Thursday, March 22, 2018

[U] "The Fire, This Time" -- Right To Try Passes House; Awaits Senate/House Harmonization

UPDATED @ 2:40 PM EDT: Fine comment by an erstwhile Anon., here:

"When I was a post-doc, I helped run a pediatric cancer trial with children who relapsed while they were receiving chemotherapy. The prognosis for every child affected was death within several months. Parents were then offered a chance at the experimental drug/protocol I was involved with. I questioned the theory behind the study and why standard animal toxicology studies had not been run but was ignored. The parents were then lied to when "informed" consent was obtained, and the untested drug combination resulted in an interaction (which likely would have been seen if the appropriate animal toxicology studies had been performed). The reaction was absolutely horrific and instead children wound up dying absolutely horrific painful deaths.

While this is an extreme case. In my opinion this proposal may actually harm rather than help as in the scenario I describe, and may delay or inhibit the development of truly effective drugs when people insist on something that may actually not work and as a consequence not enroll in studies with drugs that may actually help.

March 22, 2018 at 1:41 PM. . . ."
[Do go read these comments. End, update.]

The Senate earlier passed a similar bill. As I said about a week and a half ago, neither version contains an adequate definition of what triggers the right to try -- that is simply. . . irresponsible.

Yesterday, the House passed another version of the national right to try legislation, which Mr. Pence claims is saving lives in Indiana -- at the state level. Of course, his claim is entirely without any actual evidence. The idea that someone only has two options -- take an unapproved drug candidate out of Phase I, or die -- is simply a classic false dilemma, in logic. There will never be any way to prove whether the patient was harmed or helped by the Phase I drug candidate. [End, Updated Portion.]

I suppose, if I were a truly-jaundiced skeptic, I might suggest that the failure to define what triggers the right to try, with precision, is intentional -- to allow wide latitude to (unapproved) drug makers -- in selling their wares, to often quite-desperate patients and their anguished families. But I am not such a skeptic (cough). . . .

In any event, it will be entertaining to watch what Scott Gottlieb does (he opposes the idea -- and had earlier also asked for a definition) -- once the House/Senate reconciliation measure arrives.

I'll likely be off-grid until tomorrow, now. And. . . "Go Ramblers"! Keep it spinning in good karma, down south. . . . smile.


Wednesday, March 21, 2018

53 Years Ago This Morning: The Kings Began A Third, And Successful, March To Selma -- From Montgomery...

There were about 3,200 people, poor and wealthy, black and white -- women and men -- who rose early, and left, on foot with Dr. King and Coretta 53 years ago this morning. . .

They slept in the fields at night, under cover of federal military troops, as the Alabama state troopers were instructed to make the march as difficult as they possibly could. As they marched, day by day, their numbers swelled to over 25,000 -- with nearly two thirds of those being whites who joined along the way, having read of this, the third attempt.

Then, after a federal court judge ruled that SCLC had the right to march over the Selma bridge, to protest for civil and human rights -- a few days from now, in 1965. . . they did just that.
. . . .Our lives are not fully lived if we're not willing to die for those we love, for what we believe. . . .

-- Rev. Dr. Martin Luther King, Jr. (1965)

I needed to shift the Universe's energy, here -- we have an end (albeit a violently awful one) to the white terrorist's bombings in Austin -- and now we must move forward. We must march onward. And so we will -- as "yes, we can. . ." And yes, I will. Smile. . . .


Allergan's Reply Brief (Restasis®/Mohawk Patent Invalidity) -- In The Federal Circuit, Is Now Available...

Honestly, I'll just post a link to the 39 pager.

I'm not really feeling it, today.

Out -- into the clear cold sunshine, now.


Merck Goes Outside -- To Covington -- For Newest General Counsel...

She is very qualified. She will be great. But I wonder whether Ms. Watson wouldn't have been at least as good an inside candidate. . . .

I also wonder whether Kenilworth will need a conflicts consent, from Gilead, in order to hire her. Or at least, whether she will be need to be "walled off" from at least some of the Hep C patent wars -- against Gilead.

Her bio at Covington indicates that she has worked extensively in helping Gilead secure its Hep C intellectual property, in challenges to the same. No dates are given, but it is probable that at least some of that work is or was adverse to Merck's claimed patent and IP positions.

