The 14th Amendment’s Equal Protection Clause, Reinvigorated: A Joyful Noise, Arises!

June 26, 2015 - Leave a Response

As I predicted, there is, in the U.S., henceforth — an inalienable right for children of same sex couples — to enjoy the full measure of inheritance that a lawful marriage confers. If nothing else, a just society should not penalize children for how their parents came to love one another.

And thus — this is on topic, for a health care blog. We celebrate!

. . . .The nature of injustice is that we may not always see it in our own times. The generations that wrote and ratified the Bill of Rights and the Fourteenth Amendment did not presume to know the extent of freedom in all of its dimensions, and so they entrusted to future generations a charter protecting the right of all persons to enjoy liberty as we learn its meaning. When new insight reveals discord between the Constitution’s central protections and a received legal stricture, a claim to liberty must be addressed. . . .

The fundamental liberties protected by this Clause include most of the rights enumerated in the Bill of Rights. See Duncan v. Louisiana, 391 U. S. 145, 147–149 (1968). In addition these liberties extend to certain personal choices central to individual dignity and autonomy, including intimate choices that define personal identity and beliefs. . . .

The idea of the Constitution “was to withdraw certain subjects from the vicissitudes of political controversy, to place them beyond the reach of majorities and officials and to establish them as legal principles to be applied by the courts.” West Virginia Bd. of Ed. v. Barnette, 319 U. S. 624, 638 (1943). This is why “fundamental rights may not be submitted to a vote; they depend on the outcome of no elections. . . .”

Onward — from sunny California! [Please forgive formatting glitches — all posted by iPhone.]

UPDATED — 06.27.2015 No matter what the dissenters wrote, the Constitution was intended to be a living document, that liberated and yet protected the people in ways the founders had not yet imagined. So do not buy the suggestion that if the founders didn’t think of it, as a right — it does not exist. [Consider that many founders “owned” other humans, and yet here we are.] So this right to marry is just the embodiment of a general principle, made clear by passing history. And our Union is more closely perfected, thereby:

//www.youtube-nocookie.com/embed/b715GKJNWXA

SCOTUS Watch — ObamaCare Upheld! 6 to 3!

June 25, 2015 - One Response

There will only be opinions in two cases announced today. More soon.

But — with all due modesty — I told you so. Any person in any exchange is eligible for federal subsidies. Not just those created by the states, separately. The President’s health care reform measures are. . . constitutional. Again. Hopefully the tea partiers will stop — with these nonsense appeals. I buried my lead, here, earlier — this is VERY GOOD NEWS for Kenilworth, as the nationwide insurance subsidies’ availability will drive significant new drug sales — for all of pharma. From Scotusblog.com just now:

. . . .Buzzer has sounded — two boxes today. . .

First opinion: Fair Housing — Court holds that there is a disparate impact claim under the FHA as a matter of statutory interpretation, but it the Court cautions that remedial orders in disparate impact cases that impose racial targets or quotas could be unconstitutional. . . .

Second opinion: Decision of the Fourth Circuit is affirmed in King v. Burwell. 6-3 . . . .

Majority opinion: “Congress passed the Affordable Care Act to improve health insurance markets, not to destroy them. . . . In this instance, the context and structure of the Act compel us to depart from what would otherwise be the most natural reading of the pertinent statutory phrase. . . .”

Quite so. Onward — to the plane — and California, now!

Ed — at Pharmalot 3.0 — Catches Up To Our Fosamax® Femur Fracture MDL Post — Of Last Week

June 24, 2015 - Leave a Response

My buddy Ed is on this — using the New jersey Law Journal feed for his squib — in the Wall Street Journal.

As our readers know, we had this last weekend, on Saturday morning. It happened last Friday.

. . . .A federal judge in Trenton, N.J., dismissed the last remaining 570 cases [Editors’ NOTE: Femur Fracture Cases ONLY] in multidistrict litigation over Merck’s osteoporosis drug Fosamax, but the cases could be reinstated if plaintiffs win an appeal pending before a federal appeals court, The New Jersey Law Journal writes. . . .

So it goes. Onward. Ever, and ever. . . onward.

