Tuesday, August 25, 2015

August 25, 2015 Propecia® MDL Document Discovery Update -- Small Delivery Of Documents Made; And An Assertion That Many More Are. . . "Missing"


Again, I must emphasize that we should not infer too terribly much from the plaintiffs' lawyers' claims that the vast bulk of the historical Propecia® study documents have gone "missing". But the surprising news here (to my eye) is that only some 630 or so pages were turned over by the University hospital, as of yesterday afternoon.

And so, with that said, I do think the plaintiffs make a generally very solid point -- when they ask where the doctor's study files -- as PI of the clinical trials (some of which were submitted to, or filed with federal agencies) -- now reside. [There is a passing and rather vague reference, to the Dominican Republic here, as well -- and it may well turn out that some records need to be culled from storage, on the island.] As I've indicated before, the federal rules contemplate that those documents should remain under the control, directly or indirectly, of the principal investigator -- precisely in the event that questions like those raised in the present mass tort litigation arise. The rules contemplate having a repository (under the direct supervision of a particular person -- the doctor) for exactly this sort of eventuality. Here is the Response filed today (a six page PDF file), by the plaintiffs' lawyers -- and a bit of it:

. . . .On August 24, 2015, in response to the Second Subpoena, Weill Cornell Medical College produced a mere 631 pages of documents, constituting less than half a box [of a purported 40 boxes]. . . .

The documents appear to contain nothing from Dr. Imperato-McGinley’s days researching in the Dominican Republic, nothing about her discovery, and just a handful of documents related to Merck. The paltry production by Weill Cornell Medical College emphasizes, as opposed to eliminates, the continued need for a “show cause” hearing with regard to the issue of Dr. Imperato-McGinley’s documents, and where these highly relevant and probative documents went. . . .

Though Ms. Orwel repeatedly affirms that Dr. Imperato-McGinley has no documents in her possession, custody, or control, these statements must be disregarded under Second Circuit precedent, as Ms. Orwel does not claim to have personal knowledge, or even any “knowledge,” regarding the factual question of what documents Dr. Imperato-McGinley has or had in her possession, custody, or control. . . .

Dr. Imperato-McGinley should appear in Court and explain to this Court why she has produced in effect absolutely nothing in response to the Subpoena served upon her. This Court should direct Dr. Imperato-McGinley to appear before this Court and show cause why she should not have to produce all responsive documents, to provide an explanation as to what if any documents were destroyed and when they were destroyed, advise what prompted counsel to initially believe there were between sixteen and forty boxes, and what those boxes contain, and find Dr. Imperato-McGinley in contempt of Court if she continues to refuse to comply with the Subpoena. . . .


The conclusion of the just filed Response renews the plaintiffs' request that the doctor be required to appear personally, and explain the whereabouts of the clinical trial documents. I remain skeptical that the Court is ready to order that appearance. I do think the Court will ask the counsel for Weill-Cornell to make an accounting of what was in the 40 boxes -- and which parts of it might not be discoverable. So -- do stay tuned for September 2, 2015. Onward -- and be excellent to one another!

3 comments:

Anonymous said...

Well, if you're a part of the camp that believes there is a "smoking gun" this news is definitely adding a little more fuel to the fire! It just seems odd to me that they would initially claim there were 16-40 boxes but then only produce one half of a box full of documents.


Mr. E

Anonymous said...

OK, now this is getting weird. Mr. I

Anonymous said...

Condor... on a separate topic, there is a Propecia case management conference scheduled for today, correct?

Mr. E