A Baltimore County woman claims her newborn died of a listeria-related illness that she contracted from eating from a tub of vanilla fudge ice cream while pregnant, according to an April lawsuit against the frozen dessert’s producers and the local market where it was sold.

The woman purchased the ice cream from Seven Mile Market in Pikesville on June 28, 2023, according to the lawsuit. In July of that year, the Centers for Disease Control and Prevention traced a multistate listeria outbreak to Ice Cream House, the company that produced her allegedly contaminated vanilla fudge tub.

Her lawyers argue that Ice Cream House and Real Kosher Ice Cream, which shared production of ice cream products, as well as co-producer Leiby’s Dairy Inc. were negligent for not enacting the necessary quality controls to ensure their product was free of listeria. They argue that Seven Mile Market was also negligent in allowing the contaminated product on shelves.

The woman is seeking up to $30 million in damages, according to the Baltimore County Circuit Court complaint filed on April 2.

None of the defendants responded to requests for comment.

The lawsuit alleges the woman ate from the 56-ounce tub of Klein’s Vanilla Fudge Ice Cream from the market on July 17, 2023, when she was 36 weeks pregnant.

Over the next three days, the woman experienced sinus congestion, headaches and abdominal discomfort. She visited MedStar Health Urgent Care for tests on the third day, and then again on the 11th day. She was diagnosed with acute bronchitis, the lawsuit said.

On July 29, 2023, she went to the emergency room at Sinai Hospital. Due to concerns over her and the baby’s health, an emergency delivery was performed, the lawsuit said.

Notes from the hospital included in the complaint described the newborn: “At ten minutes of life, infant started to have spontaneous respiration and improvement in color but continued to be limp without movement.”

The patients were transferred to Johns Hopkins Hospital on or about July 31, 2023, where blood tests showed the mother and baby suffered from a listeria infection, according to the lawsuit: “This infection had been passed through the placenta from the mother to the infant while in utero.”

The infant died on Nov. 8 of listeria-related complications, according to the lawsuit.

Unlike other bacteria causing food sickness, listeria can survive and multiply in cold, damp spaces, making it a common concern among ice cream manufacturers. The bacteria is known to cause illness in immunosuppressed groups such as pregnant women, whose infection could lead to miscarriage. Common symptoms of infection include fever, fatigue and muscle aches, according to the U.S Food and Drug Administration’s website.

While the lawsuit claims the FDA took action to initiate a recall on June 28, the day the woman purchased her ice cream, the earliest public announcement of a listeria-related recall for the accused ice cream manufacturers came about two months later.

The woman’s lawyers declined requests for comment.

On Aug. 9, 2023, Real Kosher Ice Cream voluntarily recalled their soft-serve, on-the-go ice creams, and on Aug. 30, Ice Cream House recalled every dairy product with its logo, which included the quarts of vanilla fudge.

The recalls were spurred by a listeria outbreak that hospitalized one person in New York and another in Pennsylvania. Publicly available inspections of the Ice Cream House facility in Brooklyn, New York, from Sept. 6 to Sept. 26, 2023, revealed the plant was not in “adequate repair,” employees were not taking “reasonable measure or precaution,” and procedures were not in place to identify and minimize hazards, according to a timeline of FDA actions.

About a month later, the CDC declared the listeria outbreak over. “Since the recall, the company has taken corrective actions and is now back in operation,” the FDA said in an Oct. 26, 2023, update on their website. But the following year, the agency said they remained concerned about Ice Cream House’s practices.

A follow-up inspection that lasted from Feb. 21 to March 26, 2024, showed the same strain of listeria from the year prior persisted in the facility, according to a warning letter issued to Ice Cream House in September 2024.

“We continue to be concerned about your ability to maintain a sanitary environment,” the FDA said in the letter. Regulators indicated the listeria strain continued to survive near or on surfaces in contact with food, and more infection-causing bacteria had grown. Other issues, including a roof leaking liquid into a bucket and leaks in the soft-serve ice cream machine, had yet to be fixed. A profile of Ice Cream House does not show further actions taken by the FDA to address these concerns, though the letter does request the company make further changes by their next inspection.

A timeline of the FDA’s actions regarding the other ice cream company, Leiby’s Dairy Inc., showed one 2023 inspection and no recalls.

Seven Mile Market, considered one of the largest kosher markets in the nation, still stocks Real Kosher Ice Cream, also known as Klein’s Real Kosher. In the lawsuit, the lawyers allege the companies have continued to disregard sanitary conditions and consumer health, “flouting the law, thereby deserving of punitive punishment.”

The filing comes at a time when federal and state regulators are facing further scrutiny over food safety enforcement. Up to 170 administrative and management staff were reportedly laid off at the FDA’s Office of Inspections and Investigations, scientists of several food safety labs across the country were eliminated, and so was most of the staff at the agency’s Office of Policy and International Engagement, which shared data with other countries to help respond to foodborne illness outbreaks.

The systems for food safety are changing and the FDA has been struggling to keep up, said Darin Detwiler, a food safety advocate and lecturer whose son died of E. coli contamination. A January 2025 U.S Government Accountability Office report showed the FDA has not been performing the number of inspections needed to ensure food safety.

The job cuts could make the system for identifying and responding to outbreaks even weaker, he said, risking longer delays for removing contaminated foods from shelves.

Issues have also been compounded by a Biden-era reorganization that led to funding cuts for states, which perform 90% of inspections at produce facilities and 50% of inspections at manufactured food facilities, according to a Time magazine report.

Come September, Maryland will lose about 60% of its funding for responding to outbreaks.

Brian Ronholm, director of food policy at Consumer Reports, a nonprofit dedicated to consumer research and safety, said while inspectors were not let go, the workers who support and facilitate their inspections were.

“We’re not going to see a result in immediate outbreaks,” he said. “It will show up in subtle, harmful ways that could lead to outbreaks lasting longer than they typically would.”

This could lead to less-effective recalls, which Ronholm said largely fall on state health departments to enforce.