Something. . . Wonderful — Perfect, In Fact — From 2009

June 23, 2015 - Leave a Response

I’ll simply reprint my December 6, 2009 post — from long before the latest travails; long before late August 2012, and also long before July 10, 2013. And. . . this update belongs here because henceforth, the Merck Manuals will be digital only.

There will be no more printed versions — after over 100 years. And that’s the kind of change — that’s a good thing. Onward.

December 6, 2009: I spend a lot of time on this blog critiquing the moves of New Merck (as the successor-in-interest to Schering-Plough, as of November 4, 2009), but this — I must say — is at least one thing that Merck has gotten absolutely right.

Perfect, in fact.

For a year or so now, Merck’s Manual has been available as an application for PDAs. The iPhone version is both beautiful, and elegantly functional. [The image above is courtesy AgilePartners; you may puchase it there as well — via this link.] Having it around, in digital form, at a moment’s tap, whether one is in the high Andes, in the rolling hills of northwestern Ireland, or the deserts of Arizona — or even on the southern tip of Florida Keys — is far easier than traveling with that hard-copy, wonderful, but weighty tome in tow.

So — well done, Merck — spot on! Highly recommended:

. . . .Based on the world’s most widely used textbook of medicine—The Merck Manual—but written in everyday language by 300 outstanding contributors. . . .

Not entirely unrelated aside: The New York Times is running a very long article this afternoon — on how Apple’s App Store has so completely overwhelmed older methods of distribution — that now each competing smartphone (or software platform) is offering its own App Catalog (Palm; WebOS), Windows Marketplace for Mobile (Microsoft; WindowsME), Android Marketplace (Google; Android) and Owners’ Lounge (Blackberry; RIM).

And each of these is sure to soon have (or already does have) the Merck Manuals in smartphone-accessible forms. Well, nothing exceeds like. . . excess, eh?

And so. . . all of life. . . is about moving toward — or away — from something, or someone. I’m. . . out.

No “ObamaCare” Opinion — From The Supremes. . . Yet. Maybe This Thursday.

June 22, 2015 - Leave a Response

The issued opinions have all been unboxed, opened, and read — in paper format, this morning (yes the Supremes are still very. . . old school) — and no decision in King v. Burwell was in those boxes. So, Christmas morning is still as much as week off, yet.

There may yet be a bonus opinion day, later this week. UPDATED: Thursday of this week will be the “bonus” day. Oh well. I’ll be off-grid, on an airplane. Or we may get the decision on next Monday the 29th — also while I’m off the grid. In any event, I still confidently predict an ObamaCare win — authored by Chief Justice Roberts, with Kennedy joining the usual four who will support it. So I see it as a 6-3 decision.

. . . .Opinions this term still left unpublished: Texas Fair Housing Act, Arizona redistricting commission, King v. Burwell, Michigan v. EPA, Johnson v. US, Obergefell v. Hodges and Glossip v. Gross. . . .


Amy Howe (at Scotusblog.com): There will definitely be orders on 6/29; I would be surprised if there weren’t opinions on the 29th as well, because it’s hard for me to imagine that they would release all seven remaining opinions on Thursday. . . .

Do stay tuned. Onward.

The End Draws Nigh, For Fosamax® Femur Fracture MDL Claims — Materially Good News For Merck

June 20, 2015 - Leave a Response

We have expected this, for quite a while now. The femur claims (as distinguished from the ONJ ones) MDL is likely to come out as a complete win for Merck — we have been following it since 2010.

I post yesterday’s ruling so that the kind and gentle folks following the federal Propecia® MDL litigation will be able to see — by analogy — how important the label warnings have become, after the Supremes decided Wyeth v. Levine. From the full order, then (an 18 page PDF file):

. . . .On March 26, 2014, the Court entered judgment as a matter of law dismissing the claims of hundreds of Plaintiffs who allegedly suffered femur fractures prior to September 14, 2010 on preemption grounds. See In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., MDL 2243, 2014 WL 1266994 (D.N.J., Mar. 26, 2014) (the “Preemption Ruling”). The Preemption Ruling is now on appeal to the Third Circuit. . . .

