Wednesday, March 4, 2009

Supreme Court Rejects Drug Manufacturer Claim that FDA Precludes More Stringent Label Warning

Wyeth v. Levine, No. 06-1249 (U.S. Mar. 4, 2009)  Findlaw Link

 

Petitioner Wyeth manufactures the antinausea drug Phenergan. After a clinician injected respondent Levine with Phenergan by the "IV-push" method, whereby a drug is injected directly into a patient's vein, the drug entered Levine's artery, she developed gangrene, and doctors amputated her forearm. Levine brought a state-law damages action, alleging, inter alia, that Wyeth had failed to provide an adequate warning about the significant risks of administering Phenergan by the IV-push method. The Vermont jury determined that Levine's injury would not have occurred if Phenergan's label included an adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as a professional musician. Declining to overturn the verdict, the trial court rejected Wyeth's argument that Levine's failure-to-warn claims were pre-empted by federal law because Phenergan's labeling had been approved by the federal Food and Drug Administration (FDA). The Vermont Supreme Court affirmed.

Held: Federal law does not pre-empt Levine's claim that Phenergan's label did not contain an adequate warning about the IV-push method of administration. Pp. 6-25.

     (a) The argument that Levine's state-law claims are pre-empted because it is impossible for Wyeth to comply with both the state-law duties underlying those claims and its federal labeling duties is rejected. Although a manufacturer generally may change a drug label only after the FDA approves a supplemental application, the agency's "changes being effected" (CBE) regulation permits certain preapproval labeling changes that add or strengthen a warning to improve drug safety. Pursuant to the CBE regulation, Wyeth could have unilaterally added a stronger warning about IV-push administration, and there is no evidence that the FDA would ultimately have rejected such a labeling change. Wyeth's cramped reading of the CBE regulation and its broad assertion that unilaterally changing the Phenergan label would have violated federal law governing unauthorized distribution and misbranding of drugs are based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. It is a central premise of the Food, Drug, and Cosmetic Act (FDCA) and the FDA's regulations that the manufacturer bears responsibility for the content of its label at all times. Pp. 11-16.

     (b) Wyeth's argument that requiring it to comply with a state-law duty to provide a stronger warning would interfere with Congress' purpose of entrusting an expert agency with drug labeling decisions is meritless because it relies on an untenable interpretation of congressional intent and an overbroad view of an agency's power to pre-empt state law. The history of the FDCA shows that Congress did not intend to pre-empt state-law failure-to-warn actions. In advancing the argument that the FDA must be presumed to have established a specific labeling standard that leaves no room for different state-law judgments, Wyeth relies not on any statement by Congress but on the preamble to a 2006 FDA regulation declaring that state-law failure-to-warn claims threaten the FDA's statutorily prescribed role. Although an agency regulation with the force of law can pre-empt conflicting state requirements, this case involves no such regulation but merely an agency's assertion that state law is an obstacle to achieving its statutory objectives. Where, as here, Congress has not authorized a federal agency to pre-empt state law directly, the weight this Court accords the agency's explanation of state law's impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness. Cf., e.g., Skidmore v. Swift & Co., 323 U. S. 134. Under this standard, the FDA's 2006 preamble does not merit deference: It is inherently suspect in light of the FDA's failure to offer interested parties notice or opportunity for comment on the pre-emption question; it is at odds with the available evidence of Congress' purposes; and it reverses the FDA's own longstanding position that state law is a complementary form of drug regulation without providing a reasoned explanation. Geier v. American Honda Motor Co., 529 U. S. 861, is distinguished.  Pp. 17-25.

March 4, 2009 in Cases | Permalink | TrackBack (0)

Tuesday, March 3, 2009

Columbia Basin Bulletin e-book on Columbia River salmon lititation

I'm not a big fan of paying for PDFs, but here's a resource that students of the Columbia River salmon litigation should be aware of. CBB link If you're not familiar with CBB, go take a look.  You can sign up for their free weekly newsletter and you can subscribe to their archives.

Salmon and Hydro

An Account of Litigation over Federal Columbia River Power System Biological Opinions for Salmon and Steelhead, 1991-2009

First Edition, February 2009

A NOAA Fisheries "biological opinion" is the federal government's primary guide for recovering13 species of Columbia River Basin salmon and steelhead listed under the Endangered Species Act . A "BiOp" must insure that these ESA-listed fish survive and thrive in the Columbia/Snake River Basin hydropower system . Yet, since the first salmon ESA-listings in 1991, these biological opinions have been the subject of continual litigation. It is in federal court where one sees most clearly the divisions and difficulties of Columbia Basin salmon recovery. This issue summary offers a historical account of this continual litigation since the first ESA listings and summarizes the major issues that have dominated Columbia Basin Salmon recovery since 1991.

