Tylenol, and its generic acetaminophen, belongs to a class of medications called analgesics (pain relievers) and antipyretics (fever reducers).  Manufactured by McNeil Healthcare LLC., a division of Johnson & Johnson, this over-the-counter (OTC) medication is used to combat headaches, muscle aches, arthritis, colds and fevers in addition to other minor aches and pains.  Approved by the FDA in 1951, Tylenol is considered a high efficacy drug because it consistently provides intended results.

Liver Damage

If proper dosing directions are followed, Tylenol is highly effective.  Yet, according to the Mayo Clinic, too much acetaminophen “is the most common cause of acute liver failure.” Sometimes human error is to blame for overdosing, but recently, Tylenol has been negligent in its self-branded commitment to provide the public “with top quality, over-the-counter healthcare products.”  In the last four years, McNeil has been required to recall hundreds of thousands of bottles medicines because of labeling and manufacturing issues.

In June 2005, Children’s Tylenol Meltaways, SoftChews, and Junior Meltaways were recalled because erroneous labeling and faulty packaging designs, including the blister pack, led to unclear and confusing dosing instructions.  In November 2010, three Tylenol Cold Multi-Symptom liquid products were recalled because of mislabeling.  Children’s and Infant’s Tylenol products were also recalled in 2010 because the U.S. Food and Drug Administration (FDA) found that these products had a higher concentration of ingredients then stated on the label.  These continued improper and inadequate warnings and faulty packaging resulted in overdosing errors and serious liver-related side effects in children and adults.

Contaminated Products

Complaints of musty, moldy smells began in 2008, but McNeil did not pursue these problems until a year later at the urging of the FDA.  As a result, in what is called a “rolling recall,” McNeil participated in 26 Tylenol product related recalls involving 50 different medications for adult and children between 2009-2012 because of manufacturing deficiencies.  Deficiencies include

  • the presence of 2,4,6-tribromoanisole (TBA), a pesticide and wood preservative used to treat wooden pallets
  • the inclusion of trace amounts of wood and metal
  • inclusion of raw materials containing the infectious bacteria Burkholderia cepacia
  • improper labeling, including improper dosing instructions
  • over-concentration of ingredients and lack of potency of ingredients

In early 2010, the rate and consistent nature of Tylenol recalls forced the FDA to step in and oversee quality control in three McNeil’s manufacturing facilities in the United States. Regulators found that manufacturing practices failed to comply with federal laws.  One facility, in Fort Washington, Pennsylvania, was closed indefinitely due to bacterial contamination and dirty equipment.  Since the recalls begin in 2009, consumers have reported 775 serious side effect events, including nausea, stomach pain, diarrhea, and vomiting, and 30 deaths associated with recalled products.

Have You Been Affected by Tylenol?

Any individual or the relative of an individual who has suffered due to Tylenol’s side effects is permitted to file a lawsuit.  The lawyers can help you determine whether you are qualified to seek compensation.  You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered).

Different states have different legislation regarding medical lawsuits, so it is essential to hire an experienced and effective lawyer who can file the case.   We can match you attorneys who have the experience to handle even the most complex claims and is accepting new cases. If you need further information about the harmful side effects of Tylenol or legal advice concerning personal injury matters, you are invited to fill out the form on this website for a free case evaluation.

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