Her appointment becomes effective in mid-April, as Mr. Holston heads off to GE. In any event. . . I am reasonably sure the parties will sort it all out -- and I am even more certain that she will be a stellar GC, when they do (from the presser, overnight):

. . . .“We are delighted to welcome Jennifer as our new general counsel. Her extensive experience across the biopharmaceutical industry makes her an exceptional addition to our team,” said Kenneth C. Frazier, chairman and chief executive officer, Merck.

Zachary is currently a partner at Covington & Burling in the firm’s food, drug, and device practice group where she advises a wide range of manufacturers and industry trade associations on FDA’s requirements for the development, manufacture, and distribution of prescription and over-the-counter drugs, biologics, and medical devices. Zachary began her career in FDA’s Office of Chief Counsel, where she served as an Associate Chief Counsel for Enforcement from 2005 to 2011. Zachary also served as a Special Assistant U.S. Attorney in the Civil Division of the U.S. Attorney’s Office for the District of Columbia.

"I’m honored and excited to have the opportunity to join Merck’s Executive Committee,” said Zachary. “I have long admired Merck for its steadfast commitment to its core values and I look forward to contributing to the company’s long-term success,” she said. . . .

Excellent choice -- she is a Harvard law alum, just like Mr. Frazier -- but comes with a strong chem background to boot -- and summa cum laude, at ASU! Nice -- and onward, with the domestic terrorist situation now resolved in Austin -- I will resolve. . . to smile more, today. . . . Loyola and Atlanta tomorrow. Smile.


Tuesday, March 20, 2018

[U, X3] So... (echoing 1964) black and brown families, all — are being bombed in Austin.

UPDATED: March 21, 2018 @ Dawn @ Noon -- Final Update: As more of the investigative materials become public (now that the bomber is dead), it seems the targets were, in fact, reasonably prominent African American families, some of whom were active in social justice causes. I've revised the "anonymous" descriptors below.

The white supremacist Austin bomber has blown himself up, as law enforcement teams closed in. . . end, updated portion.

. . . .At least four families’ residences — over three weeks now — thus far. . . none of them with any obviously discernible connections, to one another or political activism, of any kind (not that that should matter, of course).

. . . .save the color of their skin. That is so far, the one most salient factor that unites all the victims:

. . . .[Only crickets, from 45. Yet these too, are Americans, one and all, in the words of Langston Hughes, Mr. President.]. . . .

But within an hour of an attack by Isis in Germany, London or Paris, 45 is on the case. All over Twitter. He is an entirely transparent. . . racist. I’m sickened — and enraged. You should be, too.

When I was at Loyola, we were taught (by the Jesuits, and the lay professors alike) to use the law "to set the world on fire" -- for social justice. It was a core teaching -- embedded in all the coursework. Be warned, 45 -- I am coming for your brand of racism -- with all the force of lawful authority I might muster. . . .
UPDATED -- Tuesday Night: Trump apparently said. . . something, half-heartedly, this afternoon. But Sarah Huckabee Sanders then subsequently refused to call it terrorism -- saying the President "doesn't believe it is." Well. . . he and Sarah aren't terrorized, because they are. . . not. . . brown. They are not the targets.

Even so -- (or maybe even in spite of his hate) let me offer this, tonight -- to say. . . love will win:


Sunday, March 18, 2018

T.H. v. Novartis: In Which California Gets An Innovator's FDA Label Liability Standard Wrong, If A Generic Consumer Sues...

The Massachusetts news of Friday reminded me that I am. . . deeply delinquent, in critically analyzing this truly unfortunate case -- out of California's highest state court, from around Christmas-time 2017. [But first, a little background by way of explaining the unusual state of affairs here. . . .]

Massachusetts, rightly I think, has held (as of Friday) that willful failures to protect patient safety (related to issues on updates of FDA mandated label warning copy) should be actionable -- that is a "knowing, or reckless disregard of important facts" standard. Not surprising. Due to a rather-wrinkly history on approving generics at FDA -- it turns out that generics must use the innovator's label copy without alteration or enlargement, as a condition of the approval of the same.

So -- only the innovator may negotiate with FDA about changes to the label -- and all label changes must be cleared through FDA staffers, once a drug (branded or generic) is on market.

In a surprisingly ill-informed opinion, in a case called T.H. v. Novartis (Cal. Sup. Ct., Case No. S-233898, December 21, 2017), however, the divided California Supreme Court held that (i) a "mere negligence" standard would apply when a generic consumer sued a branded manufacturer for injuries from drugs allegedly caused by inadequate label warnings; and (ii) more surprisingly, a duty of care would persist, even after the original innovator had sold the rights to the branded drug -- to an independent third party.

