One More Merck Federal MDL Winding Down: NuvaRing® Remand Suggestion — From The Able USDC Judge Rodney W. Sippel, In Missouri

September 22, 2017 - Leave a Response

Except for a few opt-out cases, it would seem likely that the legacy Organon/Schering-Plough (i.e. inherited by Merck, almost a decade ago — thanks, Fred!) NuvaRing® birth control injury federal putative class action is about to be dissolved, and the remaining individual cases returned to the districts from which they arose. This would spell the effective end of this blog’s ability to timely monitor the matter — and as a practical matter, leaving only quarterly periodic updates in Kenilworth’s SEC filings, as a means of learning more about the litigation generally.

This litigation was lengthy, massive and involved some rather astonishing efforts — on all sides — to arrive at the $100 million settlement (an excellent compromise given that Merck never lost a bellwether trial in this MDL). Here is the entire order, an 11 page PDF file — and a bit:

. . . .In total, 3,825 plaintiffs and claimants enrolled in the national settlement program and dismissed and released their claims related to NuvaRing. . . .

Certain plaintiffs chose to opt out of the national settlement program to pursue litigation of their claims. Additionally, some new plaintiffs filed cases alleging injuries related to NuvaRing after the last date of the enrollment period under the Master Settlement Agreement. These cases have been transferred to, and are currently pending in, MDL 1964. Currently, there are 76 cases pending in, or expected to be transferred to, MDL 1964. . . .

During the pendency of MDL 1964, this Court presided over 76 in-person and telephonic Case Management Conferences, which were attended by lead counsel for defendants and by lead counsel for plaintiffs, which included members of the Plaintiffs’ Steering Committee, as well as by other plaintiffs’ counsel. This Court issued approximately 30 orders on case management, covering a variety of topics including the organization of plaintiffs’ counsel, plaintiffs’ common benefit fund, pleadings and challenges thereto, removal and remand, plaintiffs’ initial discovery obligations, defendants’ initial discovery obligations, electronic discovery, general and case specific discovery, mediation and settlement, and postsettlement orders for preservation of records and production of discovery information. . . .

More than 2.4 million pages of documents were produced by defendants in discovery and made available to all plaintiffs, including documents related to the research and development, FDA regulatory approval and oversight, sales and marketing, pharmacovigilance reporting, and scientific studies of NuvaRing.

Plaintiffs took 25 depositions of defendants’ company witnesses, many of them in the Netherlands, on the above topics related to NuvaRing. Approximately 87 depositions of plaintiffs, prescribing physicians, and other fact witnesses were conducted in selected cases in MDL 1964. Additionally, the parties conducted discovery of defendants’ and plaintiffs’ general experts and of some case specific experts. Following the national settlement program, the Court ordered the supplementation and completion of general fact discovery, which included the supplemental production of defendants’ regulatory documents and additional company witness depositions related to the label update for NuvaRing approved by the FDA in October 2013. . . .

The claims of individual plaintiffs were selected for bellwether trials in both this MDL case and in the coordinated NuvaRing® mass tort litigation proceeding in the New Jersey Superior Court, Bergen County. Defendants filed motions for summary judgment and motions to exclude plaintiffs’ experts in those cases. Defendants’ motions for summary judgment were granted in the following New Jersey cases: Bozicev v. Organon, BER-L-2869-09; Mariconda v. Organon, BERL-2692-09; Barrow v. Organon, BER-L-2707-09; Fields v. Organon, BER-L-2793-09; Wilson-Johnson v. Organon, BER-L-597-10; Namack v. Organon, BER-L-2831-09; Ziwange v. Organon, BER-L-2829-09; Millian v. Organon, BER-L-2848-09; and Marino v. Organon, BER-L-3081-09. . . .

In addition, Defendants’ motion for summary judgment in Prather v. Organon, 4:08 CV 558 RWS was granted in part and denied in part. Defendants’ unopposed motion for summary judgment on statute of limitations grounds was granted in James v. Organon, 4:09 CV 216 RWS. . . .

Now the MDL awaits a concurrence from a supervising panel of judges; but the newsworthy portions of this matter have concluded. We are not likely to mention it again.

[This post was auto-generated, by an experimental algorithm, invented by the Condor. It was not reviewed for content or context by any human. If it is in error, it will be corrected, rewritten or retracted in due course. Copy-left 2017.] It’s been a wild ride. Travel light.

