The Wall Street Journal has a new article this week celebrating the flood of new jobs for lawyers created by the Affordable Care Act. The WSJ article rattles off a dozen or so examples of legal questions that arise from the new legislation and litigation, providing lots of fodder for a health law class. This comes after a provocative session at ASLME’s health law professors conference last week, discussing an effort by the American Health Lawyer’s Association to create a model law school curriculum, starting with a survey course and broadening into a range of courses that could constitute a “certificate program.”
The Journal of the American Medical Association (JAMA) has just posted online (ahead of print) a new article by Ben Harvey and I entitled “The Looming Threat of Liability for Accountable Care Organizations and What to Do About It.” We discuss the Accountable Care Organizations (ACOs) that that the Affordable Care Act seeks to incentivize, the malpractice and other liability claims they may, and how the lack of an Employee Retirement Income Security Act (ERISA) shield of the kind enjoyed by Managed Care Organizations will impact the liability environment ACOs will face. We also discuss self-help remedies available to ACOs as well as potential congressional intervention to deal with these issues.
Zachary D Caplan JD, attorney at law firm in Philadelphia that filed amicus brief on behalf of drug wholesalers and pharmacies in FTC v. Actavis
Arthur Caplan PhD, Division of Medical Ethics, NYU Langone Medical Center
Amidst all the news about various Supreme Court decisions there is one that ought not be overlooked for its impact both on public health and healthcare reform—FTC v. Actavis. Today the Court decided, by a vote of five to three, that Big Pharma companies can be sued over deals with generic companies to not bring generic drugs to market. In so deciding, the Court endorsed the idea that Big Pharma companies with weak patents on their drugs may not pay off other companies that want to make cheaper generic versions to not do so. This practice, known as pay-for-delay, has run rampant in the pharmaceutical industry over the last two decades costing American consumers billions and restricting access to cheaper versions of drugs.
In FTC v. Actavis, the Federal Trade Commission had alleged a pay-for-delay arrangement between Solvay Pharmaceuticals and Actavis that was intended to keep Actavis from producing a generic version of Solvay’s blockbuster AndroGel testosterone drug. A lower court—the Eleventh Circuit Court of Appeals—dismissed the FTC’s complaint. Now the Supreme Court has reversed that dismissal.
The Supreme Court keeps coming out with major opinions in the biotech/pharma area, with today seeing a major blow to reverse-payment settlements wherein brand-name pharma companies pay generic companies to delay their entry into the market. This type of settlement shows the opposite pattern to that in most patent litigation, where the accused infringer (here, the generic drugmaker) usually pays the patent-holder, rather than the patent-holder paying the infringe, and is a result of the dynamics of generic drug market entry created by the Hatch-Waxman Act. Since reverse-payment settlements result in the generic agreeing to stay out of the market in return for payment from the patent-holding brand name company, they look like antitrust violations – the question is whether the involvement of a patent (which creates a monopoly) means the settlements are acceptable under antitrust law.
Today, the Supreme Court came down on the side of protecting competition and sticking with traditional antitrust doctrines. The Court didn’t go so far as to say that all reverse settlements are presumptive unlawful, instead requirings courts to apply a “rule of reason.” But the Court firmly rejected the idea that a reverse payment settlement is immune from attack as long as it falls within the nominal scope of the patent. The Court also noted that a large reverse settlement payment may itself provide evidence of a patent’s weakness, avoiding the need for a full determination of patent validity in the context of the antitrust action. The opinion is here.
Prof. Einer Elhauge and Alex Krueger wrote about the economics of this question last year; their article can be found here.
“The Supreme Court has finally done what should have been done years ago — declared that genes which naturally exist in all of us cannot be patented. For years Myriad Genetics, the company that sells the genetic tests used by Angelina Jolie and thousands of other women to assess their risk of breast cancer and ovarian cancer, has held back the development of better tests and access for many women to testing by invoking their patent claims on key genes. Now the Supreme Court has rightly said that kind of patent is not valid.
“Patenting a naturally existing gene never made any sense. Sure, it takes work to figure out what genes do, but the rewards for that are publications, tenure, professional honors and even a Nobel Prize — not a patent. Patents should be given not for discovery, but for inventions: What genes can you change; what test kit can you build; what program can you run to screen genetic risks?
