Acella Pharmaceuticals Hit with Class Action Over Alleged Sale of ‘Defective’ Thyroid Medication [UPDATE]
Last Updated on March 26, 2024
Faulkner v. Acella Pharmaceuticals, LLC
Filed: May 12, 2022 ◆§ 2:22-cv-00092
A proposed class action lawsuit alleges Acella Pharmaceuticals has for years falsely touted its NP Thyroid medication.
March 26, 2024 – Acella Thyroid Medication Lawsuit Settlement Website Is Live
The official website for the Acella NP Thyroid class action settlement is live and can be found at NPTSettlement.com.
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To receive class action settlement benefits, eligible class members must file a claim online or by mail between June 1 and November 30, 2024.
As part of their claim, class members must provide documentation showing an NP Thyroid prescription was dispensed between May 12, 2018 and April 30, 2021. If you seek a payment greater than the $10 minimum, the documentation must indicate the amount you paid out of pocket. All required documentation must be submitted by the November 30 deadline.
To file a claim form online, along with related certification and authorization forms, head to this page after June 1, 2024. Alternatively, you may download the PDF claim form and all other forms once the submission portal opens or contact the settlement administrator to request paper copies to return by mail.
A final approval hearing is set for May 14, 2024. Payments will be distributed to eligible class members if the court grants final approval to the settlement and after any objections or appeals are resolved.
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February 20, 2024 – Acella Agrees to More Than $41M Settlement in Thyroid Medication Lawsuit
The proposed class action lawsuit detailed on this page has been resolved with a settlement worth an estimated $41 million, with consumers covered by the deal set to receive anywhere from $10 to $50 each.
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The settlement, which was preliminarily approved by the court on February 7, 2024, covers anyone in the United States for whom a prescription for NP Thyroid was dispensed between May 12, 2018 and April 30, 2021, regardless of whether the NP Thyroid purchased was subject to a recall by Acella.
The plaintiffs first notified the court of the agreement with Acella, and filed a 42-page unopposed motion detailing the terms of the deal, on February 2 of this year. The parties now await final approval of the settlement terms from United States District Judge Richard W. Story.
As part of the settlement, Acella has agreed to refund eligible class members’ out-of-pocket prescription expenditures up to the lesser of $50 or a 90-day NP Thyroid supply, the motion relays. The company has also agreed to pay $10 to eligible class members who had no out-of-pocket expenses or if their costs fall below that amount, the document adds. Per the motion, no class member will receive more than $50.
The motion points out that individuals are not eligible for a settlement benefit if they have already received a refund for any purchase associated with the NP Thyroid recalls in May 2020, September 2020 or April 2021, or if they have requested a refund for any purchase made between May 12, 2018 and April 30, 2021 through a different program.
According to the motion, the reimbursement benefit is estimated to be approximately $41,473,000 in value, which will be divided among roughly 1,200,000 class members.
Court documents show that notice of the settlement will be disseminated to class members through digital media campaigns and posted on Acella’s website within 15 days of the judge’s February 7 order.
ClassAction.org will update this page once an official settlement website is established. A final approval hearing is scheduled for May 14, 2024.
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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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Hair Relaxer Lawsuits
Women who developed ovarian or uterine cancer after using hair relaxers such as Dark & Lovely and Motions may now have an opportunity to take legal action.
Read more here: Hair Relaxer Cancer Lawsuits
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