Whistleblower Claims Major Baby Formula Company Used Defective Packaging

The business pages are lighting up this morning with the news that baby formula biggie Mead Johnson Nutrition — makers of Enfamil — is being bought by Reckitt Benckhiser (whose brands include baby-stopping Durex condoms) for $16.6 billion, but we’re more interested in a new whistleblower lawsuit from a former Mead Johnson executive who claims the company ignored concerns about defective packaging and fired her for trying to get the problem addressed.

In a complaint [PDF] filed yesterday in an Illinois federal court, Linda O’Risky — the former Global Product Compliance Director for Mead Johnson — says that after 25 years on the job she was fired from the company after she “began raising and escalating concerns about serious safety issues related to defects in the manufacture of Mead Johnson’s ready-to-use infant formula.”

O’Risky contends that this was allowed to happen because of a “culture and organizational structure that increasingly prioritized profits over safety and compliance.”

According to the complaint, the first signs of a problem appeared in early 2015. That’s when O’Risky claims that recently produced 8-ounce containers of Mead Johnson formula began showing signs of spoilage and defective seals.

After the company rejected three batches — nearly one million units — in March 2015 for leaking seals, O’Risky began to grow concerned. She says in the lawsuit that in her decades with the company it was rare to have even a single full batch of formula rejected, let alone three.

Combined with what she claims were an increased number of consumer complaints about spoiled product, O’Risky became concerned that there was a larger systemic problem and that “even more products” could be at risk for contamination during shipping and storage.

She began having consumers who complained about spoiled formula send bottles back so they could be analyzed by Mead Johnson’s Quality Assurance lab, and says she later confirmed that the defect in the seal on those products appeared to be the same defect that had resulted in rejection of the three batches.

According to the lawsuit, the company’s Associate Director North American Quality failed to provide O’Risky with either an explanation for the cause of the defect or what the Mead Johnson would do to remedy it.

She claims that Mead Johnson’s Director of Global Food Safety “largely dismissed her concerns” and said she was mistaken that the FDA regulations regarding canned foods with low acid content applied to their liquid baby formula.

O’Risky says she pointed out that this was demonstrably inaccurate, as the FDA audits Mead Johnson for compliance with those very regulations.

Even when presented with this information, the lawsuit alleges that the Director said that since the product was sterilized at the plant the worst that could happen was spoilage.

Moving up the ladder to Mead Johnson’s Chief Medical Officer, O’Risky says she was told that this matter was a “legal issue beyond the scope of her team’s duties.”

O’Risky says she brought her concerns to the company’s Chief Scientific Officer in April 2015, which resulted in an internal inquiry, but at the expense of allegedly putting her in the crosshairs of upper management.

The lawsuit claims that O’Risky’s boss confronted her after that April meeting, telling her to stop pursuing this issue because a Senior VP at the company was “very annoyed that she had brought forward her concerns.” She says there was a vague promise that the company would handle the situation, but this was insufficient assurance for O’Risky.

“Ms. O’Risky knew that Mead Johnson was failing to meet its legal and regulatory obligations,” notes the complaint, “and she had evidence that Mead Johnson’s management team knew or should have known the same.”

She subsequently took issue with the investigators’ conclusion that these allegedly defective seals didn’t constitute a food safety concern or violate federal guidelines. O’Risky says their argument was that “any spoilage resulting from a defective seal would be obvious to a consumer.”

O’Risky argued that this didn’t matter as “FDA regulations are clear that defective processes and incidents of spoilage in the market must be reported,” particularly for liquid infant formula.

When she pointed out this requirement to the company’s Quality Council, O’Risky claims that her concerns were dismissed.

“It became clear that senior management’s hope was that the defective products would make their way through the marketplace without any major incidents of harm to consumers,” alleges the complaint.

By Aug. 2015, O’Risky says she had twice escalated her concerns to the Mead Johnson Integrity Concern hotline. Though this process was supposed to be anonymous, she’d been so outspoken about this issue, so everyone involved knew that it was her filing these complaints.

That’s when, according to O’Risky, she began being shut out of meetings, and getting cut out of the loop on information that was important for her to do her job.

Mead Johnson dismissed O’Risky in late 2015, claiming her layoff was a cost-cutting aspect of the company’s “Fuel for Growth” initiative.

However, O’Risky contends that she was the only laid-off employee whose computer was immediately confiscated and who was escorted out of the building.

She claims that it was only after Mead Johnson fired her that the company brought the allegedly leaky seals to the attention of the FDA.

The lawsuit alleges that Mead Johnson illegally retaliated against O’Risky for raising valid food safety concerns to her employer. The Food Safety Modernization Act explicitly outlaws employers in the food industry from taking action against whistleblowers.

Likewise, the Sarbanes-Oxley Act prohibits retaliation against whistleblowers for raising concerns about potential fraud, as does the Dodd-Frank Act.

In a statement to the Chicago Tribune about the lawsuit, a rep for Mead Johnson said, “The company’s main focus is — and has been for more than a century — the quality and safety of our products… The packaging matter cited in the suit was thoroughly reviewed by the U.S. Food and Drug Administration, and no action was required.”