“The implications of the decision could be far broader than Myriad, whose stock price went up after the ruling. Many companies have taken out patents on genes not only those found in humans but in animals, microbes and plants. All of these are now in question — which may cause some reevaluation of the worth of some companies who have been touting their ownership of genes to Wall Street.”
You can read the full piece here: Patenting natural DNA never made sense.
By Scott Burris
Training lay people to reverse opiate overdose with naloxone continues to gain steam in the evidence base, popular media and legislatures. Here’s a great blog post the covers recent developments and links to a new film. The Open Society Foundations and a group of harm reduction groups have launched a new website to promote these interventions.
This morning the House Energy & Commerce Health Subcommittee held the first of a series of hearings on prescription drug abuse. ONDCP Director Kerlikowske & Dr. Doug Throckmorton of FDA have both testified and both discussed naloxone.
Meanwhile, last week, Vermont became the 13th state to pass a law expanding lay access to naloxone.
This morning on WBUR, Eric Lander discussed the significance of the Supreme Court’s unanimous decision in Association for Molecular Pathology v. Myriad Genetics that DNA cannot be patented. Lander, the Director of the Broad Institute of MIT and Harvard, filed an amicus brief in the case that was co-authored by Petrie-Flom Center Faculty Co-Director and Bill of Health editor I. Glenn Cohen.
You can hear Lander’s full interview here.
For more about the amicus brief, see Glenn Cohen’s April 17 post at Bill of Health.
While awaiting the torrent of academic commentary on this case that is no doubt forthcoming, for now I thought I’d highlight a few interesting aspects of today’s unanimous Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, 569 U. S. ____ (2013).
Briefly, this case concerned whether genes can be patented. The company Myriad Genetics held several patents related to two genes: BRCA1 and BRCA2. When mutations of these genes are present, it may indicate that a woman is at a high risk for getting breast or ovarian cancer. Myriad also held patents on a proprietary test to evaluate for the presence of BRCA gene mutations that costs over $3,000. This screening has been in the news recently due to Angelina Jolie’s decision to undergo preventive double mastectomy after testing positive for BRCA mutations.
In today’s case, Myriad’s patents were being challenged because they limited competition from other companies and researchers that could have independently tested for the same gene mutations. The outcome of this case has been critically anticipated for years because of its impact on patient access to medicines and funding medical research and development. Thousands of human genes have been patented in the U.S. over the past 30 years.
Before reaching the Supreme Court, a U.S. District judge in New York invalidated Myriad’s patents in 2010, ruling that genes were ineligible for patent protection as “products of nature.” However, the Court of Appeals for the Federal Circuit disagreed, holding that genes were eligible for patent protection because DNA isolated from the body is “markedly different” in chemical structure than DNA as it exists inside the body. The Supreme Court remanded the decision back to the Federal Circuit in light of its decision in Prometheus, and the Federal Circuit affirmed its decision that DNA was patent eligible.
A case from the employment discrimination world that might be of interest to health law folks is EEOC v. Houston Funding II, Ltd., 2013 U.S. App. LEXIS 10933 (May 30, 2013). The employee in the case, Donnicia Venters, was told that her position had been filled when she returned to work post partum and requested to use space in a back room to express milk. The issue in the case was whether firing Venters for expressing breast milk is sex discrimination under Title VII of the Civil Rights Act. The district court had concluded that it was not, as a matter of law, and the 5th Circuit reversed. Although at first glance this outcome is apparently a favorable one for women and children, it also reveals ongoing mismatches between anti-discrimination law in the US and the health needs of workers and their families.
The relevant detail of employment discrimination law is that the Pregnancy Discrimination Act (PDA) provides that discrimination “on the basis of” or “because of” sex includes discrimination on the basis of or because of “pregnancy, childbirth, or related medical conditions.” In holding that breastfeeding is a related medical condition of pregnancy, the 5th Circuit stated “Lactation is the physiological process of secreting milk from mammary glands and is directly caused by hormonal changes associated with pregnancy and childbirth.” Thus, on the 5th Circuit’s plain meaning interpretation of the statute, breastfeeding is within the PDA.