नमस्ते

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With Several Natural Disasters Swirling… And Repeal Lunacy Rising (Anew)… We Are Sorely In Need Of Some Good News Here.

September 21, 2017 - Leave a Response

I may be scarce here for a while. Just too much going on in “real life” (though this too, is real, in every sense of that word). I do want to offer an uplifting, “real life” story of STEM, on fleek, as I depart. . . .

Do see the below — and just a bit of our prior reporting, on the STEM topic, generally.

The event will air live on NASA Television and the agency’s website.

. . . .U.S. Sen. Mark Warner, Virginia Governor Terry McAuliffe, and author Margot Lee Shetterly are among the dignitaries honoring Katherine Johnson, former NASA employee and central character of the book and movie Hidden Figures, at 1 p.m. Sept. 22 at NASA’s Langley Research Center in Hampton, Virginia.

They will join Hampton Mayor Donnie Tuck and Langley Center Director David Bowles in cutting the ribbon to officially open the center’s new Katherine G. Johnson Computational Research Facility, a state-of-the-art lab for innovative research and development supporting NASA’s exploration missions. . . .

The Katherine G. Johnson Computational Research Facility (CRF) is a $23-million, 37,000-square-foot, energy efficient structure that consolidates five Langley data centers and more than 30 server rooms. The facility will enhance NASA’s efforts in modeling and simulation, big data, and analysis. Much of the work now done by wind tunnels eventually will be performed by computers like those at the CRF. . . .

Until next time ’round, then — do travel well — but do travel light, Joe. . .

नमस्ते

If You Care About The Rule Of Law… And Preserving A Constitutional Democracy

September 19, 2017 - Leave a Response

. . .please do read the New York and Washington, DC papers of record — today and tomorrow. Especially the front pages of each lady.

This is a (third party’s) nice summary of where we are, in the “shock and awe” criminal investigation of 45 and his campaign:

. . . .[Overnight] the New York Times reported that Mueller told Trump’s former campaign chairman Paul Manafort he was going to be formally charged with a crime following a raid on his Virginia home over the summer.

Mueller has also issued subpoenas to Manafort’s spokesman Jason Maloni and former attorney Melissa Laurenza to testify before a federal grand jury.

The developments indicate that Mueller’s probe “is nearing the litigation stage,” said Brookings Institution fellows and legal experts Benjamin Wittes and Susan Hennessey.

“Combined with a flurry of stories about subpoenas, grand-jury appearances and other activity, it’s reasonable to expect that Mueller is moving forward on a number of different fronts and is getting close to entering a litigation phase,” wrote Wittes and Hennessey, a former attorney for the National Security Agency.

“The key question is what he will allege, to what extent it will deal with campaign activity, and against whom he will allege it,” they added. . . .

Go get ’em, Bobby Three Sticks. Too busy to say much more — as I dash for the door — on this soggy but hope filled morning. . . maybe more, tomorrow. Be well, all.

नमस्ते

How Soon… To Arrival Of Muslim Ban 3.0?

September 17, 2017 - Leave a Response

Ahem. It is finally time to say aloud what we’ve all been whispering about for months now: it may well may be that the travel cases on Muslim Ban 2.0 are dropped from the Supremes’ docket after next weekend, entirely.

Several blog-authors (myself included) have tacitly avoided mention of the below topic — not wanting to give 45 any useful trail-maps on possible paths through the woods he’s made for himself.

Today his administration indicated that a new travel ban order is actively being vetted. I say bring it on. What, at bottom, he wants to do. . . cannot lawfully be done by his office acting alone. And as of next Saturday, his current ban expires by its own terms. The Supremes won’t decide a moot case, under a couple centuries‘ worth of black letter precedent. So, without an identically-worded Muslim Ban 3.0, one with a later sunset date, the final outcome will be that Trump lost 13 of 13 cases in which his travel ban was litigated, on the merits.

So, I’d expect an identical Muslim Ban this week, one we will call 3.0. And to be clear, if it is not in every respect (save only expiry date) identical to the last one, applicable precedent will mean that Mr. Trump will have to start re-litigating 3.0 all over again, at the bottom — defending it in trial courts around the nation, where it too will lose. And so, he won’t reach the Supremes again until perhaps election day in 2018. Poetic justice, that.

We will bring it — with plaintiffs named in original federal constitutional litigation — all as newly filed complaints, in the USDC of Hawaii, Brooklyn and in DC — as well as now-likely challenges in San Jose and Chicago. Bank on that. In sum, we will resist. Resist. Resist. Onward.

