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Note - Not Exactly the Same: an Examination of How Generic Substitution Laws Inadequately Protect Consumers’ Needs if Taking Generic Drugs Results in Injuries


Every day, millions of Americans take generic prescription drugs, not thinking once about what their legal options would be should taking those drugs result in injuries. Unbeknownst to them, due to very recent developments in the law, in all but a few jurisdictions consumers are totally powerless to recover if they are hurt after taking generic drugs.

Common knowledge dictates that there is no difference between generic and brand-name drugs, and state laws even require pharmacists to fill consumers’ prescriptions with the generic versions of brand-name drugs, absent explicit directions from the physicians to the contrary. While it is true that generic and brand-name drugs are identical in terms of bioequivalence and therapeutic effect, they are not identical in one crucial, but underappreciated, regard: the possibility of recourse if taking generic drugs results in injuries and the consumers want to recover under failure to warn or design defect claims. Starting with a Supreme Court decision in 2011, case law has made it clear that in these situations, neither the generic nor the brand-name manufacturers of the drugs are liable, thus leaving consumers entirely without recourse.

This Note examines the history of the FDA and drug regulation, the federal laws and cases that make up the current regulatory landscape, and state generic substitution laws. This Note then identifies a problem that goes largely undiscussed: because recent Supreme Court decisions have made it so consumers are powerless to recover for injuries sustained after taking generic drugs, which generic substitution laws effectively forced upon them, those laws should change to reflect the needs of consumers. This Note then suggests solutions to this problem, including a call for consumers to petition their legislatures to change generic substitution laws to be more favorable to consumers, and a challenge to the constitutionality of the laws.