Other courts have reached conclusions less favorable to breastfeeding. The district court in Colorado wrote thus in deciding that a refusal to give breaks for breast feeding was not sex or disability discrimination: “A plaintiff could potentially succeed on a claim if she alleged and was able to prove that lactation was a medical condition related to pregnancy, and that this condition, and not a desire to breastfeed, was the reason for the discriminatory action(s) that she suffered.” Falk v. City of Glendale, 2012 U.S. Dist. LEXIS 87278 (D. Colo. 2012). Indeed, understaffing at the Glendale police department was so severe that no one was able to take breaks, even to use the restroom—so the court concluded that Falk’s problem was equal opportunity bad working conditions, not sex discrimination. Continue reading
UPDATE: A class action lawsuit has been filed in federal court against UAB providers and IRB members on behalf of infants enrolled in the SUPPORT study (through their parents). The Amended Complaint, which was filed May 20, can be found here. In addition, here are two more sets of reactions to the SUPPORT study in the NEJM, both in defense of it, from a group of prominent bioethicists and from NIH. Here is a new post from John Lantos at the Hasting Center’s Bioethics Forum blog. And here is coverage of the most recent developments in the New York Times. I’ll continue to aggregate links as warranted.
Regular readers may recall that recently, OHRP sent a determination letter to one of multiple sites (the University of Alabama at Birmingham (UAB)) involved in an RCT (the SUPPORT study) of optimal oxygen levels for premature infants (prior coverage here, here, and here). OHRP’s criticism itself led to considerable criticism among many research ethicists and physician-researchers (see, e.g., here, here, and here), as well as the SUPPORT researchers themselves (here), while others defended OHRP to varying degrees (here, here, and here).
Now, in a new letter to UAB, OHRP clarified that it has no objections to the study design; its objections, instead, pertain to what parents were told in the informed consent documents. Then, in a remarkable move, it announced that it is suspending its compliance actions against UAB, and plans no further action vis-a-vis other SUPPORT sites, pending its issuance of new guidance to address the risks that must be disclosed when conducted clinical trials like SUPPORT. OHRP promises not only the usual notice and comment period following the draft guidance but also an open public meeting, presumably in advance of the draft.
As the OHRP letter itself suggests, the fight within the research ethics community over the SUPPORT study can be seen as part of a larger conversation about the future of human subjects research regulation in the learning healthcare system. OHRP’s guidance-making process in this matter will clearly be one to watch.
In my last post on Maryland v. King, I suggested that both proponents and opponents of King should find the philosophical case for a universal DNA database stronger than they might otherwise have thought. Obviously, moving in that direction — or even including mere suspects in a database — would raise legal questions that merit (and, one hopes, receive) further consideration by the Supreme Court. But how likely is it that the Court will have another opportunity to consider the constitutionality of a statute that continues to draw the line at arrestees?
The Supreme Court’s decision in King was necessarily limited to the fact pattern presented by Maryland’s particular statute authorizing the collection of DNA from arrestees. For instance, the Court repeatedly noted that the Maryland statute at issue limited DNA collection from arrestees to those who had been “charged” (not, in fact, merely arrested) with “serious crimes,” defined as crimes of violence or burglary, or attempts to commit these crimes. (Although Justice Scalia expressed skepticism that, under the Court’s analysis, it would or could find in any subsequent case a limiting principle preventing the collection of DNA from, say, those arrested for traffic violations, it is of course possible that the Court could find such a distinction.) The Court also noted that in Maryland, samples may not be processed or added to the database until after arraignment, when a judicial officer “ensures that there is probable cause to detain the arrestee.” The presence of probable cause, and the arrestee’s corresponding reduced expectation of privacy, were “fundamental” to the Court’s decision to uphold the collection of DNA from “arrestees.” The Court also noted that samples must be expunged if the arrestee is not convicted. Finally, the Maryland statute strictly limits use of the DNA database to solving cold cases and identifying remains and missing persons; use of the database for other purposes (research, to test for paternity, to analyze health or other traits) is criminalized. The Court explicitly said that a database that was not so limited would raise additional privacy concerns that would require a new analysis.
