The Week in Health Law, Back to School Edition

If you want to learn about a fast-changing field, check out health law. It’s hard to keep track of all the recent developments in subfields of it (bioethics, insurance regulation, malpractice, EHRs and privacy, among others), let alone the field as a whole. Fortunately, there are many scholars and practitioners who are diligently working on all these issues. Nic Terry interviewed many of them for our “Back to School” podcast on health law.

Here are the contributors, with links to articles on the issues they discussed:
Micah Berman – PBS Unnatural Causes
Erin Fuse Brown – Physician Self-Referral Updates (STARK)
Glenn Cohen – Egg freezing and egg banking: empowerment and alienation in assisted reproduction
Brietta Clark – Pickup v. Brown
Nicole Huberfeld – Armstrong v Exceptional Child Center Inc. 
Elizabeth Weeks Leonard – King v. Burwell
Frank Pasquale – Narrow Networks
Ross Silverman – Should childhood vaccination against measles be a mandatory requirement for attending school? Yes
Norman G. Tabler, Jr.–  Can an Arbitrator Rule Against a Hospital for Not Violating the Anti-Kickback Statute?
Nicolas Terry – North Carolina State Board of Dental Examiners v. Federal Trade Commission

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter: @nicolasterry and @HealthPI (for my health tweets) or @FrankPasquale (for law & tech, surveillance, algorithms & political economy). @WeekInHealthLaw is the show feed.

 

2

Early Voting and a Uniform Election Date

I’ve got a question for folks who are knowledgeable about election law. During the early nineteenth century, states held elections for the House of Representatives and for Presidency on different dates.  The results would slowly trickle in over a few months.  Eventually, Congress concluded that this was not a good system and established a uniform national election day for federal offices.

Why then is early voting in some states for these offices permissible? In effect, we no longer have a uniform national election day.  I can think of a few ways of reconciling this (after reading the statutes):

1.  The “election” means the last day that votes can be cast.  You cannot have late voting, but you can have early voting.  Maybe, but does that mean that a state can set early voting to begin at any time after the nominees are known?  Say, a day after the primary? And did Congress really have early voting in mind when they created a uniform election day?

2.  The “election” means the day that the votes are counted.  We want all of the results announced on the same day (if possible), and that is what the statutes require.  Maybe, but I would think that the ordinary meaning of an election involving casting and counting, not just counting.

3.  There have always been exceptions to a uniform election day (namely, absentee voting).  Thus, the federal statutes do not require all votes to be cast on the same day.  True enough, but how far can you take this logic?

UPDATE:  The Fifth Circuit addressed this issue in Voting Integrity Project, Inc. v. Bomer, 199 F.3d 773 (5th Cir. 2000).  Basically, the Court went with a combination of all three reasons listed above.  The only limit to early voting that a state may not conclude the election prior to Election Day.

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15

FAN 72 (First Amendment News) Megyn Kelly — Bold Defender of Free Speech Freedoms

In America we stand for liberty, and freedom to offend, to provoke, to persuade, and to defy. — Megyn Kelly

Megyn Kelly

Megyn Kelly

Though she is a news anchor, she is very much in the news these days. She is the object of a national discussion about women. And it all stemmed from a pointed, polite, and entirely appropriate  question she posed to the most outspoken candidate currently seeking to be President of the United States.

She is, of course, Fox’s Megyn Kelly, the one who has a TV following of 2.8 million followers. Before entering the world of journalism, Ms. Kelly held her able own at the Jones Day law firm.

Her calling card: Feisty, informed, incredulous, and quick-witted. Make of her what you will — too conservative, too blond, or maybe too tough on the likes of Karl RoveDick Cheney and Donald Trump. As for the Trump flap, Ms. Kelly stood her free-press ground: ““I certainly will not apologize for doing good journalism, so I’ll continue doing my job without fear or favor,” she told viewers of The Kelly File. By the same journalistic measure, recall Ms. Kelly’s skepticism, which proved to be founded, concerning Duke University’s alleged sexual assault incident.

However you cast her, there is also this: Megyn Kelly is bullish on the First Amendment. While we still need to hear more from her on any variety of free-speech issues, what we do know at this point is that she is a woman who yields no ground when it come to our First Freedom.

