How a stun gun incident at Abbott’s Michigan plant led to a nationwide baby formula recall

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How a stun gun incident at Abbott’s Michigan plant led to a nationwide baby formula recall

Sat, 08/06/2022 - 02:40
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KAYLA RUBLE, RILEY BEGGIN and MELISSA NANN BURKE The Detroit NewsDETROIT — Inside the quality services department at the Abbott Laboratories baby formula manufacturing plant in Sturgis, employees were in their cubicles on a Friday morning in May 2020 when the sound of an electric shock sizzled through the office space.

One employee thought someone had been electrocuted. A worker holding a stun gun promised it was just a bug zapper before deploying the device again, sending another jolt of electricity through the office.

“It’s definitely a stun gun and not a bug zapper,” said one worker, according to internal Abbott employee communications obtained by The Detroit News.

Later an employee who was in the room at the time sent an email to Abbott management about a “possible weapon” in the quality systems department.

“Since, whatever this is, is being played with openly, I am concerned someone is going to get hurt,” the worker wrote in an email that morning.

The incident emboldened awhistleblower, a quality assurance specialist at the plant at the time, to come forward and confront supervisors at the Abbott’s Sturgis site over its safety. 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 that is blamed for sickening infants after the U.S. Food and Drug Administration issued a warning against several of the plant’s products.

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 establish 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 theemployee 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 following month, the now former employee filed hisfirst of two complaints with government regulators. His complaint in September 2020 about the stun gun incident to MIOSHA was the opening salvo for wider-ranging whistleblower allegations that the Abbott plant operated under what he later described to federal regulators as a culture of “unrelenting pressure to meet metrics” that routinely trumped product safety concerns in the production of baby formula.

(See BABY, Page 4B)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.

MIOSHA dismissed the former Abbott employee’s initial workplace safety complaint in June 2021, just over a year after the stun gun incident. But by then, the fired Abbott employee had already elevated his concerns about product safety to higher levels of government.

Four months before Michigan regulators dismissed his original complaint about the stun gun incident, the former Abbott employee was seeking whistleblower protection under the Food Safety Modernization Act of 2011. His federal Occupational Safety and Health Administration complaint alleged that the employee was fired for engaging in protected activity related to repeatedly raising or objecting to product safety issues, which he believed violated FDA regulations.

With the help of a lawyer, the former Abbott employee later sent a more detailed accounting of alleged product safety allegations to the FDA in September 2021, about five months before federal regulators shut down the plant.

Abbott Nutrition’s plant had lax cleaning procedures, untested baby formula was sent to store shelves after the discovery of harmful micro-organisms and a bottle-labeling machine in the factory frequently failed, causing some products to become untraceable in the event of a recall, according to the fired employee’s complaint sent to the FDA.

The whistleblower outlined cleaning practices that were “inadequate in countless ways.” An FDA inspection report from February also said the company failed to ensure all surfaces that came into contact with baby formula were maintained to prevent contamination of the product.

In another allegation, the former employee claimed there were years-long issues with drying equipment that was “failing and in need of repair.” As a result, he said bacteria was not properly cleaned from equipment pipes, causing the baby formula to pick up the bacteria as it flowed through the pipes.

Several concerns and claims outlined in the whistleblower report have since been corroborated by an FDA investigation and the company’s own admissions to federal regulators, leading to the plant’s closure from February through early June. The shutdown was blamed for contributing to a nationwide shortage this spring of certain blends of baby formula.

However, Scott Stoffel, a spokesman for Abbott, said the former employee “was dismissed due to serious violations of Abbott’s food safety policies.”

“While at the company, the former employee did not bring forward product safety violations to our Office of Ethics & Compliance or others,” Stoffel said in a statement to The Detroit News. “After dismissal, the former employee brought forward a complaint to Michigan OSHA unrelated to product safety. That complaint was dismissed.”

A ‘highly regarded’ employeeThe complaint came from a quality service specialist at Abbott Laboratories who had worked at the Sturgis plant for nearly six years prior to being fired on Aug. 24, 2020. Before taking the job in Sturgis, he worked as a packaged quality supervisor at Monsanto.

According to the filings with MIOSHA as well as the complaint lodged with federal regulators after his termination, the employee had a habit of raising complaints about regulatory violations and refusing to go along with protocols to sign off on products leaving the plant.

