Friday Night “Federal” Fights: Judge Trenga (USDC ED VA) Has Entered An Opinion — On Muslim Ban 2.0…

March 24, 2017 - Leave a Response

We now have, as of Friday night, several trial level federal court opinions that are in direct conflict with one another. Earlier last month in Boston, and now, tonight in Alexandria, Virginia (as a 32 page PDF file), there are two opinions finding a TRO or preliminary injunction is not warranted, or appropriate, on this second executive order.

On the other hand (as we’ve amply reported here), in Seattle alone, there are two — a trial level, and an appellate level opinion, coming out the other way. Moreover, in Brooklyn, Baltimore and Honolulu — there are three more rulings in favor of TROs. [I believe there is at least one each in Central, and Northern California, and one Wisconsin — all against the ban, as well.]

I tally it as at least 7-2, in favor of striking the Muslim Ban.  But there is plainly a yawning chasm/split of authority, among the federal District Courts, here.

That fact alone may allow that the Supremes will take it up directly (without intervening appeals), should either side make such a motion. When we overlay this clear split, onto the notion that this is an extremely important and ground-breaking question — one with profound implications for Constitutional separation of powers, and executive branch authority — I will bet that within a month, or two at the outside, some form of one of these Muslim Ban 2.0 TROs will be placed on the Supremes’ docket.

Until then, we will have to wait. As of tonight, Friday, March 24, 2017 — Mr. Trump has filed no definitive, substantive appeal — on any of the TROs, nationwide. Perhaps he is in no hurry, thinking his SCOTUS nominee will be seated by the time it reaches briefing.

[Personally, I already see five solid SCOTUS votes — to strike Muslim Ban 2.0, with or without 45’s nominee. And I think 45’s people well know it. That’s why he is doing a slow cha cha here.

I predict, more specifically — that Justice Kennedy will join the expected four (Justices Ginsburg, Kagan, Breyer and Sotomayor), and strike his ban. If that is so — Gorsuch will not matter, at all (and it is not beyond belief that Chief Roberts and Newbie Gorsuch might join the other five). Not probable; but possible. We shall see. Goodnight, to all of good will. Today was a great day — for people with a modicum of compassion, in their hearts.]


[U] One Early Stage Israeli (Phase I) Immuno Oncology Long-Shot Comes Up Dry, For Merck…

March 24, 2017 - Leave a Response

Ahem. In the world of bio-science, it often turns out this way. And a $95 million upfront is tiny — meaningless to Kenilworth. A disappointment? Sure. But, as with all other things, one takes a deep breath, writes it off, and. . . moves on.

Here’s the June 2015 backgrounder; and here’s today’s denouement of that story, and a bit:

. . . .A spokesperson for the company confirmed something that is already posted to the US public clinical trials registry.

“Merck has decided to stop further clinical development of MK-6018 (CM-24). In the initial Phase 1 dose-ranging study, no efficacy signals were detected. The decision to discontinue further development is not due to any known safety risks.”

And there goes a deal completed with a $95 million upfront and $510 million in milestones that won’t get paid. . . .

UPDATED: 3 PM EDT — just as I repeatedly said, OrangeCare is DOA. Even though the GOP clearly controls both chambers, and the Oval Office, they couldn’t even get it to the starting line — let alone finish it. And whether I disagree with its goals or not is of no moment, at the moment. What it points up, clearly, is that Mr. Trump has no ability to parse details, in anyone’s positions.

In short, he is unfit to govern, since he doesn’t even understand (or care to discern) which ones might be the right questions to ask. Mr. Ryan bears responsibility here too — but it is hilarious that Mr. Trump is blaming Democrats for the defeat of his ill-starred OrangeCare lunacy. He won in a sweep, in November — and as the ides of March arrive — he cannot even get his own party to agree on what they ran on. Hilarious — but this has nothing to do with Democrats, or even to do with ObamaCare. . . it is an epic internal failure of the GOP. After all, the ACA of 2010 passed without a single GOP vote. So 45 looks foolish, again. [I might look for a renewed effort in 2018, after the mid-terms. End, updated portion.]

