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Not too long ago (March 28, and April 2) we read with interest a couple of articles on 360 that brought back unpleasant memories.  The articles discussed congressional inquiries to the FDA (including “pointed questioning” of FDA Commissioner Margaret Hamburg) about undisclosed (to the public, anyway) meetings between “FDA officials” and the plaintiff’s bar concerning its current extremely controversial proposal to change its generic drug regulations in an effort to eliminate preemption of product liability claims involving such drugs.  Because 360 requires a subscription, we’ve hunted around on the Internet and found the same matter discussed here.

We’re not sure at the moment whether the FDA provided equal access to those with opposing views, but we wouldn’t be surprised if it didn’t.  Why not?  Because we’ve seen this all before.  Back in 1997, shortly after Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and long before Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), courts were just beginning to draw the distinction between 510k clearance and FDA pre-market approval that the Supreme Court ultimately found critical in Riegel.  Then as now, from our perspective, anyway, it appears(ed) the FDA suffered what is sometimes called “agency capture” by pro-plaintiff elements.  So then as now, the FDA did what the other side wanted and issued a proposal to change its regulations designed to thwart preemption in product liability litigation.  That proposed rule was published at 60 Fed. Reg. 65384 (FDA Dec. 12, 1997).  Less than a year later, however, the FDA was forced to withdraw its proposal to gut preemption.


You guessed it.  The FDA was exposed as having had improper, one-sided contact with the plaintiffs’ bar concerning its 1997 anti-preemption proposal.  As the FDA ultimately admitted:

FDA has decided to withdraw the rulemaking to amend its regulations regarding preemption of State and local requirements applicable to medical devices.  FDA is taking this action because . . . [c]oncerns have been raised by industry and congressional representatives that the agency did not share its thinking on its interpretation of [the relevant provisions], even though an early draft of the proposed rule was shared during the spring of 1997 with attorneys for Public Citizen Litigation Group, who represented Lohr in the Lohr case. The remedy under FDA’s regulations for disclosure of a draft regulation is ordinarily to issue a notice in the Federal Register. . . .  Such a contemporaneous notice was not, however, provided in this case.

Because of the great policy significance of these preemption issues, the concern that Congress was not aware of the agency’s thinking during [its] deliberations, and the potential interplay between the [relevant] device provisions and device preemption, the agency believes that it is imperative for all interested parties to have confidence that the agency is addressing their concerns in an impartial manner.  Therefore, the agency is taking the unusual step of withdrawing the proposed rule.

63 Fed. Reg. 39789, 39789 (FDA July 24, 1998) (emphasis added).  Déjà vu all over again?

If it turns out that the FDA was meeting with the plaintiffs’ side, but not with the defense/industry side (a point that is not yet clear), then we have an example of history repeating itself – the FDA would yet again have exhibited institutional favoritism towards the plaintiffs’ bar with respect to a proposed regulatory change intended to adversely affect defense positions on preemption.  One would hope that, should such favoritism turn out to have occurred, the current FDA would have the good sense to do what the FDA did back in 1998, when the Agency’s impartiality was similarly subject to question.  Thus, if the FDA has indeed been meeting with plaintiffs’ lobbyists, but not their defense/industry counterparts, then the pending proposal to do away with generic preemption should be withdrawn – never again to see the light of day.

Whenever the other side starts cranking out the crocodile tears about the FDA being a supposed “puppet” of industry, just remember that we’re not the ones that have been caught – now, it looks like twice – with our hands stuck in the FDA preemption cookie jar.