If somebody were to ask us whether as a general proposition it’s relevant to the presentation of a product liability case about a prescription medical product that the FDA had approved/cleared the product and the defendant had complied with FDA regulations, our immediate reaction would be “Duh, of course, it’s relevant.” We may have an overriding preemption or standing argument under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), but relevance? Particular aspects of FDA approval or compliance might not pertain to the particular defect allegations in a given case, but in general, the relevance of the fact the FDA has allowed the product on the market, and that the manufacturer complied with pertinent FDA regulations, seems unassailable.
Ask that to the other side, however, and the answer will be “only if it helps me win.” Plaintiffs are more than happy to offer evidence of FDA approval/compliance evidence – but only if it’s about non-approval/noncompliance. If the FDA pedigree of a particular product doesn’t include any sort of FDCA violation, then the same counsel who so zealously advocated the relevance of the FDA last week is quite happy the next week to disavow every word of it. That happened to us recently, hence this post.
When an application is required to sell an FDA-regulated product (including almost all such products likely to be involved in litigation), the manufacturer cannot sell it in the U.S. until and unless the FDA says ‘yes.’ Indeed, over a dozen states have statutes that, to one extent or another, presume that products passing FDA muster aren’t defective. For reasons such as these, the overwhelming majority of the caselaw recognizes the relevance of the FDA’s decisions.
Putting aside preemption (which is predicated on federal, not state, legal principles) the general state-law rule is that a product’s compliance with FDA regulations – whether they’re characterized as “minimum” or otherwise, is relevant, albeit not controlling, in product liability litigation.
[A] product’s compliance with an applicable product safety statute or administrative regulation is properly considered in determining whether the product is defective.
Restatement (Third) of Torts, Products Liability §4(b) (1998). The supporting Reporters’ Note to §4(b) confirms:
The overwhelming majority of jurisdictions hold that compliance with product safety regulation is relevant and admissible on the question of defectiveness, but is not necessarily controlling.