नमस्ते

Trump Loses Again — This Time In Chicago — Just As We Said He Would, Back In August…

September 15, 2017 - Leave a Response

Just as we said it would transpire, back in the first week of August, my fair City has brought the small-handed tyrant to heel — once again. [Muslim Ban 1.0 and 2.0 epic failures being earlier examples.] And it really took very little time — at all. 45’s latest attempt to punish sanctuary cities has now been enjoined, nation-wide.

Since the early 1980s, the City of Big Shoulders has kept in effect one form or another of a “welcoming ordinance“. That law “reflects the City’s belief that the ‘cooperation of the City’s immigrant communities is essential to prevent and solve crimes and maintain public order, safety and security in the entire City’ and that the ‘assistance from a person, whether documented or not, who is a victim of, or a witness to, a crime is important to promoting the safety of all its residents‘. . . .” In other words, we won’t demonize someone simply because that person might arguably lack papers.

Against that specifically humane local law’s backdrop, a very able federal District Court judge in Chicago has ruled today that Mr. Trump’s attempt to add conditions to a statutory grant, where Congress specifically withheld the right of the President to add such conditions. . . cannot pass muster, and so my City is entitled to a preliminary injunction, stopping Mr. Trump and Mr. Sessions from trying to enforce this extra-legislative attempt at law-making. Here is the finely-reasoned 41 pager — and a bit:

. . . .The Attorney General’s reading of the statute therefore ignores the ostensibly clear decision by Congress to withhold comparable authority in the Byrne JAG provisions. See, N.L.R.B. v. SW General, Inc., 137 S.Ct. 929, 940 (2017) (noting the expressio unius canon’s application when “circumstances support a sensible inference that the term left out must have been meant to be excluded”) (quotations and alterations omitted). Regardless, it would be quite odd for Congress to give the Attorney General authority to impose conditions on the discretionary grants if it had already provided the Attorney General authority to impose conditions on all grants through Section 10102(a)(6). . . .

On this issue, Mr. Trump is so plainly out of bounds I’ll likely not spend a lot of time covering subsequent wins — should 45 attempt to press forward with this nonsense. If I do, it will be strictly for grins.

So you may henceforth safely assume that Mr. Trump’s hare-brained Chicago-aimed scheme (like so many others) has died a simple death, if I do not mention it again. Onward, and goodnight — wonderful Indian Summer weekend ahead here!

नमस्ते

No Graphic — But A New Low From 1600 Penn: 45, Insulting Our Ally, During A Terror Strike.

September 15, 2017 - Leave a Response

When (in an inevitably understated way) multiple British officials characterize the response of the President of the United States — to a terror attack inside London’s Tubes, early this morning our time, as “unhelpful” — we should all take pause. This is without a doubt our closest ally telling us our leader is. . . manifestly unfit, in a crisis. Any crisis.

That’s all I need say about that.

नमस्ते

[U] “A Gazing Out, From Far Away… Alone.” An Irish Poet’s Prescient Verses…

September 14, 2017 - Leave a Response

Believing that less is more — at a time like this (a handful of hours from now) — we will lay rest to longer strokes on our keyboard, and just sit a moment under the dawn’s canopy of stars. And we will look with awe, toward the spot above Saturn — where Cassini will soon. . . flamed out.

In fact, we will still be receiving transmissions, for 83 minutes after she’s gone. It will take that long for the last of the radio waves to reach us here at the dish, in Australia, after she’s sprinted into shattered bits, giving her last full measure of devotion, to advancing science. So thank you, sweet Cassini — oh you, gossamer thing of unwasted grace.

. . . .And after the co- mmanded journey, what?

Nothing magnificent, nothing unknown.

A gazing out from far away, alone.

And it is not particular at all,

Just old truth dawning: there is no next-time-round. . . .

Seamus Heaney, that giant of Irish poems may just as well have been speaking of. . . the swift, lithe, copper-hued Cassini, lo’ these 13 years, a shepherded moon-lette, of sorts. [Though cousin Seamus is in need of a smallish revision (as it pertains to Cassini, at least): far from “nothing left unknown” — yes, so much still to discover — to explore; to probe; to taste and see. Smile.]