Let's attack the second part first: the entire FDA file jacket, on any drug -- once sold to a third party -- is transferred to the acquiror (and the acquiror takes over discussions with FDA, on this score -- that has always been true, since the 1970s). Some mention is made in the majority opinion that indemnity clauses in the transfer agreement are the answer to its ruling. I might ask. . . "why"?

Why is it a logical requirement that -- assuming a bona fide sale has occurred, to a third party purchaser for fair market, arms' length negotiated fair value -- the original seller is on the hook, even theoretically, for the label copy? That makes no sense -- and the dissent (by footnote) rightly compares it to prior cases [including one federal MDL, in which I sat for depositions for the defense (videotaped, and in front of perhaps 45 separate plaintiffs' lawyers -- including the irrepressible Ralph Knowles!) -- as a disclosure of interest, here]:

. . . .One example of tort liability leapfrogging scientific knowledge occurred in. . . . the early 1990s with breast implants. Despite little scientific evidence of an association, thousands of suits were filed across the country alleging silicone breast implants caused autoimmune disorders. (Bernstein, The Breast Implant Fiasco (1999) 87 Cal. L.Rev. 457, 477.) Eventually, several large-scale epidemiological studies conclusively refuted this proposition, finding no link between implants and systemic disease. (Id. at pp. 480-484.). . . .

And even so, the courts uniformly held -- in the 1990s -- that 3M (via Mentor) could not be held liable for alleged injuries, after it had sold the line to McGahn Medical (as to alleged injuries from devices implanted after the transaction had occured, at least), and transferred all its FDA filings and (importantly) terminated its ongoing insurance coverage for the product line.

So too, here -- requiring new indemnity clauses in M&A agreements to avoid the outcome of an illogical decision in California seems. . . silly. Why would the California court entertain an illogical outcome (and one not needed to reach the termination of the matter) -- and then in the same breath say effectively "industry may easily" draft around this absurd result, by a couple of paragraphs of clever language? What public good is there served? I dunno.

Now, to the first prong -- in contrast to the Massachusetts case, California effectively held that the innovators owe an ongoing duty of care, to even remote patients, ones who NEVER took the branded product -- but were only generic consumers -- in the updating, amendment, and general administration of the branded/innovator company's FDA label copy.

While I may actually agree that the innovator will in fact act with due care, since it will want to protect its branded franchise(s) -- and it is likely in pretty steady formal communication with FDA staffers, about emerging pharmacovigilance issues, and occasional updates to the label copy -- I do not see a need to impose a full-on duty of care, where the statute compels no such result.

I think it would be enough to say the law is only violated where, for example (as Massachusetts just did), an innovator intentionally refuses to update a label, to drive down/end sales of the generic, by frightening the generic maker into a voluntary withdrawal from the market, or something similar. But even that seems preposterous. Even if the innovator decides to exit the market, by sale or shut-down, I am certain FDA would (on its own) require label copy changes, as emerging longitudinal data in the experience of the generic company's prescribing patterns. . . suggested new- or newly-increasing risks.

So -- in my not so humble opinion, the California case from December got it wrong -- in almost every imaginable way.

Yet on this sunny Sunday morning -- I am grinning ear to ear, and have revised my masthead for the coming sweet 16 matchup, against Cincy, if my brackets hold true to form -- and this one win (RAMBLERS!) alone last night now guarantees that I will beat President Obama's bracket -- nine long years, a goal of mine:

to out-bracket-ologize (outdo). . . the Master. [Mr. Obama had Tennessee beating Loyola.]

Finally, in 2018, it seems. . . I have
! Onward, shortly -- to a heavy weights workout, swim, sauna, steam and shave!


Saturday, March 17, 2018

As A Practical Matter, Rafferty v. Merck, In Massachusetts, Probably Means Very Little...

But first, "top o' the mornin' to ya' -- and Happy St. Padraich's Day!"

Okay, yesterday there were several rather breathless reports in the MSM, about the Supreme Court of Massachusetts holding that Merck, as a branded manufacturer of Propecia®/Proscar®, could be required to stand trial for injuries allegedly caused when someone took not the company's drug -- but a COMPETITOR's generic version. That does sound rather. . . unfair, and would set up some unfortunate incentives -- if it were as broad a ruling as some media reports make it out to be.

