Research Fellow & Lecturer in Law Kate Greenwood in a Featured Op-ed in Pharmalot on the U.S. Supreme Court and Liability for Defects in Generic Drugs
Filed under: Health Law, Pharma, Uncategorized
Research Fellow & Lecturer in Law Kate Greenwood published a Featured Op-ed in Pharmalot on the U.S. Supreme Court and the prospect of liability for personal injury from defects in generic drugs. In “Betting on Liability for Generic Defects,” Ms. Greenwood writes:
As reported on Pharmalot, the US Supreme Court has agreed to review the First Circuit Court of Appeals’ decision in Mutual Pharmaceutical Company v. Bartlett that federal law did not preempt a New Hampshire jury’s determination that the generic drug sulindac had a “design defect” and so should have been recalled (back story with briefs).
It is highly likely that the Supreme Court will reverse the First Circuit’s decision, and, in so doing, confirm that manufacturers cannot be held liable for failing to re-design or recall unsafe generic drugs, just as they cannot be held liable for failing to update the labeling of such drugs. The ball will then be in Congress’ court to fill the resulting postmarketing safety gap.
As the First Circuit explained in the Bartlett decision, New Hampshire law provides that a drug has a design defect “‘if the magnitude of the danger outweighs the utility of the product.’” At trial, plaintiff Karen Bartlett’s expert testified that sulindac met this standard and the jury agreed, finding Mutual Pharmaceutical liable for selling a product with a defective design and awarding Bartlett over $21 million for the horrific SJS/TEN-related injuries she suffered after taking sulindac.
Read more in the feature Op-ed, “Betting on Liability for Generic Defects.”
Filed under: Cost Control, Private Insurance, Treatment, Uncategorized
The degree of effort put into selecting health care professionals varies among consumers. For instance, many relatively young users of health care may only go through the motions of selecting a primary care physician, whom they may seldom visit, and never investigate specialists that provide more particularized care. A recurring question, however, amongst more frequent health care consumers is “who provides the best care?” As consumers become older, mature, develop ailments more frequently, and raise families, this question becomes asked more and more frequently. Where is such a consumer to look for reliable information? Yes, rating systems of health care professionals are available. But the objectivity of such systems is often questioned because of the agenda of those developing the rating systems. For instance, Andrew Cuomo, the former New York Attorney General, injected New York State into the practices through which an insurance company rated the health care providers in its network. The concern identified by the Attorney General’s office was that insurance companies would rate health care providers based upon their ability to provide care cheaply, rather than on their ability to provide quality care. This concern stemmed from the undeniable profit self-interest of the insurance company. However, was such a stance by the now Governor necessary or appropriate? I think not.
Determining the quality of care delivered by a health care provider is an inherently subjective task. The outcomes of individual patients will depend upon a multitude of factors, many of which are out of the control of the provider. Different patients will react differently to different treatments because of their unique physiology. The same ailment will have indiscernibly progressed to varying degrees in different patients. A doctor could follow all the proper protocols, provide the care called for (i.e., satisfy the standard of care), yet a poor outcome could nonetheless result. The outcome in these instances is largely the result of the “luck of the draw” with respect to a patient pool. Thus, trying to determine which doctors provide the best care is inevitably a limited, if not fruitless, endeavor.
Additionally, a mechanism is already in place to ensure that substandard doctors are not practicing. The training to become a doctor and the required certifications to practice serves as the screening mechanism to ensure that health care providers have the requisite skill to perform their trade. So long as doctors are meeting this minimum established by their field, patients should be led to believe in the ability of those doctors to provide adequate care. Ranking doctors based on outcomes naturally leads consumers to believe that entry level standards are watered down such that doctors “at the bottom” are not competent to perform; which is simply not the case.
Finally, ranking doctors based upon efficiency or cost factors serves a valid societal purpose. Firstly, putting utility aside, such metrics are readily quantifiable, accurate, and objective. And with respect to utility, many patients want efficiency. An efficient doctor is, it would seem, much less likely to engage in “defensive medicine.” For a time pressed patient, as many of us are, reassurance that our time will not be wasted with unnecessary tests and precautions holds real value. And on a societal level, it is obvious that health care costs are out of control. I have recently been put in a position where I must acquire a policy for my family on the open market (I am leaving a secure government position with subsidized health benefits for a position as a law clerk with a small law firm, which does not extend health benefits to its clerks). My monthly contribution is currently $330 for a health plan with no deductible and $20 co-pays. It appears as though my best option on the open market is a $1200/month plan, with a $1,000 deductible. My family is young and healthy. Our annual doctor visits consist of well visits, totaling approximately $1,000 in total costs. With this in mind, if insurance companies can encourage the use of efficient providers (who have been vetted by their profession as proficient at what they do), then this practice should be encouraged. A “high efficiency” network at a reasonable cost would certainly perform well on the open market, particularly among us consumers that don’t actually anticipate using their policies. Health care is or will be a significant factor in everyone’s life at some point. However, if we can prevent it from becoming the driving financial concern among the middle class, that would appear to be a worthy cause.
