It has recently been reported that Johnson & Johnson has decided to put red warning labels on bottles of Tylenol in order to inform users of the potentially fatal risks of acetaminophen overdose. This is a testament to the usefulness of products liability litigation.
The move by Johnson & Johnson can be considered a response to a growing number of lawsuits concerning liver injuries and deaths caused by acetaminophen overdose, as well as increased FDA scrutiny and safety proposals that could curtail the use of acetaminophen products. Manufacturers and the FDA quite often follow in the footsteps of products liability attorneys, who are often the first to bring to light the dangers of pharmaceutical drugs.
For example, when in 1994 Johnson & Johnson added a warning about the risk of liver damage when combining alcohol with Tylenol, it was ostensibly done in response to a lawsuit. The FDA subsequently made the alcohol warning mandatory for all manufacturers of acetaminophen, in 1998.
It is unusual for a manufacturer to change a product warning while litigation is pending because they run the risk that the existence of a new warning can be used against them at trial. The drug company will typically argue that they take safety concerns very seriously, and that the number of poor outcomes is small. Yet products liability attorneys will rely upon the existence of a new warning to show that the prior warning was inadequate.
There are rules that sometimes prevent the introduction of this kind of evidence, called subsequent remedial measures, defined as actions “that would have made an earlier injury or harm less likely to occur.” The reasoning behind this is to avoid what could appear to be an admission of fault. However, there are exceptions to this rule, such as when the evidence is needed to impeach the manufacturer’s credibility—if they dispute that the drug could have been made safer or whether they could have changed the warning—or to prove ownership, control, or the feasibility of precautionary measures.
Lobbyists for the pharmaceutical industry are constantly pushing for legal reform, making it more difficult for people injured by defective drugs to recover for their injuries. But this is one of the few ways to motivate drug manufacturers to make their products as safe as possible.
Lopez McHugh LLP is currently handling cases involving injuries caused by Tylenol and acetaminophen overdose. Consultations are free for any persons who believe they may have been injured from using this medication. Additional information on the Tylenol litigation can be found here.