Krauss on Rights of Generic Versus Branded Drug Manufacturers

Professor Michael Krauss discusses Mutual Pharmaceutical Co., Inc. v. Bartlett in an essay that considers whether generic drug manufacturers have more rights than branded drug manufacturers.

Krauss examines underlying facts and the legal issue on appeal, as well as the court's holding, finding that "It is clear now that only manufacturing defect (i.e., the generic drug was not made correctly, was diluted or contaminated, etc.) is available to those suing the manufacturers of generics."

"Perversely, this gives more rights to plaintiffs suing brand-name manufacturers than to those suing off-patent producers," he says. "The former remain liable for manufacturing, informational and design defects, while the latter are only liable for manufacturing issues. Clearly this is a weird equilibrium, as it reduces the brand-name manufacturer's profits relative to the generic maker's. The former of course bears all development and testing costs, while the latter 'free-rides.'"

MUTUAL PHARMACEUTICAL CO., INC. v. BARTLETT: Do Generic Drug Manufacturers Have More Rights than Branded Drug Manufacturers?, June 25, 2013. By Michael Krauss.

"At the margin, this may encourage drug makers to select generic manufacturing instead of R and D. Sooner or later, I think, either Pliva and Bartlett will have to be repudiated, or (much more likely) the logic of their protection will have to be extended to informational and design defect cases against the makers of brand-name drugs, repudiating cases such as Wyeth v. Levine."

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