We've just been informed by a source at Drinker Biddle (Dan Carroll of that firm that won the case) of a brand new decision in the New Jersey Levaquin litigation granting summary judgment and finding that an FDA-mandated black box warning was adequate as a matter of law. Hain v. Johnson & Johnson, No. ATL-L-8568-11 MT, slip op. (N.J. Super. L.D. June 20, 2013). The main holdings are: (1) "by mandating each manufacturer include the strongest type of warning" of a particular risk, "the FDA ensured each prescriber's attention would be focused on [that] risk." Slip op. at 7. (2) "[P]rescription drug warning labels containing a boxed warning, mandated by the FDA, are adequate as a matter of law." Id. at 7. (3) Where the warning is otherwise adequate, lack of claimed "comparative" risk information (that the product has a "greater" incidence of a warned-about risk than "other" similar products) does not render the warning inadequate. Id. at 8, 10-11. (4) Even in the absence of a boxed warning, warnings that provide "specific detailed information on the risks" of a product are adequate as a matter of law. Id. at 9-10.
Congratulations, and keep those wins coming.