A couple from Ellensburg, Washington State, are suing the pharmaceutical company, Johnson & Johnson, after their two-year-old son, River, died of sudden liver failure the day after taking Children’s Tylenol from a batch of medicine that had been recalled.
The medicine was part of a 30th April, 2010 recall of several children’s medicines including Children’s Tylenol, Motrin, Zyrtec and Benadryl products. The recall was issued due to a manufacturing concern that more of the active drug may be placed into the medicine than medically necessary, meaning children who took the medicine may be at risk of overdose. There were also problems with particles being found in the medicines.
River was given Children’s Tylenol Very Berry Strawberry flavor and within half an hour of taking the drug was spitting up blood. He was rushed to hospital, where despite their best efforts he died the next day.
Tests showed he did not have a virus or bacterial infection and that his liver enzymes were above the normal level. Very high enzyme levels are usually the result of ingestion of medication so the pathologist found that he died from sudden liver failure.
Lawyers for the family said they believe that River received an overdose because the medication was too potent. They argued in their writ that the company ignored the low standard of manufacturing conditions at their plants, demonstrated by a string of recalls that continues to this day. The latest recall, of Motrin, occurred in late December of 2011.
The lawyers also alleged that in 2008 Johnson and Johnson initiated a secret recall of Motrin and Children’s Tylenol and instead of alerting the FDA to the problems they were having, they sent agents into the stores to buy up all the defective products in order to save their money and their reputation.
"This clandestine phantom/stealth recall was done without notification to the customers or the retailers to avoid the public shame, the financial impact and regulatory ramifications of a formal recall," they stated in their complaint.
According to Courthouse news, the FDA later became aware of this after they received an internal memo containing emails between Johnson & Johnson staff. As a result of this the FDA initiated the July 2009 recall of Motrin, approximately eight months later than it needed to be withdrawn, and a congressional investigation into the matter was launched.
The parents of River say that this proves that they were negligent:
"Johnson & Johnson and its highly compensated executive knew of the problems with their products, and instead intentionally decided to gamble with River Moore's life because they were more concerned with company profits and meeting the Wall Street analysts' earnings projections, than the health and safety of American children."(Courthouse News)
The family are seeking damages for product liability, recklessness, breach of warranty, negligent infliction of emotional distress, violation of consumer protection law, civil conspiracy and wrongful death.
A Johnson & Johnson representative said, “We are sympathetic to the pain and hardships suffered by the Moore family. We are deeply concerned about all matters related to our medicines and we remain committed to providing safe and effective pediatric medicines.”
The Food and Drug Administration said that some children have become seriously ill, some dying from liver failure because of parental confusion over the dosage that should be given to babies and children.
Minimizing the Risk of Overdose
• If you are giving your child a medicine, check the label to find out the concentration, dosage and directions for use.
• Only use the measuring spoon provided with the medicine to administer it to your child. This has been made to the exact size needed to give the correct dose.
• Newer medicines will be made less concentrated to reduce the risk of overdose. Some older products are still on the market that contain a stronger concentration. Be warned that these may still be labelled as "new".
• If you are confused about the concentration of medicine to give to your child, speak to your child’s pediatrician.
• Dosing advice can be found here: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm284563.htm
Sources:
Grieving Parents Blast J&J 'Stealth Recall, Court House News Service. Web. 9 January 2012. http://www.courthousenews.com/2012/01/04/42739.htm
Couple says defective recalled J&J med killed son, Ledger-Enquirer, 5th January 2012.
http://www.ledger-enquirer.com/2012/01/05/1882127/couple-says-defective-recalled.html
McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products, FDA Press Release, 30th April 2010. http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2010/ucm210443.htm
McNeil Recall of Motrin® IB Tablets and Caplets, FDA Press Release, 21st December 2011.
http://www.fda.gov/Safety/Recalls/ucm284942.htm
Know Concentration Before Giving Acetaminophen to Infants, FDA Consumer Update. Web. 9 January 2012. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm284563.htm
Reviewed Jan 11, 2012
by Michele Blacksberg RN
Edited by Jody Smith