bioIP Workshop – Deadline for Abstracts Approaching

Call for Abstracts: 2015 bioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the first annual bioIP Faculty Workshop on May 7, 2015 at Boston University School of Law.

The Workshop will offer a unique opportunity for three junior scholars (in their first decade of teaching) to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology/life sciences/FDA and IP (hence, bioIP), broadly defined. A Review Committee will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience interested in having their papers reviewed should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at  thutchinson at aslme.org by Oct 1, 2014. Selected abstracts will be announced later in Fall 2014 with the full draft papers due by April 1, 2015. The organizers will cover reasonable travel and lodging expenses. VAPs and Fellows are eligible for the Workshop.

The Workshop Committee consists of faculty from: The Boston University School of Law; Georgia State University College of Law; Indiana University Robert H. McKinney School of Law; and the Loyola University Chicago School of Law.

For questions, please email Kevin Outterson, mko@bu.edu.

AHLA Health Law Curriculum Manual

The American Health Lawyers Association is the nation’s largest group of practicing health law attorneys, with awesome CLE programs.

For the past couple years, a group at AHLA has been evaluating how health law is taught at law schools, with a view to prepare students for the practice of health law. AHLA surveyed many health law practice group chairs and other leaders. With that data, a large group of AHLA members and some full time professors evaluated health law curricula nationwide. A guidance document is now out (html or pdf):

We found some significant gaps, however, between what law schools offer and what the profession hopes to see in new health lawyers. Members of the American Health Lawyers Association (AHLA) want to see more substantive classes in fraud & abuse, business, tax, life sciences, and health care reimbursement. Desired skills include working in teams, processing practical transactional skills, and effectively analyzing client-focused problems.

Two take-away slides from the AHLA survey of health law practice leaders and hiring partners:

Continue reading

bioIP Junior Faculty Workshop: Call for Abstracts by Oct. 1

Call for Abstracts: 2015 bioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the first annual bioIP Faculty Workshop on May 7, 2015 at Boston University School of Law.

The Workshop will offer a unique opportunity for three junior scholars (in their first decade of teaching) to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology/life sciences/FDA and IP (hence, bioip), broadly defined. A Review Committee will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience interested in having their papers reviewed should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at  thutchinson at aslme.org by Oct 1, 2014. Selected abstracts will be announced later in Fall 2014 with the full draft papers due by April 1, 2015. The organizers will cover reasonable travel and lodging expenses. VAPs and Fellows are eligible for the Workshop.

The Workshop Committee consists of faculty from: The Boston University School of Law; Georgia State University College of Law; Indiana University Robert H. McKinney School of Law; and the Loyola University Chicago School of Law.

For questions, please email Kevin Outterson, mko@bu.edu.

Halbig is out and the gov’t lost (but long live the King)

My post at TIE: 4.683 million people get tax bills, lose coverage http://theincidentaleconomist.com/wordpress/4-683-million-unanswered-questions-in-halbig/

Also Nick Bagley at TIE: http://theincidentaleconomist.com/wordpress/a-stinging-defeat-for-the-government/

UPDATE: Gov’t wins in the 4th Cir companion case: http://theincidentaleconomist.com/wordpress/the-government-may-have-lost-in-d-c-but-it-just-won-in-the-fourth-circuit/

Public health in the shadow of the First Amendment

The First Amendment has been repurposed as a powerful deregulatory tool, especially in health care (NEJM on data privacy) and public health (NEJM on smoking). Amy Kapczynski at YLS has put together a timely and powerful conference, Public Health In The Shadow of the First Amendment. October 17-18 in New Haven. Register here.

@koutterson

 

Messing with the data, law school edition

(cross-posted from TIE)

One important outcome measure for law schools is employment of their graduates, especially jobs for which bar passage is required and are long-term, full-time jobs (BPRFTLT). If a law school can boost that number, it will appear to be better than its rivals. A job is “long-term” if it is expected to last at least a year. Can you guess what many law schools have done? Hired dozens of their grads for a little more than a year:

  FBPRFTLT2012 / 2013 2012 % of EBPRFTLT 2013 % of EBPRFTLT
GEORGE WASHINGTON 119 / 88 25.5% 20.7%
WILLIAM AND MARY 35 / 43 23.3% 25.9%
UMASS DARTMOUTH 3 / 3 23.1% 10.3%
VIRGINIA 54 / 58 15.7% 16.7%
NYU 58 / 42 13.2% 8.3%
GEORGETOWN 41 / 73 8.9% 13.5%
EMORY 17 / 64 8.7% 26.0%
COLUMBIA 38 / 29 8.7% 7.0%
CHICAGO 17 / 13 8.3% 6.5%
YALE 11 / 9 6.0% 5.6%
ILLINOIS 7 / 20 5.3% 11.9%
MINNESOTA 7 / 5 4.5% 2.6%
HARVARD 16 / 11 3.1% 2.2%
UCLA 7 / 25 2.9% 9.6%
PENN 7 / 13 2.7% 5.5%
STANFORD 4 / 5 2.4% 2.9%
WASHINGTON UNIVERSITY 4 / 4 2.0% 2.0%

(First column is the law school; second is the number of law-school funded jobs that the law school described as bar passage required, full-time, long-term (BPRFTLT) to the ABA for the classes of 2012 and 2013; third and fourth columns are the % of BPRFTLT jobs funded by the school for the classes of 2012 and 2013, respectively. The chart includes all schools in the ABA data set who reported more than 2% BPRLTFT funded jobs for the class of 2012. Schools are ordered descending by column 3. The class of 2013 data was released by the ABA this week.)

Some comments:  Continue reading

The other oral argument on Tuesday

Cross posted from The Incidental Economist:

The opponents of the Affordable Care Act certainly know their way around a courtroom. Oral arguments in the contraception mandate case (Hobby Lobby) will be heard on Tuesday at the Supreme Court. That same day, another challenge will be heard in a federal courtroom nearby, in the Court of Appeals for the DC Circuit (the WSJ photo identifies the wrong court).

To the Cato Institute, the tax credit cases (Halbig v. Sebelius and a related case in the Fourth Circuit, King v. Sebelius) represent their last shot to cripple the four-year-old law by wiping out health insurance subsidies to millions of people in the 36 states that did not create state exchanges. (I’ve blogged about these cases before, and Cato folks have also posted summaries of the anti-ACA amicus briefs. Sunday’s WSJ ran an editorial following the Cato line).

Today, I wanted to highlight the amicus brief filed on Thursday March 20, 2014 by the Commonwealth of Virginia in King v. Sebelius (the 4th Circuit case, not the one up for oral argument on Tuesday). I appreciate the beauty of this argument, for it uses a conservative victory in federalism to support the federal government, and it comes from the newly-elected attorney general who replaced an early opponent of the ACA. (Mark Herring won by only 165 votes, but #electionsmatter).

I’m talking about the Pennhurst doctrine, which requires Congress to give states “clear notice” if conditions on states are attached to federal spending. So Virginia asks the very interesting question: Did Congress give “clear notice” that the penalty for failing to build a state exchange would be the loss of billions of dollars of health insurance subsidies?  When you put it that way, Cato’s argument collapses. From the brief:

For no one can reasonably claim that the federal government gave Virginia clear notice that its citizens would be denied premium tax-credit assistance as punishment for the Commonwealth’s decision to forgo building its own health insurance exchange.

And later:

 [The Plaintiffs argue] that everyone in Congress silently but mistakenly assumed that every State would create its own Exchange. (Appellants’ Br. 6, 42.) That claim finds no support in the record. The ACA was controversial when it was debated and adopted, and it was well known that numerous States objected to it and would not go along willingly.

The brief also notes that no Member of Congress expressed such a view and even the architects of this litigation (Cannon and Adler) were surprised by this “glitch” after the fact. The brief also reviews the official correspondence to and from the Governor on this issue; any notice whatsoever is lacking, much less “clear notice.”

What bothers me the most about this litigation is Cato’s willingness to try to hurt millions of vulnerable people in order to score political points, even after losing the 2012 Presidential election and the first bite of the Supreme Court apple in NFIB v. Sebelius. The Virginia brief puts the emphasis on the people:

Two sovereign interests compel the Commonwealth of Virginia to file this brief. First, the Commonwealth represents the interests of the hundreds of thousands of Virginians who depend on federal premium tax-credit assistance to afford the health insurance that is now available under the Patient Protection and Affordable Care Act of 2010 (the “Affordable Care Act” or “ACA”). Their interests are not represented by the Appellants here, four individual Virginians who do not want health insurance. Second, the Appellants’ legal theory contradicts the fundamental assumption on which the Commonwealth elected to forgo building its own health insurance exchange in favor of a federally-facilitated exchange: that doing so would not harm the interests of Virginians. The Appellants’ theory must be rejected under the Pennhurst doctrine, which prevents Spending Clause statutes like the ACA from being used to impose unusual conditions about which States were not provided “clear notice.” What is more, if Congress had actually done what Appellants claim — made State citizens financial hostages in a scheme to force State governments to adopt State-based exchanges —it would have violated the Tenth Amendment’s prohibition on coercing States to carry out federal policies. Accordingly, this Court should reject Appellants’ arguments and affirm the ruling of the District Court.

h/t Tim Jost

@kevinoutterson

The contraception mandate decision

From my post at The Incidental Economist:

The Gilardi v. HHS decision is out today (on scribd), blocking the PPACA contraception mandate for the plaintiffs. Two brothers own Freshway Foods and a related company that offer a self-insured health plan to their 400 employees. For non-grandfathered plans with an annual enrollment period starting on or after September 23, 2010, PPACA required zero deductibles and cost sharing for a package of preventative services. One component of that package includes FDA-approved contraception. The Gilardi brothers claimed this requirement violates the Religious Freedom Restoration Act (RFFA). A majority of the Court agreed, sending the case back to the District Court for a reconsideration of the injunction.

This case raises an interesting point about pluralism in our society. When do we get to abstain from generally-applicable laws that violate our moral beliefs? Even more attenuated, when do we get to opt out because other people’s actions violate our beliefs? Can the Freshway companies decide to drop hospice care for their employees as violating their Catholic beliefs? Could a Muslim employer prevent employees from bringing home the bacon with their paychecks? Could a Baptist employer fire employees for watching porn at home on HBO?

Continue reading

Empirical proof health law is complex

I hear complaints from time to time about the complexity of health care law. Now we have some evidence.

Katz and Bommarito (gated, free registration) at Michigan State analyzed the US Code for complexity using a variety of big data techniques. The most complex area of US statutory law? Our friend, Title 42, home to Medicare, Medicaid, and the Social Security Act. Title 42 beat (lost?) to tax law by a substantial margin (tax was #2, noted Paul Caron).

But according to Katz (by email), the underlying data is from 2010, before PPACA was codified into Title 42. So health law is in no danger of losing the lead.

@koutterson

How global regulations are written

In secret, during “trade” negotiations. Just one example: the 12 years of data exclusivity for biologics is currently US law, but that may get carved into stone in the new Trans-Atlantic Trade and Investment Partnership (TIIP). Once enshrined in a trade agreement, this rule and thousands more will be immune to change by any national democratic process.

Who participates in this process? Generally, only “cleared advisors” from the Fortune 500.

A partial (leaked) list of the initial bargaining positions for the EU are downloadable here. In the Initial Positions Papers, the EU notes that they have approved 16 biosimilars which have not yet been recognized as such in the US. Other topics include generic approvals, GMP inspections, and regulatory science for drug approvals.

All of decisions have immense potential impact for consumer welfare. My concern is the undemocratic lack of transparency for the entire process.

(cross-posted from TIE)
@koutterson

Politics after a SCOTUS decision

Some SCOTUS opinions stir up politics and legislation (think: Roe v Wade). Others tend to end the process. When the Court is interpreting a federal statute, if they get it “wrong” it is of course possible for the elected branches to reverse them. But for some of these issues, political stalemate in Congress gives the Justices the last word, perhaps for decades.

Which makes the Roberts Court both activist and powerful.

For more, see “Political gridlock empowers US justices” in today’s Financial Times, quoting me.

@koutterson

Maintenance of Effort in Maine

After the NFIB decision in June, Maine tried to expand Justice Roberts’ remedy to also make the “maintenance of effort” provision optional for states. Maine was unsuccessful in the First Circuit with the argument, for procedural reasons.  Prior coverage here.

The Obama Administration is sticking to the letter of the law, and announced Tuesday that it is refusing to allow cuts for Medicaid beneficiaries at or below 133% (138% after the 5% income disregard) of FPL in Maine.