In fact, the State of California had previously ruled similarly (but not against Merck) -- and that California case is the more important of the two (more, on that case, likely tomorrow afternoon, after the Ramblers best the Vols, tonight!). I say that because in the local Massachusetts courts yesterday, all the Massachusetts Supreme Judicial Court held was that "willful" or "reckless" failures to update an FDA-mandated label could theoretically result in. . . a branded manufacturer having to stand trial, if a patient taking the generic version is injured, and injured by a risk that the branded manufacturer "recklessly" failed to update the FDA label about.

As a practical matter -- proving a reckless act -- by a multi-national pharma concern, as to a drug that still generates hundreds of millions of dollars for the company -- where the FDA requires a review and pre-approval, for all label changes. . . would be a tall order. Companies like Merck are essentially in constant contact, and negotiations with the FDA staffers -- about emerging pharmacovigilance developments. So -- as I say -- as a practical matter, there is only a negligible chance that a plaintiff could prove recklessness, here.

That said, one of the better reports was filed by Reuters, thus:
. . . .The Massachusetts Supreme Judicial Court ruled that brand-name drugmakers can be sued for recklessness if they intentionally fail to update warning labels for their drugs that makers of cheaper, generic versions must adopt as well. . . .

The top court. . . [ruled] Rafferty [could theoretically] sue Merck for recklessness rather than negligence. This requires a higher standard of proof showing a drugmaker intentionally failed to update its warning label despite knowing the risks.

“Where a brand-name drug manufacturer provides an inadequate warning for its own product, it knows or should know that it puts at risk not only the users of its own product, but also the users of the generic product,” Chief Justice Ralph Gants wrote.

Shielding brand-name manufacturers from liability entirely would leave consumers with no chance to sue generic drug companies, whose products command about 90 percent of the market, Gants wrote for the 4-0 court. . . .

That coverage at least gets it right -- but fails to provide the broader context, for how difficult "willfulness" proof would be, in this setting.

So then, to California tomorrow -- as I have a team to cheer on, and some green-hued vanilla milkshake to down, after my workout today. . . . chasing my grown triathlete son, who will lap me several times, over the course of a mile, the pool, in a bit. But I will have small green shamrocks tattoos to my cheeks, for . . .absolute "Black Irish" power! Smile. . . .


Thursday, March 15, 2018

So... Nearly TWO Years Too Late -- But Whatever...

The Treasury Department -- under Steve Mnuchin -- just finally admitted that Russians were "meddling" in our elections.

Meddling is like calling "nerve gassing" just some "mal-ware"... oh wait, they did that too. And that.]

I will gladly take it, even as late as it comes -- because it finally vindicates Merck -- and Chairman & CEO Ken Frazier, on NotPetya. [Just one of many backgrounders, here.] Of course, over a month ago, UK intelligence identified NotPetya as a Russian state actors' thrust -- and 45? He... clammed up.

Here's a bit, from the US Treasury:

. . . .Today’s action counters Russia’s continuing destabilizing activities, ranging from interference in the 2016 U.S. election to conducting destructive cyber-attacks, including the NotPetya attack, a cyber-attack attributed to the Russian military on February 15, 2018 in statements released by the White House [Condor's editorial note: only the UK was that early -- White House was much later] and the British Government. This cyber-attack was the most destructive and costly cyber-attack in history. The attack resulted in billions of dollars in damage across Europe, Asia, and the United States, and significantly disrupted global shipping, trade, and the production of medicines. Additionally, several hospitals in the United States were unable to create electronic records for more than a week. . . .

Now you know -- what a strange world, indeed. We would note that if 45 blocks Stormy Daniels from appearing on "60 Minutes" -- he will have imposed more onerous sanctions on an adult film actress, than on the above Russian state actors -- who are/were trying to destabilize our democratic republic.

Let that sink in. And, with that, I'm off to enjoy a clear cold day with my son. . . Art Institute and such. . . keep it spinning in good karma!


Wednesday, March 14, 2018

An [Unrelated] Epilogue, Of Sorts: Theranos' Elizabeth Holmes -- All Done. Game, Over.

"Billy The Kid" was handed an early St. Patrick's Day present today, when the SEC announced settled civil charges against Elizabeth (A., for Ayn, as in "Rand") Holmes, the "kingqueenpin" behind Theranos.

The voluminous SEC complaint against Ms. Holmes has been widely disseminated. [This is cross-posted, from one of my other projects.]

What has not been seen until now, are her "civil deal" documents -- with the SEC. To be clear, this six page judgment, and the eight page order settling... formally DO NOT resolve any criminal charges. At least not today, they don't....

