Author: condor

A Long-Term Follow-Up: Merck Files Its Brief In Third Circuit For Another Go-‘Round, On Fosamax® And Brittle Bone Warnings…

~ condor ~ Leave a comment

This Fosamax® (alendronate sodium) litigation, involving (in part) non-impact hip fractures, and jawbone death (both alleged to be the result of long term alendronate sodium regimens, without at least annual drug holidays) has been to the Third Circuit at least twice before, and once, to the US Supreme Court. It returns now on the issue of whether Merck could have, or should have warned earlier. Merck’s brief runs over 50 pages. It argues that the FDA’s rules and letters prohibited it from changing its warning labels any earlier than it did.

And as long term readers know, of course, we have followed this litigation morass since 2008. [Earlier, if one counts the Wyeth pre-emption body of law, at the Supremes.] Here is some of the latest, from the Merck brief just filed:

…[T]he FDA told the Supreme Court it rejected Merck’s warning based on “lack of adequate data to support a warning,” not “because of the warning’s use of the term ‘stress fractures.’” A1524. Judge Wolfson reasonably “credit[ed]” the FDA’s representation about its own rationale. A102.

Plaintiffs claim the court erred by giving credence to “the government’s litigation position expressed years later in an amicus brief.” Br.58. That misstates the law. It is proper to “defer[]” to an agency’s amicus brief if, as here, “the agency was not a party to the litigation, and had expressed its views only in response to the Court’s request.” Kisor v. Wilkie, 139 S. Ct. 2400, 2417 n.6 (2019). Of course, courts do not “defer[] to an agency’s conclusion that state law is pre-empted,” but they do respect agencies’ “unique understanding of the statutes they administer.” Wyeth, 555 U.S. at 576-77. The FDA’s briefs explained its earlier actions in view of the statutory and regulatory background. That certainly warranted at least “some measure of deference….”

Ironically, Plaintiffs urge the Court to instead defer to the view of a single, former FDA official, Dr. Sharfstein, who joined an amicus brief on Plaintiffs’ side. Br.58. But, unlike the FDA’s briefs, Dr. Sharfstein does not speak for the agency; played no role in the underlying events; and did not file his amicus brief at the Supreme Court’s request. Plaintiffs also pretend the Supreme Court itself somehow resolved this issue in their favor in the facts section of its opinion. See Br.53, 58. As Judge Wolfson appreciated, that is not a plausible understanding of the Court’s decision….

Onward, with my eldest headed back to London for another three months this evening… with a sad smile, then.

नमस्ते

Scott’s Authored Three Pieces — On One Gram Of Coke?!

~ condor ~ Leave a comment

I think we may safely say Powerliners… have become desperate: nothing connects this to the President. And nothing ever will. It was found while he was at Camp David.

So someone (maybe even a plant) dropped a one inch by two inch bag of less than a gram of powder that turns out to be cocaine. So what?

Scott is correct (about this much): there is almost zero chance any reliable evidence will ever connect this to even a low level staffer at 1600 Penn.

It is… nothing; Junior was regularly coked up on video calls from 1600, in 2019 and 2020, for official GOP appearance speeches.

But most of all — Tangerine faces an indicted 78 felony counts across two separate indictments, voted by one state grand jury, and the other by a federal grand jury.

One of those clearly sets out national security felonies.

Yep — the three stories on one baggie on the grounds… is sweaty desperation, as separately DeSantis is imploding — and the GOP cannot find any real option other than retreading what may be by then a jailed felon.

[To top it all off, the Freedom Caucus “mean girls” are in a cat fight: MGT has been kicked out of the clique by Boebert’s ditto-heads. Yep — national GOP winger Congressional caucuses are now no more than mean high school level lunch room table seating cliques, among dumb sociopaths.]

Hilarious!

No, Hinderaker — Not At All “Frustrating, For Democrats” –That Rasmussen Polling Is Expected.

~ condor ~ Leave a comment

John thinks this means… something. It does not.

Rasmussen notoriously oversamples the hard right — and the retirees.

Even so, more of them think Trump is a crook.

Especially when you add in the “not sures”.

But — crazy thing! Only one of them faces a pair of felony indictments, each averring dozens of… 20 year felonies.

I forget — hey Hinderaker! — which guy is that?!

Exactly correct, John: Trump is a crook.

Hilarious.

Minor Power Alley Update — Zenara Patent Matter Was Settled In May of 2023…

~ condor ~ Leave a comment

I’ve been derelict, with both graduations and vacations intervening, in getting this small update out: Merck and several other parties have consented to a judgment in Delaware federal court, finding that Zenara infringes the Merck patents.

