Daniel and Katy Moore of Ellensburg, Washington, claim 2-year-old River Moore was given Very Berry Strawberry flavoured Children's Tylenol for a slight fever late on July 22, 2010 and began spitting up blood 30 minutes later.
He was rushed to a hospital and died the next day of liver failure. The family's lawyer, Joseph Messa of Philadelphia, said Thursday that the liquid medicine contained excessive acetaminophen that damaged the child's liver, causing his death.
Johnson & Johnson said in a statement that its 2010 recalls of children's products were not related to the "serious adverse events or cases of overdose" alleged in the lawsuit. It said the New Brunswick, New Jersey-based company promptly notified consumers, doctors, retailers and regulators about the recall.
Messa said in an interview that extensive testing done on River before and after his death ruled out viruses or other conditions as the cause.
The lawsuit, filed last Friday in Philadelphia's Court of Common Pleas, accuses Johnson & Johnson of recklessness, negligence, breach of warranty, infliction of emotional distress, conspiracy and other offences. Besides the company, it names as defendants CEO William Weldon, three J&J subsidiaries, former consumer health business head Colleen Goggins and other company executives and board members, along with retailers and distributors who handled the product.
The suit seeks unspecified compensatory and punitive damages, interest and legal expenses.
"We are sympathetic to the pain and hardships suffered by the Moore family," J&J said in the statement. "We are deeply concerned about all matters related to our medicines and we remain committed to providing safe and effective pediatric medicines."
The recall was one of more than two dozen that J&J has issued since September 2009, for products ranging from adult and children's nonprescription Tylenol, Motrin, Benadryl and other medicines to prescription drugs for HIV and seizures, defective hip implants that caused severe pain and contact lenses that irritated the eyes.
Reasons for the recalls have included nauseating odours from packaging, liquid medicines containing small glass or metal particles, and wrong levels of active ingredient.
The number of recalls and the company's handling of them — including a 2008 "stealth recall" in which J&J paid another company to secretly buy up defective Motrin packets from stores — have generated investigations by Congress and the Food and Drug Administration. They also forced the shutdown and gutting of the Fort Washington, Pennsylvania, factory operated by J&J's McNeil Consumer Healthcare unit that made many of the recalled over-the-counter medicines, including the product involved in the lawsuit.