Abbott Michigan plant back under federal investigation over baby formula

The Justice Department is investigating conduct at the Abbott Laboratories infant-formula plant in Sturgis, Michigan, following its shutdown last year that worsened a nationwide formula shortage.

Attorneys with the Justice Department’s consumer-protection branch are conducting the criminal investigation, sources exclusively told the Wall Street Journal Friday.

The branch, which has criminal as well as civil authority, was involved last year in a settlement with Abbott that allowed its Sturgis plant to resume operations after Food and Drug Administration inspectors found a potentially deadly bacteria there, according to WSJ.

"DOJ has informed us of its investigation and we’re cooperating fully," Scott Stoffel, a spokesman for Abbott, told The Detroit News.

Abbott representatives did not provide details of the investigation or how many people it employs in Michigan.

The Sturgis plant is the country's largest manufacturing plant for infant formula.

Abbott's recalled products included powder formula sold under the labels Similac, Alimentum and EleCare labels after four children became ill with bacterial infections and two died.

Several Abbott employees are accused of manufacturing the baby formula under conditions that did not meet regulatory standards for quality and safety, according to a federal court filing. 

A Detroit News report dove into a whistleblower claim last year on how a stun gun incident at Abbott's Michigan plant led to a nationwide baby formula recall.

A quality assurance specialist at the plant at the time came forward and confronted supervisors at the Abbott’s Sturgis site over its safety in 2020. It set off a series of events that led to several investigations and the company's ultimate decision to shut down the facility for months and issue a nationwide recall of formula.

The details of the whistleblower's actions are detailed in 658 pages of Michigan Occupational Safety and Health Administration (MIOSHA) documents obtained and reviewed by The News under an open records request. The records detailing the state's investigation of Abbott established a more complete timeline for the events that transpired at the troubled baby formula plant.

They also provide insight into the nearly year-long effort by one Abbott employee and his Kalamazoo-based attorney to warn government agencies about internal problems at the facility that they believed put both consumers and plant workers at risk.

By June 2020, when the employee felt his supervisors in Sturgis failed to take action, he elevated his concerns to upper management at the company’s headquarters in Illinois. 

Less than two months later, the employee was fired, sparking claims that Abbott had retaliated against him for speaking up about a safety issue that violated company policy and for “repeatedly” raising issues about product safety, according to the state records.

The state documents also reveal the whistleblower raised product safety concerns with state investigators in December 2020, two months before federal regulators were alerted to problems at the Sturgis plant. 

In May, Abbott reached a deal with the U.S. Department of Justice to restart production. The consent agreement required Abbott Laboratories to take a series of steps aimed at increasing safety at the facility and bring the company into compliance with federal regulations before it could resume operations.

srahal@detroitnews.comTwitter:@SarahRahal_