On June 17, 2014, the Court granted summary judgment in favor of Merck in the Gaynor case and found that the 2011 Fosamax warning regarding atypical femur fractures is adequate as a matter of law because it “is accurate, clear, consistent and as a whole conveys a meaning that is unmistakable as it relates to AFFs.” Gaynor v. Merck Sharp & Dohme Corp., Nos. 12-1492, 08-08, 2014 WL 2738224, at* 11 (D.N.J. June 17, 2014). The Gaynor Plaintiff has appealed this ruling to the Third Circuit. . . .

Following the dismissal of Gaynor, the PSC advised the Court by letter and during telephonic status conferences that to the best of their knowledge no Plaintiff is alleging that the 2011 Fosamax label was a proximate cause of his or her injuries and that the adequacy (or inadequacy) of that label has not been placed at issue by any Plaintiff. On November 5, 2014, the Court ordered those Plaintiffs whose cases had not previously been dismissed by the Preemption Ruling and who claim that the warning about AFFs in the January 2011 Fosamax label was inadequate and a proximate cause of their alleged injuries to show cause why their claims should not be dismissed in light of the prior rulings by the Court (the “November 5, 2014 Order”)(Dkt. 3927). The November 5, 2014 Order further provided that if any Plaintiff did not make such a claim, then they would be forever barred, precluded, and estopped from claiming that the January 2011 Fosamax label was inadequate and a proximate cause of their alleged injury. . . .

[T]he Court has determined, after consultation with the PSC, that the claims of all remaining Plaintiffs in this litigation are based on the alleged inadequacy of the pre-2011 Fosamax label. Because the adequacy of the pre-2011 Fosamax label is the issue currently being decided [on appeal] by the Third Circuit, the decision on appeal will determine whether the claims of the remaining Plaintiffs in this litigation (identified in Appendix I hereto) remain viable or not. Consequently, IT IS on this 19th day of June, 2015, ORDERED that the claims of all Plaintiffs listed on Appendix I against Merck are hereby conditionally dismissed without prejudice pending the decision by the Third Circuit on the appeal of the March 26, 2014 Preemption Ruling. . . .

So it goes. So too, on a cool, quiet Saturday — we are actually quite melancholy — about the lunacy of white domestic terrorists/supremecists our nation’s NRA lobby refuses to address in any constructive way. But the mouthpieces for the NRA are first to the fore, when the terror threat is browner, or not born on our soil. Ironic — and tragic. Will the NRA condemn these latest photos of Mr. Roof spitting on, and burning, the stars and stripes? I won’t hold my breath. In fact, one NRA board member blamed the pastor of Mother Emanuel — for the death of the other eight church-goers. That puts NRA Board member Charles Cotton on a par — with the terrorist, himself — in my view. I won’t repeat the tortured reasoning by which Cotton justified his deplorable libel.

At least on Father’s Day, please be better to one another than this. Please. . . .

Say A Prayer For Charleston. . .

June 18, 2015 - Leave a Response

UPDATING | 06.19.2015: It looks as though this massacre was not just a hate crime, but also domestic terrorism. It seems completely improbable to think that Dylann Storm Roof was unaware that he had chosen the evening of June 17 to commit this particular act of terrorism, at this particular church — a clear ringing, of the bells of historical memory — all the way back, to 1822. From today’s New York Times, then — a bit:

. . .So, meeting in [founding lay pastor and former slave Denmark] Vesey’s Bull Street home and within the walls of the Emanuel [AME, the place of this current massacre], Vesey and his lieutenants called for domestic slaves to kill their masters in their beds and fight their way to the docks, where they would seize ships and sail south. Originally, the plan was set for July 14, 1822 — Bastille Day — but the plot began to unravel, and Vesey moved the plans forward to the night of June 16. The uprising would begin when the city’s churches tolled midnight, meaning that the actual black exodus out of Charleston would take place on June 17. [The revolt failed, and Vesey paid for it with his life, as did 34 others — and 34 more were deported from the country.] Either the shooter in Charleston yesterday knew the importance of this date, or the selection of June 17 was a ghastly coincidence. . . .

The depravity of the 21 year old Mr. Roof is completely unfathomable, to my mind, at least.
Jon Stewart is. . . spot on:


END, UPDATED PORTION.

We will fall silent this day. We may return tomorrow — hoping that all people of good will seek both answers — and justice.