But as I told the very able and erstwhile Matt Herper earlier today -- I'll be surprised if it does not turn out (eventually) that there is a deal to take criminal charges off the table, for her personally, as well.

We know she is diming out Sunny. What I didn't know (and Yellow Butterfly reliably informs me -- having seen it in today's WSJ online) is that Sunny was (allegedly)... at one point, her lover(!?). Ouch.

And it isn't likely that the kingpin would flip on subordinates, unless it would get her immunity in exchange for truthful but highly damaging testimony (against Sunny primarily).

I'll keep an eye on the federal criminal docket on this one, too -- just for grins.

Separately, it is "well, with my soul" -- to see so many fine young Americans taking their rights (to advocate peacefully for change) into profound account -- makes me. . . proud. G'night, to all of you -- all, of good will. . . .


And... #ENOUGH -- In Under 30 Seconds.

Not even three hours ago. . . smile.

Spread peace. . . .

Stephen Hawking would have wanted you to.


He Certainly Took A Wonder-Filled Ride -- Now He Rides A Beam Of Star-Light -- Travel Well; Travel Light, Stephen Hawking...

Anything I might say, about his life would taste. . . trite, given his vast achievements -- won, over great bio-physical limitations.

So I will simply say he led a full life -- and re-run this one, from just about a year ago, now (he had long-ago predicted the escaping light would behave. . . just the way it did):

Thirty Years Ago, This Week... Out Of Hydrus -- A VASTLY POWERFUL Flash Of Starlight Reached Earth: First Fully Recorded Super-Nova.

This sort of arriving star stuff still gives me goosebumps, now thirty years on -- as I saw it originally from Tim's backyard telescope in the Rockies, that night in 1987, on a trip home. . . smile. [Click at right to enlarge.]

Here is the full NASA page -- and a bit:

. . . .To commemorate the 30th anniversary of SN 1987A, new images, time-lapse movies, a data-based animation based on work led by Salvatore Orlando at INAF-Osservatorio Astronomico di Palermo, Italy, and a three-dimensional model are being released. By combining data from NASA's Hubble Space Telescope and Chandra X-ray Observatory, as well as the international Atacama Large Millimeter/submillimeter Array (ALMA), astronomers — and the public — can explore SN 1987A like never before. . . .

It was visible to the naked eye, even across an unfathomably vast black ocean of space-time, and it took hundreds of thousands of years for the light to reach us. So, in a sense, we were looking backward, into a time machine, those first nights in 1987 -- with our backyard mountain-top telescope. Whoosh.

Fascinatingly (and, as Einstein and Hawking had correctly predicted), a pulsing pair of anti-neutrino bursts reached Earth, and were recorded, just a bit ahead of the light's arrival. Those little neutrino pulse-monsters were not delayed, as the light-waves were, since the light took a tic to break through to the surface of that exploding star (dubbed 1987A) and head outward toward us -- from the Large Magellanic Cloud. . . . Now, there is I think an allegorical lesson here, in staying on course, and not delaying travel toward one's beloved -- as the one that does -- will first arrive, and with a satisfied grin, too. . . now I'm off for the weekend, grinning just the same. . . .


Tuesday, March 13, 2018

[U] Now That The GOP-Led Effort On A Federal "Right To Try" Has Failed, Again...

At some substantial risk of returning to the weedy details that used to animate this blog, I will note that the GOP -- despite controlling the White House, and the Senate and the US House -- once again this afternoon failed to advance a federal "right to try" bill.

In the Senate, the measure is known as S. 204; in the US House it is known as HR 2368.

The House version would define "terminal illness" by reference to individual state laws, while the Senate version contains no definition of that indisputably critical term, at all.

So then. . . to my punch-line: the next time the Congress-critters decide to take the matter up, it would be a very good idea to define what the term means, in the bill -- with nationwide effect, along the lines I've laid out, at right. Why?

Because there are some states that have no definition of the term that drives the whole process [including states such as Tennessee (which does have a law; but lacks these definitions), and all the other states that do not have a state "right to try" law, at all]. Without a definition, this piece of legislation is worse than useless -- and all the state laws, in Louisiana, Texas, Tennessee and Indiana (for example) are for naught, since no prescriber may lawfully deliver any unapproved drug, without FDA oversight, and concurrence. [Excellent waste of red state and local dollars there, folks.]

And without the UNIFORM definition of what triggers the "right to try", doctors will continue to be at considerable risk of liability, even under the patchwork of state laws -- and even if they only prescribe inside the state with a law. Gee -- that must be why. . . we have an FDA!