Adam Peterson is a third-year evening student at Seton Hall University School of Law. He received his B.S. in Conservation Biology from the State University of New York College at Cortland in 2007. Since that time he has worked for the New York State Department of Environmental Conservation as an Environmental Analyst, reviewing development projects for compliance with New York State environmental regulations.
Image by Ludraman.
Filed under: Seton Hall Law, Uncategorized
We are pleased to introduce and welcome Professor Zack Buck to Health Reform Watch. He is a Visiting Assistant Professor here at Seton Hall Law and specializes in various health law topics, focused primarily on issues surrounding mental health law and public health law. Professor Buck teaches health law courses, including mental health law and healthcare fraud and abuse. He holds a J.D. from the University Pennsylvania Law School (2009), a Masters of Bioethics from the University of Pennsylvania (2009), and a B.A. with highest distinction, in Political Science and Journalism, from Miami University (2006). Prior to joining Seton Hall, Professor Buck was a litigation associate at Sidley Austin LLP in Chicago. He is a member of the bar of Illinois (2009) and is a former legal writing instructor at Penn Law (2008-09).
His first post, ACA Litigation, Implications for Medicaid and Mental Health Care, may be found below.
ACO Symposium: Professor Tim Greaney to Present Accountable Care Organizations: A New New Thing with Some Old Problems
In conjunction with the Center for Health & Pharmaceutical Law & Policy, this year’s Seton Hall Law Review Symposium on October 28, 2011, will explore recent changes in the structure of health care delivery, in particular the rising popularity of Accountable Care Organizations (ACOs). For more information or to register, click here.
The keynote speaker will be Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers, and legal scholars and practitioners from around the country will present panel discussions on structural development, public health implications and lessons learned from state ACO programs. One such distinguished presenter is Thomas Greaney, Chester A. Myers Professor of Law and Director, Center for Health Law Studies, Saint Louis University School of Law, who has been a frequent contributor to HRW, will take part in the panel on “ACOs in Practice: Research on Current Implementation of ACOs,” and will be presenting Accountable Care Organizations: A New New Thing with Some Old Problems.
A nationally recognized expert on health care and antitrust law, Professor Thomas (Tim) Greaney has spent the last two decades examining the evolution of the health care industry and is a vocal advocate for reforming the health care system and protecting consumers. He also has a strong interest in comparative antitrust law, having been a Fulbright Scholar in Brussels and a visiting lecturer at several European law schools.
After graduating from Harvard Law School, Greaney began his career as a legislative assistant on Capitol Hill and as a law clerk with the Federal Communications Commission. He then moved on to the Antitrust Division of the U.S. Department of Justice where he was a trial attorney and became the assistant chief in charge of antitrust matters in health care. His career at Justice spanned ten years and involved him in civil and criminal antitrust litigation in health care, banking, communications and other regulated industries as well as policy formulation and legislative matters.
Greaney came to SLU LAW in 1987 after completing two fellowships and a visiting professorship at Yale Law School. Professor Greaney became Chester A. Myers Professor of Law in 2004 and was named Health Law Teacher of the Year by the American Society of Law, Medicine and Ethics in 2007. His academic writing has been recognized six times by the Thompson Coburn Award for SLU Faculty scholarship.
Professor Greaney’s extensive body of scholarly writing on health care and antitrust laws encompasses articles published in some of the country’s most prestigious legal and health policy journals. Professor Greaney has authored or co-authored several books, including the leading health care casebook, Health Law. A frequent speaker in academia and the media, Professor Greaney has also offered expert testimony at hearings sponsored by the Federal Trade Commission on the issues of applying competition law and policy to health care, and submitted invited testimony to the U.S. Senate on competition policy and health care reform.
I just wanted to introduce a new feature on Health Reform Watch: Recommended Reading. We will be posting short descriptions and recommendations of selected health law scholarship. Our aim is to give readers article abstracts and a brief account of why we thought the article was interesting and useful. Inspired by Larry Solum’s Legal Theory Blog and Michael Froomkin’s Jotwell initiative, our goal is to help readers find particularly insightful pieces in an era of information overload. My colleague Kathleen Boozang’s post on recommended nonprofit and tax law scholarship is the first in the series; we’ll be adding categories in health care finance & regulation and bioethics soon. If you have any recommendations for the Recommended Reading series, feel free to email me or comment below.