Faculty Scholarship updates
BU Law Welcomes Visiting Professor Kathryn Zeiler
BU Law welcomes Kathryn Zeiler, visiting professor for 2013-2014, teaching courses on health law and torts as well as organizing the Law and Economics Workshop Series. She is a professor at Georgetown Law School and co-directs the Georgetown Law & Economics Workshop.
She previously served as a visiting professor at Harvard Law School and New York University School of Law, and has taught law and economics courses at ETH Zurich, Hebrew University, and the Gerzensee Study Center in Switzerland.
Zeiler's research focuses on health care law and economics, medical malpractice liability and insurance, disclosure regulation, experimental economics, and behavioral law and economics.
"Teaching at BU Law has been a true pleasure," she says. "The students are very serious about health law and policy, so I feel like a fish in water. It's been particularly impressive to observe how hard the faculty works to deliver a top-rate legal education to the students. It's clear they are succeeding. The students are not only well trained but also happy to be members of the BU community."
Zeiler earned a B.S. degree from Indiana University, an M.S. in taxation from Golden Gate University, a Ph.D. in economics from the California Institute of Technology, and a J.D. from the University of Southern California.
William Fairfield Warren Distinguished Professor George J. Annas, J.D./M.P.H., has published extensively this year on various ethical questions surrounding current events.
Professor Annas, with Professor Wendy Mariner, co-authored “Limiting ‘Sugary Drinks’ to Reduce Obesity—Who Decides?” (New England Journal of Medicine May 2013). They offer views in support of the New York County Supreme Court’s decision to strike down the New York City Board of Health’s partial ban on selling “sugary drinks,” citing undue legislative interference and the existence of reasonable alternatives to the ban as objections. “Agencies that overstep their bounds,” they write, “or adopt rules that are intrusive or just plain silly invite backlash, which can make effective public health regulation impossible.”
In “Guantanamo Bay: A Medical Ethics-free Zone?” (New England Journal of Medicine June 2013), Annas, Professor Leonard Glantz and Associate Professor Sondra Crosby, M.D., condemn the practice of force-feeding hunger-striking prisoners. They call on American medical professionals to "take constructive political action" against force-feeding competent detainees, holding it "is not the practice of medicine; it is aggravated assault."
Annas argues in "Health and Human Rights in the Continuing Global Economic Crisis" (American Journal of Public Health June 2013) that government spending on public health should not decrease during times of economic crisis. He challenges the International Monetary Fund-inspired economic model and says that population-based prevention programs like vaccination, clean water and sanitation initiatives should, in fact, be "budgetary priority items ... when vulnerable populations are most at risk."
Most recently in February, Annas published "Legally Blind: The Therapeutic Illusion in the SUPPORT Study of Extremely Premature Infants" with Catherine Annas in the Journal of Contemporary Health Law and Policy. The article explores "the recurrent problem of equating research and treatment, and its recurring (but misinformed) rationale—that in practice, informed consent only applies to research, and not treatment."
In the Media
In an NPR interview, Annas examined the ethical issues involved in the case of Jahi McMath, the California teenager kept on a ventilator after she was declared brain dead following a routine tonsillectomy. NPR also consulted Annas on human gene patenting and the organ donor shortage.
A New Yorker article about Five Days at Memorial, a book investigating medical care in the days following Hurricane Katrina, quoted him regarding the dilemmas physicians face during crisis situations.
Additionally, Annas was the featured commentator on the ethics of engineering replacement parts for human bodies and developing a robot-biological cyborg in the British documentary film “The Incredible Bionic Man” (2013), which made its U.S. debut on the Smithsonian channel in October 2013.
In the Classroom
Annas continues to chair the Department of Health Law, Bioethics & Human Rights and teach in the Schools of Law, Public Health, and Medicine, including Health & Human Rights; Public Health Law; and Health Law, Bioethics & Human Rights. He also supervises independent studies in health law.
Together with Professor Mariner, he is completing the second edition of their law school casebook, Public Health Law, for publication in 2014.