Enjoy your return to primordial star stuff, now Cassini — as you are heated, and then incinerated down into simpler bits — primarily atoms of carbon, hydrogen, and oxygen once more — under the crushing atmospheric pressures and friction, of mighty Lord Saturn.

We do thank you for opening our eyes — to a wide array of new planetary science wonders, over this last decade.

नमस्ते

Back To The “Power Alley” Of This Blog: FDA & “Preemption”, After Wyeth; Merck’s Latest Fosamax® Appeals

September 14, 2017 - One Response

We have covered — on and off — nearly the entire preemption FDA waterfront, starting now almost a decade ago — all of which led to the Supremes’ decision in Wyeth v. Levine. And we have covered a recent interim win, for Merck’s opponents — the Fosamax® plaintiffs — in the federal appellate courts sitting over New Jersey — here. That is the Third Circuit.

[Thoughts from a decidedly pro-industry, but very able, blogger may be found here. My backgrounders, by way of slight but substantial contrast, from June 2016, here, and a prior April 2014 one, is here. This matter — as much as any other — has also been the subject of at least $100 million of lobbyist efforts, industry wide, over the last decade or so. So it is a cause of particular moment — as preemption all but closes the court house doors on many, many would be drug products liability class action suits. The most recent Merck prior Third Circuit opinion, in full, is under that link.]

And so we arrive at a moment where the Supremes are being asked to weigh in — again. Here’s a bit, from the current Merck cert. petition before the Supremes, now — a bit:

. . . .Wyeth v. Levine, 555 U.S. 555 (2009), rejected an argument that the FDA’s mere approval of a drug’s label immunizes the manufacturer from any state tort liability for failure to warn. Rather, only if the FDA would have rejected a warning should the manufacturer be shielded from liability for failure to give it. In the latter scenario, it would truly be impossible to comply with both federal law (blocking the warning) and state law (mandating the warning). In Levine, however, there was no evidence that the FDA had paid more than “passing attention” to the risk at issue; no evidence that the drug manufacturer had provided the FDA with “evaluation or analysis” of the risk; no evidence that the manufacturer had “attempted to give the kind of warning” demanded by the plaintiff; and no evidence that the FDA had ever “made an affirmative decision” against allowing such a warning. Id. at 572-73.

In this case, by contrast, each of those factors is undisputed. Petitioner (“Merck”) submitted data and analysis to the FDA suggesting that its Fosamax drug may be associated with certain bone fractures. Merck also proposed a warning addressing that risk. After back-and-forth, the FDA ultimately rejected the proposed addition, stating that it was not supported by the data. Pet.App.59a-61a. Despite all of this, the Third Circuit held that respondents’ failure-to-warn claims were not legally preempted, because it believed that a jury could infer that the FDA’s objection had been only to Merck’s wording, and thus, as a “hypothetical” matter, that the agency might have approved the warning had it merely been phrased slightly differently. . . .

Unfortunately, the decision below is not unique in its hostility to preemption. Despite Levine’s recognition that preemption would be appropriate if the FDA would have rejected the label demanded by the plaintiff, courts have erected a series of procedural and substantive hurdles to this defense, making it virtually impossible to establish, certainly as a matter of law. This case presents a particularly extreme illustration, with the court inventing a “clear and convincing evidence” standard exclusively for drug manufacturers, demanding “smoking gun” proof of why the FDA had rejected Merck’s on-point warning, and leaving a lay jury to speculate about the intent of a federal regulatory authority. This Court should grant certiorari to revive failure-to-warn branded drug preemption in the wake of the lower courts’ interpretation of Levine. . . .

I certainly think additional clarity would be helpful — and it is clear that Merck’s fact pattern — in these New Jersey MDL Fosamax® cases — offers industry a very strong probability of expanding the limits on class action suits announced by the Supremes in Wyeth. So do stay tuned. With Justice Gorsuch firmly in his seat, and taking an activist’s “pro-business interests” role — I suspect the high court will take this case. . . and I additionally suspect the outcome will not be very good for would-be plaintiffs. It ought to be pretty good for Kenilworth though. Now you know — both five years, and a full decade on. . . . Onward.

नमस्ते

Sentencing Date: January 16, 2018 — And, That’s A Wrap — On Martin Shkreli.

September 14, 2017 - Leave a Response

Well, now that we know his sentencing date — I will let this incarcerated felony convict’s weed-strewn field lie fallow for a bit (as yesterday has a three year echo to it, for me, personally).

