Where Are We Now: Post 3, The Agony (and Potential Ecstasy) of Defeat

By Scott Burris

Law has been an extremely effective mode of public health intervention in the last thirty years, which means that proponents of its use have won more than a few tough political battles.  Nonetheless, it is hard to escape the fact that, in recent years, the public health side has been getting killed wherever law is made. The First Amendment turns out to create a right to mine prescription records for data (Sorrell v. IMS Health), advertise liquor prices (44 Liquormart), keep warning labels off cigarette packs (RJ Reynolds v FDA)  – even operate a tattoo parlor in a city that lacks the resources to regulate its safety.  With the Heller case, the strictest forms of gun control were taken off the table, and there is a lot more litigation ahead to define what can be done. The ACA case raises the possibility of future limits on federal regulation via the spending clause. In the latest and most chilling development, the DC Circuit panel in the FDA label case laid the foundation for questioning whether there is even a rational basis for regulations aimed at discouraging people from using “lawful” but dangerous products:

We are skeptical that the government can assert a substantial interest in discouraging consumers from purchasing a lawful product, even one that has been conclusively linked to adverse health consequences.

Things aren’t a whole lot better over in the elected parts of government.  State and local health departments have been experiencing steady budget strangulation ever since (and even before) the Great Recession. The federal life-line, the Prevention and Public Health Fund, was raided once already by Congress, and remains a tempting target. Using the money we do get to promote legal interventions for health is under attack: with the help or acquiescence of Democrats, the long-standing restriction on lobbying in the HHS appropriations bill was changed. Despite legal analysis concluding that the old lines – educating public and policy makers is OK, just don’t push for specific legislation – are still in place, broad language about “future” legislation and threatening letters from an outfit called “Cause of Action” has reportedly chilled a lot of funding recipients.

For many of us, the succession of reverses and cuts looks like public health as usual: public health is usually the underdog whatever the topic. On the other hand, there are arguments that things are different now, ranging from the simple claim that the cuts have now reached bone to the belief that there is an active effort to put the “new public health” entirely out of business. So what is happening?

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Elhauge on Solving the Patent Settlement Puzzle

Founding Director of the Petrie-Flom Center, Professor Einer Elhauge, has just published an article with co-author Alex Krueger on an issue that the Supreme Court just granted certiorari on in FTC v. Watson: the proper antitrust analysis of reverse payment patent settlements.  In such settlements, the alleged infringer receives a payment and agrees to stay out of the market for a number of years.  Such settlements have been particularly prevalent in the pharmaceutical industry that has such a large effect on health care costs. The appellate courts have all recognized that such settlements have anticompetitive potential to exclude entry for far longer than merited by the probability of patent victory.  However, the courts have split on whether to find these settlements presumptively anticompetitive or lawful if within the formal scope of a non-sham patent.  The latter courts have focused on the possibility that a settlement might not exclude entry for longer than merited by the probability of patent victory and the administrative difficulty of conducting case-by-case inquiries into that probability.  Professor Elhauge’s article seeks to solve this puzzle by showing that case-by-case inquiries are unnecessary when the reverse payment amount exceeds the patent holder’s future anticipated litigation costs, because one can infer that such settlements will exclude entry for longer than merited by that probability of patent victory, whatever that probability may be.

Twitter Round-Up (12/2-12/8)

By Casey Thomson
This week’s Twitter Round-Up features an “American Idol-style” selection of research grant winners, the problems facing children in Syria attempting to be vaccinated, and a review of where we stand with current patient health information privacy and security.
  • Michelle Meyer (@MichelleNMeyer) retweeted an article about a newly emerging landmark case in the United Kingdom. In the suit, a childless couple denied IVF funding due to the woman’s age is suing Health Secretary Jeremy Hunt (because he is “ultimately accountable for healthcare in England”) on the basis of age discrimination. Thought to be the first venture to sue the Health Secretary concerning decisions about this NHS fund rationing, this case also will be the first instance where age discrimination laws have been employed to try for fertility treatment. (12/3)
  • Alex Smith (@AlexSmithMD) shared an article about a problem patients must deal with when approaching post-hospitalization care: Medicare’s offer to pay for hospice care or for a Skilled Nursing Facility (S.N.F.), but only rarely at the same time. Not only does the choice create a financial predicament, but it also has extensive repercussions for the patient’s health. Calls for a combined benefit process between hospice/palliative care and S.N.F. have been made, including a proposed “concurrent care” demonstration project in the Affordable Care Act. (12/6)
  • Dan Vorhaus (@genomicslawyer) linked to a summary of the Ponemon Institute’s Third Annual Benchmark Study on Patient Privacy & Data Security, reporting on the challenges still being faced to safeguard protected health information (“PHI”). (12/6)
  • Michelle Meyer (@MichelleNMeyer) additionally retweeted a link explaining Brigham and Women’s Hospital’s attempt to deal with the rising difficulty of choosing which research grants to support: an “American Idol-style” public online voting. With almost 6,500 votes cast, the public engagement experiment picked a project hoping to research methods for integrating genomic sequencing into newborns’ routine medical care. When future grant holders are struggling to award between a set of equally deserving project proposals, this push for public involvement (after having confirmed scientific rigor) may have intriguing implications. (12/6)
  • Daniel Goldberg (@prof_goldberg) also linked to a study in Denmark testing the relationship between socio-economic status (SES) and blood pressure levels. Despite having a healthcare system that is free and equal-access regardless of factors like SES, the study found that SES had a “significant effect on BP [blood pressure] control” in this survey. (12/7)
  • Arthur Caplan (@ArthurCaplan) posted a report by UNICEF on the efforts by parents in the Syrian Arab Republic to get their children vaccinated. With many medical centers destroyed by the conflict, and with health practitioners having to operate and transport supplies in the dangerous environment, children have been unable to receive routine vaccinations for several months. This campaign aims to provide such vaccinations (specifically for measles and polio) to children, having advertised via churches, mosques, schools, television, and even by SMS to get greater coverage. (12/7)
  • Frank Pasquale (@FrankPasquale) included a book review of Pharmageddon by David Healy, a look at how pharmaceutical companies are excessively influencing the medical industry particularly with “diagnostic categories and clinical guidelines.” The result, according to Healy: a society where people “think about their bodies as a bundle of risks to be managed by drugs,” with a workforce that is “getting ‘sicker,'” and with “major pharmaceutical companies…banking on further overdiagnosis and overtreatment,” all “undermining universal health care.” (12/8)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Myriad Updates: Clinical Data as Trade Secrets and a Pending Certiorari Decision