[N]o matter how abhorrent one might find another’s words, in this country, we defend their right to say them. Standing up for that principle is not an endorsement of the controversial speech. It is promoting a value at the very core of who we are.  Megyn Kelly

There’s a spark of Nat Hentoff in her steadfast commitment to free speech. Just consider her response to a claim made by TV critic Howard Kurtz: “There’s a reason free speech is in Amendment number one. It goes to the core of our principles as Americans and what we stand for. You can hate the message, you can hate everything they’re saying … that is allowed in the United States of America, because, as the Supreme Court once put it, the answer to speech you do not like is not less speech. It’s more speech,”

Mr. Kelly & Mr. O'Reilly

Ms. Kelly & Mr. O’Reilly

When it comes to free speech, the TV news anchor and commentator is willing to go toe-to-toe with  anyone, even if that someone is Bill O’Reilly: “The relevnt question is not [whether] those under attack say something offensive, the relevnt question is what we do about a group that wants to kill us for exercising our contitutional rights.” (See also here)

Before the recent Trump flap, she gave the blustery billionaire a civics lesson: “What do we stand for as Americans if not freedom of speech and the ability to express yourself?”

Not surprisingly, some in the First Amendment community are taking note of Ms. Kelly and her views on free speech.

Alan Dershowitz: “Megyn Kelly has demonstrated how the First Amendment can be used to expose the real views of candidates. She provokes, and she succeeds. Keep it up.” (see also here)

Nadine Strossen: “As a law professor, I join Prof. Alan Dershowitz in awarding Megyn Kelly an A for her solid understanding of core First Amendment principles that Justices across the ideological spectrum have consistently upheld.  As a civil libertarian, I award her an A+ for her fearless, impassioned, and eloquent defense of those principles when too many others – also across the ideological spectrum – seek to trim back our First Amendment rights in response to what the Supreme Court has called “the heckler’s veto,” but what Megyn has correctly referred to as “the assassin’s veto.”

Robert Corn-Revere: “Megyn Kelly provides a clear and consistent reminder that the right to free expression includes the right to offend, and, in fact, that right cannot exist when some assert a right not to be offended.  Ms. Kelly recognizes that the role of some people in the marketplace of ideas may be mainly to serve as bad examples – but that is the only way the system can work effectively.  Everyone should have their say, and people will choose what ideas to accept or to reject.”

“Kelly speaks in a jazz-improv progression of italics, all-caps and boldface.” That is how Jim Rutenberg portrayed her in a recent and lengthy New York Times magazine profile titled “The Megyn Kelly Moment.” There is truth there provided one adds the word informed.

Ms. Kelly & Richard Fowler

Ms. Kelly & Richard Fowler

When it comes to free speech, her passion tracks her informed grasp of her subject. Simply consider her exchange with Richard Fowler when they were discussing the “Draw Muhammad” cartoon contest: “The more offensive speech is, Richard, the more protection it needs. That’s how the First Amendment works. We can defend the First Amendment right to say it without aligning ourselves with the message.” She took exception, strong exception, to notion that Americans should be squeamish or apologetic about their exercise of their First Amendment rights. She took even strainer exception to those who counseled otherwise.

In much the same vein, she took the Catholic League’s President, Bill Donohue, to task over his criticism of the Charlie Hebdo cartoonists. With finger pointed and eyes scanning, she quoted approvingly from Chief Justice William Rehnquist’s 1988 majority opinion in Hustler Magazine v. Falwell: “[T]he freedom to speak one’s mind is not only an aspect of individual liberty – and thus a good unto itself – but also is essential to the common quest for truth and the vitality of society as a whole.” [quoting Bose Corp. v. Consumers Union of United States, Inc. (1984)]

Ms. Kelly & Professor Eugene Volokh

Ms. Kelly & Professor Eugene Volokh

In a May 7, 2015 program, Kelly found a First Amendment ally in UCLA Law Professor Eugene Volokh. At the outset of that program she was emphatic: “The terrorist point was to shut us up, not just the organizers of the [Draw Muhammed Cartoon Contest] but also any American who danes to disagree with their  way of life or thinking. . . . In this country we have every right to say what we want to say about Muhammed or about anyone else for that matter.” Volokh agreed: “People are free to engage in much more offensive speech than that.” He went on to explain how the contours of modern free speech law were consistent with Ms. Kelly’s views and how such speech had value as “a reaffirmation of our free speech rights . . . “

Will her commitment continue? Will she vacillate when other tough First Amendment issues are presented to her? Who knows?  That said, it seems likely that Ms. Kelly will become an even grander figure in the world of free speech in the days and months ahead.

