A New Database Compiles Millions of FOIA Records to Analyze Trends
Abbott Laboratories (NYSE: ABT), the giant U.S.-based medical device and health care company, revealed on February 17 that it faces civil and criminal investigations by the Justice Department, the Securities and Exchange Commission, and the Federal Trade Commission related to multiple problems in its infant-formula business. But long before that, numerous law firms and news organizations were investigating the same alleged crimes by the pharmaceutical giant, a new database reveals.
The existence of previously unreported inquiries into Abbott’s alleged misconduct, including deadly contaminants at its main plant in Sturgis, Mich., is disclosed in a new information resource, FOIAengine, which tracks federal Freedom of Information Act requests in as close to real-time as their availability allows. The data from FOIAengine, a competitive-intelligence tool created by PoliScio Analytics, illustrates how far ahead of the government some private players were and raises questions about whether lives were needlessly lost due to inaction.
The FDA had been scrutinizing the Sturgis plant for months before finally issuing a public warning on February 17, 2022 that parents shouldn’t use the market-leading Abbott products sold under the brand names Similac, Alimentum, and Elecare because of potential cronobacter contamination. Abbott initiated a recall the same day. The warning and recall came after four children — one in Minnesota, one in Texas and two in Ohio — fell ill with bacterial infections. Two died. The FDA said it found cronobacter in the Sturgis facility and that the bacteria “may have contributed to the cause of death for both patients.” Abbott denies that there is a direct link between its products and the illnesses or deaths reported in infants.
FOIAengine shows the predictive early-warning power of the more than 800,000 FOIA requests that federal agencies receive each year. Fifteen months before the FDA’s action, a law firm specializing in baby-formula cases raised an alarm about the safety of Abbott’s baby-formula products. In its FOIA request, the law firm wanted to know what the agency knew – and when – about diseases, including necrotizing enterocolitis (NEC), that could endanger premature babies who were fed formula made by Abbott. The firm’s request also named another baby-formula maker, Mead Johnson, a subsidiary of London-based Reckitt Benckiser Group (NASDAQ: RBGLY).
The initial FOIA inquiry from the baby-formula lawyers came into the FDA on November 25, 2020. The plaintiffs’ law firm did not disguise its intent: The four-lawyer Connecticut firm of Levin, Rojas, Camassar & Reck runs a website called BabyFormulaLawyers.com. The firm’s lawyers knew they were on to something. Docket Alarm analytics show that Levin, Rojas was the first to file baby-formula lawsuits. The firm now has dozens of lawsuits pending against Abbott and Mead Johnson.
The lawyers’ FOIA request was specific and sweeping in its scope, with subpoena-like questions that should have put the FDA on notice. Among many things, the law firm sought any and all records the FDA possessed about adverse effects, including NEC, from Similac and other infant formulas fed to premature babies.
The FDA rebuffed the lawyers’ request. “Your request will take approximately two years and fees will need to be increased to $16,000 to fulfill,” an FDA official replied. The lawyers later revised their request in order to receive some documents within two months, at a cost of $1,300.
“[It would have been] an astronomical amount of money to get all those records,” said attorney Stephen Reck. “I guess I was naïve. I always thought these documents were free.” Reck said the documents that the FDA produced were useful. But “I feel like it wasn’t as easy as it should have been. It felt like we had to negotiate to get information from the federal government, which doesn’t seem right. Huge amount of money and time.”
That first FOIA inquiry presaged looming problems for Abbott. At the time, the company was riding high, achieving record revenue of $43.7 billion and winning raves for its breakthrough rapid test for COVID-19.
The FDA, meanwhile, was struggling to keep up with baby-formula plant safety inspections, including at Abbott’s Sturgis facility, the nation’s largest. It would be almost another year – September 20, 2021 – before the FDA finally got around to conducting a routine inspection at the Sturgis plant. Only then, according to an official FDA timeline, did an FDA investigator search the agency’s records for related consumer complaints. The on-site inspection found minor violations, but wasn’t immediately followed up on due to agency bungling and a COVID-19 outbreak at the plant. By then, the first FOIA inquiry about possible infant-formula contamination had been in the FDA’s database for 10 months.
Soon, the FDA was hearing from state authorities, consumers, and confidential informants that infants who consumed powdered formula from the Sturgis plant had developed deadly infections. But the agency concluded the pathogens weren’t attributable to Sturgis, and didn’t reinspect the Abbott facility until another four months had gone by. The reinspection resulted in the FDA’s shutdown of the Sturgis plant, causing a nationwide shortage of baby formula and a national political controversy. The U.S. military began airlifting supplies from Europe. “We have all seen the images of empty store shelves and heard the stories of parents of kids unable to find the food their children need to survive,” the FDA’s commissioner later testified. “This situation is unacceptable.”
FOIAengine’s database shows that FOIA inquiries about Abbott quickly mounted as the company’s Sturgis plant finally shut down in mid-February 2022 and its stock price plummeted 30 percent from its all-time high. Eventually, FOIA requests to the FDA numbered 74 over an 18-month period. Many of the information demands were from the news media – notably Bloomberg, CNN, NBC, the New York Times, the Wall Street Journal, and the Washington Post – signaling no end to the bad publicity for Abbott. There also was a direct correlation between FOIA demands about Abbott and lawsuits filed against the company, which as of January 31 totaled 399 in federal and state courts, according to Abbott’s recent Form 10-K filing with the SEC.
As FOIAengine reveals, the lead time was long between the first FOIA request from Levin, Rojas and the cascade, following Abbott’s recall, of FOIA requests from lawyers, securities analysts, public-interest groups and news organizations. Negative publicity led to even more FOIA demands, such as when a food-safety activist’s FOIA request disclosed that the FDA had been sitting on 128 consumer complaints about Abbott’s formula, and reports of nine deaths, before it took action. The FDA said not all the complaints could be traced back to Sturgis.
Still, that very first FOIA inquiry was an early tip-off about all the bad news to come.
Abbott now has multiple law firms fighting three federal investigations and hundreds more baby-formula lawsuits in the U.S., Canada and Israel. According to last week’s SEC filing by Abbott, “While it is not feasible to predict the outcome of such pending claims, proceedings, and investigations with certainty, management is of the opinion that their ultimate resolution should not have a material adverse effect on Abbott’s financial position, cash flows, or results of operations.”
John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. His most recent book is The Partisan: The Life of William Rehnquist. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (www.PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To subscribe to FOIAengine, click here.