Whistleblower Outed Abbott Labs Two Years Before FDA Closed Sturgis Plant

Sturgis, MI Evidence of contaminated baby formula sounds like it should have been an “all-hands-on-deck” emergency for Abbott Laboratories and the Food and Drug Administration. Instead, it took the FDA nearly two years to send inspectors to the Sturgis, Michigan plant, where they found “shocking” conditions. By then two babies had died and several more had become ill. Had it not been for the dogged persistence of a whistleblower who filed federal and state OSHA complaints as well as an FDA complaint, the tainted formula could have hurt many more.

A disturbing timeline, a toxic culture

Early in 2020, an Abbott employee, whose name is redacted in the complaint released by Rep. Rosa DeLauro, notified management about potential bacterial contamination of formula manufactured at its Sturgis plant. Shortly thereafter, the company fired him, alleging that he had violated food safety policies.

The worker filed a Michigan OSHA lawsuit that charged Abbott with discrimination and retaliating against him. In February 2021, he filed a complaint under the federal Food Safety Modernization Act. Ultimately, in October 2021, he filed a complaint with the FDA.
The management culture at the Sturgis plant was reportedly tight and socially friendly. According to Politico, “current and former employees were ‘fearful of retaliation’ — a dynamic made more extreme by the fact that Abbott is the highest paying and largest employer in Sturgis.”

The FDA did not send inspectors to the Sturgis plan until in March 2022. The plant closed, reopened briefly and then closed again in June because of flooding. In what looks like the old middle school, “I’m rubber; you’re glue” defense, Abbott accused the worker of retaliating against the company by repeatedly escalating his complaints after he was fired.

And a history of contamination

The issues raised by the anonymous worker and eventually confirmed by FDA inspectors seem serious enough, even to those of us with no background in food manufacturing safety. He reportedly cited equipment in need of repair and formula released without adequate evidence that it was safe for consumption.

The FDA inspectors’ observations were more damning. They noted:

• cracks in key equipment that allowed bacteria to enter;
• a leaking roof and water collecting on the floor;
• workers handling raw materials, packing, and equipment without properly washing their hands; and
• nooks, crannies and pitting in food processing equipment where bacteria could lodge and grow.

They concluded that Abbott “did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition.” The conclusion may not have been surprising given sanitation problems at the plant noted in the past.

In 2019, Abbott had found the potentially deadly cronobacter pathogen in its finished product. The 2019 inspection also noted, as the whistleblower did in the following year, that plant workers were not adequately testing for pathogens. Earlier, in September 2010, the company recalled some of the Similac powdered formula produced at the Sturgis plant after beetles and beetle larvae were found in the finished product.

Whistleblowers are protected from employer retaliation    

          
There are more than 20 federal whistleblower protection laws that cover industries including airlines, consumer products, environmental companies, financial reform and food safety. Although industry- specific, they share many basic characteristics, including protections for whistleblowers.

The Food Safety Modernization Act (or FSMA), which is at issue here, specifically protects workers in the food manufacturing industry from employer retaliation.

The kinds of activities that OSHA considers “whistleblowing” under FSMA include:

• providing information relating to any violation of the federal Food Drug and Cosmetic Act or any act that they reasonably believe to be a violation of that law;
• testifying, assisting, or participating in a proceeding concerning a violation of the Food Drug and Cosmetic Act;
• objecting to or refusing to participate in any activity that he or she reasonably believed to be in violation of tat law.

When a worker exposes potentially illegal conduct, employers may retaliate in many ways, including:

• firing or laying off a worker;
• reducing pay or hours;
• denying overtime;
• blacklisting;
• demoting or denying a promotion;
• reassigning;
• disciplining;
• denying benefits:
• failing to hire or rehire; and
• intimidating or threatening a worker.

How to file a retaliation complaint

Employees who believe they have been retaliated against may file a complaint with OSHA by visiting or calling a local OSHA Office, sending a written complaint to the closest OSHA office or filing a complaint online. Many workers choose, at this point, to work with an attorney who specializes in OSHA cases.

The agency will then investigate the complaint and take action where it seems appropriate. If OSHA chooses not to pursue action against the employer, an employee may still bring a whistleblower lawsuit in court. This will certainly go better with legal representation.

Time is very important, however. An employee who believes that he or she has been retaliated against in violation of FSMA must file a complaint within 180 days after the retaliatory action. There is no time to waste if you believe that your employer has retaliated against you for outing violations of law.