Recent Preemption Decisions Offer a Mixed Bag for Generic Drug Manufacturers

November 30, 2009

By Kurt R. Karst –    

Returning from the Thanksgiving Holiday, we found our inbox chock-full of recent preemption decisions of note involving generic drugs. 

First off is a decision from the U.S. Court of Appeals for the Eighth Circuit in Mensing v. Wyeth.  That case involves generic REGLAN (metoclopramide), allegations that use of the drug caused tardive dyskinesia, and an appeal from an October 2008 decision from the U.S. District Court for the District of Minnesota in which the court dismissed, among other things, certain tort claims (failure to warn and misrepresentation) against generic manufacturers of metoclopramide on the basis of federal preemption.  In reversing the district court’s decision on this point, the Eighth Circuit, following a rationale harkening back to the recent decision from the U.S. District Court for the District of New Hampshire in Bartlett v. Mutual Pharma. Co. (see our previous post here), ruled that the plaintiff stated a viable claim against generic metoclopramide manufacturers.  Some of the more notable passages from the decision include:

  • The Hatch-Waxman Amendments are part of this 70 year history and they do not explicitly preempt suits against generic manufacturers. Congress could have crafted a preemption provision for generic drugs in its 1984 amendments, having done so for medical devices less than 10 years earlier. It chose not to do that. . . . After [Wyeth v. Levine], we must view with a questioning mind the generic defendants' argument that Congress silently intended to grant the manufacturers of most prescription drugs blanket immunity from state tort liability when they market inadequately labeled products.

  • The parties agree that generic labels must be substantively identical to the name brand label even after they enter the market. . . .  Because of this requirement, the generic manufacturers argue they are prohibited from implementing a unilateral label change without prior FDA approval through the [Changes Being Effected (“CBE”)] process.  Yet, 21 C.F.R. § 314.97compels generic manufacturers to “comply with the requirements of §[] 314.70[.]”  Section 314.70 includes the CBE process and the prior approval supplement process.  In this case we need not decide whether generic manufacturers may unilaterally enhance a label warning through the CBE procedure because the generic defendants could have at least proposed a label change that the FDA could receive and impose uniformly on all metoclopramide manufacturers if approved.  [(italics in original)]

  • In addition to proposing a label change, the generic manufacturers could have suggested that the FDA send out a warning letter to health care professionals.  When the FDA first adopted its labeling regulations, well before the Hatch-Waxman Amendments, it stated that the requirements “do not prohibit a manufacturer . . . from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered.”  44 Fed. Reg. 37434, 37447 (June 26, 1979); see also CDER, Manual of Policies and Procedures (MAPP) 6020.10, NDAs: “Dear Health Care Professional” Letters (July 2, 2003) (guidance document to name brand manufacturers stating that the letters may be ordered by the FDA or sent by manufacturers without FDA involvement).

The second decision of interest is from the U.S. District Court for the Northern District of California (San Jose Division) in Gaeta v. Perrigo.  In that case, the court denied Gaeta’s Motion for Reconsideration of a pre-Levine Order granting Perrigo’s Motion for Summary Judgment.  The pre-Levine Order found that Gaeta’s state law causes of action were preempted to the extent that they allowed for liability based on a lack of adequate warning on Perrigo’s over-the-counter ibuprofen drug product.  Gaeta argued that “although the specific facts of Levine involved a brand-name drug, the Court’s holding was broad enough to also encompass the interaction between FDA regulations and state tort law with regard to generic drugs.”  The court disagreed, however, ruling that “Levine does not govern whether the Court may grant summary judgment on Plaintiff’s state tort claims,” because “Levine did not address a dispositive issue in this case, namely, whether a generic drug manufacturer may use the CBE process to make warning-label changes without prior FDA approval.”

The applicability of the Supreme Court’s decision in Levine to generic drug manufacturers was also noted – more specifically, sidestepped – in a third recent ruling.  In Morris v. Wyeth, which again involves metoclopramide, the U.S. District Court for the Western District of Louisiana (Monroe Division) granted a Motion for Summary Judgment in favor of the brand-name drug manufacturers because the plaintiff in the case did not consume REGLAN, but rather a generic version.  The court stated that “Levine held only that the FDA’s approval of a branded drug’s labeling does not preempt a plaintiff’s state law failure-to-warn tort claim against the manufacturer of the branded drug.  Levine certainly does not stand for the proposition that the brand-name manufacturer of a drug may be held liable under the law of Louisiana for the warning provided by a generic manufacturer.”  The court goes on to comment in a footnote, however, about the applicability of Levine to generic drug manufacturers:

Levine did not address generic drugs and if or how its analysis might apply to claims against generic drug makers.  The Court is aware that generic drug manufacturers continue to argue that failure to warn claims against them are preempted because they are bound by FDA regulation to conform their labels to that of the brand-name drug. . . .  However, . . . that issue is not before the Court in this motion. . . .  The Court recognizes the inequity that may result if a plaintiff who was harmed by a generic drug is preempted from obtaining damages from the generic manufacturer on the basis of its failure to warn, but also has no cause of action against the name-brand manufacturer who prepared the warning used by the generic manufacturer.  Nevertheless, these are two separate legal issues, and the Court cannot render a finding of liability . . . based on the possibility that the generic manufacturers . . . may or may not have a preemption defense to Plaintiffs' failure-to-warn claim.    

Although legislation has been proposed that would preempt tort suits against generic drug makers, it does not appear to have made it into the current version of the House and Senate health care reform bills.