Professor Wendy K. Mariner, J.D./LL.M./M.P.H., published "Did Legal Education Fail Health Reform? And How Health Law Can Help" in the Indiana Health Law Review (January 2013). In this article, she demonstrates how modern legal education in general could benefit from the practices of health law education, which is interdisciplinary by nature and emphasizes examining real-world problems in a larger context.
Additionally, Mariner recently co-authored an article, “Limiting ‘Sugary Drinks’ to Reduce Obesity—Who Decides?,” with Professor Annas, which is detailed above.
In November 2013, Mariner presented on why volunteers responding to disasters don’t need special liability laws at the American Public Health Association’s Annual Conference. Her presentation was part of a panel on Myths in Public Health Law, which also featured BU Law Professors George Annas and Leonard Glantz.
In July, she flew to the University of Reading in England to participate in the 4th International Health Law & Bioethics Seminar, a joint project of the Department of Health Law, Bioethics & Human Rights at BU's School of Public Health and the Universidade Nova de Lisboa’s BioLaw Project. Her presentation, entitled “Allocating Responsibility for Health Care Decisions Under the United States Affordable Care Act,” will be published in the Portuguese Journal of Public Health.
This fall, Mariner taught Essentials of Public Health Law at the School of Public Health and Health Law at the School of Medicine. She is currently teaching Legal Strategies to Reduce Health Risks and Health Insurance, Health Reform and the Law in addition to supervising independent studies in health law. She remains director of the joint J.D./M.P.H. program.
Together with Professor Annas, Mariner is completing the second edition of their law school casebook, Public Health Law, for publication in 2014.
In April, Fran Miller ('65) gave the Third Annual Delta Omega Distinguished Lecture at the University of Hawaii’s School of Public Health. Her lecture—entitled “Public Health & Law: Uneasy Alliance or Marriage Made in Heaven?”—explored what happens when public health's focus on population well-being collides with individual rights and personal choices (e.g., HPV vaccination, helmet laws).Professor of Law Emerita
Professor Miller was named faculty lead for the Robert Wood Johnson Scholars in Residence Program, which places master teacher/scholar law faculty in beleaguered and traditionally underfunded state and local public health agencies. The scholars bring expertise to bear on current problems and bring their real-world experience back to inspire their law students to consider careers in public health. The first residencies began in June 2013.
Miller also served as a moderator for a discussion of the film The Descendants for the International Seminar on Law and Film at the University of Hawaii in February of 2013.
In the Media
Miller critiqued Hawaii’s Health Insurance Exchange, the only one in the country set up as a private foundation, in the Honolulu Star-Advertiser. "It may not be working flawlessly (elsewhere), but it's at least working," she said. "It doesn't make sense to me given the lead time they had. It only has two insurance companies in the mix—that's the part that makes it hard to believe."
In November of 2012, Miller weighed in on the issue of regulating compounding pharmacies in relation to the Framingham pharmacy implicated in a national fungal meningitis outbreak. “The irony is you have these people who are subject to far less stringent regulation jumping into the breach and producing an inferior product,” she said in a Boston Globe article.
Peter Paul Career Development Professor Abigail R. Moncrieff's latest American Journal of Law & Medicine article, "The Individual Mandate as Health care Regulation: What the Obama Administration Should Have Said in NFIB v. Sebelius," makes the argument the Obama Administration's lawyers should have made in defense of the Affordable Care Act. She states that comprehensive health insurance policies "play an unusually aggressive regulatory role" in correcting known market failures arising from consumer-directed health care. The article is a fleshed-out, academic version of an argument made in a student-coauthored amicus brief written as part of her Constitutional Health Care Litigation class a few years ago.
Moncrieff serves as a reviewer and commentator for CHEST magazine, the publication of the American College of Chest Physicians. She recently published three commentaries on the implications of the ACA: "Will My Job Be Safe if I Defend My Patients?: When Patient Advocacy Collides with Employment Law" (with Constantine A. Manthous), "Understanding the Failure of Health-care Exceptionalism in the Supreme Court’s Obamacare Decision," and "Obamacare's (3) Day(s) in Court."
Moncrieff recommends Kenneth Abraham's "Four Conceptions of Insurance" in "Obamacare and the Competing Conceptions of Insurance" (JOTWELL 2013). She lauds his taxonomy, which explicitly names four divergent conceptions of what health care is/should be. Moncrieff believes these conflicting ideas contribute to much of the tension in modern debate surrounding Obamacare and recognizing them will be important in the near future.
