Supreme Court permits Maine Residents to Sue Tobacco Company

Continuing its streak,  of tobacco-related cases this term, the Supreme Court ruled in Altria v. Good that cigarette manufacturers could be sued for their alleged deception concerning the health risks of “light” or “low tar” cigarettes. 

In the past, the Supreme Court has not permitted lawsuits from smokers to go forward on the ground that smokers were not adequately warned about the dangers of smoking. Federal laws passed in 1965, the Federal Cigarette Labeling and Advertising Act, and 1969, the Public Health Cigarette Smoking Act, required warning labels on cigarette boxes.  Accordingly, in 1992 in Cipollone v. Liggett Group, the Court ruled that these laws barred claims from smokers who said they were not warned about the health risks.

This 5-4 ruling suggests that the Court has changed course by permitting individuals to bring suits against cigarette manufacturers for deceptive advertising under state law. 

Many American smokers buy “light” or “low tar” cigarettes for their perceived health benefits relative to regular cigarettes.  When smoked by test machines, the cigarettes produce less smoke, tar, and nicotine.  When smoked by actual smokers, however, the cigarettes yield about the same amount of smoke, tar and nicotine as regular brands. Allegedly, the tobacco industry has known these results for at least 30 years.

Writing for the majority, Justice John Paul Stevens said those who sold products had a “duty not to deceive” the public through their advertising or marketing. Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Stephen G. Breyer joined in the opinion, while Chief Justice John G. Roberts Jr. and Justices Antonin Scalia, Clarence Thomas and Samuel A. Alito Jr. dissented.
Ten years ago, the tobacco industry agreed to a $206-billion Master Settlement Agreement with 46 states to end lawsuits over the health care costs of smoking. That agreement, however, did not block new private lawsuits.  Class-action lawsuits disputing the labeling of cigarettes as “light” or “low-tar” are purportedly set to go forward in Massachusetts, Minnesota and Missouri.

Bush Administration Issued Last-Minute Rule Reinforcing Protections for Health Care Workers’ Conscientious Objections

In the Bush administration’s final days in power, the Bush administration issued a federal rule reinforcing protections for doctors and other health care workers who conscientiously object and refuse to perform abortions or other procedures due to religious or moral objections. 

Under existing federal law, health institutions are not permitted to discriminate against individuals who refuse to perform abortions or refer patients to abortion providers.  According to administration officials, this new rule ensures that federal funds do not go to providers who violate those laws by requiring recipients of federal funding to certify their compliance with laws protecting conscience rights.

Despite multiple laws on the books protecting health providers, the administration argued that the rule was needed “to raise awareness of federal conscience protections and provide for their enforcement.”  Critics say the protections are so broad they limit a patient’s right to get care and accurate information; they fear the rule could make it possible for a pharmacy clerk to refuse to sell birth control pills without ramifications from an employer.

The rule will take effect on Jan. 18, two days before Obama takes office.  The Obama administration could issue new regulations that would trump these recently passed rules.

Scholar’s Corner: Recent Scholarly Works in Global Health Law

 President’s Emergency Plan for AIDS Relief: Health Development at the Crossroads


Lawrence O. Gostin
Georgetown University Law Center – O’Neill Institute for National and Global Health Law; Georgetown University Law Center

JAMA, Vol. 300, pp. 2046-48, 2008
Georgetown University O’Neill Institute for National & Global Health Law Scholarship Paper No. 18

The President’s Emergency Plan for AIDS Relief (PEPFAR) was the largest commitment by any nation to combat a single disease in human history, authorizing up to $15 billion over 5 years. On July 30, 2008, President Bush signed into law the historic reauthorization of PEPFAR, dramatically increasing the financial commitment by authorizing up to $48 billion over 5 years, including $5 billion for Malaria and $4 billion for Tuberculosis. PEPFAR’s global targets are inspiring: treat 3 million people; prevent 12 million new HIV infections, and care for 12 million people, including 5 million orphans and vulnerable children. But, PEPFAR has been mired in controversy. To some, it exemplifies America’s extraordinary compassion and generosity, and to others America’s politicization of public health and unilateral approach to international health. The truth lies somewhere in between. American healthassistance to the developing world stands at a crossroad. As PEPFAR is scaled up, will it provide opportunities to fulfill basic human needs, or will its limited focus pull resources from sustainable, capacity-building support in line with poor country priorities?

Available at SSRN.

Gates Foundation funds global health news coverage

bill_melinda_gatesThe Bill and Melinda Gates Foundation has donated $3.5 million grant to “The NewsHour With Jim Lehrer to help its correspondents produce 40 to 50 reports over three years on malaria, AIDS,  tuberculosis, measles, neglected diseases and other global health issues, reports The New York Times.

The plan is to use the money to produce 40 to 50 documentary-style reports over that time frame, plus online content and a PR effort to put the reports in front of key policymakers, health professionals and others.

“Health stories and international reporting have always been important to The NewsHour and our audience,” said Linda Winslow, executive producer. “Thanks to the support of the Gates Foundation, we now have the resources to give global health the attention it deserves.”

