Guilty for Obeying the Feds J&J is punished in state court for following federal labeling rules.
http://www.wsj.com/articles/guilty-for-obeying-the-feds-1452817258
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 labelling 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.
The legal doctrine at issue is federal pre-emption, and in 2009 the U.S. Supreme Court ruled (Wyeth v. Levine) that some state court lawsuits against drug companies over warning labels are pre-empted by federal law if the FDA has made its opinion on labelling clear. While some cases might require guessing about FDA directions, in this case the FDA was asked to consider a specific warning and rejected it.
Samantha’s case is tragic, but the FDA is required to act in the interest of public health. Over-the-counter painkillers help millions of people, and the severe side effects in this case are extremely rare. The FDA also must consider overall costs and benefits, such as whether more explicit warning labels might discourage people who would otherwise be helped by the product.
If the Reckis judgment stands, drug labeling will be driven by jury verdicts from state to state rather than a single, clear national standard. It would also open up a new area of jackpot justice for plaintiffs lawyers against companies that can be found guilty even if they follow federal rules to the letter. Johnson & Johnson is asking the Supreme Court to hear the case, and we hope the Justices take it to clarify pre-emption law for businesses, regulators and consumers.
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