 See here for a listing of Ms. Kelly’s various comments concerning the First Amendment.

Opinion in Amarin Pharma, Inc. v. U.S. Food & Drug Adminstration Read More

1

Griswold and Abortion

This part of the oral argument speaks for itself:

Justice Black: Would your argument with reference to all these things you’ve been talking about relating to privacy and so forth, would invalidate all laws that punish people for bringing about abortions?

Mr. Emerson: No, I think it would not cover the abortion laws or the sterilization laws, Your Honor.

Those – that conduct does not occur in the privacy of the home.

Justice Black: There is some privacy, as a rule, and the individual doesn’t usually want it made known, it’s a very private thing.

Mr. Emerson: Well, that aspect of it is true, Your Honor, but those are offenses which do not involve the type of enforcement apparatus as to what goes on in the home that this —

Justice Black: Part of it goes on in the home, undoubtedly?

Mr. Emerson: Part of it does, Your Honor, but the conduct that is being prohibited in the abortion cases takes place outside of the home, normally.

There is no violation of the sanctity of the home.

Justice Brennan: Well, apart from that, Mr. Emerson, I take it abortion involves killing the life of a being, doesn’t it?

Isn’t that a rather different problem from contraception?

Mr. Emerson: Oh, yes, of course.

Justice Brennan: And isn’t it different in the sense of the State’s power to deal with it?

Mr. Emerson: Oh, yes.

Of course, the substantive offense is quite different here.

Justice Black: Are you saying that all abortions involve killing or murder?

Mr. Emerson: Well I don’t know whether you need characterize it that way, but it involves taking what has begun to be a life.

Justice Black: But the State thinks each of them is wrong, and it passes a law to forbid it being done.

It relates to a pretty closely analogous situation [Inaudible]

Mr. Emerson: Yes, Your Honor, but that case is different from this situation because in the abortion cases Connecticut does not apply this moral principle.

It is the use of an instrument to prevent birth taking place, but they do not apply the moral principle that it can never be done.

In Connecticut, abortion is allowed where it is necessary to save the life of the mother or the child.

So that the basic moral principle that Connecticut is trying to enforce here, they simply pay no attention to in their abortion laws.

It’s a completely inconsistent application of the principle.

They don’t take it seriously in the abortion cases, only in contraception cases.

1

Lochner What Now?

I hesitate to post about Lochner v. New York, as David Bernstein over on Volokh is the expert on the case.  But I was listening to oral argument in Griswold v. Connecticut today, and I came across this interesting exchange.

Thomas Emerson, arguing on behalf of Griswold, told that Court that he was not asking the Justices to revive Lochner.  Justice Hugo Black responded that “it sounds to me like you’re asking us to follow the constitutional philosophy of that case.”  Black then said:

“That was the one that held that it was unconstitutional, as I recall it, for a state to regulate the size of loaves of bread . . . . because people were being defrauded, was that it?”

Well, not exactly.  Lochner was about the regulation of maximum hours for bakers.  Maybe Justice Black was just old and forgetful at this point, but to me this is further evidence that Lochner was just not that well known in 1965.

Berlusconi-fication: Cutting Out the Middle Man

2630085549_eebd0ce895_oRecently Rick Perlstein described American elections as a “plutocrat’s right to choose.” Such concerns have also been raised by conservative media. A political economy premised on the trading of money for power, and power for money, gives rise to an oligarchic constitutional order. Political science responds with “investor theories” of politics, where the key players are not the voters, but the donors. Politicians become vessels for their agendas.

As Jeffrey Winters observes, many types of oligarchies can develop. Americans might be interested in learning more about what might be deemed a “direct” oligarchy, where one-time donors forego buying the favor of leaders, and simply run for office themselves. Some very wealthy candidates of the right and left have fit this bill, and done passably as leaders. But the independence afforded by great wealth can also lead to flamboyantly erratic behavior, particularly among men long unaccustomed to accounting for their actions to others. Consider, for instance, the billionaire Silvio Berlusconi, a long-time Italian leader:

Perhaps the most famous example of Berlusconian rule-bending—and the one with the most popular results—was his takeover of Italian TV. Television was introduced to Italy, in 1954, through a single channel, RAI, administered by the ruling Christian Democratic Party; the highlight of its programming was the Pope’s Sunday-morning Mass, which is still on the air. For decades, the government controlled television: in the seventies, political parties were allotted news coverage in exact proportion to their votes in parliament. Then, in 1976, the Italian Supreme Court ruled that private broadcasting could be allowed on a local level. Berlusconi, who had made a fortune building suburban housing developments, began buying up local stations and broadcasting the same content on all of them. In order to comply with the letter of the court’s ruling, he staggered the broadcasts by a few seconds on each network.