The Gates Foundation has in the past funded health journalism; it donated $6 million to WGBH in Boston for a series on global health; $5 million to Public Radio International, a partnership between American public radio and the BBC; $2 million to the International Center for Journalists to train African reporters; $1.2 million to Harvard for fellowships for health reporters; and $1.6 million to Johns Hopkins to send top editors on a fact-finding trip to poor countries.

US spending on generic drugs drops

generic drugsDue to fierce competition among drug manufacturers and pressure from insurers lowered prices, American consumers and health insurers saved about $1 billion on generic drugs in the past 12 months ending September, reports IMS Health.

According to the report, total spending on generic drugs reduced by 2.7 percent to $33 billion, the biggest decline in at least a decade. Furthermore, the average price pharmaceutical companies charged wholesalers for the generic drugs fell 8 percent while consumer demand increased 5.4 percent.

The IMS Health report said that the trends are likely to rise through 2012 as half the current 20 top-selling drugs get competition from generic copies, which can cost 70 percent less than their brand-name counterparts.

According to the report, the large number of generic drugs flooded the market this year (after patents expired on $16 billion worth of medicines)drove the increase in their use. In addition, low prices for generic medications offered by retailers and pharmacy chains and increased competition among companies that manufacture the treatments led to the savings. Furthermore, the report found that health insurers have encouraged members to use more generic medications.

Murray Aitken, senior vice president for health care insight at IMS Health, said, “We’re seeing the combination of pressure from large retailers to make generics available at ever-lower prices for their customers”.

In an interview with Bloomberg, Aitken said “We are seeing a very significant intensification of price competition among the generic competitors that has resulted in this significant decline in the market. We haven’t seen this in the recent past,”  

According to Bloomberg, President-elect Barack Obama says he wants to expand health- care coverage and reduce costs, partly by increasing the use of generic drugs. Obama also wishes to give Medicare, the U.S. health program for the elderly, authority it now lacks to negotiate prices with drugmakers, which Democrats in Congress say may lower prices further.

The rise in generics was stimulated by the 1984  Hatch-Waxman Act which gives the first generic-maker to copy a drug six months as the exclusive seller. The law also allowed the Food and Drug Administration (FDA) to approve generics without requiring lengthy human tests to prove safety and effectiveness.

Biologic drugs do not face generic competition because U.S. regulators have no legal authority to approve copies. Obama supports making copies of biologic medicines available, and Congress is expected to debate next year how to establish a regulatory pathway to get the products on the market.


Former Senator Daschle Picked by Obama to Reform Health Care

As reported earlier, former Senator Tom Daschle was picked by President Elect Barack Obama to head up the Department of Health and Human Services.   As recently announced, Senator Daschle will also would also be the director of the newly-created “White House Office of Health Reform.”  Mr. Daschle, in Obama’s words, will be the “lead architect” of proposals to expand coverage and rein in health costs.

Jeanne M. Lambrew, a former aide to President Bill Clinton and a former colleague of Daschle’s from the Center for American Progress, will be deputy director of the new office.  Lambrew collaboratedwith Daschle on his book Critical: What We Can Do About the Health-Care Crisis.

Obama’s choice of two authors of Critical, a book that he endorsed, suggests a blueprint for health reform as envisioned by Obama.  Daschle and Lambrew advocate for the creation of a Federal Health Board, an independent entity like the Federal Reserve, that would make coverage decisions for federal health programs–in other words, permit trained and knowledgable experts to make the technical decisions rather than having Congress fight each battle.

Scholar’s Corner: Recent Scholarly Works in Global Health Law

The Ethical Health Lawyer: An Empirical Assessment of Moral Decision Making

Joshua E. Perry, Vanderbilt University Medical Center – Center for Biomedical Ethics and Society

Ilene N. Moore, affiliation not provided to SSRN

Bruce Barry, Vanderbilt University

Ellen Wright Clayton, Vanderbilt University School of Law

Amanda R. Carrico, Vanderbilt University

December 10, 2008


Writing in 1999, legal ethics scholar Brad Wendel noted that “[v]ery little empirical work has been done on the moral decision making of lawyers.” Indeed, since the mid-1990s, few empirical studies have attempted to explore how attorneys deliberate about ethical dilemmas they encounter in their practice. Moreover, while past research has explored some of the ethical issues confronting lawyers practicing in certain specific areas of practice, no published data exists probing the moral mind of health care lawyers. As signaled by the creation of a regular column “devoted to ethical issues arising in the practice of health law” in the Journal of Law, Medicine & Ethics, the time to address the empirical gap in the professional ethics literature is now.

Accordingly, this article presents data collected from 120 health care lawyers. Presenting this population with a number of hypothetical scenarios relating to how they would respond when confronting an ethical dilemma without an obvious solution or when facing a situation in which their personal values were in tension with their professional obligations, this article represents a first step toward better understanding how lawyers who practice in health care settings understand and resolve the moral discomfort they encounter in their professional lives.

Available at SSRN