Salmon and Hydro: An Account of Litigation over Federal Columbia River Power System Biological Opinions for Salmon and Steelhead, 1991-2009, a 77-page document in an easy-to-read Adobe PDF format, is available for digital download through our secure payment system. Price: $19.95

 


Salmon and Hydro book
 

 

TABLE OF CONTENTS

For Excerpts Click These Links:

INTRODUCTION

 

I. 1991-1995: Three ESA Listings, Four Biological Opinions, Five Court Challenges

II. 1995-1998: Reasonable And Prudent Alternatives, Spread The Risk, Long-Term Configuration, Adaptive Management; River Governance; Regional Parties Stake Their Positions; A BiOp Finally Passes Legal Muster

 

III. 1998-1999: More ESA Listings; A Supplemental Steelhead BiOp Guiding River Operations; Independent Science Advisory Board Weighs In On Smolt Transportation; Appeals Court Upholds 1995 BiOp; Supplemental BiOps On New Listings, Snake Water

IV. 1999-2004: Not Just Hydro, But All The ‘Hs’; Recovery In 48 years?; Mitigation Must Be Certain To Occur; Another BiOp Bites The Dust; A Remand; Corps Rules On Snake River Dam Removal

V. 2004-2008: A New BiOp Says No Jeopardy From Hydro Operations; A New ‘Environmental Baseline’; Redden Says No Again; Discretionary Actions vs. Non-Discretionary (Dams’ Existence); Court Runs The River; Upper Snake River Gets Own BiOp

VI. 2008-2009: A ‘Collaborative’ BiOp; New Fish Funding Agreements, New BiOp Support; Montana Finally Likes The Reservoir Plan; Earthjustice Says New Approach Inadequate; Oregon Left As Only State Opposed To BiOp; Should Independent Scientists Evaluate BiOp?; Parties To Litigation Grows; Clean Water Act Now An Issue; A New Round Of Briefings

VII. Conclusion: Rushing To Redden’s Finish Line

March 3, 2009 in Biodiversity, Cases, Energy, Environmental Assessment, Governance/Management, Law, Sustainability, US, Water Quality, Water Resources | Permalink | TrackBack (0)

Obama Directs Agencies to Consult with FWS and NMFS on Endangered Species

President Obama today told federal agencies to consult with the expert fish and wildlife agencies concerning whether a decision may affect threatened or endangered species.  The memorandum effectively suspends a December 2008 rule issued by the Bush administration, which waived requirements that agencies like the Army Corps of Engineers consult with experts at the Fish and Wildlife Service or the National Marine Fisheries Service when deciding whether projects like building dams affect threatened or endangered species.  Today’s decision did not throw out the Bush administration rule, which had prompted lawsuits from California and a number of environmental groups. Instead, Mr. Obama asked that the secretaries of commerce and the interior “review” the Bush regulation and determine whether new rules are needed.  “Until such a review is completed,” Mr. Obama wrote, “I request the heads of all agencies to exercise their discretion, under the new regulation, to follow the prior longstanding consultation and concurrence practices” involving the Fish and Wildlife Services and the National Marine Fisheries Service. 

The text of the memorandum appears below:


THE WHITE HOUSE

Office of the Press Secretary
________________________________________________________________
For Immediate Release                  March 3, 2009

March 3, 2009

MEMORANDUM FOR THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES

SUBJECT: The Endangered Species Act

The Endangered Species Act (ESA), 16U.S.C. 1531 et seq., reflects one of the Nation's profound commitments. Pursuant to that Act, the Federal Government has long required a process of broad interagency consultation to ensure the application of scientific and technical expertise to decisions that may affect threatened or endangered species. Under that interagency process, executive departments and agencies (agencies) contemplating an action that may affect endangered or threatened species have long been required, except in certain limited circumstances, to consult with, and in some circumstances obtain the prior written concurrence of, the Fish and Wildlife Service (FWS) and/or the National Marine Fisheries Service (NMFS)-- the expert agencies that have the primary responsibility to ensure that the ESA is implemented in accordance with the law.

On December16, 2008, the Departments of the Interior and Commerce issued a joint regulation that modified these longstanding requirements. See 73Fed. Reg. 76272. This new regulation expands the circumstances in which an agency may determine not to consult with, or obtain the written concurrence of, the FWS or NMFS prior to undertaking an action that may affect threatened or endangered species. But under the new regulation, agencies may continue the previous practice of consulting with, and obtaining the written concurrence of, the FWS and NMFS as a matter of discretion.

