The Orthopedic Bone Screw litigation would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product.  In that instance, the FDA had limited its cleared “intended use” to disc spaces in the lowest part of the spine, while essentially identical, equally safe placement in adjacent disc spaces was off-label (and also the medical standard of care).  That was what the Bone Screw plaintiffs attempted to convert into a tort, with spectacular lack of success.

Given what a salami-sliced intended use put our clients through in Bone Screw, we’re still alert to similar attempts, even in areas outside of product liability.  Thus, we were pleased that the Medicare recipient in Dobson v. Secretary of HHS, 2022 WL 424813 (11th Cir. Feb. 11, 2022), prevailed against similarly crabbed thinking.  The claimant in Dobson had a severe spinal cord injury that caused “severe nausea and vomiting multiple times each day.”  Id. at *2.  Only one drug worked – but it was an off-label use:

But [the drug] is not FDA-approved for use in this way, so Medicare Part D would not reimburse [claimant] for the drug unless his use qualified as an approved off-label use, known as a “medically accepted indication.”  This case requires us to determine whether the statutory definition of “medically accepted indication” covers [this] off-label use

Id. at *1

Medicare covers quite a few off-label uses, because the relevant term – “medically accepted indication” – includes all drug uses, whether or not FDA-approved, that are “supported by one or more citations included or approved for inclusion in any of the [certain medical] compendia.”  42 U.S.C. §1396r-8(k)(6).  For a much longer, and heavily footnoted description, this issue, see James Beck, “Off-Label Use in the Twenty-First Century:  Most Myths & Misconceptions Mitigated, 54 UIC J. Marshall L. Rev. 1, 32-34 (2021).  In Dobson, one of those compendia, the Drugdex Information System (we can’t link directly to it because it’s proprietary), included two on-label and six off-label uses for the drug.  2022 WL 424813, at *3.  One of those off-label uses was for “[i]ntractable nausea and vomiting related to metastatic cancer of the gastrointestinal mucosa.”  Id.  But because this claimant’s intractable nausea and vomiting arose from a spinal cord injury, not the particular cancer mentioned in Drugdex, the government denied coverage.  Id. at *4.

The drug in question was a palliative – it did nothing to treat the underlying condition that caused vomiting, be it spinal cord damage or cancer.  Thus, from a medical perspective, what caused the vomiting really didn’t matter much.  But it mattered to the folks that administered Medicare.  It presented a question of law of first impression:  how “to construe the term ‘supported by’ in the governing statute.”  Dobson, 2022 WL 424813, at *6.  Dobson contains a lot of administrative law mumbo-jumbo, but the bottom line of the decision is clear:  don’t salami slice the support for the off-label use.

The Medicare statute did not define “supported by,” so Dobson resorted to common dictionary definitions.  Id. at *7.  The dictionary definition precluded the government’s attempt to limit coverage solely to those victims of intractable nausea and vomiting who had the aforementioned “metastatic cancer of the gastrointestinal mucosa.”  Rather:

Using these definitions to construe the phrase “supported by” . . . requires the conclusion that the compendium citation must tend to show or help prove the efficacy and safety of the prescribed off-label use.  Nothing about the common meaning of “support” means that a compendium citation must hyperspecifically identify a prescribed off-label use to tend to show or help prove its efficacy and safety.

Id. (emphasis added).  “Hyperspecifically identify” is what we call salami slicing for short.  All the medical article in Drugdex had to do was check three general boxes, which it did in Dobson.

[The court] conclude[s] that the citation supports [claimant’s] use:  nausea and vomiting − check; disease-related − check (Central Cord Syndrome and Eagle Syndrome); treatment refractory − check (the usual drugs used to treat nausea and vomiting did not work . . .).

2022 WL 424813, at *8.  Nor was there anything in the article in question that “contraindicate[d]” the off-label use at issue.  Id.  Thus, the claimant’s “understanding of the citation to support refractory, disease-related nausea and vomiting is consistent with the notion indicated in the overview” of the article.  Id.  “Nothing about that process [of drug action] is described in a way peculiar to cases of diffuse gastrointestinal mucosa metastases (as opposed to being applicable to nausea and vomiting caused by disease in general).”  Id.

Further, this relatively broad construction of “supported by” was consistent with the purpose of the statute.

Congress’s decision to amend Medicare Part D to reimburse for previously uncovered off-label uses of outpatient drugs that are supported by a citation in the compendia obviously represented an enlargement of Medicare drug coverage. . . .  We think that suggests the same or very similar concerns motivated the 2008 amendment to Part D − namely, that Medicare participants receive coverage for off-label uses but that those off-label uses be objectively demonstrated to be efficacious and safe, as demonstrated by their inclusion in one of the drug compendia.  Plus, the statutory definition of “medically accepted indication” logically indicates as much.

Dobson, 2022 WL 424813, at *10.  Thus, Dobson “conclude[d]” that all of the considerations relevant to statutory construction “require[d] the conclusion that ‘supported by one or more citations included or approved for inclusion’ in [a compendium] means that the [compendium] citation relied upon must tend to show or help prove the efficacy and safety of the prescribed off-label use.”  Id.

Why do we care, and why should our drug clients care?  Here’s a big reason – the False Claims Act.  Almost all the cases in Bexis’ law review article on Medicare and off-label use are FCA cases.  The “supported by” language that Dobson construed broadly also determines what off-label uses are and are not covered by Medicare, and thus what FCA plaintiffs can sue over when they allege that this or that off-label use was improperly paid for by the government.  Dobson’s rejection of salami slicing likewise is strong precedent for rejecting FCA plaintiffs’ attempts to nitpick the reimbursabilty of off-label uses on a much broader scale.  For that reason, it’s a pity that Dobson – a thorough treatment (eleven Westlaw pages) of a question of first impression – is not precedential.

Note:  in case our readers did not realize it, Thompson/West has discontinued the Federal Appendix reporter as of January 1, 2022.