As usual, it’s more likely that the Court will have another opportunity to examine the constitutionality of DNA collection from arrestees if a circuit split arises regarding one or more of these or other practices. And that, in turn, depends, on how widely states and the federal government vary in their authorizing statutes. An Urban Institute report from May 2013 suggests that variation is, in fact, widespread on these potentially constitutionally relevant factors:
Seriousness of offense
Of the 28 arrestee DNA states, 13 collect DNA from those arrested or charged with any felony; 14 (like MD) collect only from a subset of felonies, typically involving violence, sexual assault, or property crimes; 7 collect from anyone arrested or charged with select misdemeanors; 1 (OK) collects from “any alien unlawfully present under federal immigration law”; and the federal government accepts profiles of any arrestee and any non-US citizen detained by the US government. In addition, 2 states collect DNA immediately upon arrest only if the arrestee has been previously convicted of a felony (CT) or other qualifying crime (TX).
Public Health Law Research has released its fifth call for proposals on studies that focus on the effects of laws and policies on public health.
The new call for proposals is available online: www.rwjf.org/cfp/phlr5
The deadline for submitting proposals is July 24, 2013 at 3 p.m. ET.
As much as $1 million is available in this round of funding for short-term studies. Studies up to 18 months long will be funded at up to $150,000 each.
While PHLR funds studies that mainly focus on the intersection between law and public health, researchers from other disciplines, such as medicine, economics, sociology, psychology, and public policy and administration are encouraged to be part of multi-disciplinary teams of applicants.
PHLR’s previous four calls for proposals were issued in 2009, 2010, 2011, and 2012. Fifty-one studies have been funded to date, addressing a wide range of legal and public health issues, including: the impact of lead laws on public health; effective legal decision-making during public health emergencies; issues related to the public health infrastructure at the state and local levels; the impact of laws on distracted driving and teen driver injury and mortality rates; and many more.
A conference call for applicants will be held June 18, 2013. Applicants are required to register through the RWJF website: www.rwjf.org/cfp/phlr5.
By Scott Burris
A couple weeks ago, I was in a conference room at a global health organization, all ready to give my talk on monitoring and evaluating legal health interventions. The chief of the organization’s formidable M&E operation was my host, and after briefly going through my bio he wound up his introduction by describing me as “the guy who will be telling us how to measure the un-measurable.”
In that one flourish, he captured the biggest barrier to more and better research on the impact of laws and legal practices on health: the cultural belief that law is different from other forms of individual and institutionalized human behavior and belief, so that it, alone, must perforce remain an evidence-free zone. This is certainly a tragedy of low expectations if ever there was one. Uncertainty is part of any hard decision, but if people in the organization I was visiting were talking about defining the optimum treatment regimen for a particular disease, they would take for granted that the deliberations of the decision-makers would be guided by a substantial evidence base. Yet when the question is what package of laws and legal practices create the best environment for preventing the same disease, or encouraging people to seek treatment, they see nothing strange about proceeding entirely on intuition and experience.
As Evan Anderson and I have recently written, the importance of law to health, and the overall success in properly evaluating its impact, belie this continued cultural prejudice. Law can be hard to evaluate, but so are most other influences on our behavior and environment. In a number of areas of legal intervention, researchers have found ways to measure the hard-to-measure and produce credible findings that have shaped policy. They have done so in ways that respect the prosaic realities of practical science work: developing reliable measures and data and deploying them within robust designs is not the work of individuals, it’s not cheap, and it is not quick. Where legal evaluation has thrived, it has done so because enough money was available for long enough to support multiple lines of inquiry by multiple teams of researchers. Careers, or stands of careers, could be built, and competition and disagreement could drive rigor and relevance.
This week, PHLR is celebrating one very tangible result of investment in the field: the publication of Public Health Law Research: Theory and Methods, which was conceived by the PHLR Methods Core and edited by Alex Wagenaar and me. The book, which was written both as a methods class text book and a general reference work, is an important piece of field-building, in that it tries to define the basic good practices of PHLR. But I think it does more: Alex, whose work on crash law exemplifies all that legal monitoring and evaluation can be, has led the production of a book that we can drop on the desk of every person in every funding and health services organization who thinks that measuring law is measuring the un-measurable.