As we turn away from the sad farce that is Mr. Shkreli (now known as Inmate No. 87850-053 — at least until 2 PM EST on January 16, 2018), I found this Washington Post news analysis piece, from a little after midnight this morning — on the evening’s events — to be pretty cleverly put-together:

. . . .Martin Shkreli wanted to be an Internet supervillain. This time it cost him.

For Martin Shkreli, the acts of ridiculing and trolling weren’t just a solitary hobby. They were a performance for the benefit of his small army of online fans, who loved watching their favorite Internet supervillain get away with it. . . .

He became reviled for the very same behaviors his superfans cheer on: his cocksure displays of immaturity and indifference, and for exuding the impression that he was somehow, always, above reproach. . . .

In his defense, Shkreli’s legal team used a version of the same refrain he’s always used to explain his behavior online: that he wasn’t really serious. Essentially, he’s invoking Poe’s law, the old Internet rule that has to do with the impossibility of proving whether an extreme statement online is earnest or ironic unless you truly know the author’s intent. . . .

In recent years, a version of this rule has become the go-to defense for abusive or offensive online behavior: the claim that it was all just a joke, one that the victim is failing to appreciate. But in this case, [the very able USDC Judge Kiyo] Matsumoto wasn’t buying it. . . .

Shkreli has a habit of live-streaming to his fans after major events in his trial. A day after posting bail following his initial arrest in December 2015, Shkreli spent hours live-streaming, alone, in his apartment. At one point, showing a full view of his computer screen to his viewers, he began to browse the OkCupid dating site, streaming to hundreds of strangers the photos, profiles and messages he could see.

He did it again in August, after he was convicted. . . .

But to be clear, he is now in custody, awaiting a formal sentence, because — as a previously thrice convicted felon — he solicited the assault of someone for a $5,000 bounty, and never repudiated the offer of the bounty — literally on her head (or hair).

It really shouldn’t matter (as she’s just a private citizen now) — but that someone happens to have life-time Secret Service protection. So, it is hard to imagine a more flagrantly stupid and childish — but now likely final — crime. It was his burden to prove — by clear and convincing evidence — that he is no danger to society. He failed to do that, last evening.

And so, as Lauren Duca (an astute and capable journalist, and one of his earlier “crime spree” victims) tweeted, he’s found himself at “the intersection of karma and justice” — indeed.

Indeed. Be well, one and all. See ya’ next year, Shkreli — the Infinite willing.

[Subsequent note: this too is a worthwhile read.]

नमस्ते

Lest There Be Any Doubt — About Where Muslim Ban 2.0 Is Generally Headed…

September 13, 2017 - Leave a Response

As I earlier said they would, the fine lawyers at the pro bono legal clinic arm of the prestigious Yale Law School have just now (about 14 days later) made available the full unredacted settlement agreement — in the New York (Brooklyn) federal District courthouse. This is a trial court level agreed settlement. That’s significant. No appeal sought by, or available to, 45’s lawyers.

Do consider, as you read it, that the Trump Administration has by agreement surrendered a complete win here — to the people detained at JFK that night. Consider what that means: the government — just about a week and a half ago, agreed to eviscerate by settlement, the guts of Ban 2.0. That my freinds, is a more candid assessment of where 45’s lawyers actually think the Supremes are going to come out, on the bans. Here’s just a bit, from that agreement:

. . . .We wrote to you before because you have not entered the United States.

If you still want to travel to the United States, you may contact your nearest U.S. embassy or consulate. You may also contact non-governmental organizations and attorneys that might be able to assist you free of charge. (See attached.)

We wish to advise you that, should you wish to apply for a new visa, Executive Order 13,769 has been revoked and you are free to pursue a new visa application at any time. The previous revocation/cancellation of your visa pursuant to Executive Order 13,769 will not adversely affect a new visa application. . . .

Of course, we are precluded by U.S. law from guaranteeing that you will be found eligible for and issued a visa. We are additionally precluded from providing any guarantee that you will be granted admission at a port of entry should you be issued a visa. Nevertheless, we assure you that any application will be given proper consideration. . . .

Now you know. Onward — as we await word that one Martin Shkreli (the pocket-sized pharma bro-heem), thrice felony convicted — has been carted off to the Brooklyn Metropolitan Detention Center — in about three elapsed hours. This — as his bond is revoked. There he will stay, until his sentence is pronounced — that’s my prediction. Smile. What a great afternoon, indeed.

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