UPDATE: Federal Propecia®/Proscar® MDL — Revised “Bellwether” Likely First Trial Dates

January 4, 2017 - Leave a Response

life-propecia-01-04-17 I still think one of the the federal bellwether cases will go to trial first, but the distance on the time line, between the similar New Jersey state cases — and the federal ones — is closing in a bit, to be sure.

I’ve not reworked my earlier graphic now just yet — and will both set out the operative bit from the new order, just entered overnight — and attach the full four page PDF, here:

. . . .The parties will make their designated experts for all four cases available for deposition between July 20, 2017, and October 1, 2017.

Motions. All motions to exclude or limit expert testimony pursuant to Federal Rule of Evidence 702 and all dispositive motions shall be filed as follows:

Opening Briefs: October 20, 2017;

Opposition Briefs: December 1, 2017; and

Reply Briefs: December 22, 2017.

The Court will hold a hearing to consider these motions on a date to be determined later. Total briefing for each parties’ Daubert briefs shall be limited to 50 collective pages per side for opening briefs, 50 collective pages per side for opposition briefs, and 25 pages per side for reply briefs.

Other Dispositive Motions. Each party shall be entitled to request motion practice, including dispositive motion practice, pursuant to the Local Rules and consistent with this Court’s Individual Practices. Nothing in this Order shall prohibit the opposition party from arguing that the motion is premature and/or untimely.

Final Discovery. The parties shall complete any remaining discovery within 60 days of the start of trial.

teacTrial Schedule. The Court anticipates that the First Bellwether Tranche shall be trial ready by March 2018. Following the entry of all orders disposing of all Daubert motions and dispositive motions, the Court will issue a scheduling order governing all trial related obligations, including the specific date for commencement of trial. . . .

At some point tonight, I’ll get a revised tabular graphic up, on all of this — but for now (my other) duties call. [There really is nothing like old school turn-tables and real vinyl, for playing the older and wiser cuts. . . . smile.]

नमस्ते

UPDATED | Space Science: New Programs’ Discovery Press Briefing — From NASA This Afternoon, With Video…

January 4, 2017 - Leave a Response

life-exoplanet-mission-nasa-press-01-2017 I’ll listen in today at 4 PM EST (3 PM local) — and let you know what we learn.

This is (for me) what real space science should be all about — the discovery of. . . the undiscovered. Let us hope it will continue under the new administration:

. . . .NASA will discuss the results of its latest Discovery mission selection during a media teleconference at 4 p.m. EST on Wednesday, Jan. 4.

The briefing participants are:

Thomas Zurbuchen, associate administrator of NASA’s Science Mission Directorate in Washington
Jim Green, director of NASA’s Planetary Science Division in Washington
Principal investigator(s) of the selected mission(s)

To participate in the telecon, media should email their name and affiliation to Dwayne Brown at dwayne.c.brown@nasa.gov or call 202-358-1726 by 3 p.m. (EST) Jan. 4.

Members of the public also may submit questions to be answered during and immediately following the briefing using #AskNASA.

The Discovery Program was founded in 1992 as an innovative way for NASA to explore space, calling on scientists and engineers to design missions that unlock the mysteries of the solar system. These cost-capped missions are led by a principal investigator and managed for NASA’s Planetary Science Division by the Planetary Missions Program Office at Marshall Space Flight Center in Huntsville, Alabama. . . .

[With credit (and kudos) here, to the gifted graphical artist who created the Van Gogh “Starry Night” version of NASA’s wordmark — Bernard Eisen.]

UPDATED: here are the two missions, in a one and a half minute NASA explainer:

And now, smiling broadly — on a cold but bell-clear Tuesday morning walk in. . . all is well with my soul. Do not let Ms. Burress’s off-message remarks dissuade you from seeing the sublime “Hidden Figures“. That movie deserves your patronage — trust Pharrell here. Smile.

नमस्ते

[U] Slight Proposed Adjustments To Federal Propecia®/Proscar® MDL Schedule: Now Two Trial Tranches?

January 2, 2017 - Leave a Response

propecia-schedule-01-02-17UPDATED | 01.05.2017: Later rulings analyzed here. The plaintiffs’ executive committee lawyers are asking the court to at least consider starting with two of the original three bellwethers by September of 2017, but allowing the later added one (Finn) to slide to a “trial ready” date of January 2018. [Latest prior update, here.]

Specifically, they note that many of the same activities — by some of the same law firms — are also occurring in the New Jersey state proceedings, taxing all involved. Here’s the four page proposal, as a PDF filed at year end — and a bit (from the footnotes) — relevant to my conclusion that the first federal bellwether trial will occur at least 90 days ahead of the state ones:

. . . .Additionally, the PEC notes that the Parties are also engaged in case-specific and expert discovery in the New Jersey consolidated proceedings. The PEC makes this observation because Lead Counsel in that case are members of the PEC and PSC in this Multi-District Litigation.


