Three former Abbott employees’ case marks groundbreaking use of False Claims Act in infant formula manufacturing
WASHINGTON, Sept. 14, 2026 /PRNewswire/ — Following a 2022 Complaint filed by Stein Mitchell Beato & Missner LLP on behalf of three whistleblowers, Abbott Laboratories (“Abbott”) has agreed to pay the United States and participating Medicaid States nearly $385,000,000 to settle allegations about the quality and safety of powdered infant formula and other nutritional products made at Abbott’s plants in Sturgis, Michigan and Casa Grande, Arizona. The Sturgis plant’s temporary closure in 2022 due to concerns with microorganism contamination triggered a nationwide shortage of infant formula and a federal investigation into Abbott’s manufacturing practices.
The settlement announced today resolves federal and state False Claims Act (“FCA”) allegations that Abbott failed to manufacture certain powdered infant formula and nutritional therapy products that complied with federal and state statutory and regulatory requirements. The products were purchased with government funds under the Special Supplemental Nutrition Program for Women, Infants, and Children (“WIC”) program administered by the U.S. Department of Agriculture (“USDA”), which pays for more than fifty percent of all infant formula sold in the United States. The FCA Complaint was filed by Stein Mitchell Beato & Missner LLP on behalf of former Abbott employees Scott Millard, Kristine Cooper, and Loren Cooper (the “Whistleblowers”) who worked in Abbott’s quality and maintenance operations and reported the misconduct to federal regulators based on concerns with the public health implications for a vulnerable population.
“This landmark settlement demonstrates that the False Claims Act protects not only the public fisc, but also the integrity of essential nutrition programs serving infants and families. When a manufacturer seeks payment through WIC or Medicaid, the government is entitled to truthful certifications and products manufactured in accordance with the requirements that make them eligible for public reimbursement. Our clients showed extraordinary courage and persistence in bringing these issues forward,” said Andrew M. Beato, Chair of Stein Mitchell Beato & Missner LLP’s False Claims Act and Whistleblower Practice Group.
The case information is United States et al. ex rel. Scott Millard, Kristine Cooper, and Loren Cooper v. Abbott Laboratories, No. 1:22-cv-00994-HYJ-SJB (W.D. Mich.).
The settlement is a groundbreaking application of the FCA to infant formula. It recognizes that compliance certifications made to obtain government-funded infant formula business are not empty formalities: they safeguard public funds and help protect infants and children who rely on government nutrition and health programs.
“Parents have every right to trust that infant formula, particularly formula supported by taxpayer dollars, meets required standards. Our clients came forward because they believed Families deserved the truth and transparency. Families should not have to guess what is in the formula can and the government’s decision to intervene reflects how seriously those concerns were taken,” Beato continued.
THE WHISTLEBLOWERS’ ALLEGATIONS
Stein Mitchell filed the original action in the Western District of Michigan on behalf of the Whistleblowers under the FCA’s qui tam provisions. The lawsuit alleged that Abbott knowingly made and sold powdered infant formula and other products that did not comply with federal manufacturing requirements including the Federal Food, Drug, and Cosmetic Act (“FDCA”) and applicable current good manufacturing practices (“CGMP”), thereby increasing the risk of microorganism contamination. At the time the lawsuit was filed, Abbott was responsible for making a substantial portion of the infant formula sold in the United States, including well-known products such as Similac®, Similac Alimentum®, and EleCare®.
The Department of Justice (“DOJ”), acting on behalf of USDA, and six States partially intervened in the qui tam lawsuit in November 2025. According to the DOJ’s Complaint, Abbott certified in bids and contracts that its infant formula complied with FDCA and CGMP requirements. The DOJ alleged that Abbott knowingly caused false claims for powdered infant formula manufactured at Sturgis by misrepresenting compliance with those requirements, including the risk of microbial contamination. The settlement resolves allegations for powdered infant formula and nutritional products manufactured at Sturgis and Casa Grande during the period from January 1, 2018, through December 31, 2022.
A PUBLIC-PRIVATE ENFORCEMENT PARTNERSHIP
The settlement reflects the public-private partnership at the heart of the FCA. The statute empowers private citizens with knowledge of wrongdoing—known as relators—to file qui tam actions on behalf of the United States to combat fraud and recover government funds. Relators, including current employees, are encouraged to bring concealed conduct to the government’s attention for investigation. In this case, the information supplied by the Whistleblowers led to a coordinated multi-agency investigation involving the DOJ’s Civil Division, Commercial Litigation Branch, and Civil Fraud Section; the U.S. Attorney’s Office for the Western District of Michigan; FDA; USDA; and the offices of the attorneys general and Medicaid Fraud Control Units for participating states. That collaboration enabled federal and state authorities to evaluate complex manufacturing and quality evidence and connect alleged regulatory and contractual noncompliance to claims paid by WIC and Medicaid.
“This result shows why the False Claims Act’s public-private model is so important. Insiders see problems that government payors cannot see from a claim form. When courageous employees come forward and work with federal and state enforcement partners, their firsthand knowledge can help achieve accountability, stronger protection for the people public programs exist to serve, and a return of taxpayer dollars” said Melissa S. Fox, a partner in the firm’s False Claims Act and Whistleblower Practice Group.
ABOUT THE FALSE CLAIMS ACT
The FCA is the federal government’s primary civil tool for addressing fraud involving public funds. Qui tam actions by private citizens acting as relators are filed under seal, and the statute provides a civil remedy for retaliation. Successful relators typically receive 15% to 30% of the recovery. Under the FCA’s qui tam provisions, the Whistleblowers have been awarded $69 million from the federal settlement as a share of the recovery. Congress created the relator share mechanism to recognize the value that relator’s information provides to public enforcement efforts and encourage their assistance as a form of incentivized integrity. Since Congress strengthened the FCA in 1986, settlements and judgments have exceeded $85 billion.
ABOUT STEIN MITCHELL BEATO & MISSNER LLP
Stein Mitchell Beato & Missner LLP is a full-service litigation firm that represents whistleblowers in complex federal and state whistleblower matters. The firm combines the resources and trial experience for high-stakes litigation with the close client attention of a litigation boutique. Our attorneys have represented whistleblowers in matters that have recovered more than $3.9 billion for federal, state, and local governments.
Contact Us
Andrew M. Beato, Esq.
Chair of the False Claims Act and Whistleblower Practice Group
abeato@steinmitchell.com
(202) 661-0938
Melissa S. Fox, Esq.
Partner, False Claims Act and Whistleblower Practice Group
mfox@steinmitchell.com
(202) 539-6186
See: U.S. Department of Justice, “Abbott Agrees to Pay Over $384M to Settle Allegations Related to Contaminated Infant Formula” available at https://www.justice.gov/opa/pr/abbott-agrees-pay-over-384m-settle-allegations-related-contaminated-infant-formula (Sept. 14, 2026).
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SOURCE Stein Mitchell Beato & Missner LLP