Moncrieff examines David Strauss's The Living Constitution in “Common-Law Constitutionalism, the Constitutional Common Law, and the Validity of the Individual Mandate” (Boston University Law Review 2012). She agrees with much of his thesis, but argues that a viable justification for a living constitution needs to embrace and defend the courts’ essentially political nature.
She wrote an essay for the Fall 2013 issue of The Record, BU Law's alumni magazine, titled "Why I Teach: An Answer in Two Parts."
- America's Political Dysfunction: Constitutional Connections, Causes and Cures, Boston University School of Law, November 2013
- Substance as Structure: The Problem with Fundamental Rights Theory, University of Virginia Faculty Workshop, October 2013
- Elhauge, Originalism, and the ACA: The Trouble with Popular Constitutionalism,Tulsa Law Review Symposium Honoring Einer Elhauge, October 2013
- When the Tenth Justice Doesn’t Bark: The Unspoken Freedom of Health Holding in NFIB v. Sebelius, Boston University Faculty Workshop, April 2013
- Health Insurance as Health Care Regulation: Why the Regulatory Nature of Insurance Should Have Mattered, But Didn’t, in the Obamacare Litigation, Boston University School of Management and Health Policy Institute, November 2012
Professor Kevin Outterson was appointed by Massachusetts Governor Deval Patrick to a special commission to review the regulation of compounding pharmacies following the 2012 deadly meningitis outbreak linked to the New England Compounding Center. He called for stricter federal regulation on compounding in two recent New England Journal of Medicine articles—"The Drug Quality and Security Act: Mind the Gaps" and "Regulating Compounding Pharmacies after NECC." Additionally, he has been interviewed frequently in the media—including the New York Times, Forbes, the French publication L’Hebdo, and NPR—on the subject.
Outterson was recently named a Visiting Fellow at the Royal Institute for International Affairs, at Chatham House, a leading think tank in Europe. He will work on antibiotic innovation models for the European Union.
He continues to pursue his research interest in antimicrobial resistance and, in February, presented a paper, "New Business Models for Sustainable Antibiotics," at the Petrie-Flom Health Law Workshop at Harvard Law School. He also has recently published several articles on the subject:
- "Preventing Untreatable Bacterial Infections: New Business Models for Sustainable Antibiotics," Chatham House Centre on Global Health Security Working Group Papers (London, Jan. 2014)
- "Approval and Withdrawal of Antibiotics and Other Antiinfectives in the US, 1980-2009," 41(3) J.L. MED. & ETHICS 688-696 (2013) (with Powers, Seoane-Vazquez, Rodriguez-Monguio, & Kesselheim)
- "All Pain, No GAIN: Need for Prudent Antimicrobial Use Provisions to Complement the GAIN Act," 30:1 APUA Clinical Newsletter 13 (2012)
- "Combatting Antibiotic Resistance Through the Health Impact Fund," with T. Pogge & A. Hollis, in The Globalization of Health Care: Legal and Ethical Issues, Glenn I. Cohen, ed., Oxford University Press (2012)
Building on their experience with an influential amicus brief in the ObamaCare cases in the Supreme Court, Professor Outterson published a detailed critique of the Court's view on federal coercion in the Medicaid program: "Plunging into Endless Difficulties: Medicaid and Coercion in the Healthcare Cases," 93 B.U. L. REV. 1 (2013) (with Huberfeld & Leonard).
Outterson recently participated on two panels regarding tobacco legislation. At Boston University, he was a panelist on “The Future of Global Tobacco Control: Current Constitutional and Treaty-Based Challenges,” hosted by the American Journal of Law & Medicine. At Harvard Law School he was a panelist for “Tobacco and Obesity Policy and the First Amendment," co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, and the New England Journal of Medicine.
Additionally, Outterson blogs at The Incidental Economist, a health policy blog with over a million views per year. He received tenure this year and served as a visiting professor in fall 2013 at the University of Iowa College of Law.
