BABY FORMULA LAWSUIT LAWYERS
The attorneys at Parker Waichman LLP, a top-rated national product liability law firm, are investigating potential lawsuits on behalf of parents whose babies were harmed by contaminated infant formula. The U.S. Food and Drug Administration has reported that four babies have been severely injured or died after consuming contaminated baby formula manufactured at the Abbot Nutrition plant in Sturgis, Michigan. The FDA investigated and inspected the Sturgis plant and discovered unsafe manufacturing conditions at the plant. Parents whose babies have been harmed by the contaminated baby formulas are filing lawsuits against the manufacturer seeking legal justice and compensation.
If your child was harmed or tragically killed after consuming baby formula, you may be entitled to substantial compensation. Parker Waichman’s attorneys are offering free legal consultations. To learn how our experienced contamination lawsuit attorneys can help your family, we urge you to contact us today by completing the form on the right or calling us at 1-800-YOUR-LAWYER (1-800-968-7529).
FDA Releases its Final Determination Concerning its Infant Formula Response
On September 20, 2022, the U.S. Food and Drug Administration published its review of decision-making and review activities concerning the closure of Abbott’s infant formula facility in Sturgis, Michigan. The ten-page report titled “FDA Evaluation of Infant Formula Response” stated that between September 2021 and January 2022, the FDA received four incident reports concerning illnesses or deaths in infants who were fed powdered infant formula manufactured by Abbott Nutrition. Upon discovering that parents unknowingly fed their babies contaminated powdered infant formula products manufactured at Abbott Nutrition’s plant located in Sturgis, Michigan, the FDA initiated an investigation and inspection of the facility. The FDA investigators discovered unsanitary conditions at the Sturgis plant, causing the FDA to issue a public warning to consumers. The warning urged baby formula users to avoid using certain infant formula products manufactured at this facility. The U.S. Food and Drug Administration (FDA) warned against using recalled Similac, Alimentum, or EleCare powdered infant formulas produced at the facility. Similac PM 60/40, a specialty liquid formula, was added to the recall a few weeks later.
On February 17, 2022, Abbott Nutrition voluntarily recalled certain infant formula products that were manufactured at the Sturgis plant, and Abbott temporarily halted production. Following the recall, a shortage of baby formula products transpired and created a substantial hardship for parents and caregivers who depend on baby and specialty formulas to feed their infants.
The FDA stated that this incident involved unusual circumstances, demanding that the agency address a dangerous pathogen, Cronobacter sakazakii, that was discovered in certain infant formulas. Tragically, the FDA’s foods program had to make difficult decisions about product safety and availability in a way the agency has never had to do in the past. This happening revealed the need for a multidisciplinary, integrated strategy that included clinical, scientific, analytical, nutritional, and inspectional expertise; supply chain and policy considerations; legal processes; and resources to assist this multidisciplinary task. With the unique circumstances and substantial consequences of the baby formula shortage, as well as the process, technology, policy, and resource problems that arose during the incident, the FDA began an exhaustive evaluation of the events that led up to, during, and after the June 4, 2022 baby formula recall.
Dr. Steve Solomon headed the FDA’s evaluation team. Dr. Solomon conducted more than 40 interviews with over 60 employees who offered viewpoints from different levels of the agency. He also represented many FDA offices and centers that were involved in response to this incident. Interviewees identified many different activities their offices initiated during the incident. For example, there were improvements in the way whistleblower and consumer complaints are triaged and escalated. The Office of Operations, ORA, OFPR, and CFSAN are working together to create a Powdered Infant Formula Prevention Strategy.
What is Cronobacter Sakazaki?
The infant formula recalls were initiated after it was discovered that the infant injuries and deaths were connected to Cronobacter sakazakii contamination. Cronobacter sakazakii is a dangerous microorganism that can cause meningitis or a dangerous blood infection (sepsis). Cronobacter is found naturally in the environment and can live in dry foods, such as:
- Herbal teas
- Powdered infant formula
- Powdered milk
After a lengthy delay, the FDA finally inspected the Sturgis plant. Although the whistleblower alerted the FDA to the deplorable conditions of the Sturgis plant in September 2021, the FDA failed to investigate the plant until February 2022. At that time, Abbott denied a connection between its plant and the reported illnesses. The FDA’s inspection of the Sturgis plant revealed that Abbott failed to properly clean surfaces in the handling and production processes. FDA inspectors also uncovered a history of cronobacter contamination at the Sturgis plant, including eight incidents between 2019 and 2022.
