Ethics Newsline®

“The judgment was made by the pharmacokeneticists at the time that in doing the calculation, it was probably appropriate to make that correction. Later on when people looked at it in a different time frame, they concluded that probably the correction shouldn’t be applied.”

– Johnson & Johnson lawyer Bob Tucker, talking to the New York Times in an article examining what should happen when the FDA approves drugs whose flaws were either hidden or unknown during the approval process. Johnson & Johnson is fighting a lawsuit accusing the company of obscuring unfavorable test results while seeking FDA approval for its popular Ortho Evra birth control patch. The drug was approved and now Johnson & Johnson, in a position supported by the Bush administration, says the public should not be able to sue over an FDA-approved drug that only later was shown to be harmful, a standard known as pre-emption. The Times notes that the Supreme Court “is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.”

Source: New York Times, Apr. 6.