I hereby request the Secretaries of the Interior and Commerce to review the regulation issued on December16, 2008, and to determine whether to undertake new rulemaking procedures with respect to consultative and concurrence processes that will promote the purposes of the ESA.

Until such review is completed, I request the heads of all agencies to exercise their discretion, under the new regulation, to follow the prior longstanding consultation and concurrence practices involving the FWS and NMFS.

This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. Agencies shall carry out the provisions of this memorandum to the extent permitted by law and consistent with statutory authorities.

The Secretary of the Interior is hereby authorized and directed to publish this memorandum in the Federal Register.

 

                  BARACK OBAMA

March 3, 2009 in Biodiversity | Permalink | TrackBack (0)

Monday, March 2, 2009

Times They are a Changing.... Way Faster Than We Thought

About 3 years ago, my blog began posting all climate change research I could find in hopes of convincing my peers and readers that climate change was real and needed to be placed at the top of our collective political/social agenda.  It was leading edge research, even though the message had been blaring at us for more than a decade. 

In the past year or two, the focus of my efforts has shifted a bit.  As American society seemed to appreciate the reality of climate change, I shifted to blogging about research on climate change impacts, the emissions reductions necessary to minimize those impacts, and the policy tools available to reduce emissions --  in hopes of highlighting the dramatic environmental impacts already occurring due to climate change and the danger that we are reaching climate tipping points.

What has become apparent is the potentially devastating inadequacy of global emission reduction goals currently being discussed in Congress and in international treaty discussions. We don't just need to reduce our 1990 emissions by 80% (the most radical goal that has been part of the political discussion), we don't just need to go carbon neutral (the most radical goal that individuals and institutions have set), we need to become carbon negative -- we need to reverse the impact of human activity on the global climate....and fast.

Let's be clear....we need to act immediately, we need to make dramatic changes, and we can ill afford to allow the smoke and mirrors of commentators in the pocket of the energy business to sidetrack the discussion.  What the industry claims is an adequate response, or the most we can afford, or the most supported by the current science, or the most that the technology can achieve now should be viewed with well-founded skepticism. 

Since 1970, industry has repeatedly claimed with respect to a wide variety of environmental problems that we didn't yet have the technology, that the costs outweighed the benefits, that we couldn't afford the price tag, that jobs were being lost, and other hogwash about environmental protection.  They did so with knowledge of technologies in their pocket, awareness they were inflating costs and minimizing benefits, attributing job losses caused by changing technology to the environment, and placing more emphasis on profits and  maintaining the size of their bonuses than on creating a sustainable society.

I make this claim as one who has always been reluctant to classify myself as an environmentalist because my experience with industry and government was broader and deeper than my involvement with any environmental group.  That remains the case even today.  But enough is enough! We have a true crisis.  We need great courage to deal with that crisis, particularly with the shape of the global economy left to us by our neoliberal friends. 

This article from ENS and the reports I have linked to below underscore the problem:

Climate Tipping Point Near Warn UN, World Bank  ENS link

Link to World  Bank report referenced in ENS story

Link to UNEP Annual Report referenced in ENS story

The planet is quickly approaching the tipping point for abrupt climate changes, perhaps within a few years, according to the UN Environmental Programme's newly released 2009 Year Book and a separate World Bank report now being presented throughout Latin America.

The UN agency warns that urgent action is needed to avoid catastrophic climate events such as major food and water shortages, shifts in weather patterns, and destabilization of "major ice sheets that could introduce unanticipated rates of sea level rise within the 21st century."

The report warns that climate changes are occurring much faster than anticipated by the latest Intergovernmental Panel on Climate Change report, issued in 2007.

While earlier estimates forecast up to half a meter (19.5 inches) risein sea level in the coming century, updated calculations suggest that the rise may be as high as two meters (78 inches). 

Melting ice sheets and glaciers in the northern and southern hemispheres will not only contribute to sea level rise, but will also leave many regions around the world without basic water resources for human consumption and industrial production.

In its new report[entitled "Low Carbon, High Growth: Latin American Responses to Climate Change,"] the World Bank focuses on four climate impacts of special concern: "the warming and eventual disabling of mountain ecosystems in the Andes; the bleaching of coral reefs leading to an anticipated total collapse of the coral biome in the Caribbean basin; the damage to vast stretches of wetlands and associated coastal systems in the Gulf of Mexico; and the risk of forest dieback in the Amazon basin."

