds that some patients may also experience fevers, coughs, shortness of breath, swollen lymph nodes, eye irritation, vision problems and headaches.

 

Although the precise cause of granuloma formation remains unknown, the suit references research suggesting that the interaction between hyaluronic acid and butanediol diglycidyl ether (BDDE), a chemical crosslinking agent used to stabilize filler, can create chronic dermatological inflammation in some patients.

The suit alleges that AbbVie has nevertheless failed to disclose the granuloma risk in the materials prospective customers and medical providers rely on before treatment. Instead, the case claims, the company’s labeling characterizes potential “nodules” and growths as harmless, temporary side effects that typically resolve on their own within a month.

The complaint references an AbbVie clinical study involving 72 subjects, in which more than 60 percent of the participants suffered from lumps and bumps at the injection site and up to 22 percent developed nodules. However, the company failed to investigate or warn consumers about whether those reactions could represent or progress into granulomas, the suit claims.

“Thus, for over a decade and a half, Defendant has known of the risk of nodules at the injection site: but their own studies did not follow through to examine the risk of granuloma and delayed-onset granuloma even though there were similar (yet not identical) issues that came up,” the complaint alleges.

The case also references the federal Food, Drug, and Cosmetic Act, which requires cosmetic and medical products to be truthfully labeled and updated whenever new risks are discovered, even after a product is already on the market. Per the suit, AbbVie was obligated to warn consumers and medical providers about the risk of delayed-onset granulomas once evidence of the complication surfaced, but instead continued marketing Juvederm without adequate mention of the alleged danger.

The lawsuit contends that the significance of the omission is heightened by the popularity of Juvederm, which is one of the most popular facial injection brands in the United States.

“This is particularly problematic for those who develop granulomas from HA filler injections like Juvederm because the presence of hard lumps, [n]odules, scarring, and disfigurement generally occur in injection sites which are in the worst possible place: the face,” the filing asserts.

The plaintiff, a California resident, paid thousands of dollars out-of-pocket for numerous Juvederm injections in 2023, the lawsuit says. The woman claims she later developed a delayed-onset granuloma that made her extremely sick and required hospitalization, and saw no reference to the risk prior to receiving the injections.

The Juvederm class action lawsuit seeks to represent all individuals in the United States who purchased Juvederm products from the beginning of any applicable statute of limitations period through the date of judgment or until the alleged conduct ceases.

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