One of two universities in New England to offer distinctive program
Boston University will begin offering a six-year Doctor of Medicine (M.D.) and Doctor of Law (J.D.) degree through a joint program between two of its most prestigious professional schools—the Schools of Law and Medicine. With the implementation of this new dual degree in fall 2014, BU joins Yale as the only two universities in New England to offer this distinctive program.
The complex interactions of medicine and law combined with changes to health policy and government regulation and mandates have created a need for individuals trained in the nuances of each of the areas. Today those trained as both physicians and lawyers may find themselves at the juncture of these forces. Career paths for those holding both degrees may include working in health care administration, on a wide array of health law issues including legislation and programs to end health disparities, on intellectual property issues related to medical research and technologies, or in areas such as medical licensing.
“From the implementation of the Affordable Care Act to patenting innovations in biotechnology to managing the growing complexities of health care organizations, the legal and medical fields have become increasingly intertwined,” says BU School of Law Dean Maureen A. O’Rourke. “We want to prepare future leaders who can manage the rapid changes that are happening in these interdisciplinary fields.”
Students earn both degrees one year sooner than they would if they pursued them independently.
The program is conducted under the auspices of both Schools with simultaneous admission to both required for acceptance into the program. Matriculating students will be advised by faculty members from both Schools.
Consistent with other M.D./J.D. programs, students will complete the required coursework in both schools over the six years. This will begin with the first three years of medical school, including the eight core clerkships, to gain a foundation of clinical medicine. It then will proceed with the required 58 credits of courses in law over the next two years, and in the final year combine medicine and law electives consistent with the area of concentration of the student’s choice.
“This degree, which combines medical and legal expertise, is excellent preparation for students considering hospital or health care system leadership opportunities or careers in medical policy and academic administration. By collaborating across the University with our outstanding law school colleagues, we believe that we have designed what will become one of the highest quality, most comprehensive and sought-after M.D./J.D. programs in the U.S.,” says BU School of Medicine Dean and Medical Campus Provost Karen Antman, M.D.
Applications to the program will be accepted in spring 2014.
Professor says public health requires immediate action in state legislation, FDA enforcement, and provider vigilance
Governor Deval Patrick appointed BU Law Professor Kevin Outterson to a special commission of experts and policy-makers to provide recommendations for improving the regulation of these facilities, which alter drugs to fit unique patient needs (e.g. removing ingredients due to allergies).In fall 2012, a nationwide meningitis outbreak linked to the New England Compounding Center in Framingham, Massachusetts, infected 751 people across 20 states, ultimately killing 64. In response,
An authority on global pharmaceutical markets, Outterson similarly served as an expert witness in an unrelated case in Florida about compounding pharmacies in summer 2012. He has published extensively on the subject. The media—including the New York Times, Forbes, and NPR—continues to rely on his expertise as the federal government ramps up efforts to better moderate compounding.
This November, President Obama signed the Drug Quality and Security Act (DQSA), proposed by Representative Fred Upton of Michigan. Its enactment amends the Federal Food, Drug, and Cosmetic Act (FDCA) to give the Food and Drug Administration more authority to regulate compounding pharmacies, and it purportedly makes it easier to track drugs from these facilities throughout the U.S. supply chain.
In "The Drug Quality and Security Act: Mind the Gaps" (New England Journal of Medicine December 2013), Outterson pokes holes in the bill for falling “short of the mark on both accounts.” Additional, immediate action is needed, he writes, more specifically: “Public health requires new legislation in the states, robust enforcement by the FDA, and greater vigilance for patient safety by plans and providers.”
For one, states will bear a hefty portion of responsibility for enforcing quality standards. Outterson points out that most states traditionally have failed to inspect carefully out-of-state compounders or share enforcement or inspection reports between them. Such is the case with the NECC-linked outbreak, as demonstrated by the fact that the states with the highest fungal meningitis death tolls did not regularly inspect out-of-state compounders. Nor does it necessarily make sense to do so. “We need to protect consumers, but it is inefficient for Massachusetts to try and regulate Tennessee compounders, nor is it easy for Tennessee hospitals try to think about regulating Massachusetts compounders,” Outterson said in an interview with BU Law.