By Dan Vorhaus (Cross-Posted from Genomics Law Report)

Earlier this month, my colleagues John Conley, Robert Cook-Deegan, James Evans and I published a policy article in the European Journal of Human Genetics (EJHG) entitled “The next controversy in genetic testing: clinical data as trade secrets.”  The EJHG article is open access so you can read the entire article at the EJHG website, but here is the abstract:

Sole-source business models for genetic testing can create private databases containing information vital to interpreting the clinical significance of human genetic variations. But incomplete access to those databases threatens to impede the clinical interpretation of genomic medicine. National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing. They can create incentives for sharing data and interpretive algorithms in several ways, including: promoting voluntary sharing; requiring laboratories to share as a condition of payment for or regulatory approval of laboratory services; establishing – and compelling participation in – resources that capture the information needed to interpret the data independent of company policies; and paying for sharing and interpretation in addition to paying for the test itself. US policies have failed to address the data-sharing issue. The entry of new and established firms into the European genetic testing market presents an opportunity to correct this failure.

In certain respects, this article is an expansion of a previous piece three of us wrote on the Genomics Law Report last year discussing Myriad Genetics’ response to the rise of whole-genome sequencing technologies in the context of diagnostic genetic testing. The current EJHG expands upon that discussion, while still using Myriad Genetics as a case study, particularly the company’s development of a proprietary database of DNA sequence variants (including variants of uncertain significance, or VUSs) and related clinical information pertaining to the breast cancer genes BRCA-1 and BRCA-2.

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Another Contraceptives Mandate Case

Following up on Chris Robertson’s and Kevin Outterson’s posts below (here and here), I just wanted to draw your attention to another federal district court opinion on the contraceptives coverage mandate.  This one is from Nov. 19 and involves the owners of Hobby Lobby.  The court denied their motion for a preliminary injunction on the following grounds:

Plaintiffs have not demonstrated a probability of success on their First Amendment claims. Hobby Lobby and Mardel, secular, for-profit corporations, do not have free exercise rights. The Greens [the individual owners] do have such rights, but are unlikely to prevail as to their constitutional claims because the preventive care coverage regulations they challenge are neutral laws of general applicability which are rationally related to a legitimate governmental objective.

Plaintiffs also have failed to demonstrate a probability of success on their Religious Freedom Restoration Act claims. Hobby Lobby and Mardel are not “persons” for purposes of the RFRA and the Greens have not established that compliance with the preventive care coverage regulations would “substantially burden” their religious exercise, as the term “substantially burdened” is used in the statute. Therefore, plaintiffs have not met their prima facie burden under RFRA and have not demonstrated a probability of success as to their RFRA claims.

There are tens of cases challenging the contraceptives mandate pending at the moment, and several have already been dismissed on procedural grounds.  But my current count of the substantive cases is 3 preliminary injunctions granted (Newland, Weingartz Supply, and Tyndale House Publishers), 1 denied (Hobby Lobby), and 1 case holding outright that the mandate violates neither the First Amendment nor RFRA (O’Brien).  Have I missed any?

Opinion granting preliminary injunction on contraceptive coverage mandate

By Christopher Robertson

Yesterday (Friday Nov 16), U.S. District Judge Reggie Walton granted a preliminary injunction barring enforcement of the contraceptive coverage mandate that was part of the regulations implementing the Affordable Care Act (ACA).  There is lots of news coverage (e.g., HuffPo and WaPo), but as usual, the news organizations do not link to the opinion.  For your convenience, I’ve linked to it in the prior sentence, and provide some very preliminary observations below the fold.

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Gowder on Death and Taxes in the individual mandate: The Finger-Wagging Lopsided Giant?

