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Regulatory Preemption - Class II Devices and Special Controls

By James M. Beck and Mark Herrmann

The Reed Smith Life Sciences Blog has an interesting post today about a proposed FDA regulation imposing special controls on a class II medical device (tissue expanders) that specifically states the Agency's intent that those controls have preemptive effect. That, the RS blogger notes, is a first.

Like RS we wonder whether it's necessary. Where there are device-specific special controls, even in non-Class III devices, the courts have already tended to find preemption. There is (as the RS post notes) the widely recognized preemptive effect of toxic shock warnings in tampons. And both a 1998 regulation applicable to latex gloves, and a 1997 regulation applicable to contact lens care products, have likewise been accorded preemptive effect due to their specificity. See Morgan v. Abco Dealers, Inc., 2007 WL 4358392 (S.D.N.Y. Dec. 11, 2007) (latex gloves); Tuttle v. Ciba Vision Corp., 2007 WL 677134 (D. Utah Mar. 1, 2007) (contact lens care products).

These controls should follow the same pattern.

So, since the tissue expander controls are of the same order of specificity, why bother with the explicit express preemption discussion? Without it, the FDA's controls are still analogous to tampons, gloves, and the rest. But if that language does not survive, it only complicates preemption argument down the road.

Full post as published by Drug and Device Law on December 29, 2008 (boomark / email).