As he outlines in an earlier NEJM article, though the FDA has well-defined authority to regulate drug manufacturing, “compounding falls into a gray area between state and federal oversight.” Certification and licensing for compounders has generally been left to state law, which is discordant with the fact that much of the compounding industry has evolved to industrial-scale national business. The FDA attempted to police these larger operations with the Compliance Policy Guide in 1992, but it was met with enough criticism that Congress created a safe-harbor compounding statute in 1997, Section 503A of the FDCA.
The Supreme Court initially threw out 503A in Thompson v. Western States Medical Center because it violated compounders’ constitutional rights to advertise their products. This was in place to distinguish drug manufacturers from compounders—theoretically, compounders would not need to advertise their products since traditionally their business was to respond to individual prescriptions.
But the DQSA reinstates Section 503A, minus the advertising restrictions. This means compounders can operate without fear of federal regulation and that “by inference, the FDA has stronger authority to proceed against any compounder that exceeds the limits of Section 503A.” Outterson thus calls for robust enforcement by the FDA and strong support from its stakeholders—e.g., Congress should provide adequate funds for the inspection of compounders that do not register as outsourcing facilities.
That the bill creates an optional new license for these “outsourcing facilities,” aka sterile compounders, is another of Outterson’s critiques. There is little motivation for compounders to seek the license, which would apply tougher (and more costly) standards to holders and require them to report production and sales information to the FDA, as well as pay a user fee for FDA inspections. States must immediately and stringently regulate these unregistered compounders and share their information with each other, Outterson argues.
Finally, Outterson suggests that consumers, providers and health plans could force change by demanding their compounded drugs come exclusively from FDA-registered outsourcing facilities. This would encourage compounders to register with the FDA and prevent their undercutting registered competitors with cheaper products.
Outterson concludes that while the DQSA was a first step toward a safer compounding industry, “states, the FDA, and health care providers and plans [must] act quickly to fill in the gaps left by Congress.”
In one of the country's top cities for health care, BU Law students have the opportunity to apply their legal education to cutting-edge issues in health law and policy through the Health Law Externship program. Participants develop practical lawyering skills and gain greater understanding of the doctrines, substantive laws, and context of health care through live-client and real-life practice experiences working in a Boston biotech firm, health care institution, or health advocacy nonprofit.
Students in the field
Michael Cannella (J.D./M.P.H. '14) Drafts Legislation Allowing Mass. Students to Retain Prior Health Insurance
Michael Cannella (J.D./M.P.H '14) has helped create a new law in Massachusetts before he even graduates from law school.
As a participant in BU Law's American Legislative Practice (ALP) Clinic, Cannella worked with Massachusetts State Senator Mark Montigny’s office as an outside project consultant tasked with writing legislation to address a constituent complaint regarding student health insurance requirements.
"There is nothing that motivates me more than putting in the time to figure out a way to address a problem that is harming the people in my community," he says.
In the clinic, he researched the existing state of the law and reached out to important stakeholders and government agencies to craft a solution. He worked closely with Senator Montigny to draft the statutory language and produced a committee report that explained the drafting choices to garner support for the law.
While some ALP students work in the State House as interns and others work to make changes to existing bills, his particular assignment required him to begin almost completely from scratch.
"Reducing Financial Barriers to Education and Health Services," which retains Cannella’s original title, is an amendment to H. 3452. It addresses an inequity in Massachusetts law that impacted lower-income students as a result of piecemeal health care reforms over several decades.
Cannella explains the complicated history of the Commonwealth’s student health insurance laws:
A hold-over from the Dukakis-era universal coverage plan is the requirement that all persons enrolled as students at institutions of higher learning in the Commonwealth must purchase university-provided health insurance or provide evidence that they were otherwise covered by a comparable health plan. This policy has value in that the Commonwealth is home to a large number of academic institutions and has robust public health insurance programs for residents.
“The concern was that out-of-state students (regardless of their true level of financial support from their parents or family) would file taxes as an individual, claiming that they had little to no income, and potentially qualify for a public health insurance program, despite the fact that the program was not intended for their benefit.