Disclaimer: I’m not a Fourth Amendment person. Rather, my interest in King is in its implications for policies for the use of DNA in the criminal justice system. I spent the better part of a year after my Ph.D and before beginning law school helping to research and edit a book on DNA and the criminal justice system and co-authoring its final chapter with the book’s editor, David Lazer. Although that was ten years ago now, most of the major policy issues in this area have not much changed over the last decade. So, with that caveat, and an invitation to readers to point out anything I say that is out of date or otherwise inaccurate, here are a few quick thoughts on King.
The majority and dissenting opinions spill most of their respective ink taking contrary positions on the primary purpose served by collecting DNA from arrestees. The majority somehow manages to argue with a straight face that the primary purpose (and indeed, to guess from its analysis, apparently the only purpose) of collecting DNA from arrestees is to identify the body of the arrested individual sitting in the booking room. As Justice Scalia wrote in dissent, this claim by the Court “taxes the credulity of the credulous” (slip op. dissent at 1). The clear primary purpose and actual use of statutes authorizing the routine collection of DNA from arrestees is to solve other cases than the one “at bar,” if you will, in the booking room.
One might have thought that the Court went out of its way to avoid finding that the primary purpose of the DNA collection at issue is “to detect evidence of ordinary criminal wrongdoing,” (Indianapolis v. Edmond, 531 U. S. 32, 38 (2000), in order to avail itself of the “special needs” exception to the Fourth Amendment’s usual requirement that searches be conducted pursuant to individualized suspicion. But no. The Court ultimately concludes that the special needs cases “do not have a direct bearing on the issues presented in this case, because unlike the search of a citizen who has not been suspected of a wrong, a detainee has a reduced expectation of privacy” (slip op. at 25). In upholding the state’s power to collect DNA from arrestees, then, the Court relied on — along with the minimally intrusive nature of the search — the arrestee’s reduced expectation of privacy. Indeed, the Court deemed the latter feature “fundamental” to its analysis (id. at 24).
Consider, then, that no such reduced expectation of privacy can be attributed to an even larger class of individuals who are indirectly included in DNA offender databases: the relatives of arrestees (and others who are directly included in offender databases).
In this guest post series, I’ll write about ethical career choice. Within law school, students often face a dilemma about which field to go into. On one hand, one could go into an ‘ethical’ field, such as a district attorney or public defense job — and, for the readers of this blog, I guess that health law and academia are also salient options. On the other hand, one could go into corporate law, where there are more jobs, better pay, and less bureaucracy, but little direct positive impact. For many people, this can seem like a dilemma between doing what’s best for yourself, and what’s best for the world.
The Indian Federal Department of Pharmaceuticals has released a new Drugs (Prices Control) Order that expands the list of “essential” drugs subject to government price control. Currently, a 1995 order restricts prices on 74 bulk drugs and their formulations; the new order would control prices on a total of 348 medicines that make up 60 percent of domestic drug sales. The price for these drugs will be based on a simple average of all brands with a market share of at least one percent.
The Indian Pharmaceutical Alliance (IPA), which represents major Indian pharmaceutical manufacturers, estimates that prices could fall between 20 and 90 percent. Price controls are certain to improve access to medicines in a country where two-thirds of the citizens have no health insurance and pay health care costs out-of-pocket. India spends less than 1.5 percent of its GDP on public health, ranking among the lowest spenders from developing countries.
Coming soon after India issued compulsory licenses for on-patent medicines, and the recent high-profile Glivec patent case I blogged about in April, expanded price controls reflect a growing willingness to challenge multinational corporations (MNCs). Whether this will result in backlash from MNCs remains to be seen—but they have not historically failed to respond to such challenges.
