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We are not the Hatfields and the McCoys.
Occasionally, even the innovators can be pleased when the generics win a victory — at least when the case doesn’t involve intellectual property, but rather the preemption defense.
On Friday, June 13, Perrigo Pharmaceuticals picked off a nice preemption victory in Gaeta v. Perrigo Pharmaceuticals Co., 562 F. Supp.2d 1091 (N.D. Cal. June 13, 2008). We’re blogging from home on a weekend and so not yet in a position to provide a link, but bright and early Monday morning you’ll find the opinion slip opinion here.
Augustine Gaeta allegedly suffered liver failure (and subsequent amputation of necrotic tissue on his fingers and toes) as a result of having consumed ibuprofen manufactured by the defendants, Perrigo, PAR Pharmaceutical, and BASF Corporation. The Complaint pleaded the usual causes of action — strict liability, negligence, and breach of warranty, among others.
The court’s analysis was slightly different from what we usually see, since the case involved a generic, over-the-counter drug, rather than the usual patented, prescription drug.
The Food and Drug Modernization Act of 1997 amended the Federal Food, Drug, and Cosmetic Act to provide for express preemption of state laws regarding over-the-counter drugs. The Modernization Act then has a savings clause, providing that preemption does not affect “the liability of any person under the product liability law of any state.” Id. at 5, citing 21 U.S.C. Sec. 379r(e). That savings clause, however, “‘does not bar the ordinary working of conflict pre-emption principles.'” Id., quoting Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000).
To obtain approval of a product, a generic manufacturer must submit to the FDA an Abbreviated New Drug Application that certifies that the labeling and warnings of the generic drug are the same as those of the listed drug. Unlike innovators (who, under limited circumstances, may have the ability to add a warning about a newly-discovered risk of a drug subject only to after-the-fact FDA approval), generic manufacturers are specifically barred from adding a warning or contraindication without prior FDA approval. “‘CBE changes are not available for generic drugs.'” Gaeta, slip op. at 7, quoting 73 Fed. Reg. 2848, 2849 n.1.
As readers of this blog know all too well, the FDA’s Preemption Preamble says that “‘FDA approval of labeling under the act . . . preempts conflicting or contrary State law.'” Gaeta, slip op. at 7, quoting 71 Fed. Reg. 3922, 3934. And the Preamble goes on to say that, “‘Overwarning, just like underwarning, can . . . have a negative effect on patient safety and public health.'” Gaeta, slip op. at 8, quoting 71 Fed. Reg. at 3934-35.
“In the absence of clear authority to the contrary, a court is to give deference to an agency’s interpretation of the scope if its authority to regulate.” Gaeta, slip op. at 8, citing Chevron U.S.A., Inc. v. National Resources Defense Council, Inc., 467 U.S. 837 (1984).
The FDA had reviewed Perrigo’s ANDA in 1987 and had again reviewed the liver toxicity issue in 2002. “The FDA concluded that warning for risk of liver injury was not scientifically supported by the available data.” Gaeta, slip op. at 9, citing 67 Fed. Reg. 54139, 54145-56.
“At the time it was administered to A.G., Perrigo’s ibuprofen followed the labeling for the listed drug, which contained the warnings mandated by the FDA.” Gaeta, slip op. at 9. Including additional warnings would have put “Perrigo’s ANDA in jeopardy for failing to conform with the FDA’s approved labeling for the listed drug.” Id. Gaeta’s state law claims were thus preempted. Id.
Good language about overwarning, Chevron deference to the Preemption Preamble, and a preemption win in a slightly different context.
Not bad at all.
Thanks to Kelly Savage of Sedgwick Detert for alerting us to this recent victory.