Acella Pharmaceuticals Hit with Class Action Over Alleged Sale of ‘Defective’ Thyroid Medication

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A proposed class action lawsuit alleges Acella Pharmaceuticals has for years falsely touted its NP Thyroid medication as made in accordance with the highest manufacturing standards and containing specific amounts of its active ingredients, among other representations. 

The 75-page complaint in Georgia says that despite Acella’s claims, the FDA has cited the company for “quality control issues” dating back to at least 2012. In fact, the lawsuit relays, the agency concluded after inspections in late 2019 and early 2020 that “[t]here is no quality control unit” at Acella, and that the company was guilty of “significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.” 

According to the filing, Acella issued three Class I recalls—the most serious kind of recall—of NP Thyroid between May 22, 2020 and April 30, 2021. The first, the case says, concerned “super-potent” pills in which the amount of an active ingredient exceeded the amount listed on the bottle by an “unsafe amount.” The next pertained to two lots of “sub-potent” thyroid medication, for which the amount of an active ingredient was below what was promised, the lawsuit states. The third and most recent recall concerned 38 lots of sub-potent thyroid medication with manufacturing dates ranging from March 4, 2020 through March 16, 2021, the suit says. 

The complaint additionally alleges that despite Acella’s claim that it performs “batch-to-batch” testing for NP Thyroid, the company, in truth, only reviewed “the final product testing packet” from one of its associated manufacturers “of less than 1%” of the medication, and did nothing to verify the integrity of the test results, much less ensure that the drugs were properly manufactured. 

“As a result of these and other issues, Acella consistently and knowingly sold defective products, including continued sales of defective NP Thyroid after Acella received multiple citations and a formal warning letter from the FDA for selling adulterated and unapproved drugs,” the lawsuit alleges. 

According to the lawsuit, Acella acknowledged approximately 50 adverse events linked to the apparently defective thyroid drugs. The case alleges that “there were likely more defective lots that went undetected due to Acella’s documented issues related to testing and quality control.”

The lawsuit claims that the plaintiff, a Suffolk County, New York resident, is a victim of Acella’s alleged conduct. According to the case, the plaintiff was damaged not only economically by purchasing NP Thyroid medication that was “worthless” given its alleged defectiveness but also physically as a result of taking sub-potent thyroid pills. From the complaint: 

“While taking Acella’s subpotent medication—but before Acella initiated the third recall and announced that patients should avoid defective NP Thyroid pills—Plaintiff began experiencing significant symptoms of hypothyroidism, including hair loss, extreme fatigue, painful sensitivity to temperature changes, and debilitating hives. Plaintiff has been working with her providers to try to restore her thyroid levels to normal following these events and address the related complications, but it has been a long, painful, and expensive process.” 

The lawsuit aims to represent all persons in the United States who bought or paid for NP Thyroid that was subject to Acella’s recalls or that was similarly defective but which Acella failed to recall. 

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