The U.S. Supreme Court ruled this morning, in Maryland v. King, that it is constitutional under the Fourth Amendment’s protection against “unreasonable” searches and seizures for the state to compel collection of DNA from arrestees. The probable cause required to arrest someone under the Fourth Amendment permits fingerprinting and taking photographs during the booking process, and the Court held that collecting DNA (limited to 13 loci in supposed “junk DNA”) was not relevantly different. The decision was 5-4, with Kennedy writing for the Court and joined by Chief Justice Roberts and Justices Thomas, Alito, and Breyer. Justice Scalia dissented in his usual spirited way, joined by Justices Ginsburg, Sotomayor, and Kagan.
I suspect that one or more Bill of Health bloggers will have some analysis of this decision once they’ve had the chance to digest it. In the meantime, here is a still-relevant primer I co-authored in 2004 on legal and ethical debates involving DNA and the criminal justice system (including issues related to both offender DNA databases and post-conviction access to potentially exculpatory crime scene DNA). Note that Justice Breyer, in addition to being the Court’s resident patent expert (except him to play a large role in the upcoming Myriad gene patenting decision), has been following debates about DNA and the criminal justice system for some time. He authored Chapter 2 of the book I just linked to.
Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell  came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated that pluripotent cells may also be formed by reprogramming adult cells to an embryonic state, resulting in induced pluripotent stem (iPS) cells without having to use eggs or cloning, or destroy embryos. However derived, pluripotent cells are capable of differentiating into virtually any cell type in the human body. This imbues them with great promise for scientific breakthroughs and medical advances, but also raises serious ethical, legal and safety concerns about their use.
Less controversial are “multipotent” adult stem cells (ASCs) which do not involve embryos or raise as many safety concerns as pluripotent cells. ASCs are found throughout the body. Their ability to differentiate is more limited than pluripotent cells but is vast nonetheless. The NIH’s clinicaltrials.gov site lists some 4500 ASC trials as compared with 27 for embryonic stem cells and 21 for induced pluripotent stem cells. Recent announcements of new stem cell treatments usually involve ASCs, such as last month’s news that a toddler born without a trachea received a new one made from her own adult stem cells. It is therefore no surprise that ASCs have captured the attention of researchers, investors, physicians, patients and – increasingly – regulators, both here and abroad.
A growing number of physicians routinely offer treatments involving ASCs to their patients which can be performed in their offices. Autologous adult stem cells, used to treat a variety of conditions, are harvested from the patient, processed, and returned to the same patient. It is no surprise that moving ASCs from laboratories to physician offices raises complex questions of law. We consider one of the more pressing ones: to what extent can the FDA regulate a physician’s ability to treat a patient with that patient’s own stem cells? In the coming months, the D.C. Circuit Court of Appeals will hear oral arguments on this very issue in United States v. Regenerative Sciences.
On May 29th, HHS issued the final rule governing wellness incentives in group health plans. While the incentives themselves are not a surprise, the scope they are given is worthy of ongoing attention. Wellness incentives have been controversial because of their potential for intrusion into individual choice, their subtle (or not so subtle) coerciveness, their valorization of a particularly model of health, and the possibility that they will impose differential burdens and costs on people with disabilities or other disfavored groups. The final rule attempts to meet these objections in several helpful ways.
Nonetheless, the final rule still will allow programs that are differentially burdensome as a result of factors other than health status. It will also allow programs under which it is more difficult for some than for others to obtain rewards because of their states of health. In programs that give rewards for health outcomes, alternatives must be available for those who do not meet targets—but the reasonableness standard for these alternatives permits requirements that may be differentially burdensome so if they are medically appropriate and follow the recommendations of the patient’s personal physician. HHS supports wellness programs as engaging individuals in their health, as encouraging them in healthy behaviors and discouraging them in unhealthy behaviors, and as incentivizing people to make use of recommended health care services such as screenings. Continue reading
One fear about GMOs is that they will escape whatever controls are placed them and end up in the wild. A version of that story appears to have come true in the wheat industry this week, when the USDA announced that farmers in Oregon had discovered an unexpected and unapproved patch of Roundup-Ready genetically modified wheat in a conventional wheat field. Monsanto developed Roundup-Ready wheat (which is not resistant to its Roundup herbicide) and tested it between 1998 and 2005, but it was never approved for sale and was discontinued. Japan has cancelled or suspended orders of wheat from the Pacific Northwest in response.