From our 44th President’s reflections, on the hate crime — just now:

. . .Mother Emanuel is, in fact, more than a church. This is a place of worship that was founded by African Americans seeking liberty. This is a church that was burned to the ground because its worshipers worked to end slavery. . . .


When there were laws banning all-black church gatherings, they conducted church services in secret. When there was a nonviolent movement to bring our country in closer line with our highest ideals, some of our brightest leaders spoke and led marches from this church’s steps.


This is a sacred place in the history of Charleston and in the history of America. . . .


At some point, we as a country will have to reckon with the fact that this kind of mass violence does not happen in other advanced countries. It doesn’t happen in other places with this kind of frequency. . . .


It is in our power to do something about it. . . .



Sadly, so true. . . Pax tecum one and all.

Why Merck MAY Be “Of Two Minds” — About The Pending TPP “Fast Track” Measures

June 17, 2015 - Leave a Response

At the outset, let’s note that a blog post (like this one!) is almost certainly not the best format, or forum, for a breezy top-level discussion of a complex, manifold international trade agreement.

But let’s take a stab at it anyway, shall we? Yes, let’s. We all know that Merck (like Pfizer, Lilly, GSK and AZ) makes far more from its branded pharmaceuticals and biologics, than it ever will from its “authorizedgenerics — even taking into account the huge market opportunities in the BRIC nations — India, Russia, China and Brazil — for example. However, Kenilworth has acknowledged that some medications — like sitagliptin in India for the 63 million diabetics there — need to be made more affordable to the common people of India. So Merck has an arrangement with Sun Pharmaceuticals — to make the non-branded version of Januvia®/Janumet® available, at a relatively modest discount.

Here is the rub, though — others, including Glenmark and Aprica, are making non-authorized versions in India, creating havoc for Merck’s branded efforts. Now, enter TPP — a measure Merck has been staunchly supporting — as has PhRMA — because it will give the branded producers greater ability to knock out these unauthorized generics, and bio-similar manufacturers.

I write this morning then, to simply point out that this might come at the expense of some existing revenue streams Merck already enjoys. Those being the authorized generics, around the globe — so, as I say, Merck may be of two minds about the fast track. And, in a bit of grandstanding here — I do think it is fair to say that TPP is less about open trade, and more about forcing trading partners to respect patents, trade secrets — and yes, trademarks. [That is — of course — why big tech is also so intently throwing money behind TPP passage, as well — in my estimation. And that is not inappropriate, in my view — as an end goal. I just think we should have a more candid, and open debate about the notion that TPP is more about property rights protection, than free trade.]

In any event, the below quoted bit would put real teeth into IP protection in the countries signatory to TPP — making the TRIPS 2005 protections the law — in all of them. This is from the leaked “IP protections” portion of the TPP bill, then:

. . . .Each Party shall notify the WTO of its acceptance of the Protocol amending the TRIPS Agreement done at Geneva on December 6, 2005.

5. Each Party shall make all reasonable efforts ratify or accede to the following agreements by the date of entry into force of the Agreement:

(a) Patent Law Treaty (2000); and

(b) Hague Agreement Concerning the International Registration of Industrial Designs (1999).

6. A Party may provide more extensive protection for, and enforcement of, intellectual property rights under its law than this Chapter requires, provided that the more extensive protection does not contravene this Chapter.

7. In respect of all categories of intellectual property covered in this Chapter, each Party shall accord to nationals*1* of the other Parties treatment no less favorable than it accords to its own nationals with regard to the protection*2* and enjoyment of such intellectual property rights and any benefits derived from such rights.

8. A Party may derogate from paragraph [7] in relation to its judicial and administrative procedures, including requiring a national of the other Party to designate an address for service of process in its territory, or to appoint an agent in its territory, provided that such derogation is:

(a) necessary to secure compliance with laws and regulations that are not inconsistent with this Chapter; and

(b) not applied in a manner that would constitute a disguised restriction on trade.

9. Paragraph [7] does not apply to procedures provided in multilateral agreements to which any Party is a party and which were concluded under the auspices of the World Intellectual Property Organization (WIPO) in relation to the acquisition or maintenance of intellectual property rights.