In other words, although not set forth in detail here, the Parties are collectively engaged in the same case-specific and expert discovery work in the New Jersey litigation which trails this case by approximately ninety (90) days. The fact the Parties are simultaneously engaged in these two cases explains, in part, the allocation of work in this MDL (i.e., certain firms were primarily tasked with MDL work, while others were primarily tasked with overseeing the New Jersey consolidated proceedings). . . .

Now you know. . . And now, onward — still thrilled by the graceful, understated arc of the story-telling, in the historical drama “Hidden Figures“. So much more enthralling than the dry narrative of the book, truth told. Smile. . . .

नमस्ते

With The Arrival Of A New, “Lower Sciences IQ” Administration — NASA’s Chief Scientist Has Announced She’s Leaving…

January 1, 2017 - Leave a Response

life-ellen-stofan-2017It may just all be an uncanny coincidence — but as I revel in all the “STEM on Fleek” wonder that is the screen adaptation of “Hidden Figures” tonight (do go see it when it opens nationwide later this week — it will win Oscars!) — it strikes me that this quiet departure is due in no small part to the arrival of a President who denies climate change, and ignores basic security briefings. In short, an “evidence light” President. I might not decide to just stick around blindly — to see what he does to the space science budget, either.

Of course, we are likely to read — within weeks — that she has taken a high profile role at an elite academic institution, or in private industry. Here’s the bit of the article out tonight:

. . . .It appears [NASA’s chief scientist, Ellen] Stofan officially left her role on or around December 20th, with NASA quietly confirming that in an interview it posted on Tumblr. The space agency has merely said that Stofan is “departing for new adventures,” which doesn’t tell us much. She has a long history with the space agency, and was appointed NASA’s chief scientist in August 2013.

The big question now is what NASA has in store for the coming months, namely what it will do in Stofan’s absence and whether it already has a successor planned. The departure happened just before the new presidential administration comes into power, and the many questions surrounding that — about NASA’s future and the budgets it will get, that is — leaves a big question mark to conclude the year. . . .

Now you know. I’ll try to resist seeing these departures all as part of a larger (and rather bleak) narrative, but it is sensible to believe (I think) that this departure might be read as a lack of faith in the incoming Administration. We will hopefully have a less jaundiced view in the coming days (as more information becomes available). Yes — that I will hope.

नमस्ते

For Now, Merck Need Not Widely Disclose Details Of Former HQ Sales Contract

January 1, 2017 - Leave a Response

life-mrk-readington-confid-2017For over seven years, we have followed the would-be (and actual) HQ moves made by the legacy Schering-Plough executives, and subsequently, for at least five, the correlative moves — by Merck executives.

The latest chapter here — in the ongoing battle over preserving essential services (schools, trash pickup and plowing, as examples) inside Readington Township, New Jersey has been over whether the public should be allowed to see the basis for the $124 million tax assessment (the highest tax assessment in the township) — that belonging to Merck’s former HQ site. For now, a New Jersey tax court has ruled that the details of the sale — since scuttled — need not be made public.

So we will keep an eye on this. For now, here’s the bit, from MyCentralJersey.com — as of this New Year’s morning:

. . . .The Oldwick Road property has a three-story, hexagonal building with 1,747,632 square feet of office space, to underground parking garages, a 25,200-square-foot childcare center, a separate three-story 220,000-square-foot office building, two other parking garages and a 67,035-square-foot central utility building.

Merck offered the property for sale in October 2013. Merck then moved its headquarters to Summit, then, a year later, relocated to Kenilworth. Prior to moving to Readington, Merck’s headquarters was in Rahway. . . . Readington was seeking the terms of the sales agreement so it could defend the $124 million assessment because, in New Jersey, assessments are based on purchase amounts. . . .

But Merck objected to turning over the sales agreement to the township because of its confidential provision. . . .

It matters a fair bit that the sale did not close. Obviously, once closed, the public land title and tax records will shed much light on a given buyer’s identity and various other specifics. But that didn’t happen, here. And it is true that Kenilworth would be put at a disadvantage — in future efforts at marketing the property, if the public knew details — of each failed sale. So, onward — as ever — into 2017, with Merck still paying the taxes — on this behemoth. To the movies, then. . . and smiling of sublime space science — in copper colored hues. . . .

नमस्ते

A Poem At The New Year…

January 1, 2017 - Leave a Response

10cc1-life-hiddenfigures-real-2016-2017Off to see a pre-release screening of the movie “Hidden Figures” in about two hours, with all the college kids here.

