If Johnson & Johnson withheld information about the level of hormones delivered by the Ortho Evra birth control patch, in what universe should FDA approval shield the company from lawsuits? According to this NY Times article,
More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug.
J&J lawyers argue that FDA approval of the patch “preempts” (read: shields the company from) any litigation. If a court buys that argument, then what happens when the FDA turns out to be wrong in approving a drug? Does the name “Thorazine” ring a bell?