Technically, these were local broadcasts; effectively, as Berlusconi made clear to advertisers, he had a national market, which he glutted with American programs like “Dallas,” “Dynasty,” and “Falcon Crest”—stories of sex and money…Berlusconi…believed that appetites existed to be stoked and sated, and he imported both American entertainment and the advertising environment that supported it. “I’m in favor of everything American before even knowing what it is,” he once told the Times.

Despite a long record of self-dealing, scandal, and outrageous statements, Berlusconi spent 9 years as Prime Minister. He had great appeal as a rascally anti-hero, exulting in a mix of la dolce vita and la vida loca. Thank goodness America, a mature democracy, could never fall for such a dubious mix of wealth and celebrity.

Photo Credit: CluPix.

3

The Bill of Rights in World War Two

18339_150pxI came across a speech that Fiorello LaGuardia, the famed Mayor of New York, gave on Bill of Rights Day in 1941. I thought his analysis was interesting, especially with respect to the Second Amendment:

“Could Hitler, the Mikado [Emperor Hirohito], or Mussolini remain in power if their people had freedom of speech?  Of course not. Could their governments retain power if they had a provision as to the right to bear arms?  Could they last at all if their people were free to assemble and discuss public issues?  Could they maintain concentration camps and continue a policy of persecution if they had a proviso for indictment and trial by jury.  Not at all. Could they for a moment have freedom of religion when the Mikado and Hitler are deluded into believing that they are the Ersatz for the Almighty”

 

4

Richard Nixon’s Oral Argument

203px-Richard_M._Nixon,_ca._1935_-_1982_-_NARA_-_530679The Oyez Project, run out of the Chicago-Kent Law School, is a terrific resource for Supreme Court scholars.  They have put online the audio of every oral argument going back to 1955, when the Court starting taping its arguments.  I’ve been listening to some old ones (mostly out of curiosity), and one that is weirdly compelling is Time, Inc. v. Hill, a 1967 false light case that is still used in casebooks.

Hill was Richard Nixon’s only oral argument before the Court, and he ended up losing (5-4).  I say “weirdly compelling” because it’s just fun to hear Nixon talking like an appellate advocate, going back-and-forth with Hugo Black, and so on.  Check it out if you can. Nixon starts at around the 51:00 minute mark (arguments were longer back then).

0

FAN 71.2 (First Amendment News) Floyd Abrams prevails in off-label drug case — Court grants preliminary injunction

[Today a] U.S. judge . . . barred the U.S. Food and Drug Administration from stopping Irish drugmaker Amarin Corp from promoting its fish oil drug for off-label uses, saying the company is protected by the First Amendment.The preliminary order by U.S. District Judge Paul Engelmayer in Manhattan means Amarin can promote its Vascepa pill to doctors for off-label use as long as it does so truthfully. Friday’s decision is a preliminary injunction, not a final order. However, Engelmayer said in granting the injunction that Amarin was likely to prevail. –Reuters, Aug. 7, 2015

Four days ago I wrote a post titled “Amarin v. FDA –Important Commercial Speech Case May be Decided Soon.”

Well, that case was decided today. In a detailed and nuanced 71-page opinion, U.S. District Judge Paul A. Engelmayer ruled in the Plaintiffs’ favor and granted a preliminary injunction. Floyd Abrams was the lead counsel for Amarin.

Recall the respective claims made by the parties:

→ Plaintiff’s Claim: “Amarin Pharma wants to provide healthcare professionals with truthful, non-misleading information about its prescription drug Vascepa®, and four doctors who want to receive that information, as they determine when and whether to prescribe that drug. If Amarin provides that information, however, it is at high risk of criminal and civil sanctions being sought against it by the United States.”

→ Government’s Claim: “Plaintiffs seek a court order that would allow Amarin to distribute its drug Vascepa under circumstances which could establish that Amarin intends an unapproved new use for Vascepa, i.e., a use for which FDA has not determined that the drug is safe and effective. But Plaintiffs’ legal arguments strike at the very heart of the new drug approval process, and a court decision in Plaintiffs’ favor has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses.”