“After the 2006 health care reform law the Health Connector was placed in charge of determining, by regulation, which health plans could relieve a student of the obligation to purchase a student plan. To avoid the potential free-riding problem posed by out-of-state students, the regulations made students ineligible for Commonwealth Care (because they had student insurance as an option), and it prevented persons already on Commonwealth Care from using that insurance to waive out of the requirement to purchase student health insurance.
“The regulations did permit MassHealth coverage to be used as a waiver, but individual academic institutions could determine which of the many insurance policies/types of coverage within MassHealth would be honored for purposes of the waiver. The net result was that, for many of the Commonwealth's lower-income students who worked hard and obtained admission to institutions of higher learning, the cost of attendance included losing health insurance coverage that they would otherwise be entitled to in exchange for demonstrably poorer-quality coverage under the student health insurance plans. Moreover, being lower-income students, the added costs of the student health insurance meant that they would often have to take out student loans to cover the additional $4,000-$8,000 needed to pay four years of premiums at a standard undergraduate program.
Ultimately, "Reducing Financial Barriers to Education and Health Services" and its regulations were released in December 2013. Despite massive changes to the Commonwealth’s public health insurance programs since Cannella first began drafting in fall 2012, the bill retained his proposal that students who had at least one year of coverage prior to enrollment can waive out of the university-provided plans. This both prevents the out-of-state free-riding problem and allows students from Massachusetts who qualify for the MassHealth coverage to retain it while pursuing an education.
“Otherwise, I hope that my committee report, which highlighted the cost to students and the perversity of punishing the Commonwealth's most vulnerable residents for seeking a higher education, proved useful when Senator Montigny and his hard-working staff worked to get the support needed to make this change,” Cannella says.
For someone who would like to practice health policy advocacy, the ALP Clinic was an ideal opportunity to gain valuable on-the-job experience in researching and drafting legislation.
"Classroom time is important,” Cannella explains, “but there is considerable value to having a practical experience that allows you to apply those legal principles and learn about the real-world dynamics of a particular legal field."
Currently, Cannella, who is president of the American Civil Liberties Union student group, is pursuing a dual degree in law and public health. He is a teaching assistant (TA) to Professor Wendy Mariner, which has afforded him the opportunity to deepen his understanding of the legal concepts he teaches while thinking of creative ways to respond to student questions and needs.
"Whether or not you become an educator, a large portion of collaborating in the legal field relies on how well you can teach the other members of your team an area of the law they are not familiar with," Cannella explains.
As a native New Yorker and Mets fan now living in Red Sox territory, Cannella's classroom work and clinic experience will help him reach his career goals of effectively navigating the Commonwealth’s complex legal system.
“The clinic experience gave me a brush with the level of hard work that goes into trying to craft thoughtful and effective new policy. Moreover, I am now more familiarized with the idiosyncrasies of Massachusetts state government.”
Monisha Chakravarthy (J.D./M.P.H. ’14) was standing in line for the scanner in the library when she overheard a student in front of her recommend Fran Miller’s Food, Drug, and Cosmetic Law seminar. The student also mentioned that Professor Miller had an excellent network at the Food and Drug Administration’s Office of Chief Counsel.
“Out of around 100 attorneys, at least seven went to BU Law, and many of them took her class,” Chakravarthy says.
She had first become interested in the FDA during her 1L year, when she heard Abram Barth (J.D. ‘07/M.P.H. ’08), associate chief counsel, speak at a career panel held by BU's Health Law Association. Barth and Chakravarthy met up the following summer and discussed how much he enjoyed his work. “He told me that it was a great place to get excellent legal training as a law school graduate,” she remembers, “in part because of the people, but also because the FDA's public health mission allows it to work on such an array of important and complex issues.”
In fact, Chakravarthy was first drawn to the idea of law school in order to pursue a career where she could impact such issues. As the daughter of two physicians and a neuroscience major at U Penn (with minors in philosophy, English and South Asia studies), she originally thought medicine was interesting. But, she says, “My clinical experiences taught me that there was actually a lot of work to do with regard to better structuring and regulating the way that health care is delivered.”
After college, Chakravarthy studied the classical dance form Bharatanatyam in India as a Fulbright Scholar and applied to law school. In her personal statement, she wrote about BU Law’s top-ranked Health Law Program and how she hoped to create a better health care system for patients.
