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Bert Rein, of Wiley LLP, prepared the following guest post. We thank him for the contribution, and the credit for what follows naturally goes to Bert alone:
As we anticipate decision in Wyeth v. Levine when the Supreme Court reconvenes on February 23, we continue to see how contentious an issue preemption has become in public and political debate. Congressman John Dingell, for example, has jumped on the salmonella-contaminated peanut butter bandwagon to introduce legislation expanding food safety inspection and civil penalty powers and added a sweeping savings clause precluding the FDCA, or any amendment to FDCA from “modifying or otherwise affecting any action or the liability of any person … under the law of any state.” The AAJ (formerly ATLA), never hesitant to endorse an opportunity for expanded litigation, has applauded Mr. Dingell’s recognition that “FDA enforcement is not enough” and that we need “the right of consumers to seek justice on these issues in the court system.”
It would only be realistic to anticipate a similar political response to a pro-preemption ruling in Levine. Whether a savings clause would succeed in overriding implied Constitutional preemption – as one failed to do in Geier – is a difficult question. Nevertheless, future preemption litigation would be complicated by such an expression of Congressional intent, even one that glosses over the fact that the real issue in preemption is not whether a legal remedy exists for the plaintiff, but what standard (a priori federal regulatory or ex post common law) will be used to evaluate the defendant’s conduct.
To complicate the political picture, there are instances in which those seeking the benefit of preemption push it to extremes that can obscure the core standards issue and conflate preemption and immunity from suit. A prime example is the position taken by generic companies, as recently evidenced in the Conte v. Wyeth case, that label-based liability cannot be asserted against them so long as their labeling is identical to the labeling of the branded drugs they copy. Since only NDA holders can initiate labeling changes, they argue, faulting generics for failing to initiate a labeling change even when they dominate the market and have access to significant new safety information would make it impossible for them to comply with both state and federal law.
The flaw in this argument is its failure to distinguish between the identical labeling required for a generic to gain ANDA approval and the FDA responsibilities incurred by an ANDA holder after approval. FDA has made it clear that ANDA holders may initiate labeling changes by sNDA, regardless of the position of the branded manufacturer. Moreover, by informing FDA of new safety information, an ANDA holder can prompt FDA to take persuasive and now compulsory action to modify the labeling of all manufacturers of the drug. Thus, a generic manufacturer seeking to disclaim the possibility of modifying its label on the basis of information that would require a branded manufacturer to make a change is crying wolf and crying wolf on a basis that disparages the compelling arguments for the preemptive effect of fully-informed FDA labeling decisions. That is not to say, of course, that a preemption defense should not be available to generic manufacturers. It is simply to point out that generic preemption should be subject to the same conditions and limitations as branded preemption.
Courts that have thoughtfully considered generic responsibility have concluded that Hatch-Waxman was not intended to absolve generic manufacturers of responsibility for their labeling. Foster v. American Home Products Corp., 29 F.3d 165, 169 (4th Cir. 1994); Kelly v. Wyeth, No. Civ. A. MICV200303314B WL 4056740 at *54 (Mass. Super. Ct. May 6, 2005); Sharp v. Leichus, Case No. 2004-CA-0643, 2006 WL 515532 at *7 (Fla. Cir. Ct. Feb. 17, 2006). Conversely, courts that have given generics a free pass — either on preemption grounds or by permitting them to rely on the branded PDR for commercial purposes while disavowing it for legal purposes as in Conte — have contorted product liability law to foist unwarranted liability on branded manufacturers.
If preemption and uniform federal conduct standards are to be preserved against the inevitable onslaught from those who never saw a lawsuit they didn’t like, we who advocate preemption must be sensitive to potential excesses, cognizant of promising preemption on the decisions of a properly informed FDA and willing to avoid taking positions that allow preemption to be portrayed as a “get out of jail free” card rather than a vehicle for ensuring uniform, nationwide regulation under scientifically-based standards.