Less sarcastically, it simply makes no sense to say that a patient in Illinois may try a drug, while one in Indiana may not, since the latter did not define what "terminal illness" meant, at all.

To be clear, the House version needs to explicitly set a nationwide federal standard -- not simply refer to (in some cases) non-existent state-level definitions -- of the "trigger" condition.

It is actually pretty painful to watch these characters try. . . to legislate. . . anything. But next time, 'round -- perhaps they will take (also soon to be former?) Commissioner Gottlieb's advice, at FDA.

[A lower level issue to fix would be to allow a sponsor-independent Chair of any IRB to approve "right to try" requests -- without full IRB meetings, since essentially all these drugs are in some trial stage (post Phase I) and are being run through -- and thus are also under the purview of the US FDA.]

As I toddle off to bed, in an unrelated update -- I should point out that tonight's Fifth Circuit ruling out of Texas, on sanctuary cities there -- will have little meaning, to sanctuary cities around the nation, since the earlier Santa Clara County, California injunction remains in effect, nationwide, against Trump's order on the subject. At this point, nationwide, it means next to nothing (as the Supremes denied cert. last month, out of 45's camp -- related to the dispute in California). Now you know.

Next life-time, indeed. Now. . . . Sleep well -- all you growing little life scientists!


Exactly A Century And A Half Ago, Today... Andrew Johnson Was Impeached.

President Andrew Johnson (out of Tennessee, and a man who never attended any formal schooling, of any sort) was the first US President to be impeached -- exactly 150 years ago today (after a week long trial and a vote of the US Senate, this day), over his pattern of firings, and resisting Reconstruction, after the Civil War.

He is widely regarded as among the worst Presidents in US history -- though we can no longer label him the worst -- with 45 still in office, and still doing the all work of an entirely unschooled idiot, as well -- just this morning, willy-nilly firing people (cough! Rex. . . for having the temerity to truthfully say Vlad had Sergei Skripal and his daughter poisoned), and then installing a torture enabler -- to now head the CIA.

So. . . here is to remembering what the constitutional mechanism of impeachment was drafted by the founders to protect against: it was written to handle people like Andrew Johnson, and Donald Trump. People who abuse the public's trust -- in the discharge of their official duties of the high office.

Onward, on a gloriously sunny Spring Tuesday -- and while we support a strong education agenda -- we think a one day walkout by high schoolers and even middle schoolers. . . may be what it takes to force 45 to focus on the persistent problem of gun violence (see below). Be good to one another. I'm going to be scarce for a bit. . . with son in town -- for Spring Break!


Monday, March 12, 2018

85 Years Ago Today: He Sought To Reassure Us; To Unite Us... In A Time Of Great Peril

It was a dire time, by any measure: all US Banks had been closed for a week, for an extended "holiday" -- there had been a widespread panic, and a resulting "run" on banks' cash deposits. Many were very near insolvency. It was the darkest hour of the Great Depression.

And yet, with careful, compassionate leadership in mind, FDR decided to sit down by the [virtual] fire, and calmly -- reassuringly -- just talk, like a neighbor -- to the American people, that Sunday night, 85 years ago. It was the very first of his radio broadcast "fireside chats" (a tradition he had begun in 1929 as Governor of New York, on a smaller scale, for the people of the Empire State), and in the main, they did the trick.

He spoke not to sow fear -- not to sow divisions -- and not to demonize one group of Americans as "less than" all other Americans. He sought to help the American people see that we were better off relying on one another, and leaving our money cooperatively inside the banks, to work for one another, in the form of lending capacity -- to rebuild:
. . . .The result, according to economic historian William L. Silber, was a "remarkable turnaround in the public's confidence. . . The contemporary press confirms that the public recognized the implicit guarantee and, as a result, believed that the reopened banks would be safe, as the President explained in his first Fireside Chat."

Within two weeks people returned more than half of the cash they had been hoarding, and the first stock-trading day after the bank holiday marked the largest-ever one-day percentage price increase. . . .

And so, bit-by-bit, coupled to his willingness to use federal dollars to put ordinary Americans back to work, we, as a nation, turned the corner.

I need not belabor what tax cuts for the ultra-wealthy are NOT doing to bring any meaningful gains for ordinary workers. I will say that 45's rally in Pennsylvania over the weekend highlighted just how small a twig he is, compared to real Presidential timber.

