Monday, September 1, 2014

Preliminary Discovery Battles -- In Federal Incretin Mimetics MDL -- Two Central Questions: Pre-Emption And General Causation

Incretin mimetics, like Merck's Januvia® (sitagliptin phosphate), are suspected by some medical practitioners and researchers, of being associated with increased risks of pancreatitis -- and perhaps even certain cancer risks. But "suspected" is the key word, there. As of the moment, there appears to be no gold standard, independently rigorous study linking the increased risk of cancer claimed by some, to any incretin mimetic regimen of any particular drug manufacturer. [My earlier backgrounder here.]

But the plaintiffs, some of whom claim against Merck, are (under our legal system) entitled to try to establish that so called "general causation" -- a tort of product liability, through reasonable document discovery efforts -- against the drug companies involved (including Merck). That is what is playing out over the next few weeks, as the plaintiffs seek adverse event reports they claim Merck and others are withholding, wrongfully, from them. Perhaps most sensationally (if proved), the plaintiffs apparently also claim that one or more drug manufacturers "spiked" or withheld certain study results which (they claim) have since mysteriously gone "missing". That claim could be decidedly. . . interesting, if it turns out to have a basis in fact. So -- yes -- we will watch this one.

Moreover, the second prong of the current discovery fight centers on whether the suits are pre-empted, under the Supremes' Wyeth v. Levine reasoning of a few years back. On that prong, the question will be whether Merck and the others complied with FDA instructions regarding warnings and labeling -- such that no tort claim can arise. That argument runs that if the warning was made to the limits of what FDA would allow the drug companies to assert, then they can't be liable for a "defective" warning -- insofar as FDA would not have permitted them to vary that "FDA mandated" warning. So -- as ever -- discovery will help the parties figure out whether this "FDA preemption" state of affairs in fact exists as to any (or many) of these would-be thousands of plaintiffs.

From the orders (PDF file) by the very able Judge Anthony J. Battaglia, in the federal trial level courthouse, sitting in the Southern District of California, last week then -- a bit:

. . . .All discovery issues must be resolved without delay. Currently, there are ten (10) potential discovery disputes ( the “current” disputes) being discussed by counsel, as well as the prospect for additional issues as other responses and productions are completed ( the “future” disputes),timing for these will be as follows:

a. Counsel will continue to meet and confer on the matters listed below, and the court will review the status of these matters at the September 16, 2014 status conference. The matters are:

i. The recently received certification and production by Lilly;

ii. Amylin’s pending certification and production;

iii. EMA submissions;

iv. Health Canada and other foreign submissions;

v. Non-clinical trials;

vi. Histology slides;

vii. The addition of other custodians to the deposition list;

viii. “Ongoing” study results;

ix. Written discovery regarding “outside” source information re: causation;

x. The purportedly “missing” studies.

Regarding the EMA, Health Canada and other foreign submissions, counsel might want to discuss the prospect of narrowing this data to things submitted to other agencies that differ from the submissions to the FDA, to reduce duplication and the associated time and expense that goes with it. . . .

We will keep the readership informed here. I'll happily pop the popcorn -- should be good theater for a bit, into October 2014.

1 comment:

Anonymous said...

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