Immunotherapy: Recoverability of treatment considered
21 September 2018 21 September 2018
In their judgment, the High Court considered the scope of a compromise agreement in which the Defendant agreed to fund the Claimant's second line immunotherapy treatment for mesothelioma. The case raises several important practice points for defendants in this rapidly developing area.
The Claimant's malignant pleural mesothelioma claim was settled by way of compromise agreement. The Defendant agreed to provide an indemnity to fund the costs of "further reasonable second line immunotherapy treatment" (as recommended by the Claimant's oncologist).
Initial results using pembrolizumab were positive, however the Claimant's condition subsequently deteriorated. The Claimant's oncologist recommended a different form of immunotherapy. This raised issues in relation to scope of second line treatment under the compromise agreement.
The Claimant sought a declaration the proposed new treatment was covered. He argued this treatment was a continuation of the second-line treatment, which was specifically contemplated in the agreement. The Defendant considered the new treatment to be third-line treatment which it had not agreed to fund.
Finding for the Claimant, Master Thornett held that although second-line treatment was not defined in the agreement, it was not expressly limited to pembrolizumab, and included continuing immunotherapy treatment generally. The proposed new treatment was re-treatment and not a separate third-line therapy, such as surgery.
The Judge also considered the reasonableness of the treatment, finding that, although there was little if any support from formal clinical research studies, there was some evidence to justify the further treatment.
It was also noted that where the parties had agreed to be bound by the reasonable opinion of the Claimant's oncologist, the Defendant was unable to introduce alternative medical opinion in order to contradict them.
The question was whether the recommendation of the agreed medical practitioner was objectively reasonable, even if falling within a range of opinion. There needed to be a more convincing evidential basis to conclude treatment is unreasonable, typically because the evidence established that the risks obviously outweighed the potential benefits.
The case of Najib v John Laing Plc  EWHC 1016 (QB) was considered, which concerned whether it was reasonable to use photodynamic and drop therapy to treat mesothelioma. Whilst there was no known risk with the treatment, there was also no known benefit. This did not prevent the claim being allowed. Comparing the case, the Judge noted "In contrast to the treatment in Najib, there is evidence both as to justification and potential benefit from not only an experienced relevant clinical practitioner but the very practitioner contemplated in the Agreement: the Claimant's treating oncologist".
What can we learn?
- The Court was perhaps unsurprisingly sympathetic to the Claimant in finding the recommended treatment was reasonable. Defendants should be mindful of this likely judicial approach when seeking to challenge treatment on the basis of reasonableness in this rapidly developing area.
- It is clear that immunotherapy re-treatment will be considered to be covered within the definition of second line treatment, even where it involves a new form of immunotherapy drug.
- When negotiating the terms of compromise agreements defendants should ensure limitations in treatment are clearly drafted and may wish to consider listing the particular medications covered under the indemnity.
- As this case highlights, immunotherapy is a field of medicine that is evolving at pace, with the potential to substantially inflate damages awards and settlements in mesothelioma claims. Insurers must be mindful of this trend and need to consider accounting for the risks of unexpected treatment in their claim reserves.