Go now, and help your neighbors -- regardless of their papers. It is. . . the truest American way. It seems this time, we will need to do it, for each other, in spite of our President.

But that is just exactly what we will do -- with smiles on our faces, regardless.


Saturday, March 10, 2018

Planetary Science: Juno Teaches Us It Is Often "What Lies Beneath" That Defines... True Beauty...

Earlier this past week, NASA/JPL's sublime Juno mission, now in a stable elliptical orbit at Jupiter, released new findings -- on the surprising middle of the Jovian giant -- which, it turns out, behaves more like a solid planet, than a pure gaseous one. [At the pressures generated there, by its almost unimaginably-immense gravitational (and magnetic) fields, the gas we know as hydrogen (at our Earth temperatures and pressures) becomes a vast ocean of viscous metal, and rotates something like our iron core. But only something like it.]

Meanwhile, as the below JPL NASA video shows, the upper surface (still gaseous) layers’ structure -- like peeling an onion, layer by layer -- is wholly unlike anything we would ever experience on Earth. You see, those upper layers on Jupiter contain more mass that a million Earth atmospheres. Just. . . amazing.

Do go read it all -- but the longer I live, the more I come to believe that much of the mystery of science is better accessed through. . . poetry, than tables, equations and figures, thus:

Sunday Afternoon

the idea of you

sits like God in my mind

with a pen and notebook

on the curbside of nowhere

where angels don't sing.

you don't know that your eyes

gleam with pictures of heaven

and if i believed in such a place,

it would surely be ruled by you.

draw shapes of jupiter in my palm

and i'll write a poem about how it felt

when the girl who held the world with her fingertips

sang me to sleep

on a Sunday afternoon. . . .

And still, I am haunted by waters. . . . here is that promised NASA video:

G'night -- नमस्ते

Friday, March 9, 2018

Been meaning to jot this down for a bit... a Friday night thought.

I saw some version of this. . . somewhere (paraphrasing), a day ago (can't find it again, at the moment):

"The right wing Daily Caller is now running agit-prop by Russian overlords, with long-standing and tight ties to Vlad. The overlords are being portrayed as good guys (by/in the Daily Caller), overlords who are. . . being persecuted by US "Deep State" actors. . . ."

Let that sink in. Just let that triple-wrapped lie. . . sink in. . . .

Me? I certainly could use a. . . drink -- but. . . I think a root beer will do. Smile -- g'night.


Return Of "The Corner Office" -- This Time, On Apartheid & Death Row Cases: Kenneth C. Frazier

Given that I've written here a fair bit, and at another property, nearly daily, on the improbable story of Martin Shkreli. . . he, who is to be sentenced in about four hours. . . it seems fitting, and timely, to post his here.

Oh. And it is clearly on-topic, as to "Merck's leadership". Do go read it all, in the NYT, this morning -- but here is a bit:

. . . .[As a younger lawyer,] I read about the need in South Africa for law professors and lawyers to come from the U.S., because black law students in South Africa were obviously during apartheid only allowed to go to second-rate law schools.

I lived one whole semester in Soweto. It was completely lawless. There were no streetlights. It was a completely separated area where people were contained, because the South African government’s job, as it saw it, was to separate blacks from whites.

But what I remember more than anything else was interacting with people who their entire lives had been told that they were second class, that they were inferior, and how hard it was to get particularly the men to speak up in audible tones, because they had been in many ways told that their voice was not worth listening to. In addition to trying to teach people the substantive legal issues, it was a lot about trying to instill self-confidence. . . .

You also represented James Willie “Bo” Cochran, a death row inmate. What was your first impression of his case?

My first reaction was, “I’m much too busy to take on another piece of pro bono litigation.” But there were two younger lawyers in the firm who heard about the case, and they came to me and frankly they sort of shamed me into doing it.

You eventually won his freedom. What did that mean to you?

It was the high point of my professional career. This is a man who was facing an execution date for a crime he did not commit. And what I will never forget about Bo was that he had no sense of recrimination whatsoever. He was just thankful for every day that he had as a free man. It sort of reminds me of Nelson Mandela in the sense that he was able to live his life going forward without regard to trying to even scores. . . .

Indeed; so it goes. And hopefully, one day soon, this man might consider being. . . the next President of the United States of America. Smile. Hope is a good thing. It is perhaps the best of all things. . . and so, I will sit quietly at luminous dawn, and wait for a new, and grinning, hope. . . to rise. Onward.


Thursday, March 8, 2018

Several Quick Life-Science Law And Public Policy Updates, Here...

