Hardly a week goes by without our blogging about accusations of off label promotion. This week is no exception. On Monday, we discussed a nice New York opinion rejecting a plaintiff argument that off label promotion saved a case from preemption. And hardly a week goes by without plaintiff lawyers attempting to inject off label issues into our cases, as though mere mention of the possibility conjured up liability, punitive damages, and settlement-grids. As we have discussed many times before, the demonization of off label use is wrongheaded and counterproductive, given how off label use can be the only thing standing between patients and pain. Today’s case, Tangney v. Burwell, Secy of HHS, 2016 U.S. Dist. LEXIS 61724 (D. Mass. May 10, 2016), reminds us of that fact yet again.
The plaintiff in Tangney suffered from severe nausea and abdominal pain emanating from gastrointestinal issues, not cancer – facts that, as you will see, possibly become pertinent. It was undisputed that off label use of Dronabinol alleviated these symptoms. The issue was whether Medicare Part D covered the cost of the medicine. Such coverage is available if the drug’s use is approved by the FDA (not the case here) or is “supported by one or more citations included or approved for inclusion in any of the [listed] compendia.” 42 U.S.C. Section 1396r-8(k)(6). The particular compendium at issue in Tangney was Drugdex, which cited the successful use of Dronabinol to treat nausea resulting … in a case involving cancer.
Medicare rejected coverage because the plaintiff’s nausea was unconnected to cancer. Then a hearing officer reversed that decision and concluded there was coverage, because (1) the title of the Drugdex citation was not limited to cancer, even if the underlying case study was, and (2) the plaintiff’s real-world history showed that without coverage of the off-label use of the medicine, the plaintiff would “either have to remain in the hospital indefinitely or possibly die.” The Appeals Council then reversed the hearing officer”s decision and concluded there was no coverage, because the underlying case study involved a cancer patient, and there was insufficient evidence to show that efficacy would extend to non-cancer patients. The Appeals Council decision is considered a decision by the Secretary of the U.S. Department of Health and Human Services, Sylvia Burwell, and that is why she is listed as the defendant in the case that subsequently went before a federal judge.
The first decision for that federal judge was whether or how much to defer to the HHS Appeals Council. On this blog, we talk about product liability, not administrative law, so we will not linger on the niceties of Chevron or Skidmore deference to agency decisions. Leave it at this: the court held that the denial of Medicare Part D coverage of this particular off label use was not the sort of precedential, legislative ruling by an agency that required full-blown (and usually dispositive) Chevron deference. Rather, a lower level of deference, called Skidmore deference, came into play. Skidmore deference focuses on consistency and persuasiveness. Even with this lower level deference, the government usually wins.
But it did not win this time. The court held that the hearing officer got it right, and that it made more sense to frame the degree of generality in terms of effective treatment of nausea as opposed to effective treatment of nausea associated with cancer. Palliative care is palliative care. Our favorite part of the D. Mass. opinion is a footnote where the court observes how “Kafkaesque” it was to force the plaintiff to prove that the underlying case study supporting the Drugdex citation to off label use should apply to her, when she herself offered the most compelling case study, “with her having taken Dronabinol to near miraculous effect for three years before switching to Part D and being denied coverage.” The plaintiff herself presented a strong instance of challenge, rechallenge, etc. She suffered from severe nausea, the off label drug alleviated the pain, and then the pain returned when she had to go off the drug after coverage was denied.
Try telling this plaintiff, or millions of other patients in this country, that there is something nefarious with off label use of medicines. Try telling doctors. Or try telling judges who pay more attention to reality than rhetoric.