Saturday, January 16, 2016

Guilty for Obeying the Feds

Guilty for Obeying the Feds - WSJ:
"Can a drug company be held liable for following the directions of federal regulators on warning labels? 
Johnson & Johnson did exactly that, only to be slapped with a $63 million jury verdict in Massachusetts for inadequate warnings.
The Supreme Court is being asked to hear J&J’s appeal in a case with major implications for uniform national business regulation.
In 2003 Richard Reckis treated his seven-year-old daughter Samantha with over-the-counter Children’s Motrin for a fever.
Samantha developed a rare and advanced case of Stevens-Johnson syndrome called toxic epidermal necrolysis which caused skin blistering, as well as lung, liver and vision damage.
Her parents sued Johnson & Johnson in state court for failing to alert buyers to the potential side effects, and the Massachusetts Supreme Judicial Court affirmed the jury verdict.
The legal problem is that the federal Food and Drug Administration had rejected the specific labeling enhancement that lawyers for the Reckis family say should have been applied. 
In 2005 what’s known as a Citizen Petition to the FDA suggested that Motrin should include language on “serious skin reactions” and “potentially life-threatening diseases” and specify the names of some of the conditions.
The FDA agreed on the need for improved warnings about skin reactions, but it said it would not be helpful to include a mention of “life-threatening” conditions or the names of the conditions, which most people were unfamiliar with.
Instead, the agency said, “a description of symptoms” was more appropriate for the over-the-counter medication.
J&J would have been defying federal regulatory guidelines if it had included the warning that the Reckis lawsuit claims should have been on the bottle..."

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