n a setback to the pharmaceutical industry, the US Supreme Court declined on Tuesday to hear an appeal sought by Johnson & Johnson of a $63 million verdict that found the company failed to properly warn consumers about the risks of its Children’s Motrin painkiller.
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. The condition can cause skin blistering, as well as lung, liver, and vision damage.
A Massachusetts family successfully pressed a lawsuit claiming the company could have upgraded the warnings. In 2003, they gave their seven-year-old daughter the over-the-counter medicine and she subsequently developed Stevens-Johnson syndrome. She eventually lost 95 percent of the top layer of her skin and suffered heart failure, stroke, and an aneurysm. She is also legally blind, according to court documents. The verdict withstood appeal.
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, according to its filing with the Supreme Court. In short, Johnson & Johnson complained it was in an untenable bind, which is an argument the pharmaceutical industry has been watching closely.
The debate over preemption came to a head in 2009 when the Supreme Court ruled that a state court lawsuit is not preempted if the FDA would have allowed a drug maker to upgrade its label. That case involved a lawsuit brought by a Vermont woman who claimed she was harmed by a drug sold by Wyeth, which is now owned by Pfizer. She successfully argued that Wyeth should have updated the label for Phenergan, an anti-nausea treatment.
At the same time, 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.
The Supreme Court, however, disagreed with the argument. A spokeswoman for Johnson & Johnson, which now faces a $140 million payout when including interest, wrote us that the health care giant is “disappointed the Supreme Court declined to hear this case because we believe it raises important and unsettled preemption issues.”