The way that FDA market approval works for generic drug entry for the last three decades is that generic makers need only show that their product is bioequivalent to the original product. In that way, the generic product is essentially marketed under the originator's product label already approved by the FDA. So, the generic company is only making the claim that its product has the same risks as the originator product. Under the theory of the case, if the originator company's label did not sufficiently warn against an adverse effect, it is the originator's fault for mislabeling and not the generic's. (Any defects in manufacturing would remain the generic's fault.) This would make the originator firm responsible for making changes in labeling stemming from new information about a product for the product's entire life. Since the originator company is most likely to become aware of any newly discovered risks, this could be efficient.
However, it is possible that the source of the adverse effects is not clear. It may be due to the active ingredient not mixing well with the body chemistry for a certain sub-population of potential users. Or, it could stem from a particular handling of inactive ingredients that do not affect bioequivalence tests. If the latter, this ruling would allow generic makers to shirk on production because the liability would fall elsewhere. This will change behaviors.
“It has national implications,” said Bill Curtis, a Dallas lawyer who has filed hundreds of similar cases in several states. “I suspect that now, like most folks, if a client comes into my office, I’d be suing both the generic they took and the brand who’s responsible for the label.”
A likely result is more such cases due to branded companies having much deeper pockets than generic companies.
Hat tip: James Joaquim de Almeida Otterson
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