But as is my usual way, I’ve been reading poetry, on new year’s day. . . and this one called to me (with only the slightest of edits) — so here it is, in full:

New Year’s Day

Kim Addonizio

The rain this morning falls

on the last of the snow

and will wash it away. I can smell

the grass again, and the torn leaves

being eased down into the mud.

The few loves I’ve been allowed

to keep are still sleeping

[to teh south of me]. Here in [Chicago]

I walk across the fields with only

a few young cows for company.

Big-boned and shy,

they are like girls I remember

from junior high, who never

spoke, who kept their heads

glowered and their arms crossed against

their new breasts. Those girls

are nearly forty now. Like me,

they must sometimes stand

at a window late at night, looking out

on a silent backyard, at one

rusting lawn chair and the sheer walls

of other people’s houses.

They must lie down some afternoons

and cry hard for whoever used

to make them happiest,

and wonder how their lives

have carried them

this far without ever once

explaining anything. I don’t know

why I’m walking out here

with my coat darkening

and my boots sinking in, coming up

with a mild sucking sound

I like to hear. I don’t care

where those girls are now.

Whatever they’ve made of it

they can have. Today I want

to resolve nothing.

I only want to walk

a little longer in the cold

blessing of the rain,

and lift my face to it.

Onward then — as 2017 will be better than this, for certain. I will make it so.

नमस्ते

Yet Another “Star” Has Passed — But Not From Hollywood, This Time — This One Founded And Ran Batavia’s Fermilab

December 30, 2016 - Leave a Response

life-alt-edwin-goldwasser-1919-2016The world-renown particle physicist Dr. Edwin Goldwasser has passed — his niece has confirmed. He was 97. This man, though quiet and unassuming, made the United States the envy of the particle physics world in the early 1970s — by overseeing the build of Fermilab’s particle accelerator — at the time the largest and most powerful on the planet. [It would take a long row of volumes to explain all the ways his accelerator project in sleepy Batavia, Illinois changed our understanding of quantum particles — but their tracings appear in faint yellow, over his head at right.]

His time on this pale blue dot leaves us all a gift: he was a staggeringly powerful science vessel — fostering a life-long legacy of achievement, in the physical sciences in and around the U of I. [The photo at right captures this I think, in his eyes — while on his daily bicycle commute — there appears an enigmatic genius. And he was that, indeed.] Here’s a bit, from the New York Times obit (do go read it all):

. . . .Dr. Goldwasser, who was long associated with the University of Illinois, helped pioneer the use of powerful particle accelerators in American physics. By smashing subatomic particles together at high energies, the machines deepen scientists’ understanding of the most fundamental aspects of nature.

He was named deputy director of what was then the National Accelerator Laboratory in 1967 and given the task of constructing the most powerful accelerator in the world on farmland outside Chicago. The lab, which would later be known as Fermilab after the physicist Enrico Fermi, began operations in 1972.

“His biggest impact was Fermilab — creating the most forward-looking laboratory of its day in the United States,” said Barry Barish, a physicist who performed experiments in the early days of Fermilab before becoming the director of the Laser Interferometer Gravitational-Wave Observatory at the California Institute of Technology in Pasadena. . . .

This year — more than most — I’ve profoundly felt the weight of these many passings. Perhaps because I see a less-hopeful, buoyant world for the next four years. Or, perhaps, because it increasingly settles in on me — that one day, I too will be at the head of that line.

But for now, let us enter 2017 thinking of all the gifts these passing luminaries left behind for us: in their music, the arts, their films and yes — in the sciences. Pax tecum, Dr. Goldwasser. Smile. . . .

नमस्ते

2017: Looking Forward — For At Least Some “New Hope” — Expanded Medicare Part D Drug Coverage Likely To Continue, Under Mr. Trump

December 28, 2016 - Leave a Response

life-medicare-part-d-in-2017If he remains even remotely true to his word, and the elite GOP folks in Congress don’t stupidly mess things up, there is a strong possibility that the highly popular Medicare Part D expanded drug cost coverage program will continue in 2017 and beyond.

With PhRMA solidly touting it (why wouldn’t it? — as this leads to more drug-price coverage) — and with most people saying it works well, at an acceptable cost — I think even the elite Republicans will avoid tinkering with it. Here’s a bit from the PhRMA blog, overnight, on it all:

. . . .Part D expanded coverage to millions of Americans who previously didn’t have access to comprehensive prescription drug coverage. Prior to implementation of Part D, fewer than 6 in 10 Medicare beneficiaries had comprehensive prescription drug coverage. Thanks to Part D, that number has increased to 9 in 10 Medicare beneficiaries. And in 2016, there was an average of 26 Part D plan choices available to beneficiaries in every region. Learn more here.