“The law school has definitely lived up to its reputation as a great institution for legal teaching, and for health law specifically,” she says. But also, “BU provides great resources to help you get connected to the health care world beyond academia.”
Her out-of-the-classroom experiences have been fundamental real-world training for a future career in health law, says Chakravarthy.
During her 1L summer, Chakravarthy encountered foundational legal issues like corporate transactions, contracts, and tax at Mayer Brown and United Technologies Corporation, both of which employed her through a diversity clerkship run by the Charlotte Legal Diversity Committee. “Neither of these experiences were explicitly health-related, but exposure to these areas of law helped me analogize real-world issues that I had seen to the theoretical ones I studied in class in the health care context.”
For her 2L summer, she set her sights on the FDA. Chakravarthy applied for, and earned, a highly coveted internship, only granted to five law students per year, with the FDA’s Office of Chief Counsel.
As a legal intern, she worked with staff attorneys who had questions regarding their regulations, cases, or policies. She researched the Federal Register, case law, and other sources to determine whether the FDA had the authority to regulate a food, drug, biologic, additives, or any of its many regulated products in a particular way.
The experience helped cement her desire to one day be a government attorney influencing health policy. “The FDA attorneys really enjoyed what they did and the people they worked with,” recalls Chakravarthy.
Wanting to gain even more practical experience, Chakravarthy spent her 2L spring semester in an externship at Boston Children’s Hospital under the supervision of the general counsel, Dianne McCarthy (’97), who exposed her to the variety of issues attorneys at large institutions typically would face. In addition to advising doctors, researchers and staff, McCarthy specializes in intellectual property issues, so Chakravarthy got a sneak peek at cutting-edge technology in the pipeline.
“As someone who has grown up around academic medical centers, working in the legal department at Children's was a great way to see another side of a familiar environment.”
As she works to complete both her J.D. and M.P.H. in the next year, Chakravarthy’s schedule is packed with classes and extracurriculars, such as mock trial. She particularly is looking forward to her Health Care Transactions Class, where students analyze real deals within large health care networks with the attorneys who actually worked on them.
And despite being a busy dual degree student, Chakravarthy is always thinking toward the future and her career goals: “Throughout law school I have enjoyed attending the numerous health care-related conferences around Boston and seeing all of the thought-leaders and high-level administrators who can so effectively articulate where we stand with regard to health care delivery. I'm hoping to get there myself one day.”
Greg Pivarnik (’14) is interested in ideas. In his dream world, he would be a philosopher. “The law, to me, is a bit like applied philosophy,” he says. “I like thinking about abstract ideas, and exploring how they play out in the legal and legislative issues of the world we live in.”
It was because of his affinity for big ideas that Pivarnik chose to attend BU School of Law. He received a B.S. in Molecular and Cell Biology from the University of Connecticut, and was interested in the intertwining of the life sciences with intellectual property law.
“I started in science, and I like science,” says Pivarnik, “but I realized that being in the lab for the rest of my life wasn’t for me. I like the bigger picture, and I like talking about it with the inventors and scientists at the forefront of research and determining the implications of scientific advances.”
Pivarnik has found a niche in the law where he can do exactly those things. “At the intersection of health law and intellectual property law, I can participate in deciding the direction of ground-breaking research and shaping the policies that make progress happen. I find that kind of work endlessly intellectually engaging and exciting.”
The robust research industry in and around Boston attracted Pivarnik to the area, and BU’s role in that research, and its strong health and intellectual property law programs, made it the perfect fit for him. He began taking advantage of BU Law’s many opportunities in these fields as soon as possible.
The summer after his first year, Pivarnik took on a position as a research assistant to Professor Michael Meurer, researching patent fees and their effects on the world of research and invention. “Professor Meurer helped me a lot,” says Pivarnik. “He taught me how to think like an economist, which is very helpful in the legal field—a concept of cost and benefits is helpful in almost any profession.”
Among his favorite courses was George Annas’ Health Law and Bioethics course. “The kinds of broad-reaching questions we raised in that class have always interested me—questions about the basic rights to health care and responsibility of governments, and how those things play out in the context of Obamacare and other current topics.”