Annual performance reviews depict a “highly regarded” employee who occasionally had communication issues but appeared enthusiastic about addressing them, according to a June 3, 2021, investigation report prepared by MIOSHA investigator April Strahan.

But in his final year of employment, he and other employees found themselves at odds with management over quality evaluations and assessments, according to the federal complaint, with claims that supervisors were pushing practices aimed at meeting certain production metrics.

“Increasingly ... management directed him and others to misuse the (standard quality evaluation) procedure in order to meet metrics for the Sturgis site,” according to the product safety complaint. “At times, complainant and others objected ... on occasion, managers were repeatedly confronted and questioned as to the appropriateness of the directive being given.”

The complaints are not the first time Abbott has faced pushback from workers about how its Sturgis plant has been run. Multiple lawsuits filed against the company over the last 15 years depict a workplace marred by favoritism, inconsistent standards and selective punishment.

In a lawsuit filed in St. Joseph County in 2012 by former employee James Hoffman, the former energy center operator accused the company of violating whistleblower protections. According to the plaintiff, the company intentionally fired him as he was preparing to file a discrimination complaint with the state of Michigan over unequal workplace benefits, conditions and privileges.

The lawsuit describes efforts by colleagues to falsify testing data and records, while accusing supervisors of allowing certain employees to violate company policies without recourse. In one instance, an employee allegedly took a company camera with him on vacation that was needed in the plant. Two employees were also reportedly allowed to remove a dead deer from Abbott’s property and take it to a deer processing facility while clocked in at work.

The case was settled out of court. A 2006 federal lawsuit accused the managers at the Sturgis plant of discriminating against an African American employee by firing the worker for a mistake that White employees made without being disciplined. That suit also was settled before going to trial.

‘I would have been fired on the spot’ The four-month-long halt of Abbott’s baby formula manufacturing in Sturgis — and a subsequent nationwide shortage of formula — traces to the May 29, 2020, stun gun incident inside the plant’s quality services department, where employees are charged with ensuring the quality of the liquified and powder food products being produced for infant consumption.

Outside the plant, COVID-19 was raging. While much of the company was working remotely, the staff inside the quality systems department was still onsite working to ensure that production continued for critical products consumed by vulnerable people with often serious medical conditions, including specialty baby formula.

The electric sounds that whizzed through the Abbott office had in fact come from a stun gun that a colleague had brought into work, apparently to show to another colleague, according to an interview conducted by MIOSHA with a supervisor in Abbott’s quality assurance division and internal documents regulators obtained.

The presence of the weapon created alarm within the department. Later that morning, with the staff still shaken by the incident, the quality assurance specialist sent the email alerting several layers of Abbott management, including an immediate supervisor, a next-level manager and the plant’s quality assurance director.

After being notified, the supervisor sought to address the concerns by having a conversation with the employee who had brought in the stun gun. The employee was warned that bringing the device or any other type of weapon onto the premises was inappropriate. If it happened again, the worker was told, it could result in disciplinary action, according to MIOSHA’s investigation and emails from multiple employees.

No one alerted staff in the employee relations division and no police reports were filed, the state report said.

It wasn’t the first time weapons issues had come up at the plant. In one previous instance, multiple employees were fired for selling a gun in Abbott’s parking lot. No weapons were discharged in that incident. On another occasion, an employee arrived on company property with a rifle inside the worker’s vehicle, having gone straight to work after hunting. That employee was also terminated, according to the state’s investigation.

The quality assurance specialist was unhappy with how the stun gun situation was handled. On June 1, 2020, the employee elevated the concern to someone in upper management in Abbott’s corporate headquarters in Chicago. In an email, he told that person he didn’t “trust local leadership.”

In a later email sent on July 8, 2020, the employee expressed concern to someone in Abbott’s headquarters that the co-worker who fired the stun gun in the office was getting special treatment from his immediate superiors at the plant.

“ ... If I was the one who brought in the stun gun, I would have been fired on the spot,” he wrote. “ ... This type of employee does not make mistakes like bringing a weapon to work unless they know they can get away with it.”

In a long email that MIOSHA redacted names from, the complaining employee later wrote that “this weapon issue is just the tip of the iceberg.”

Seven weeks later, he was fired. According to Abbott, the quality assurance specialist was fired for failing to order necessary testing on three batches of products and allowing those batches to go out for delivery, something the company says qualifies as a serious mistake.

When asked by The News about the stun gun incident, Abbott spokesman Stoffel said, “We don’t allow weapons at work and addressed the matter.”