(CN) - Johnson & Johnson and Wal-Mart must face claims from a woman whose baby vomited blood until he died after taking Infant's Tylenol, a federal judge ruled.
Stacy Sherfey says she gave 2-week-old Tracen recommended doses of Infant's Tylenol in the morning and evening of Feb. 17, 2009, in Nevada, and that he soon began vomiting blood.
She had allegedly given Tracen his first dose the day before, based on a doctor's advice.
At the emergency room, Tracen was airlifted to Children's Primary Hospital in Salt Lake City, Utah, where he died from acute liver failure on Feb. 19, 2009.
In a 2012 lawsuit Stacy and her husband Neil filed in Philadelphia, the couple pinned the blame on the drug's manufacturers, distributors and retailers - Johnson & Johnson (J&J), McNeil-PPC Inc., Wal-Mart, and Inmar Inc. and its subsidiaries - as well senior officials of those companies.
They said the officials replaced full-time lab scientists with "contract workers who lacked technical pharmaceutical experience" to save money for advertising.
As sales continued, the companies allegedly ignored manufacturing defects, adverse event reports, "glaring warning signals" like a rebuke from the Food and Drug Administration and quality-control issues that McNeil noticed in 2007.
Indeed, "to prevent parents from switching permanently to less expensive acetaminophen products," Inmar implemented a "phantom" recall and conducted "market assessments" to determine the risk the defective medicines posed, according to the complaint.
Over the past year, Senior U.S. District Judge Robert Kelly has dismissed
claims against the named officials and against
Inmar, citing similar rulings for a multidistrict case
and one involving the death of 2-year-old River Moore.
The judge declined last week, however, to let Johnson & Johnson, McNeil and Wal-Mart off the hook, finding that, "although the alleged defective Infants' Tylenol was manufactured in Pennsylvania, Nevada's interests in protecting its citizens who purchased the product there and were injured there is significantly greater than Pennsylvania's interests."
While the Sherfeys waited more than three years to file suit, the discovery rule may toll the one-year statute of limitations on survival and wrongful-death claims, the ruling states.
The parents "maintain that J&J did not recall the subject Infants' Tylenol until more than a year after Tracen's death, and that 'it was only after Congress brought to light in 2010, the defendants' efforts to hide their manufacturing problems through the "phantom recall" of Tylenol products' that plaintiff, Stacy Sherfey, had any way of knowing that defendants' pediatric medicines were defective and dangerous, and should not be given to children,'" Kelly wrote. "Similarly, plaintiffs assert that the statute was tolled by the doctrine of fraudulent concealment because J&J concealed from the public the existence of manufacturing and/or quality control issues at the Fort Washington facility where the defective Tylenol products were manufactured."
As for whether the discovery rule or fraudulent-concealment doctrine tolled the one-year statute of limitations, Judge Kelley reserved judgment.
"Discovery in this matter has yet to take place," Kelly wrote. "Thus, any inquiry into defendants' alleged effort to hide knowledge of defective pediatric problems from the public would be premature at this stage given that the factual record is completely undeveloped. Thus, defendants have the option of again raising their statute of limitations arguments in a motion for summary judgment after the close of discovery."
The Sherfeys' claims for deceptive trade practices, civil conspiracy, punitive damages, and express warranty also survived, according to the ruling.
Johnson & Johnson recently announced sales of $18.1 billion for the first quarter of 2014.