By Christopher Robertson

Paul Gowder (Iowa Law) has shared a draft of his new article, Death and Taxes in NFIB v Sebelius.  Gowder thoughtfully develops some of the themes that I gestured towards in my “Lopsided Giant” post last week, trying to figure out how the Roberts opinion could uphold the constitutionality of the individual mandate as a regulatory tax but not as a regulation of commerce.  Drawing on a range of philosophical sources, Gowder tries “to aggressively apply the principle of charity to understand what the opinion actually means by making sense of it.”  (I love the ambiguity with the word, ‘making.’)

Gowder is smart in his use of philosophers (from Hayek to Raz, and others) to try to shed some light on Roberts’ ideas about coercion and regulation.  Gowder’s analysis makes me think that the Roberts’ opinion might deserve an even broader examination of whether there is a coherent theory of coercion between the individual mandate section and state mandate to expand Medicare section.  On the other hand, Gowder reaffirms my sense that the individual mandate’s Commerce Clause problem was not that it was too coercive.

The most provocative question is why the mandate was upheld as a tax.  On Gowder’s charitable reading, Roberts’ opinion does not provide Congress with unlimited power to mandate behavior using the tax power.  It is strictly limited.  But the limitation is merely one of “expressiveness”, depending on whether a mandate “labels those who break it as lawbreakers.”  (p16)  As I discuss below the fold, this creates a novel rule of Constitutional law — we might call it the finger-wagging-rule.    Read More

The Lopsided Giant

By Christopher Robertson

Professor Elhauge‘s provocative little book, Obamacare on Trial, has many of us rethinking and revisiting the NFIB v. Sebelius decision, and I had a chance to attend the nice book talk featuring Professor Elhauge and several interlocutors last week.

Chief Justice Roberts’ opinion in the case is not prominently textualist (since contemporaneous dictionary definitions of “regulate” are unhelpful to him, as Elhauge shows) nor historicist (since the founders themselves imposed healthcare insurance purchase mandates, as Elhauge also shows).  Instead, Chief Justice Roberts repeatedly relies on a slippery slope style of argument (or a reductio ad absurdum), not unlike those I heard from Fox TV commentators and friends on Facebook in the months prior to the decision.  Below the fold, I suggest that this form of argument is incoherent given the larger holding of the case.

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Good Science and Bad Verdicts

By Nadia N. Sawicki

On Monday, an Italian court convicted six scientists and a government official of manslaughter for providing the townspeople of L’Aquila with “inaccurate, incomplete and contradictory” information about risk of a 2009 earthquake in which 309 residents subsequently died. The prosecutors in the case successfully alleged that the scientists, all members of the National Commission for the Forecast and Prevention of Major Risk (La Commissione Nazionale per la Previsione e Prevenzione dei Grandi Rischi), downplayed the risks to the town at a meeting in which they described the possibility of a large earthquake “unlikely” despite a series of minor tremors.  Interestingly, the prosecutor in the case cited a 2009 ruling by the U.S. District Court for the Eastern District of Louisiana holding that the U.S. Army Corps of Engineers’ negligent maintenance of a navigation channel contributed to the flooding after Hurricane Katrina.

The defendants were sentenced to six years in prison and ordered to pay $10.2 million in damages and costs, a result one of the convicted defendants, a physicist, has decried as “medieval.”

The decision to criminally punish scientists for failing to predict a natural disaster that is inherently unpredictable is likely to have a chilling effect on critical research.  More importantly, it may lead to reluctance on the part of the scientific community to collaborate with government agencies for the public good. Indeed, the Department of Civil Protection (Dipartimento della Protezione Civile), of which the National Commission is a part, suggested that the first consequence of the court’s ruling would be a “paralysis of forecasting and prevention activities” (translation my own).  “This is the death of public service on the part of professors and professionals,” said Luciano Maiani, president of the National Commission, who, along with a number of colleagues, resigned his post on Tuesday.

The DOMA Petition You Should Be Following

By Nicole Huberfeld

You may be thinking “DOMA? Hello, this is HEALTH LAW.”  Please stick with me for a moment.  The Supreme Court appears to be collecting petitions for certiorari regarding the Defense of Marriage Act, likely to determine which circuit’s decision is the best vehicle for considering the constitutionality of this federal law.  One such petition results from the First Circuit’s decision in Massachusetts v. Department of Health and Human Services/Hara v. Office of Personnel Management, which held that section 3 of DOMA violated the Fifth Amendment’s Equal Protection Clause.  The court reasoned that promoting marriage is not rationally related to denying federal benefits to same-sex couples, thereby avoiding the creation of a new category of suspect class.  The twist is that the state of Massachusetts also claims that section 3 of DOMA, which denies federal economic benefits to same-sex couples, exceeds Congress’s Spending Clause authority and infringes the state’s 10th Amendment rights.  While the First Circuit did not agree with the state on these points, it did incorporate federalism concerns into its Equal Protection Clause analysis by noting that states traditionally have defined marriage, therefore the federal government cannot protect the state of Massachusetts from its own definition of marriage by promoting heterosexual marriage. Read More