Moving on, then — getting out, for a long garden lunch, on a flawless 80 degree Friday. . . . yep. I’m out. Be excellent to someone who may not. . . deserve it.


Friday Lenten Confessions: I’m Tardy — With This, As Well…

March 24, 2017 - Leave a Response

While we wait to see whether 45’s silly grandstanding on the “Orange-Care” health package will actually result in an “up or down” vote, in the US House. . . and then wait, ever more skeptically, to see — even if the 30 some additional votes are found, in the House — whether the US Senate will ever reach 60 votes, on the measure. . . [i.e., not plausible. . .] I’ll drop in a belated bit of Kenilworth related near-trivia.

Yesterday, exactly as expected, Merck cleared all the relevant anti-trust baffles, and closed its $400 million South American animal health acquisition we discussed near Fourth Of July, last year. Here is a bit from Yahoo! Finance News:

. . . .Vallee S.A., a leading privately held producer of animal health products in Brazil, has [been acquired by Merck]. . . . Vallee also has its presence in other Latin American countries.

As per the terms of the agreement, Merck has acquired approximately 93% stake in Vallee for about $400 million. Vallee is a leader in the animal health care products segment in Latin America. . . .

Onward. With a purely-scientific (but largely unrelated) skepticism as my new watch-word — I won’t believe it — until I see it, with my own eyes. . . . sadder, but wiser.


In Other, Brighter, News… The Weather On The Sun Has Been Flawless — For 16 Days Straight…

March 23, 2017 - Leave a Response

So, a solar minimum now approaches, over a three and a half year waning cycle. And that makes for a clear face, quite yellow and yolk-like, on the surface of our local star. Sweet.

[Of course, her placid present countenance, at the surface, is simply a form of gauzy, gossamer mask — obscuring the raging fury beneath — all as I try to bang out at least one post, to normalize, a bit. . . .] In any event, here’s the bit:

. . . .For 15 days starting on March 7, 2017, NASA’s Solar Dynamics Observatory, or SDO, returned visible light images of a spotless sun. This is the longest stretch of spotlessness since the last solar minimum in April 2010, indicating the solar cycle is marching on toward the next minimum, which scientists predict will occur between 2019—2020.. . .

This should (in theory) mean fewer telecom outages, in evidence. At least as to those regularly — and perhaps falsely — blamed on sun-weather. Now you know. Onward.

With lyrics from last night, at Hamilton, rolling in my head: I resolve. . . to “smile more — talk less. And [adding my own twist, here] laugh at those who absolutely falsely claim. . . righteousness. . . .”


In The “Tardy Posts” Dept.: Third Circuit Helps Fosamax® Plaintiffs — With Failure To Warn Claim “Revivals”…

March 23, 2017 - Leave a Response

I am tardy in getting this up. I guess I’m just. . . not feeling it, in truth. Memories from London do weigh on me, this early morning. [Backgrounders from June 2016, here, and a prior April 2014 one, here.]

Here is the full appellate opinion, and a bit:

. . . .The primary issue in this case is whether Plaintiffs’ state-law failure-to-warn claims are preempted by federal law under the Supreme Court’s decision in Wyeth. This is not a straightforward determination.
Wyeth says only that a claim is preempted when there is “clear evidence” that the FDA would not have approved a label change. This standard is cryptic and open-ended, and lower courts have struggled to make it readily administrable. This appeal, however, requires us to do so. To assess whether Merck is entitled to summary judgment on its affirmative preemption defense, we must answer two questions: What is “clear evidence”? And who should determine whether clear evidence exists?

For the following reasons, we conclude that (1) the term “clear evidence” refers solely to the applicable standard of proof, and (2) the ultimate question of whether the FDA would have rejected a label change is a question of fact for the jury rather than for the court. By describing the ultimate question as one of fact for the jury, we do not mean to suggest that summary judgment is categorically unavailable to a manufacturer asserting a preemption defense. When there is no genuine issue of material fact — that is, when no reasonable jury applying the clear-evidence standard of proof could conclude that the FDA would have approved a label change — the manufacturer will be entitled to judgment as a matter of law. We simply hold that, at the summary judgment stage, the court cannot decide for itself whether the FDA would have rejected a change, but must instead ask whether a reasonable jury could find that the FDA would have approved the change. . . .

