Abbott Questioned Over Months Delay in Reporting Similac Contamination Problems

Two U.S. senators are requesting Abbott Laboratories explain why it delayed announcing a Similac recall, indicating that it appears warnings about the contamination problems were not disclosed to parents and caregivers until several months after the company learned that Cronobacter and Salmonella may have tainted powdered formula at its Michigan manufacturing facility.

Senators Patty Murray, chair of the U.S. Senate Committee on Health, Education, Labor and Pensions, and Robert Casey, Jr., chair of the Subcommittee on Children and Families, sent the letter (PDF) to Abbott CEO Robert B. Ford on February 24, saying they were “incredibly concerned” about reports that the company had received complaints about the Similac contamination problems as early as September 2021.

The Similac formula recall was first announced on February 17, impacting certain Similac, Alimentum and Elecare formula products made at the company’s manufacturing facility in Sturgis, Michigan. At that time, the company indicated that it was aware of at least three severe illnesses and one death. However, this week, Abbott posted an update about contamination problems with another lot of Similac PM 60/40 formula not previously included in the recall, after learning about another infant’s death.

Similac PM 60/40 was recalled after Abbott learned that an infant died after testing positive for Cronobacter sakazakii, after only consuming that version of the powdered formula. This raises serious concerns that the company may have failed to properly recall all Similac, Alimentum and Elecare products that are contaminated.

Most disturbing to the senators, however, is that the company apparently knew about the contamination as early as September, yet delayed warning parents and caregivers to stop feeding the tainted baby formula to their children.

“According to press reports, the Minnesota Department of Health began investigating a case of an infant infected with Cronobacter sakazakii in September 2021,” the letter notes. “The baby was hospitalized for 22 days. The investigation revealed the infant had been fed with formula produced at Abbott’s Sturgis facility. The Minnesota Department of Health shared this information with the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) at the time. Abbott also confirmed it received a complaint the same month.”

The letter requests Abbott give Congress all internal documents and communications related to Similac contamination problems at the Sturgis facility from 2017 to the present. They also request all communications and internal documents linked to the monitoring of environmental contamination with Cronobacter sakazakii, Salmonella Newport and any other harmful bacteria at the facility, as well as documents and communications linked to the destruction of any contaminated products since 2017 and any investigations or reviews by Abbott or consultants related to manufacturing conditions and practices at the Sturgis facility in the same time frame.

Similac Formula NEC Lawsuits

The delay in reporting the Similac contamination problems came as Abbott was facing a rapidly growing number of necrotizing enterocolitis (NEC) lawsuits brought by families of premature infants diagnosed with the devastating gastrointestinal disorder after being fed the company’s cow milk formula in the NICU.

The families allege that Abbott knew for years about the risks Similac posed for premature infants, yet continued to market and promote the products for use among preemies and low-birth weight infants, causing severe intestinal perforations, infections and the need for emergency surgery or infant deaths.

In recent years, a number of studies have highlighted a link between baby formula and NEC for preterm infants, resulting in sudden intestinal perforations that allow bacteria to leak through, causing abdominal infections and intestinal tissue to die off. If the condition is not fatal, often times NEC survivors experience long term side effects from surgery to remove dead bowels, resulting in a lifetime of bowel complications.

According to allegations raised in the Similac NEC lawsuits, Abbott Laboratories withheld warnings and information from parents and medical providers for decades, placing desire for profit before consumer safety. Similar claims are also being pursued against Mead Johnson in Enfamil NEC lawsuits brought by families of babies who received this competing cow’s milk formula instead of breast milk.

Given common questions of fact and law raised in complaints filed in recent months throughout the federal court system, Abbott Laboratories filed a motion to create a Similac MDL weeks before disclosing the contamination problems, which would centralize the litigation before one judge for coordinated discovery and pretrial proceedings. The U.S. Judicial Panel on Multidistrict Litigation (JPML) is expected to schedule oral arguments on the motion during an upcoming hearing session later this month.