The infant’s grandfather, Rickie Hanes of North Haven, on behalf of the baby’s estate, is suing the hospital and the supplement manufacturer, Solgar, and its parent company NBTY.
Yale New Haven, Solgar and NBTY argued in court in August that various claims against them—including reckless disregard for safety and fraudulent misrepresentation of a product’s safety—should be eliminated.
Angelo Ziotas, an attorney representing the Lee-White estate, says a written ruling by New Haven Superior Court Judge Steven Ecker will likely come by the end of December, and the judge has set June 2017 as the date to complete discovery and fall 2018 as the trial date.
Lee-White, the son of Samantha Pineapple Lee and Aaron White, was born prematurely by C-section on Oct. 3, 2014, at Yale New Haven and died eight days later.
The lawsuit alleges that Lee-White was given contaminated probiotic ABC Dophilus Powder on several occasions during feedings at the hospital. The powder—a dietary supplement that Solgar claimed contained beneficial bacteria—was contaminated with a fungus, Rhizopus oryzae, when it left the company’s Leonia, N.J., manufacturing facility, the suit alleges.
Lee-White’s mother, father and grandmother, Betty White, saw bulges in the baby’s stomach after he was first “poisoned” by the powder, but were told by hospital staff that the bulges were related to the infant’s prematurity, according to the lawsuit.
Ziotas says he and relatives of Lee-White will not comment about the lawsuit.
Dana Marnane, public relations director for Yale New Haven Health System, says “the death of a child is tragic, and our deepest sympathies go out to the family. The hospital is aware that the FDA reported on Nov. 14, 2014, Solgar Inc. voluntarily recalled ABC Dophilus Powder. This product was used at YNHH at the time. Any allegation directed to the hospital in the complaint will be defended.”
In November 2014, U.S. Food & Drug Administration scientists confirmed the presence of Rhizopus oryzae, a mold species, in unopened containers of ABC Dophilus Powder at the hospital.
The infant, according to the FDA, “suffered from gastrointestinal mucormycosis,” a fungal infection. The U.S. Centers for Disease Control and Prevention determined that mold caused the mucormycosis.
The FDA alerted healthcare providers in December 2014 about the risks of using dietary supplements formulated to contain live bacteria or yeast in people with compromised immune systems. The agency encouraged providers who use dietary supplements containing live bacteria or yeast as drugs—“to treat, mitigate, cure or prevent a disease or condition” —to submit an investigational new drug application for FDA review.
Jodi Katz, NBTY’s director of corporate communications, says Solgar completed “its ABC Dophilus product investigation in collaboration with the CDC and the FDA.” The investigation, she says, thoroughly examined the product’s “supply chain under Solgar’s control”—the source of the raw materials, the manufacture and packaging of the ABC Dophilus powder and its transportation and delivery to the hospital pharmacy where is was dispensed.
“After numerous facility and equipment inspections, the diligent review of relevant standard operating procedures and the robust testing of hundreds of product samples by the FDA, CDC, industry-leading independent third-party laboratories and Solgar, Solgar can confirm that the contaminant at issue was not identified at any point within the product’s supply chain under Solgar’s control,” Katz says.
No other “serious adverse events” were reported “for any other ABC Dophilus product originating from the same manufacturing lot of the implicated product, including other ABC Dophilus products from the same manufacturing lot that had been dispensed by the same hospital pharmacy,” Katz says.
Last year, U.S. Sen. Richard Blumenthal, D-Conn., told C-HIT that Lee-White’s death underlines the need for better oversight of the dietary supplements industry. Blumenthal called the dietary supplement marketplace “a dangerous Wild West of inadequate regulation” that deprives consumers “of basic health and safety information” and results “in serious injuries and deaths.”
Many adults ingest dietary supplements, which the FDA defines as vitamins, minerals, herbs, extracts and other products “that aim to add nutritional value to a diet.” Unlike drugs, which are subject to FDA approval, companies can manufacture and sell supplements without the agency’s approval.
A C-HIT analysis last year revealed that every week since Jan. 1, 2008, the FDA has identified an average of two dietary supplements being sold to consumers that were “tainted” and “potentially hazardous.”
Industry leaders say that an overwhelming majority of dietary supplements companies sell safe products that include no illegal ingredients and are beneficial to millions of Americans. The FDA has stated that “some supplements are useful in reducing the risk of certain diseases.”