→ District Court Holding

The Court has held that Amarin’s proposed communications, as modified herein, are presently truthful and non-misleading. But the dynamic nature of science and medicine is that knowledge is ever-advancing. A statement that is fair and balanced today may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired. The Court’s approval today of these communications is based on the present record. Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.

→ District Court’s order:

The Court grants Amarin’s application for preliminary relief. Specifically, the Court declares that:

(1.)  Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persistently high triglycerides, and under Coronia, such speech may not form the basis of a prosecution for misbranding; and

(2) Based on the information presently known, the combination of statements and disclosures that Amarin proposes to make to doctors relating to the use of Vascepa to treat persons with persistently high triglycerides, as such communications have been modified herein,* is truthful and non-misleading.

See alsoCourt Approves Amarin (AMRN) to Tell Doctors About Off-Label Vascepa Usage,” StreetInsider.com, Aug. 7, 2015 (listing approved statements).

0

FAN 71.1 (First Amendment News) 4th Circuit Strikes Down Anti-Robocall Statute

Earlier today a three-judge panel of the Court of Appeals for the Fourth Circuit struck down South Carolina’s anti-robocall statute (S.C. Code Ann. § 16-17-446 (2014)). The unanimous opinion was written by Circuit Court Albert Diaz and joined in by Circuit Judges James A. Wynn, Jr. and Stephanie Thacker.

The case is Cahaly v. Larosa (4th Cir., Aug. 6, 2015) (Case #: 14-1651).

Here is the robocall message:

As you may have heard, Speaker of the House Nancy Pelosi is coming to South Carolina.

Do you think incumbent Democrat Anne Peterson Hutto should invite her fellow Democrat Nancy Pelosi to come campaign for her?

Press 1 if you think incumbent Democrat Anne Peterson Hutto should invite her fellow Democrat Nancy Pelosi to come and campaign for her.

Press 2 if you think incumbent Democrat Anne Peterson Hutto should not invite her fellow Democrat Nancy Pelosi to come and campaign for her.

Here is how Judge Diaz’s opinion begins:

Robert C. Cahaly, a self-described Republican political consultant, was arrested for alleged violations of South Carolina’s anti-robocall statute. After the charges were dismissed, Cahaly filed suit, challenging the statute on three First Amendment grounds: as an unlawful regulation of speech, as impermissibly compelling speech, and as unconstitutionally vague. Cahaly also sought damages from the law enforcement officials involved in his arrest (and the agency employing them), advancing claims under 42 U.S.C. § 1983 and state law for false imprisonment and malicious prosecution.

Under the content-neutrality framework set forth in Reed v. Town of Gilbert, 135 S. Ct. 2218 (2015), we find that the anti- robocall statute is a content-based regulation that does not survive strict scrutiny. (footnote omitted)

Later, and drawing on the Reed opinion, Judge Diaz added:

The Supreme Court recently clarified the content-neutrality inquiry in the First Amendment context. In Reed, the Court explained that “the crucial first step in the content-neutrality analysis” is to “determin[e] whether the law is content neutral on its face.” 135 S. Ct. at 2228. At the second step, a facially content-neutral law will still be categorized as content based if it “cannot be ‘“justified without reference to the content of the regulated speech,”’ or . . . adopted by the government ‘because of disagreement with the message [the speech] conveys.’” Id. at 2227 (quoting Ward v. Rock Against Racism, 491 U.S. 781, 791 (1989)).

. . . .  The asserted government interest here is to protect residential privacy and tranquility from unwanted and intrusive robocalls. Assuming that interest is compelling, we hold that the government has failed to prove that the anti-robocall statute is narrowly tailored to serve it. Plausible less restrictive alternatives include time-of-day limitations, mandatory disclosure of the caller’s identity, or do-not-call lists. 

. . .  In addition, the record contains evidence that the anti- robocall statute is overinclusive. The Defendants themselves cite to a report from a U.S. House of Representatives committee that concluded, “Complaint statistics show that unwanted commercial calls are a far bigger problem than unsolicited calls from political or charitable organizations.” H.R. Rep. 102-317, at 16 (1991). Yet the statute also targets political calls.

At the same time, the statute suffers from underinclusiveness because it restricts two types of robocalls– political and consumer–but permits “unlimited proliferation” of all other types. . . 

Because the statute does not pass muster under strict scrutiny, we affirm the district court’s judgment declaring it unconstitutional.

[ht: Tony Mauro]

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