Tuesday, August 18, 2015

UPDATED Propecia® MDL Documents Spat: The Weill-Cornell Med Center In-House Lawyer Weighs In, This Afternoon

Well, it once again seems unlikely that there will be any high drama show-down in Brooklyn's federal District Court, on September 2, 2015. It seems that the in-house lawyer for the entities served subpoenas intends to deliver relevant documents prior to that day.

At least that's what her sworn statements -- before the federal trial court now aver. And I trust she will. She claims the earlier mix-up was plaintiffs' counsel's fault -- that they had served a party (the doctor) who did not control the documents in question. I personally think that's a rather dangerous argument to make, because under applicable federal law, various clinical trial documents, like these -- are to remain (essentially forever) the responsibility of the so-called Principal Investigator under the clinical trial/study. The idea here is that a real person, not a company, hospital or university -- under federal law -- should be signing on for, and responsible for the safe and ethical conduct of the trial. If memory serves, the doctor was the P.I. on those old studies -- some dating back 25 or more years.

In any event, the plaintiffs have now served everyone that might have control of the study documents, and so, their in-house lawyer says the documents will be forthcoming. Here's a bit from her response -- filed today (and the full PDF of it):

. . . .I am Associate University Counsel in the Cornell University Office of University Counsel and counsel for non-party witness Dr. Julianne Imperato-McGinley (“Dr. McGinley”). Dr. McGinley is a full-time member of the faculty of Weill Cornell Medical College ("WCMC"). . . .

[Plaintiffs' counsel] mischaracterizes my communication with him to suggest we have more documents than we do. The available records responsive to the subpoena Plaintiffs served on Dr. McGinley are in the possession, custody and control of WCMC, not Dr. McGinley in her individual capacity. Dr. McGinley, as an individual, has no records in her personal possession that are responsive to the subpoena duces tecum, beyond the information produced. . . .

Most of these records are from 30, 20 and 15 years ago. WCMC reviewed a list of records it had stored, which turned up 16 boxes and potentially more (possibly up to 40) that may include records related to the subject matter of the subpoena. It is important to emphasize that not all of the documents contained in those 16 to 40 boxes are relevant records. The boxes identified in storage were for review to identify the relevant documents. . . .

She goes on to say that at least some will be produced -- but many may not be relevant -- or may be privileged. So. . . I trust that all those following this closely -- you know who you are Messrs. E. & I.(!) -- will enjoy this above bit of federal civil practice "street theater." Now you know. Onward -- and a river runs through it.


Anonymous said...

Thanks for the update. Is it safe to say these types of events aren't very common in a high profile MDL like this one? And when I say events I am also referring to the fact that Merck was found to be withholding a large number of documents that were later determined to be discoverable. As Mr. I pointed out, from an outsider's perspective it appears that Merck is trying to delay this process as much as possible. I understand that is probably not uncommon in legal matters but in this particular situation the measures they are taking seem very extreme to me.

Mr. E

Confor said...

Thanks Mr. E --

I hear you. I think time is always the friend of the manufacturers in a drug mass tort MDL. So it makes sense that Merck looks to run the clock.

That said, Merck would likely not be in favor of Weill/Cornell angering the judge. The clinical trial documents are relevant -- whatever they hold. Better not to fight an obviously losing battle here.

So my bet is that this particular skirmish is outside of Merck's influence.

More generally, it seems the in-house lawyer (unwisely, I think) treated this like a med mal case at the hospital -- and is only now learning that clinical trial documents are different in kind than treating physicians' notes.

By this I mean that if the clinical trial was run appropriately, Weill-Cornell is largely out of this dispute. The defendant is Merck, not the hospital.

So, we will wait and see -- but these are still very early stage proceedings.


Anonymous said...

This raises another question for me. Given that Merck is truly the defendant here, and if Weill-Cornell is largely out of the dispute, what is Dr. I-M's role? Is she somehow of a party with Merck as one of their main PI's?

Let's say it turns out there's a proverbial smoking gun in these documents that is bad news for Merck (realizing there may not be, but bear with me). If that's the case and that's still not really a problem for Cornell, is it a problem for Dr. I-M beyond simply reputation? - Mr. I

Condor said...

The doctor isn't accused of anything -- she just holds the study documents. SHe is a witness, of sorts -- that's all.

If she failed to report a safety signal -- which seems highly unlikely -- from the study data, it likely would have been caught by FDA staffers.

But yes, if there was any sandbagging of bad safety (or sexual dysfunction) study data, it would be a problem for the doctor -- as I say, that seems improbable to me.

Great questions!


Anonymous said...

Thank you for that explanation, but I hope you'll entertain at least one more follow-up:

Potential sandbagging aside, if there is a smoking gun, can principal investigators like Dr. I-M who are technically employees of Cornell get in trouble when Merck is the defendant? Mr. I

Condor said...

Yes, Mr. I --

If the clinical researcher failed to execute on her duty of due care, in the clinical trial, the usual recourse would be reprimand from Cornell's office of research integrity -- and if any federal money was involved -- the federal ORI might institute debarment proceedings.

But these would all be confidential investigations, and outside the MDL's discovery scope -- until a finding of culpability is issued.

Truthfully, I'd be shocked if the clinical trial documentation is irregular in any meaningful way -- it was vetted by FDA pre-approval of Propecia, after all.

But there is -- I suppose -- a remote possibility that FDA staffers missed it.

We will all wait and see.

Great queries!

Namaste -- great weekend ahead!

Anonymous said...

Yeah, that's why I keep hedging my comments about the proverbial smoking gun. I suspect Propecia is indeed more harmful than the original Merck/FDA claims said, but that doesn't mean I'm convinced that the clinical trial docs will show this. Science is complicated. As the guy from the recent Northwestern study said, the question seems to be WHY the side effects didn't show up in the clinical trials. I don't konw that I even have a guess on that. - Mr. I