Saturday, May 30, 2015

UPDATE: The Full Order -- In Merck's Propecia® MDL


Again, it would shock me if the good doctor actually does not appear, with documents in hand, on or prior to the return date -- in two and one half weeks.

To tamp down a little of the speculation here, though, Merck should have had -- in its own possession -- copies of almost all of the same documents that Dr. Imperato-McGinley would likely still have, since all these studies are long completed, and the full data sets, clinical record-books and assorted notes should have been returned to Merck for storage, under FDA rules (or copies at least).

I suppose it is possible that some "smoking gun" will surface from her files, but she would have been required to show that to FDA staffers in near real time, whilst the studies were underway -- and it would likewise shock me if FDA approved Propecia® while holding such a smoking gun. No one (to my knowlege) claims she conducted any "after the fact" look-back meta-studies of the data, for patterns that weren't discernible earlier in the life of these patients' experiences. At least I've read nothing of that. So we will see what she produces:

TO: JULIANNE IMPERATO-MCGINLEY, MD
New York Hospital, Cornell University Medical College
Department of Medicine/Division of Endocrinology
1300 York Avenue, Room A357
New York, New York 10021

. . .YOU ARE HEREBY COMMANDED to appear in Courtroom 13A of the United States Courthouse, 225 Cadman Plaza East, Brooklyn, New York 11201 on Friday, June 19, 2015 at 11:00 a.m. to SHOW CAUSE why you should not be required to respond the subpoena duces tecum served on you by the plaintiffs in this action on February 4, 2015, and why you should not be sanctioned for having failed to respond to the subpoena as directed.

If you do not appear at the above time and place, you will be subject to penalties for contempt of court. The plaintiffs shall serve this Order to Show Cause, accompanied by a copy of the subpoena and proof of service in question, on the above named respondent by personal service as authorized by the Federal Rules of Civil Procedure or the New York Civil Practice Law and Rules no later than June 4, 2015 and shall file proof of service in the record. . . .


So it goes -- but sometime before Thursday of the coming week, she will be personally served with these papers at work. Kinda' embarrassing. Onward. Me? I'm remaining cautiously optimistic, here.

6 comments:

Anonymous said...

To the owner of this blog...I've been one of the anonymous commentators on this topic for a while, but I'm not the only one. Anyhow, I'm sort of fascinated by this blog in general outside of the Propecia MDL issue. I can't quite tell what the general theme is. For example, it seems like the blog is pro-Merck in a certain sense (e.g., Keytruda) but perhaps against in another sense (e.g., Propecia)? But even there I'm not sure. Of course, I acknowledge that it's a nuanced world and one could be both for Keytruda and able to see problems with Propecia, so I don't mean to try to put anyone in a box. I just can't quite figure out what the mission of this blog is and am curious. The writing is really quality, and it seems clear that you have some kind of background in pharma or biotech or the sciences at the very least. I'll start signing of as Mr. I from now on to distinguish myself from the other anonymous commentators. - Mr. I

Condor said...

Well met, Mr. I --

Yes. I am Condor. I'm an M&A lawyer who's worked -- for over 25 years -- in life sciences. And this blog started in late 2007 as a critique of the way legacy Schering-Pough executives conducted themselves.

After Merck bailed that group of miscreants out, I started generally following "New" Merck. I respect this present management team -- though like anyone might (myself included) -- they do make mistakes.

So I call 'em -- as I see 'em.

I think Mr. Frazier may Bette best CEO in pharma right now -- easy on the ego; and watchful, while not micro-managing.

Back in 2008, this explained my handle. Great old flick -- and a fun summer beach mystery book, too! [But the book is "Six Days..."]

Namaste -- and do stop back!

Condor said...

Oops -- please excuse the typo: should read as "...Mr. Frazier may well be the best CEO in pharma at the moment..."

Anonymous said...

Mr. I here again. I'd meant to ask earlier, but what are you cautiously optimistic about in this case? It's not really clear to me from your post. That evidence incriminating to Merck will turn up one way or the other?

Condor said...

Hey -- thanks for checking back in.

No, Mr. I -- what I am moderately optimistic about is that the good doctor will in fact turn over whatever data she still possesses, and avoid sitting in federal custody, in Brooklyn -- for contempt of court.

I have no idea what her data will yield, in terms of the litigation's merit -- or lack thereof.

Namaste -- enjoying our back and forth.

AND PS: Please do not be alarmed if it takes me about 10 hours to clear your comments on weekdays. See -- I have this other gig. . . smile. I know you can relate.

Anonymous said...

Ah, thanks for clarifying. It seems clear that this is what you meant now that you explain it. This is all kind of new to me, and I confess to being somewhat confused about how Dr. Imperato-McGinley could have that much to contribute for the reason you touched on. Wouldn't Merck and the FDA be likely to already have the same information? So maybe the plaintiffs just want to be sure?

Mr. I