Maine has not yet announced whether it will take the case back to the First Circuit. With Huberfeld & Leonard, we’ve argued at length (see esp. pp. 75-83) that Maine does not have the winning argument, in an article to be published in the BU Law Review later this month. SSRN version here. The short version is that MOE is a common tool to lock-in states during transition to a new program, was discussed in the briefing, but was not part of the coercion analysis in Justice Roberts’ plurality. The key provision was 42 USC 1396c, the Secretary’s authority to reduce some or all of the funding to non-compliant states. But we will see if Maine wants to argue the substance of this point at the First Circuit.

@koutterson

BU Law Conference on New Legal Challenges to Global Tobacco Control, Jan. 25, 2013

Boston is a great city for health policy. On Jan. 25, BU Law hosts a conference on New Legal Challenges to Global Tobacco Control. Just a month later, Harvard hosts its own conference on the Global Governance of Tobacco (details here).

The BU Law conference  (announcement here; detailed schedule here) will focus on challenges rooted in constitutional law (First Amendment litigation in the US attacking FDA-required graphic images on tobacco packs); trade mark law (plain packaging in Australia); and global trade and investment treaties such as the Hong Kong-Australia Bilateral Investment Treaty and the WTO Agreements.  Speakers include some of the world’s leading public health experts on this topic:

  • Matthew Allen, Allen + Clarke Policy and Regulatory Specialists
  • Micah Berman, New England School of Law
  • Scott Burris, Temple University Beasley School of Law
  • Julien Chaisse, The Chinese University of Hong Kong
  • Richard Daynard, Northeastern University School of Law
  • Samantha Graff, NPLAN
  • Jane Kelsey, University of Auckland Faculty of Law
  • Lara Khoury, McGill University Faculty of Law
  • Mark Levin, University of Hawai’i at Manoa William S. Richardson School of Law
  • Jonathan Liberman, Cancer Council Victoria
  • Benn McGrady, Georgetown University Law Center
  • Ted Mermin, Public Good Law Center
  • Kevin Outterson, BU School of Law
  • Robert Stumberg, Georgetown University Law Center
  • Allyn Taylor, Georgetown University
  • Tania Voon, University of Melbourne Law School
  • George Annas, BU School of Law and BU School of Public Health
  • Leonard Glantz, BU School of Law and BU School of Public Health
  • Wendy Mariner, BU School of Law and BU School of Public Health
  • Alexandra Roberts, BU School of Law
  • Keynote Speaker: Dr. Michael Siegel, BU School of Public Health

The conference is open to everyone; see the schedule for details. The conference papers will be published in the American Journal of Law & Medicine.

More religious objections to contraception coverage

I wrote last week (at TIE) that corporations might have First Amendment or RFRA religious rights to object to contraception coverage. Now we have a second federal judge agreeing, this time on behalf of Tyndale Bible Publishers (complaint here; preliminary injunction here). The short answer:

The plaintiffs have therefore shown that the contraceptive coverage mandate substantially burdens their religious exercise.

The Tyndale opinion again focuses on the rights of the owners of the company (here, a family foundation) rather than the company itself:

This Court, like others before it, declines to address the unresolved question of whether for-profit corporations can exercise religion within the meaning of the RFRA and the Free Exercise Clause. See, e.g., First Nat’l Bank v. Bellotti, 435 U.S. 765, 777–78 n.14 (1978) (recognizing that corporations have First Amendment speech rights, but declining to “address the abstract question whether corporations have the full measure of rights that individuals enjoy under the First Amendment”); Stormans, Inc. v. Selecky, 586 F.3d 1109, 1119 (9th Cir.2009) (“We decline to decide whether a for-profit corporation can assert its own rights under the Free Exercise Clause …”); Church of Scientology of Cal. v. Cazares, 638 F.2d 1272, 1280 n.7 (5th Cir.1981) (same). Instead, the Court will assess whether Tyndale has standing to assert the free exercise rights of its owners…

Viewing the rights of Tyndale’s owners (in particular, those of the Foundation) as the basis for its RFRA claim, the Court finds that Tyndale has made a satisfactory showing of Article III standing.

The court also found “third party standing”

It bears emphasizing that if the Court accepted the defendants’ position, no Tyndale entity would have standing to challenge the contraceptive coverage mandate—not even the Foundation. This is because, in the defendants’ view, Tyndale—though directly injured by the regulation—cannot exercise religion, and the Foundation—though capable of exercising religion—is not directly injured by the regulation. The third-party standing doctrine serves to avoid such conundrums.

These cases are serious, but the threat is to mandatory contraception coverage, not the entire ACA.

Cross-posted from TIE

@koutterson