This simply means that Hatch-Waxman periods will apply, for the first generic after patent expiry. [Mid 2022 backgrounder here; full PDF of the May settlement order here — and a bit:]

…As used in this Consent Judgment, (i) the term “Zenara Product” shall mean the drug product sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 216842 (and defined in greater detail in the Settlement Agreement); (ii) the term “Licensed Patent” shall mean United States Patent Number 8,080,580; and (iii) the term “Affiliate” shall mean any entity or person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with Zenara; for purposes of this definition, “control” means (a) ownership, directly or through one or more intermediaries, of (1) more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or (2) more than fifty percent (50%) of the equity interests in the case of any other type of legal entity or status as a general partner in any partnership, or (b) any other arrangement whereby an entity or person has the right to elect a majority of the Board of Directors or equivalent governing body of a corporation or other entity or the right to direct the management and policies of a corporation or other entity.

Unless otherwise specifically authorized pursuant to the Settlement Agreement, Zenara, including any of its Affiliates, successors and assigns, is enjoined from infringing the Licensed Patent, on its own part or through any Affiliate , by making, having made, using, selling, offering to sell, importing or distributing of the Zenara Product.

Compliance with this Consent Judgment may be enforced by Merck and its successors in interest, or assigns, as permitted by the terms of the Settlement Agreement….

Now you know — onward, grinning on a warm, sunny Chicago noon-time stroll….

नमस्ते

The Purported USDC Judge Doughty “Order” Enjoining The Government On Social Media… Is A Comical Piece Of Self-Refuting Swiss Cheese Politics.

~ condor ~ Leave a comment

The Monroe, Louisiana Trump-appointed judge made his actual short form written order public, yesterday. By night-fall, the government had filed a notice of appeal.

The order proves it and the 155 page opinion represent no more than a political manifesto by first listing a “no contact” proscription, and then spending two more later pages saying “well, except for LAWFUL contacts“.

In sum, it is so much swiss cheese — and not even internally consistent. The government may promote its policies, Doughty says, and urge the lawful suppression of dangerously false public health misinformation on the sixth page, even though the fourth page says it may not do so.

It also specifically excludes the government’s right to an evidentiary hearing (at page 6) before injunction. That alone is plainly reversible error. No one, public or private, may be summarily enjoined — without at least a preliminary evidentiary hearing — a notice and opportunity to be heard.

Yep, this will be stricken on appeal, very shortly (but due to its swiss cheese nature, it has very little real world effect — other than for GOP fundraising sound-bites).

And the Supremes have already impliedly agreed that pandemic misinformation may be directly suppressed, on social media (it so held while Tangerine was in office, by affirming FDA pronouncements and cease orders). So there’s that. Onward, grinning. Now you know.

नमस्ते

Of Geese And Gander, Paul… Sheesh. Just Give It Up.

~ condor ~ Leave a comment

Mirengoff (inadvertently, but candidly) notes that due to the choice of activist language the six Supremes settled on last week in the Harvard and UNC cases, the notion of legacy admissions may be in peril.

But of course he puts his pearls of wisdom, such as they are, behind his paywall. That is likely because his reasoning / claim that there is no cause of action cannot withstand independent scrutiny.

Here’s what he wrote, overnight:

…Filed on behalf of three Massachusetts-based black and Latino community organizations, the complaint calls on the feds to investigate Harvard’s legacy and donor-related preferences that, for the time being, favor white applicants.

The complaint is a response to the Supreme Court’s decision that Harvard’s racial preference regime for blacks and Hispanics is unlawful. It mirrors arguments that proponents of such regimes have long made, and that are now lodged with new vigor in light of the Court’s decision. Proponents hope that doing away with legacy and donor-related preferences will open up places for members of minority groups whose levels of enrollment, these proponents fear, are in jeopardy due to the Harvard ruling….

Because the Supremes made the argument that “disparate impact” on at least nominally qualified whyte and Asian-ancestry college applicants was enough to show the programs boosting diversity at Harvard would make out a fourteenth amendment claim (in favor of the whytes), then it follows that the disparate impact “boost” from being a legacy from an almost uniformly whyte family that previously had one or more Harvard graduates, per force, must be enough to invalidate it. Right, Paul? Right!

I am not saying the Supremes are right about this — nor are the Latino law advocates here. We are just saying this is a completely logical outcome, from their stilted reasoning. It will be a century before even 30 per cent of all legacies are non-white.

Of course, the real point here… is that the Supremes’ reasoning is… flawed.

Now you know. And, you’re welcome, Paulie.

Shorter Hinderaker, On Ben & Jerry’s: We Right Wingers Are… Largely Impotent.

~ condor ~ Leave a comment

This is a classic. Hinderaker at dinnertime is warning the frothy hard righters (his own tribe!) not to waste time arguing with Ben & Jerry’s on Twitter, over its stance on America’s stolen lands.