The headliner is the Eisai deal (of perhaps as much as $5 billion all in). John Carroll has it all. Do go read that.

Do also read our erstwhile Anon.'s heads up on a great Phase I result also in immuno-oncology, for Aduro, and Kenilworth. Great stuff, Anon.!

Finally -- Akorn has filed its rather-wordy "brief" in the Allergan-Mohawk Tribe "invalid for obviousness" patent appeal, to the Federal Circuit. It is -- like the PhRMA brief before it -- more about straight patent law, on obviousness, and far less about the Mohawk gambit attempted by "he -- of the high forehead". Even so, we note that several legislators are proposing a measure to prevent the use of tribal immunity in the way Mr. Saunders attempted.

Onward, on an extremely busy day. And we will know whether soon-to-be tatted Martin Shkreli will get 15 to 18 years in the clink. . . in about 24 elapsed hours, now.


Tuesday, March 6, 2018

Additional Potential (Discussed) Dismissals -- Federal Finasteride/Propecia® MDL -- Filed Today...

As is likely to be true in each of the next few months, here is another bolus of cases that Merck contends are ripe for dismissal. There is some dispute about some of them, so the able Judge Cogan, sitting in Brooklyn -- will have to enter a subsequent order deciding these matters. I'll attach the summary letter, of where things stands, just the same, tonight -- after yesterday's hearing (which we reported upon last night).

Here is the full six page letter -- and a bit of it:

. . . .As discussed during the conference, Merck submits this letter to bring to the Court’s attention seven cases in this MDL that Merck asserts are ripe for dismissal. Broadly speaking, each of these cases may be dismissed for one of three reasons. Merck addresses each case in detail below, but for the Court’s convenience, the cases and their respective reason for dismissal are summarized [inside the letter]. . . .

Now you know. Sleep well, all you small -- but growing cowboys, and cowgirls -- smile. . . .


Upshot: The National Injunctions Stand -- DACA Stays In Place. We May Safely Ignore Judge Titus (For Now).

All this 30 page Maryland memorandum opinion, overnight does. . . is (once again) guarantee the Supremes will decide the issue. Yawn. It creates a trial level (not any Circuit level) split, but still. . . we all know the Supremes will take this issue up -- likely as early as Summer 2018. [Why? Because 45 is losing, day by day in California. And he cannot stand that -- his March 6, 2018 line in the sand. . . means absolutely. . . nothing, now.]

The first 10 pages of Judge Titus' opinion tell us quite a bit about his open politicking -- in his written decision-making. He leads by citing Rodney King (and to my eye, not with sympathy -- a three decade old wound, that has literally nothing to do with this instant DACA case), and then declaring "DACA: an Act of Desperation Born of Frustration with a Paralyzed Congress" (in fact, using such opinionated rhetoric as headlines for the section-markers, of his opinion!), he immediately gives away that what is coming. . . purely a political, not legal, opinion. He does dress it up with a few legal caveats -- but this is a political, not legal opinion -- as it treats procedural due process (the core argument of the DACA kids) with scarcely a nod.

Even more tellingly, consider this passage (for what it fails to say):

. . . .Complicating the picture for some observers is the unfortunate and often inflammatory rhetoric used by President Trump during the campaign, as well as his Twitter pronouncements, both before and after his election. Thoughtful and careful judicial review is not aided when the President lobs verbal hand grenades at the federal courts, the Department of Justice, and anyone else with whom he disagrees. . . .

As disheartening or inappropriate as the President’s occasionally disparaging remarks may be, they are not relevant to the larger issues governing the DACA rescission. . . .

What Judge Titus leaves unsaid, and (as I say) tellingly so, is that the President has made disparaging remarks, based on ethnicity, about the very class of persons he regards as Dreamers or DACA kids, even after his election. The President has further averred that his tweets are "official statements of the Commander of the Executive Branch" -- the office he holds.

I will note that some 10 to 20 other federal judges and courts (over nearly 16 months now) have refused to turn a blind eye to Mr. Trump's manifest racial and ethnic animus. But Judge Titus takes great pains to do just that -- go blind, and deaf, and dumb.

Were the law to support Judge Titus's tragically cramped 18th Century view of his duties, it is probable that Brown v. Board would have come out the other way, and Dred Scott would still be good law.

Judge Titus ought to drag his sensibilities into the current millennia.

Onward -- off to find a great piping hot bowl of lobster bisque, on a frigid rainy gray afternoon. . . .