Plaintiffs Say Warning Signs Were Ignored
FDA’s 2023 Letter Flags Allegedly Insufficient Safety Controls
According to the complaint, ByHeart knew or should have known its preventative procedures were inadequate. Valenzuela points to a 2023 FDA warning letter as evidence that the company had long been on notice that its safety practices needed reinforcement.
The suit alleges violations of New York General Business Law, negligence, and unjust enrichment, emphasizing that the proposed class seeks economic damages only, not personal-injury compensation.
Meanwhile, families of two infants diagnosed with botulism after consuming ByHeart products have already filed separate lawsuits in Arizona and Kentucky federal courts, further escalating legal pressure on the company.
Consumer Advocates Call Recall Insufficient
“This lawsuit is important to protect consumers from allegedly unsafe contaminated foods,” said Michael Reese of Reese LLP, counsel for Valenzuela. “The safety of our food system is crucial, and we look forward to protecting their interests.”
Representatives for ByHeart could not be reached Friday.
Valenzuela is represented by Michael Reese of Reese LLP, along with Kevin Laukaitis and Daniel Tomascik of Laukaitis Law LLC. Counsel for ByHeart has not yet appeared.