Last week, World Bank climate experts presented devastating news to an audience in Lima, Peru - glaciers in the Andes mountain range may disappear within the next 20 years unless immediate action is taken to mitigate climate change.  In the past 35 years, Peruvian glaciers have shrunk by 22 percent, resulting in a 12 percent reduction in freshwater for the coastal area, the home of about 60 percent of the country's population. Bolivia and Ecuador, which depend on nearby glaciers for water, also are facing serious shortages....

The damage from hurricanes and tropical storms will increase, the WorldBank reports. Estimates suggest that losses from hurricane damage along the coasts of the Gulf of Mexico "could increase tenfold from 2020 to 2025.  In Central America and the Caribbean, losses will triple or quadruple, respectively, in the same period," said World Bank economist John Nash, who presented the report in El Salvador.

Continue reading

March 2, 2009 in Climate Change | Permalink | TrackBack (0)

The New Subsistence Society

Sometimes its a good idea to stand back and contemplate the universe.  Today's early news that the Dow Jones Industrial Index took another header because of AIG's $60+ billion loss prompts me to do that. 
Dow_3209
What is the vector of our society?  What will it look like after all the dust has settled?  It is not just the financial crisis that prompts me to contemplate this.  Although the phrase is over-used, we are in the midst of a perfect storm -- a global economy that creates and distributes goods and services through the internet, computerized machines and cheap labor virtual collapse of the financial system, the advent of peak oil, and the climate crisis.  How will all of these things cumulatively affect our future?

We've lived with the first problem for decades now -- what do people do as they  become less and less important to production of goods and services.  The science fiction of our times: what happens when people and their primary asset, labor, becomes virtually superfluous.  Certainly countries with high labor costs relative to Asia and South America already are beginning to experience the problem.  Computerized machines can plant, water, and harvest the fields; robots can make the cars and prefabricated housing; department stores, bank branches, car dealers, even retail grocery stores can be replaced by internet marketing; 100 law professors lecturing to law students and 1000 college professors lecturing to college students is more than enough -- creating the prospect of a British or continental education system, with those professors raised to unseemly heights and the remainder left to do the grunge work of tutors; even more radically, 100 K-12 teachers can teach a nation of students with computer graded exams, if we believe that convergent answers are the goal of education; priests and ministers can be replaced by TV showmen and megachurch performers. 

So what do the other 6.95 billion of us do?  Now, we consume.  Voraciously.  If we don't, then the basics can be provided by a very few and the rest of us become unwanted baggage.  A non-consumer is a drag on the system.  We depend on the velocity of money, excess consumption, and inefficiency to provide each of us with a job and to maintain the current economy.

And what happens when money moves at a crawl, when people stop consuming, when production becomes life-threatening to the planet, and when a key resource for production, oil, reaches the point of no return???  The answer is a new subsistence economy.  A new world where a few are need to produce, a few more can consume, and the remainder have no economic role and are left to subsist as best they can.

Admittedly, it will be subsistence at a higher level -- through the internet, computerization, and technology, each of us will have the capacity to do things for ourselves that are beyond the imagination of today's impoverished subsistence farmers.  But, relative to those who own all of the means of production, a few entertainers (be they basketball players, lecturers, moviestars, or mega-church leaders), and a few laborers (building the machines, computers, the information infrastructure and doing basic and applied research), we will all be poor.  Perhaps only relatively and perhaps only in material terms.  But poor, living at a subsistence level, consuming food from our own gardens, building our own houses, wearing clothes for function not fashion, educating our own children through the internet, capturing essential power through distributed energy, and buying very little of goods that are bound to be too expensive for most -- probably just computers.  It won't necessarily be bad.  Perhaps we can refocus on relationships, family, community, art, music, literature, and life, rather than define ourselves in terms of our job and our things.  Perhaps we can refocus on spirituality instead of materialism. Who knows?  Maybe the new society won't be such a bad thing after all -- at least if we insist that the few who have the privilege of production have a responsibility to share the wealth with the many.

March 2, 2009 in Africa, Agriculture, Air Quality, Asia, Australia, Biodiversity, Cases, Climate Change, Constitutional Law, Economics, Energy, Environmental Assessment, EU, Forests/Timber, Governance/Management, International, Land Use, Law, Legislation, Mining, North America, Physical Science, Social Science, South America, Sustainability, Toxic and Hazardous Substances, US, Water Quality, Water Resources | Permalink | TrackBack (0)