CHICAGO (CN) - Parents say in court that contaminated Tylenol drops killed their infant son just 13 days before Johnson & Johnson recalled more than 136 million bottles of children's Tylenol - the largest recall of children's medicine in history.
Malgorzata and Michael Cherry sued McNeil-PPC and Johnson & Johnson in Cook County Court. McNeil-PPC is a division of Johnson & Johnson and the distributor of Tylenol.
"Markus Cherry was born following an uncomplicated pregnancy and delivery on February 10, 2010, weighing 9 pounds, 1 ounce," the parents say in the complaint.
"On April 14, 2010, Markus was evaluated by his pediatrician for a two-month checkup. Markus demonstrated normal weight gain and development, was deemed a 'well child' by his pediatrician and was administered routine, two-month vaccinations. "Given the well-known side effects of fussiness, fever, pain and irritation that can accompany vaccinations, Markus' pediatrician prescribed Concentrated Tylenol Infants' Drops and provided appropriate instructions as to use.
"On or about April 14, 2010, Markus Cherry ingested defendants' Concentrated Tylenol Infant Drops, 0.25 oz., Grape flavor.
"In the days that followed the ingestion of the Tylenol, Markus demonstrated a variety of symptoms of poor and deteriorating health, all caused by the ingestion of defendants' Tylenol product.
"On April 17, 2010, Markus lost consciousness and was transported to the emergency room by the local fire department.
"On April 17, 2010, Markus died.
"The Tylenol product ingested by Markus Cherry was part of a recall initiated on April 30, 2010; 13 days after Markus Cherry ingested the product and died.
"The Tylenol product ingested by Markus was contaminated with gram negative bacteria confirmed by polymerase chain reaction deep sequencing.
"The gram negative bacteria found contaminating the Tylenol is a human pathogen known to cause sepsis and death. ...
"The contaminated Tylenol caused or contributed to cause Markus Cherry's death; no other plausible explanation exists for Markus Cherry's death."
The complaint adds: "In April 2010, FDA inspectors performed an expedited inspection of the defendants' Fort Washington plant due to the defendants' repeated manufacturing and contamination problems.
"On April 30, 2010, the FDA issued a report detailing its inspection of the Fort Washington plant and identified 20 major cGMP [current good manufacturing practices] violations in the defendants' manufacturing processes respecting the product at issue herein, including known gram negative bacteria, filth and particulate contamination.
"That same day, the defendants recalled approximately 40 types of children's and infants' products manufactured at their Fort Washington plant.
"The recall included Concentrated Tylenol Infant Drops, 0.25 oz., Grape flavor ...
"The recall was the largest recall of children and infant medicine in history, encompassing over 136 million bottles of product."
The Cherrys claim that McNeil and the Fort Washington plant have an extensive history of poor quality control. They say the FDA issued numerous warning letters and reports of defective products, including contamination by pesticides and gram-negative bacteria.
"Between January 2008 and April 2010, the FDA received 775 reports of adverse events, including 30 deaths that involved the defendants' products," the complaint states.
In 2009, McNeil distributed defective Motrin IB, but "did not publicly recall the defective drug upon learning of its defective nature, but instead hired third-party contractors to quietly remove the defective products to avoid the financial and regulatory ramifications of a public recall," according to the complaint.
"These phantom recalls, in part, spurred the House Committee on Oversight and Government Reform to conduct a Congressional investigation and hold two separate Congressional hearings in 2010, resulting in the government takeover of the Fort Washington plant and a criminal investigation of the defendants' practices."
The Cherrys say: "The defendants knew or should have known that severe side effects and death could occur in patients who ingested their products manufactured in the aforementioned substandard and dangerous conditions at the Fort Washington plant."
They seek damages for wrongful death, negligent manufacturing, manufacturing defect, fraud, and misrepresentation, and a hearing on punitive damages.
They are represented by Kent Mathewson, with Donohue, Brown, Mathewson & Smyth.