J&J and Drug Safety: States Preempt FDA on Protecting Consumers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Johnson & Johnson now faces having to pay $140 million after the Supreme Court declined to hear the firm's appeal of verdict involving Children's Motrin. 


At issue was whether Johnson & Johnson should have upgraded its product labeling to reflect the risk that a patient may develop toxic epidermal necrolysis, which can lead to a rare disease called Stevens-Johnson syndrome.


However, Johnson & Johnson sought to convince the Supreme Court that federal law preempted the state court verdict.


In response to a citizen’s petition seeking upgraded labeling, the Food and Drug Administration had agreed that an increased warning about skin reactions — such as rashes and blisters — was warranted. But the agency did not agree to add the names of the skin diseases, which are unfamiliar to most consumers.


Consequently, the company maintained it would have violated federal law if the Motrin labeling was updated with the sort of specific language the family believed should have been used.


the Supreme Court acknowledged that a state court lawsuit could be preempted if there was “clear evidence” showing the FDA would not have approved a change in labeling. Such a situation would otherwise create a conflict between the state and federal labeling requirements. But ever since, the pharmaceutical industry has argued that “clear evidence” was never properly defined.


In this case, Johnson & Johnson argued the hurdle for clear evidence had been met, even though a Massachusetts appeals court disagreed. The company maintained that the less specific labeling for Children’s Motrin, which is intended for consumers, reflected FDA thinking and, therefore, was true to both the letter and intent of the law, according to its filing with the Supreme Court.