He says the Ben & Jerry’s brand is no Bud Light. That the right cannot dent its profit margins. He’s clearly right about that.

There are very few hard right Grateful Dead fans, for example. And even fewer would buy B&J, anyway.

Let’s also stipulate that two things can be true at once. I can believe that we in fact stole large chunks of what we call the US from indigenous peoples.

And I can also be fairly proud — of many other things America has achieved, on the Fourth.

[Humility is a virtue, Hinderaker.]

So, yes John… your acolytes are… impotent, as to this one.

Hilarious.

[U: Appealed.] Hinderaker Tells Us He Knows Nothing Of Old FCC Law & Procedure, Without Telling Us He Knows… Nothing Of It.

~ condor ~ Leave a comment

Updated 07.05.2023 8 pm: The Administration has already filed a notice of appeal from this nonsense. The decision will be wiped from the books, as completely untethered from existing law. End update.

Hilarious — now John weighs in on the Doughty nonsense manifesto of the Fourth.

John opines that the Supremes will affirm this pile of dung, if it becomes a final injunction.

I will take the other side of that bet, on a 7-2 majority. Only Alito and Thomas will see this as a proper injunction.

Here is why — as I said last evening:

The entire opinion rests on a laughably insipid false premise: this judge pretends that a right to say something — anything — means the NYT (for example) “must carry” it. Preposterous. Saint Ronnie Reagan got rid of the “must carry” rules — even in broadcast — in about 1985.

No one’s right to speak is abridged, just because I (a purely private actor, like FB or the NYT) refuse to sell you my bull-horn, or worse — give you a free one. Damn, Doughty. All these complaining loons may drive to NYC, and go directly into Times Square, and bark madly into the night sky. That’s the sole freedom they are accorded (no private party owns the sidewalk in Times Square) — but no one says I have to host them in my private living room. See the difference? That’s the pure idiocy of Judge Doughty.

So, his “opinion” will be stricken on appeal — and never matter in any real world scenario.

But it was some great red political meat — around the fireworks — for the Trumpers. I link it here — only so we may accord it… its richly-deserved mockery. I guess the Administration should remain silent in pandemics, when idiot doctors endanger the lives of the public with false health claims(?!). This is lunacy, as a matter of policy — and in no manner reads on the First Amendment — properly understood.

Onward — too bad these jokers didn’t pay attention to the evolution of public media and broadcast law, as informed by evolving (conservative) first amendment law, over the last half century or so.

Damn. Good theatre, though.

[U: Three!] Breaking A Record Set One Year Prior — Now On THREE Consecutive Days: Hottest Globally, In Recorded Human History.

~ condor ~ Leave a comment

It was just about a year ago that we noted the previous hottest day ever, globally.

This week, we broke that record thrice twice, on consecutive days — July 3, 4 and 5, 2023. Here are the details:

…The average global air temperature recorded 2 metres above Earth’s surface was 17.18°C (62.92°F) on 4 July, the highest that has ever been recorded. The previous record was set the day before….

Before that, the next highest-temperature on record was recorded jointly in August 2016 and July 2022, when average global temperatures reached 16.92°C (62.46°F). The two consecutive days of record-breaking global heat confirms scientists’ warnings that 2023 is likely to be one of the hottest years on record, as the twin effects of climate change and a warming El Nino climate pattern drive temperatures to new highs….

These are facts, whether the petrochemical and dirty coal industries condescend to believe them or not — they remain… facts. Onward, into only slightly less lethal heat indices here on Wednesday. Sheesh.

नमस्ते

The Sixth Circuit Itself Has Decided To Refer The Friends Of Georges Appeal By TN… To Mediation.

~ condor ~ Leave a comment

This is a clear sign from the federal courts that Tennessee’s position is a loser.

If Gov. Bill Lee is any kind of wise, he will agree to a settlement that pays the plaintiffs’ legal fees, and closes the matter. The taxpayers of Tennessee could owe an additional $600,000 or so in appeal legal fees, only to lose — again. The law is unenforceable on its face, as we’ve shown, and the able USDC judge in Memphis has ruled. Here’s that mediation referrral notice:

…The third and primary purpose is to explore possibilities for settlement. We will discuss in considerable detail the parties’ interests and possible bases for resolving the case.

You should be prepared to address all of these matters. More detailed information about mediation in the Sixth Circuit can be found on our website….

And, just for a complete record, here is the DA Mulroy’s opposition to the award of George’s attorneys’ fees, for having to bring suit against a plainly unconstitutional “law”. Onward. grinning — on a sultry, sunny day in the city of big shoulders, now….

नमस्ते