> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Supreme Court Declines Appeal in J&J $63 Million Judgment
- URL: https://www.fdaweb.com/supreme-court-declines-appeal-in-j-j-63-million-judgment/
- Published: 2016-01-19T12:00:00.000Z
- Updated: 2026-09-15T02:28:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134472

> The U.S. Supreme Court has rejected an appeal from Johnson & Johnson over a $63 million judgment awarded to a family whose daughter developed toxic epidermal necrolysis (TEN) after being given multiple doses of Children’s Motrin. The parents argued that the company should have acted unilaterally to change the product’s labeling to explicitly warn consumers about the risk of developing a life-threatening disease from taking the drug.  
>  
>  
>  
>  
>  
> An amicus brief filed by the Washington Legal Foundation (WLF) and the Allied Educational Foundation [said](http://www.wlf.org/upload/litigation/briefs/JohnsonandJohnsonvReckis-WLFAmicusBrief.pdf?ref=fdaweb.com) that the Supreme Court should have heard the case because further court guidance is needed on the law involving federal preemption of state tort law. Their brief noted that the Supreme Court held in *Wyeth* that state tort law may require brand name drug manufacturers to make certain types of unilateral changes in the absence of “clear evidence” that governing FDA requirements would not permit the change. It said the groups agreed with J&J that review is warranted to provide guidance on evidence that FDA would have rejected the supplemental application that a manufacturer must submit to the agency at the same time that it makes the unilateral change demanded by a state-law plaintiff.  
>  
>  
>  
>  
>  
> The organizations also said guidance is needed on evidence that FDA regulations do not permit a proposed unilateral label change because the change does not reflect newly acquired information. The brief noted that the drug’s labeling now and when the child contracted her disease has information on the association between ibuprofen and TEN and Steven-Johnson Syndrome and suggests that the relationship may be causal.