Another course that touched on those far-reaching issues was FDA Law. “The FDA is making a lot of policy decisions, and I like the ethical and philosophical questions that came up in that class. We talked a lot about government regulation versus individual rights.”
During the fall semester of 3L year, Pivarnik found the perfect opportunity to get real-world experience working in his chosen fields: an externship at Boston Children’s Hospital.
Supervised by Dianne McCarthy ('97), the hospital’s general counsel, he helped to oversee research affairs, deal with conflicts of interest, draft contracts, and monitor any litigation that was happening. He also had the opportunity to work in the intellectual property unit, which is separate from the general counsel’s office.
“The externship was certainly one of the most valuable and enjoyable experiences I’ve had,” he says. “I like transactional work, and I was able to really hone my contract drafting skills, for example. The experience was an overall reinforcement of my goal of working in-house, in a job that’s intellectually engaging.
“I got a taste of the path I chose, and it confirmed that it’s the right path for me. And I emerged with an arsenal of real-world knowledge and skills, as well as invaluable networking opportunities.”
Recent health law Events
Meeting the Needs of America's Heroes: A Lifetime and Community Obligation
10th annual Pike Lecture featuring Dr. Jonathan Woodson, Assistant Secretary of Defense for Health Affairs
February 10, 2014
When the bombs went off at the Boston Marathon finish line last April, Jonathan Woodson found himself fielding emails in his Pentagon office from former colleagues in Boston seeking advice on how to care for trauma victims who had lost limbs.
After three years as the top health official for the U.S. Department of Defense, Woodson had seen the synergy between battlefield and civilian medicine from both sides. As a School of Medicine professor of surgery and a vascular surgeon at Boston Medical Center, he had looked to advances in military medicine to inform his own civilian practice.
“There’s a yin and yang” between military and civilian medicine, Woodson said on Monday, when he delivered the 10th annual Pike Lecture on Health Law, hosted by the School of Law and the School of Public Health. “Many of the strategies we have developed to save limbs in wartime have been transferred to civilian practice,” he told his audience.
Improved Health Care at a Reduced Cost: Economic Perspectives on the Patient Protection & Affordable Care Act
A symposium hosted by the American Journal of Law & Medicine
January 24, 2014
As the Patient Protection and Affordable Care Act (ACA) is implemented, states, health care industry stakeholders, employers, and citizens must navigate their way through a challenging new health care market. The administration contends that this new market is the key to improved health at a reduced cost.
Panelists analyzed and discussed wide-reaching economic impacts of the ACA, including impacts on provision of health care services, labor and employment, state Medicaid programs, and the insurance industry.
Universal Health Care Reform in Turkey: Overcoming Legal and Political Barriers
With Turkish Member of Parliament and former Minister of Health Professor Recep Akdağ
October 22, 2013
On October 22nd, BU School of Law hosted Turkish Member of Parliament and former Minister of Health Prof. Recep Akdağ, who discussed the implementation of his ground-breaking health care reform in Turkey.
Akdağ traveled throughout his country when he first became minister of health in 2002, and was struck by the lack of access to quality medical care. Realizing that a new national health care system was desperately needed, he visited countries around the world to examine different reform strategies.
The Future of Global Tobacco Control: Current Constitutional and Treaty-Based Challenges
A symposium hosted by the American Journal of Law & Medicine
January 25, 2013
Many countries have enacted dramatic tobacco control legislation in the past few years, but the industry is ﬁghting back. Battlegrounds include national constitutional laws, bilateral investment treaties, the WTO TRIPS Agreement and domestic IP laws. Recent examples abound, from plain-packaging legislation in Australia to the World Trade Organization’s ruling against the U.S. ban on clove cigarettes.
The nuanced geographic and legal contexts complicate global regulatory control, which plays an important role in advancing global public health in the face of trade-related objections. What are the current legal challenges to global tobacco control regulations, and what additional obstacles lay ahead?
Public health measures are being challenged with an ever-growing array of laws, but common themes emerge across the globe. “The Future of Global Tobacco Control” examined the common denominators faced by several countries with aggressive tobacco control legislation. Special attention was given to cigarette packaging litigation in the U.S. and Australia.