Saturday, December 5, 2015

The USDC ED NY Minute Order -- From Propecia® MDL Hearing Of December 3, 2015

Nothing of material note was disclosed on Thursday -- leastwise, not in the written orders available electronically. I am now nearly certain that the doctor was able to satisfy the Magistrate Judge back in September -- by turning over whatever documents she still held in her possession [or derivatively -- held via her offices at Cornell's Med School, and its teaching hospital(s)]. It has now been three full months with no mention of her name, by either side -- so that's a safe bet, in my estimation.

The next regularly scheduled status conference -- in Brooklyn -- is now set for February 4, 2016. Here once again is a link to the general order, governing the schedule through mid 2017, in this Finasteride MDL. And. . . the docket from Thursday reads:

. . . .Minute Entry for proceedings held before Magistrate Judge Peggy Kuo.

Status Conference held on 12/3/2015. Attorneys Ian Stern Millican, Victoria Maniatis David S. Ratner, Clinton Fisher, Theodore E. Laszlo, Jr., and David T. Sirotkin appeared on behalf of Plaintiffs.

Attorneys Charles Morrow, Ben Scott, Matthew T. McLaughlin and Trent B. Miracle appeared on behalf of defendant Merck & Co.

Attorney Mili Makhijan appeared for defendant Medical Hair Restoration Bosley.

The parties advised that discovery is proceeding according to the Discovery and Trial Plan dated September 23, 2015.

The next Status Conference is scheduled for February 4, 2016, at 2:00 pm, in Courtroom 322 North, before Magistrate Judge Peggy Kuo. . . .

Off now -- for a sunny, crisp Saturday bike ride!


Anonymous said...

Huh. I was not aware that Bosley was also involved. Did they get incentives to provide the drug or something? - Mr. I

Anonymous said...

Kevin Caraher said...

How can any of us be 100 percent positive Merck would turn over all their clinical trail documents ? I mean in light of their behavior over the past few years it would not be unimaginable to think that they would claim some were lost of destroyed. The "lost or destroyed" documents would probably be the documents most crucial to the MDL no doubt.

Anonymous said...


I feel it would be impossible for Merck to 'loose' clinical trial documents. The FDA should possess the data submitted by the drug sponsor. I think the larger question pertains to the adequacy and completeness of the data that was submitted. I understand that, at the time, it was acceptable to report 'statistics' rather than 'raw numbers' for both publication purposes and for some ancillary documentation that may be requested by the FDA. It should be noted however, that the devil is in the details (or raw numbers)and thus for full transparency [all] raw numbers should be in hand according to Good Clinical Practices. Furthermore, the protocols used in each clinical trial should provide a means to reconcile any missing data. For example, a protocol for a clinical drug trial may have stated that prolactin levels were to be measured 26 months after treatment with the drug, therefore it would be ridiculous for the sponsor not to submit any data for prolactin levels measured 26 months later. If I were an FDA medical reviewer of a new drug application I would reject this application if I were not able to reconcile these missing data (here, prolactin at 26 months) with no further questions or additional statements on behalf of the FDA.

Brian D said...

I wouldn't be surprised if the MCL may be a more appropriate indicator as to where the MDL is currently. For over a year MDL case management conferences preceded MCL case management conferences by a week or less, until today as the New Jersey MCL now is proceeding the MDL (03FEB2016 and 04FEB2015, respectively). Additionally, I recall a document from PACER (Eastern NY MDL)on behalf of the plaintiff counsel stating that they felt Merck was dragging their feet (pertaining to Merck's proposed MDL trial order) in order to "...go before New Jersey".

What is your opinion?

Brian D said...

As of today the New Jersey MCL appears to be going before the MDL. This appears to be a change since, for some time now, the MDL was preceding the MCL.