Part D continues to offer affordable prescription drug coverage with monthly premiums remaining relatively stable and substantially less than original projections for 2017. And the generic utilization rate for Part D beneficiaries has steadily increased each year, from 84 percent in 2013 to 86 percent in 2015. The program also keeps costs low for taxpayers, with total Part D costs coming in $349 billion less than the initial 10-year projections. Learn more here.

Part D helps beneficiaries live longer, healthier lives with nearly 200,000 Medicare beneficiaries having lived at least one year longer since Part D was implemented in 2006. And the average increase in longevity for beneficiaries is 3.3 years. This improved health also helps reduce other health care spending through fewer hospitalizations and a reduction in nondrug medical spending for Medicare beneficiaries. Learn more here. . . .

Now, as many already likely detected/observed, the title to the post this morning pays homage to the star on the masthead — another one whose passing has arrived all too soon. Even so. . . “Punch it, Chewy!” She’s catching a ride out, via hyper-drive. . . Onward — on a clear cold morning, to the trains. . . smile. Tryin’ to get that mo jo back. . . .

12-27-2016-masthead

नमस्ते

Year End Clean Up: From November 2016 — Idenix’s Brief To Avoid A Bifurcated Trial, Just Now Unsealed

December 27, 2016 - Leave a Response

mrk-gil-verdict-hep-c-12-15-16Back around Thanksgiving dinner time 2016(!), Merck (via Idenix) was able to avoid a bifurcated patent trial the federal courts in Delaware, in early December, by filing the below brief. It had been sealed until this morning, when the public, but redacted version became available through PACER’s electronic filing desk.

Here is a bit of the brief (a 25 page PDF file), for the complete record:

. . . .Gilead’s reliance on the California trial [before Judge Labson-Freeman, detailed here], in which Gilead presented its validity case first, is inapt. (D.I. 458 at 5-6.) In that case, Gilead was the plaintiff — the role that Idenix has here.

Also, Gilead’s willfulness was not at issue in the California trial. Here, by contrast, that remains part of Idenix’s case-in-chief; the Court denied Gilead’s motion for summary judgment on willfulness, holding that “this is an issue for the jury on the record before [it]. . . .”

Now you know (the most recent prior post on this topic was here). And. . . I’m in the office now, only until Thursday evening, then off — through the new year (traditional day after new year’s day). . . My best — to one and all. I am having a hard time thinking positive thoughts about 2017, in truth — with all the deaths, and the idea that we are now undergoing a regime change, of the darker variety, more generally. But I will find my voice anew, in the new year — of that I am sure. Falling now, as silent as the snows, once again then. . . smile.

नमस्ते

Of The Persistent Racial Disparities — In Immuno-Oncology Clinical Trial Participation — NYT, At Midday

December 23, 2016 - Leave a Response

life-mrk-12-2-2106With yet another of my elderly relatives facing precisely this dilemma — and trying to get her into one of the ongoing trials here in Chicago (either Merck’s, BMS’s or even late comer Roche’s) — I am quite acutely aware of this persistent racial disparity. [In fact, for essentially all of my adult working life, I always have been — going back to the early days of kidney drugs, in the late 1980s.] General backgrounder, here.

In fairness, a broad array of factors likely cause this unhappy state of affairs. But I strongly suspect at least this one brilliant, strong, proud black matriarch might live to see quite a few more quality Christmases, if we can get her into one of these trials. For now though, her prognosis is. . . . three to six months.

Just go read it all — trust me.

. . . .As immunotherapy research takes off, the patients getting the treatment have been overwhelmingly white. Researchers know this and say they are trying to correct it. . . .

Mr. Jones, 45, has an aggressive type of Hodgkin’s lymphoma that resists the usual therapies. At the start of his most recent clinical trial, his life expectancy was measured in months. That was more than three years ago. He received a drug that helped his immune system fight cancer — a type of immunotherapy, the hottest area in cancer research and treatment.

“I’ve been over 12 months now with no treatment at all,” he said. “I walk half-marathons.”

Mr. Jones is one of many patients who have benefited from lifesaving advances in immunotherapy. But he’s an outlier: He is African-American. As money pours into immunotherapy research and promising results multiply, patients getting the new treatments in studies have been overwhelmingly white. Minority participation in most clinical trials is low, often out of proportion with the groups’ numbers in the general population and their cancer rates. Many researchers acknowledge the imbalance, and say they are trying to correct it.

Two major studies of immunotherapy last year starkly illustrate the problem. The drug being tested was nivolumab, a type of checkpoint inhibitor, one of the most promising drug classes for cancer. In both studies, patients taking it lived significantly longer than those given chemotherapy. . . .

And. . . with that, I will call it time for the Christmas break. Be excellent to one another, far and wide — smiling. . . .travel well; do travel light. Pax tecum.

नमस्ते