Merck Goes Outside — To Covington — For Newest General Counsel…

March 21, 2018 - Leave a Response

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.



[U, X2] So… (echoing 1964) black and brown families, relatively anonymous all — are being bombed in Austin.

March 20, 2018 - Leave a Response

UPDATED: March 21, 2018 @ Dawn: 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 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:


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

March 18, 2018 - Leave a Response

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!


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

March 17, 2018 - Leave a Response

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. . . .


So… Nearly TWO Years Too Late — But Whatever…

March 15, 2018 - Leave a Response

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!


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

March 14, 2018 - Leave a Response

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.

March 14, 2018 - Leave a Response

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…

March 14, 2018 - Leave a Response

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. . . .


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

March 13, 2018 - Leave a Response

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.

March 13, 2018 - 2 Responses

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 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!