10. Except as it otherwise provides, including in Article __ (Berne 18/TRIPS 14.6), this Chapter gives rise to obligations in respect of all subject matter existing at the date of entry into force of this Agreement that is protected on that date in the territory of the Party where protection is claimed, or that meets or comes subsequently to meet the criteria for protection under this Chapter.

11. Except as otherwise provided in this Chapter, including Article ___ (Berne 18/TRIPS 14.6), a Party shall not be required to restore protection to subject matter that on the date of entry into force of this Agreement has fallen into the public domain in its territory.

12. This Chapter does not give rise to obligations in respect of acts that occurred before the date of entry into force of this Agreement.

13. Further to Article ___ (Publication), and with the object of making the protection and enforcement of intellectual property rights transparent, each Party shall ensure that all laws, regulations, and publicly available procedures concerning the protection or enforcement of intellectual property rights are in writing and are published,*3* or where publication is not practicable, made publicly available, in a national language in such a manner as to enable governments and right holders to become acquainted with them. . . .

Finally, I’ll note that Democratic 2016 front-runner Hillary Clinton said on the campaign trail recently that she feels big pharma should have to give more — on pricing negotiations here in the US, with Medicare and Medicaid — in order to win these global protections, from price erosion (due to lax IP enforcement).

That will make the debate very interesting, if the back and forth on this TPP measure bleeds into 2016 — as many smart observers now predict it will. As the New York Times noted, it also puts Mr. Obama in a tough spot — because he is sure to push for passage, as is — not with more give-backs by branded pharma. And yet he will want to buttress Mrs. Clinton’s base — and her base (a la Elizabeth Warren) will want to see big pharma have to negotiate on price with the government payers here.

So. . . pop the popcorn — it will be good theater!

O/T Space Science: Rosetta/Philae Planning — And Activities — Accelerate, At ESA

June 16, 2015 - Leave a Response

At the outset, lest anyone be confused: Merck once had a subsidiary (long since divested — but originally acquired, circa 2001) called Rosetta, a company that worked in genomics; but this narrative bears no relation to that.

No, this is about “the little comet lander that could.” Or, if you prefer, “the boy of the three year nap.” Okay — Philae was out only six months, but you get the gist of it. Philae is transmitting periodically, and charging at least 135 minutes per 12 hour cycle, on comet. So we should start to see more data arrive, and soon. The graphic at right depicts where, it is thought, Philae now rests — in the shadows, upper right. We soon should have tighter data on that as well. Here is the latest from ESA — and a bit — do go read it all:

. . . .A second, smaller burst of lander data was received on Sunday, 14 June, at about 21:26 GMT, lasting just a few seconds. These data were confirmed to give the current status, showing the lander’s internal temperature had already risen to –5ºC. . . .

The telemetry downloaded [from Philae] covered the lander’s status for a full night–day cycle of the comet, which is helping ground teams to understand how the Sun is shining on the lander. The solar panels appear to be receiving power for over 135 minutes in each illumination period. . . .

The new orbit will be flown by Rosetta starting after 23:25 GMT on 16 June until 19 June, aiming to enable more and longer contacts with Philae, especially towards the end of this period. . . .

We are grinning ear to ear, here. He’s a cool little buddie!

We Were Told Whitehouse Station Was “Under Contract” — Was Google One That Passed, On The Site?

June 16, 2015 - Leave a Response

There are local stories this morning in New Jersey suggesting that the Mayor of Readington has said publicly that Google looked into occupying/buying some or all of Merck’s former Global HQ, at Whitehouse Station earlier this year. Recall that in early May 2015, we were told the property was “under contract.”

Even if that is so, there is still not firm indication as to whether a for profit entity will turn out to be the contracted for buyer of the facility. And that is very important to the local tax base — think about preserving adequate levels of tax funding for local schools, snowplows, trash collection and public park spaces, here. And so, we will keep a weather eye on this one — but I for one will be surprised if Google turns up as the ultimate buyer.

The geography doesn’t really fit the needed, or available workforce profile, in my opinion. From NewJerseyHills.com’s Hunterdon Review, then:

. . . .Mayor suggests Google “looked at” site. . . .

Onward.

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