Motion to Amend is definitely in the right direction here. This is my take which is partly guess work because I cannot tell the future here and there are a lot of variables.
As I wrote before the Motion was filed on Friday:
If they file another underwhelming motion and proposed amended complaint, then chances are not great. If they file a great motion to amend, with expert testimony refuting why the FDA document should not be necessarily credited, and attaching that expert declaration to the proposed amended complaint, I would expect the chances of getting to an amended complaint to be good in my opinion.
Ideally, the expert declaration and the proposed amended complaint would provide evidence that HCMC purchased the IQOS device and tested it; that those tests resulted in byproducts of combustion; that there is a credible factual dispute as to what constitutes combustion; and either (1) the low temperature aspect of the IQOS device is not dispositive because, according to the science, combustion can occur at these lower values or (2) that based on testing, the IQOS actually heats to a higher temperature, high enough to allow combustion.
The Motion (and attendant declaration), checks some of those boxes. (tested the IQOS device, saw byproducts of combustion).
I expect PM to oppose the Motion to Amend based on its own expert and challenge the issue scientifically, including the suggestion that combustion can occur at lower temperatures. However, that sounds like a factual dispute that the Court should not get into at this stage.
The bigger problem is Judge Batten's characterization of a potential amendment as "futile." Usually that is reserved for situations where there is no way to overcome the defect. It puzzled me when I saw it. To me it was not futile because science could provide possibilities here. Perhaps the judge was elevating Exhibit J to proof because it was submitted to the FDA, I do not know. In any event, I expect PM to challenge here and raise the issue about Exhibit J again.
However, I believe HCMC does get a chance to reply here after PM files its opposition in 14 days.
HCMC should start preparing to explain the remaining issues that I identified in addition to why Exhibit J is not to be entirely credited at this stage in addition to reinforcing why combustion can occur at these lower temperatures. To challenge Exhibit J, HCMC should have a second "FDA regulatory" expert on board for the reply to explain that the FDA takes submissions at face value in some circumstances and therefore Exhibit J should not be credited at this stage. I saw that because I am sure PM will bring up Exhibit J and the Judge seems to be treated it as proof when he should not be doing that.
In any event, just my thoughts and guesses here.
AI
