Sen. Elizabeth Warren (D-Mass.) sent a letter Wednesday to Abbott Nutrition accusing the company of employing “abusive legal tactics” to cover up health risks with its powdered infant formula product — safety concerns she said the business has been aware of for decades.
In the letter, an early version of which was provided exclusively to The Hill, Warren alleged the company used nondisclosure agreements with families who were affected by contaminated infant formula.
The senator said Abbott Nutrition has been aware of cronobacter, a bacteria that can cause deadly infections in babies, in its powdered infant formula product since 2003.
In 2011, Abbott Nutrition went to great lengths to silence families after an outbreak led to several lawsuits against the company, she alleged in the letter.
“The use of aggressive legal tactics and settlements that required families ‘to keep quiet’ undoubtedly played a role in limiting the public’s knowledge of the health risks to babies from Cronobacter and shielded your company from scrutiny even as consumer complaints and citations by federal regulators grew,” Warren wrote.
The Hill has reached out to Abbott Nutrition for comment.
The New York Times reported last month on allegations that Abbott Nutrition covered up health risks with its infant formula.
Abbott Nutrition came under scrutiny earlier this year amid a nationwide infant formula shortage, which was exacerbated by the February closure of an Abbott plant in Sturgis, Mich., over safety concerns.
The plant was closed because four infants were infected with cronobacter after consuming the company’s powdered formula product. Two infants died.
The Food and Drug Administration (FDA) investigated seven other deaths potentially linked to the Sturgis plant, The Washington Post reported in June.
Abbott has denied there is conclusive evidence that any of the deaths are connected to the formula.
Abbott eventually reopened its Michigan plant and the shortage was relieved after the Biden administration stepped in to ramp up production, including by flying in infant formula product from overseas.
Warren on Monday tied the company’s alleged efforts to cover up its product risks with the formula shortage that led to widespread difficulties for American families over the spring and summer.
She demanded answers from Robert Ford, the chairman and CEO of Abbott Laboratories, which owns Abbott Nutrition, including a list of litigation against the company related to the bacteria infections back to 2003 and a list of settlement agreements with families on the issue.
“The use of these legal tactics to keep potential risks out of the public eye is part of a broader strategy your company employed to actively cover up inadequate safety practices,” she wrote.
According to the senator, from September 2019 to September 2021, Abbott Nutrition reported five samples containing cronobacter from the Sturgis plant.
The FDA was alerted to potential problems with the Sturgis plant by a whistleblower as far back as February 2021.
The whistleblower reported concerns that product was being distributed without proof it could be consumed safely while also noting concerns with broken and failing equipment. Additional whistleblower reports were filed in the fall of 2021.
The whistleblower also charged that Abbott actively falsified test records, expiration dates, and maintenance records to reduce oversight, Warren noted.
The senator accused Abbott of making record profits amid the campaign to cover up its safety risks while not investing the money back to enhance safety or training practices.
“Even as your company continued attacking families in court and cutting corners on equipment and safety, barreling towards the crisis that has harmed infants, children, and adults across the country, you were raking in record profits,” she wrote.