The plant’s closure resulted in an immediate shortage of infant and specialty formulas, further stressing the supply chain and creating hardships for parents, particularly in low-income communities. The shortage began in 2020, as parents bought aggressively during the COVID lockdown. Global shipping issues exacerbated the problem. In early May 2022, 43% of baby formula supplies were out of stock in the U.S. The Sturgis closure created
On April 8, 2022, Politico released an investigation revealing that at the FDA, “regulating food is simply not a high priority at the agency, where drugs and other medical products dominate, both in budget and bandwidth.” According to Politico, the Center for Food Safety and Applied Nutrition, which is charged with monitoring food for the FDA, “has repeatedly failed to take timely action on a wide range of safety and health issues the agency has been aware of for several years, including dangerous pathogens found in water used to grow produce and heavy metal contamination in baby foods.” Other investigations have come to similar conclusions, finding that the FDA was slow to respond to Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) in food.
On April 28, 2022, Rep. Rosa DeLauro, chair of the House Appropriations Committee, released the detailed whistleblower complaint. In a document sent to the FDA in October 2021, a former Abbott employee provided a detailed report of the company hiding safety problems at the Sturgis production facility. The former employee claimed that Abbott falsified records on multiple occasions, removing time codes and choosing not to recall products when there was evidence of packaging problems.
Following an outcry from the public over the formula shortage, FDA Commissioner Robert M. Califf, M.D., announced on May 25, 2022, House Energy & Commerce Committee Hearing that Steven M. Solomon, D.V.M., to review the situation. Dr. Solomon, a 32-year veteran of the FDA, is the director of the FDA’s Center for Veterinary Medicine, where he regulates animal food and drugs. Dr. Solomon was charged with conducting “a top-down review of agency activities and decision-making” related to the shutdown of the Sturgis facility.
On July 19, 2022, Dr. Califf also requested a broader investigation of the FDA’s Foods Program – including its “structure, function, funding and leadership” – to be led by Dr. Jane Henney, a commissioner of the FDA from 1998 to 2001. Supported by the Reagan-Udall Foundation, working with external experts, the team is charged with reporting its initial findings within 60 business days.
Dr. Solomon released his findings on September 19, 2022. The report, based on interviews with over 60 FDA staff, including leadership directly involved with the events, acknowledges numerous mistakes but does not blame any individuals for the failure. His key finding: is that “no single action” explains the Sturgis closure and supply chain problems that follow. Dr. Solomon attributes the crisis to “a confluence of systemic vulnerabilities that demonstrate the need to focus on continued modernization and investment in the expertise and tools needed to better anticipate and address future public health challenges in this area.”
Dr. Solomon highlights five “major areas of need” in his report:
- “Modern information technology” allows real-time data exchange.
- “Sufficient staffing, training, equipment, and regulatory authorities to fulfill the FDA’s mission.”
- “Updated emergency response systems” to handle multiple, simultaneous emergencies.
- “Increased scientific understanding” specifically about Cronobacter and how to control it.
- Deeper assessment of the infant formula industry.
Dr. Califf indicated on September 20, 2022, that he agreed with Dr. Solomon’s conclusions and recommendations. Dr. Califf acknowledged that the problems at the Sturgis facility highlight “just how little authority the FDA has to compel many companies to ‘do the right thing’ without intervention.”
Scott Faber, senior vice president for government affairs at the Environmental Working Group, responded that the report did not go far enough: “What happened in Sturgis should have set off alarms within the FDA about its food safety mission. This evaluation suggests that the FDA has instead hit the snooze button.”
The FDA’s report identified several recommendations for the agency to follow to improve the safety of baby formulas and medical foods while protecting the supply chain. To properly implement these recommendations, the FDA needs the ability to acquire the necessary authorities and resources to perform these vital tasks. The resources and authorities needed will be decided as the FDA assembles its working groups to concentrate on each recommendation. However, the problem has evolved, and people involved in the response have found additional areas where authorities and resources related to the supply chain, food safety, and program capability have been insufficient.
Currently, manufacturers do not have to perform whole genome sequencing of Cronobacter isolates, nor are they required to send the FDA the Cronobacter isolates for sequencing and uploading to the national database. This issue caps all of the data available to help the FDA identify clusters of illness and potential contamination sources. Moreover, there are gaps in the FDA’s authority related to accessing and sharing information that enables proper facilitates future inspections and regulatory compliance. Without the proper authorities, it’s difficult for the FDA to recognize the early signs of potential safety problems and work with the affected manufacturers to eliminate potential hazards. The FDA doesn’t have the authority to mandate manufacturers of medical foods and infant formulas to notify the agency once they are aware of a potential issue that could cause a shortage of these essential food products. The FDA also cannot require manufacturers to implement risk management plans.
GET LEGAL HELP FROM A KNOWLEDGEABLE INFANT FORMULA LAWYER TODAY
If your baby suffered harm or tragically passed away after consuming contaminated infant formula, you may be able to pursue substantial compensation by filing a lawsuit against the manufacturer. To get a free legal consultation with one of our baby formula lawsuit lawyers, just fill out our online form or call 1-800-YOUR-LAWYER (1-800-968-7529) today.
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