And. . . it looks like 45 is still considerably short of the first round of House votes he needs — just to start the process — for his health (non-) care abomination of a bill. [And then there’s the Senate.] Now you know. Onward. I’ll be decidedly Hamiltonian for a bit. . . .


Do Travel Well — But Travel Light — Mr. Berry…

March 19, 2017 - 6 Responses

Charles Edward Anderson Berry (1926-2017).

Yep — That’s definitely. . . the stuff. Just press play. [You know you want to!]

He genuinely electrified us all. Fly free now, from your tightly-curled fingers, aging eyes, tired back, and stiffened knees, man. Whoosh. You are. . . immortal, now.


And Now — For Something Completely… Different

March 17, 2017 - Leave a Response

No health care, life science, space science, STEM, R&B or constitutional law and politics — on this particularly fine Friday.

Nope — but since I did pick Middle Tennessee State and Xavier last night (along with NU), I’ll simply express gratitude. . . for my genetically-Irish good fortune. I’m part leprechaun, you see. . .

Good luck — good ju ju, and/or good karma, actually.

And I’ll (as ever) share it, freely — with all those of you, of continuing good will. So. . . Happy St. Patrick’s!

While It Is Well, With My Soul, That Checks And Balances Work…

March 16, 2017 - Leave a Response

. . .I find myself rather profoundly saddened this morning, as I board the plane. [Perhaps I should be feeling more upbeat — that the judiciary branch is functioning exactly as it ought — 240 years on.]

I do deeply appreciate what Mr. Hamilton, et al., left us — for protection, against would-be tyrants.

And yet, I think it demeans our nation, on the world stage, to have a President who is so manifestly unfit for office. [It doesn’t speak well for the level of sophistication — minus some three million votes — of our electorate, either.]

In sum, I see little evidence that 45 can contain his own ill-founded, hateful rhetoric (for the purpose of governing) in a manner that comports with our Constitution — and his duties thereunder. [He is a forever candidate — like Bryan, of a century ago.]

More ominously, for however many months 45 is able to hold the office, I worry that he doesn’t even comprehend the Constitution’s schema, nor his place inside it. His near maniacal ravings in Nashville, after he learned of the clearly correct decision in Hawaii (and now, in Maryland, as well). . . does not bode well for his Presidency.

His health care ideas are being retooled as I type this, in the House, because (as ever) he has made promises to the American people — ones that he manifestly cannot keep. [I wonder if he is tired of. . . losing, yet.]

For the weekend, we will return to our masthead that predated much of this. It is a reminder that we as a nation will thrive — with or without him.



A Mistaken Post-Script — From One Faction Of The Ninth Circuit: In An Echo, On Muslim Ban 1.0

March 15, 2017 - Leave a Response

First, this 26 pager is not law, in any sense. It is the view of only one member of the Ninth Circuit, on appeal. [Amended version, here.]

But in fairness, I’ll post the entire PDF, here. I do so in part to make sure readers who’ve follow this less closely than I have won’t be. . . led astray. Ultimately, the Hawaii TRO (or a later preliminary injunction) opinion is likely to come before this same Ninth Circuit.

And this dissent was filed as Ban 1.0 was closed out, in the Ninth Circuit tonight. But we may yet see this sort of erroneous reasoning raised there — against enjoining Ban 2.0. [In fact, Mr. Trump echoed the most silly parts of it tonight, as he spoke in Nashville — of the “overreach of the courts,” in entering the Hawaii TRO on Muslim Ban 2.0. So we must be vigilant. Ever vigilant, against false premises, like these.]

In sum, the dissenter simply leaps from the 1952-era INA, to the 2000s and later versions, ignoring the 1965 INA amendments we have discussed here at some length. [And I should be clear that tonight, Judge Walton in Hawaii specifically reserved on the INA arguments, settling on the Constitutional violations first.]

The more fundamental error, in my view though, is that the dissenter simply ignores the way in which First Amendment claims must be handled, in the face of clear evidence of an impermissible motive on the part of the Executive Branch. The Executive is not sanitized, just because it acts on an immigration measure. In fact, that is when the First Amendment must be most jealously guarded.

