Senator Questions Abbott for Covering Up Infant Formula Cronobacter Problems With Aggressive Legal Tactics

Abbott Laboratories has been accused of using "scorched earth" legal tactics to conceal information on contaminated Similac and other baby formula products.

U.S. Senator Elizabeth Warren has sent a scathing letter to Abbott Laboratories, accusing the makers of Similac and other baby formula products of engaging in aggressive legal tactics to avoid being held accountable for food poisoning outbreaks linked to cronobacter and salmonella bacteria in its products.

Abbott’s Chief Executive Officer, Robert B. Ford, received a letter (PDF) this week from Senator Warren, inquiring about the use of “scorched earth” legal tactics designed to avoid “disclosure and accountability” for a number of illnesses and deaths, which resulted in an infant formula recall earlier this year.

The manufacturer issued a massive Similac, Alimentum and Elecare recall in February 2022, after acknowledging that powdered formula manufactured at a Michigan facility was contaminated with Salmonella Newport and Cronobacter sakazakii bacteria. However, there is increasing evidence that Abbott knew about the formula contamination problems long before disclosing it to parents and the public.

Contaminated Similac, Alimentum and EleCare Formula

At least two infant deaths and hundreds of illnesses have been reported by parents who fed the recalled formula to their children, and subsequent investigations have revealed that Abbott ignored industry safety standards and best practices at its facility for years, endangering children for the sake of profits.

Shortly after the recall, individual and class action lawsuits started to be brought, and it is ultimately expected that several thousands Similac, Alimentum and EleCare Recall lawsuits will be included in the litigation.

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Similac, Alimentum and EleCare Lawsuits

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In her letter, Warren noted the company had fought for, and received, a court order sealing trial testimony and evidence brought by the family of an infant who suffered debilitating brain damage after allegedly eating an Abbott infant formula product contaminated with cronobacter. That case was seven years before the recent recall and food poisoning outbreak.

Warren pointed out that between September 2019 and September 2021, Abbott found cronobacter in five environmental samples in its Sturgis, Michigan facility. Warren also noted that previous judges had accused Abbott of using previous court victories to assist in its cover-up, preventing parents from learning about the risks of cronobacter in its products.

“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,” Warren’s letter states. “According to FDA Commissioner Robert Califf, the 2022 FDA inspection found similarly ‘shocking’ conditions that included standing water, cracks in essential safety equipment, and even inadequate handwashing and staff sanitation that gave the agency ‘no confidence in the integrity of the Abbott Quality Program at this facility.’”

Warren’s letter calls for Abbott to provide Congress with a list of all litigation involving cronobacter and its products since 2003. It also called for a list of settlements regarding alleged cronobacter infections since 2003.

Botched Similac Recall Investigation

Soon after the recall, it became apparent that Abbott and the FDA knew about the Similac contamination problems since at least September 2021, when the Minnesota Department of Health began investigating a case involving an infected infant. However, the formula continued to be distributed, remained on store shelves and families nationwide continued to feed the contaminated products to infants for another several months.

In February 2022, Abbott was forced to close the Sturgis, Michigan plant where the formula was contaminated, due to widespread safety problems, which shut down production at one of the major sources of infant formula in the United States. This contributed to a nationwide shortage of infant formula earlier this year.

In September, the FDA issued a 10-page report highlighting a number of deficiencies on behalf of the agency, indicating it had failed to properly respond to the outbreak and problems at the facility.

Abbott now faces dozens of contaminated Similac lawsuits brought by families of infants nationwide who were diagnosed with Salmonella, Cronobacter or other infections linked to bacteria at the manufacturing facility, and serious questions are being raised about why the problems were not addressed much earlier.

Necrotizing Enterocolitis (NEC) Lawsuits Over Similac and Enfamil

Concerns about Abbott’s handling of contaminated baby formula come as the company is already facing hundreds of necrotizing enterocolitis (NEC) lawsuits that have been filed by parents of premature infants who developed a devastating gastrointestinal condition after they were fed the cow’s milk formula in the hospital or NICU.

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Baby Formula Lawsuits

Premature infants fed Similac or Enfamil cow's milk formula faced increased risk of necrotizing enterocolitis (NEC) or wrongful death.

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Litigation emerged over the past few years after studies found premature infants face a substantially greater risk of developing NEC after they are fed Similac, Enfamil or other cow’s milk-based formula products, as opposed to a mother’s breast milk, donor milk or human milk formula products.

Although there is evidence that Abbott Laboratories has known about the NEC risks for premature infants for years, the company has engaged in aggressive marketing to hospitals and parents of new borns, including versions of their product specifically intended for premature infants. As more information has come out about the risk, the company has also engaged in abusive and aggressive legal tactics in response to early NEC lawsuits, including threats to lawyers advertising to raise awareness among families about the potential for a settlement.

October 2022 Similac Lawsuit Update

The problems over Similac formula have resulted in two separate coordinated proceedings in the federal court system, including one multidistrict litigation (MDL) established before U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois for all Similac, Alimentum and EleCare recall lawsuits. A separate MDL proceeding has been established before U.S. District Judge Rebecca R. Pallmeyer for the Similac NEC lawsuits, as well as Enfamil NEC lawsuits brought over problems linked to the competing cow’s milk formula.

While early pretrial proceedings before Judge Kennelly are still being established in the litigation over contaminated baby formula in October 2022, Judge Pallmeyer has established a “bellwether” process in the NEC case, where the parties are already selecting a small group of representative claims for early trial dates.

Although the outcome of these bellwether trials will not be binding on other plaintiffs pursuing lawsuits against Abbott, they will be used to gauge how juries are likely to respond to certain evidence and testimony about the aggressive strategies employed by the company to withhold information about the risks associated with their products, and may have a large impact on the amount of Similac settlements Abbott may pay to avoid the need for each individual lawsuit to go before a separate jury.

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