It is fair to say that there has never been, in our modern post WWII era (1940s and later) a case with such blatant evidence of invidious religious discrimination, and nationality discrimination, directly from the mouth of the Commander in Chief. In public, and in repeated written statements. So this case is unlike any in the modern era — but the US Supreme Court’s First Amendment jurisprudence here is clear, and stretches back more than a century. The dissenter simply ignores it. So his view will not carry the day, when this reaches the Supremes. But we should be careful, between now and then, not to be dissuaded.

As he closes, he does make a very solid point — to personally rebuke Mr. Trump directly, about ad hominem attacks on federal judges, thus:

. . . .Even as I dissent from our decision not to vacate the panel’s flawed opinion, I have the greatest respect for my colleagues. The personal attacks on the distinguished district judge [Ed. Note: that would be Judge Robart, imaged at right] and our colleagues were out of all bounds of civic and persuasive discourse — particularly when they came from the parties [Ed. Note: this means Mr. Trump, personally].

It does no credit to the arguments of the parties to impugn the motives or the competence of the members of this court; ad hominem attacks are not a substitute for effective advocacy. . . .

Such personal attacks treat the court as though it were merely a political forum in which bargaining, compromise, and even intimidation are acceptable principles. The courts of law must be more than that, or we are not governed by law at all. . . .

Indeed, we were, are and remain a nation of laws, not just petty, small-handed, old white men. Now you know. Be vigilant about your rights, lest you lose them. Sleep well one and all — I’m in the air all day tomorrow — off grid, as it were. . . .


[U] NATIONWIDE TRO Entered! Live Blogging Of Federal TRO Hearing(s) Concluded…

March 15, 2017 - Leave a Response

UPDATED @ 6:30 PM EDT — Judge Watson just enjoined Muslim Ban 2.0, nationwide. Let the DoJ appeal — I don’t care. WILL issue a ruling, before 6 PM Hawaii time — or about four hours from now.

I will go out on a smallish limb and indicate (guess, really) that he will enter a TRO against Muslim Ban 2.0 — nationwide. You read it here first. Here is Judge Watson’s very cogent 43 page opinion. [END, UPDATED PORTION.]

. . .And, as we wait for the Sun to set, here in Chicago — and the start of the TRO hearing in Honolulu, Hawaii at 9:30 AM island time. . .

We will note that a federal District Court in Maryland held a motion hearing on a TRO request, against Muslim Ban 2.0 this morning — but likely won’t rule before midnight tonight, Eastern.

. . . .Hawaii’s State Attorney General, Douglas Chin, flashed a casual DLDL (or down low) “shaka” — or “all good” — island hand sign, as he entered the federal District courthouse in Honolulu a few moments ago. . . .

The hearing is now underway. . . . and though it’s not clear when the able Judge Watson will rule on the state’s request for a temporary restraining order, he might rule immediately from the bench — at the end of the hearing. . . .

Preeminent attorneys from the Washington, D.C. office of Hogan Lovells — acting “on brief” as special counsel to Hawaii — are on the phone conference line, as is the US DoJ (for the Trump Administration). . . .

Fourteen state attorneys general and 58 technology companies have also filed amicus briefs supporting Hawaii’s challenge. The attorneys general argue that the revised ban retains the unconstitutional components of the original order, including a broad ban on entry by nationals from six predominantly Muslim countries and a suspension of the refugee program. . . . the 1965 amendments to the federal INA prohibit barring entry on the basis of race, religion or nationality. . . . and our First Amendment prohibits religious tests, even more broadly.

Do look in here — for updates. . . . they will appear from time to time now, until late this evening. . . .

[Of course, there will eventually be appeals on all sides, either way. And those appeals will go. . . that’s right — to the Ninth Circuit, just as Ban 1.0, did a month ago. And you know what I bet will happen there. Smile. FINAL UPDATE: The very capable US District Court Judge Theodore Chuang, sitting in Maryland, has also enjoined it — that’s a 43 page PDF of the opinion, overnight. Onward.]