Another Skirmish in the Preemption War: Does FDA Approval Trump Strict Liability?

by Thomas McGarity | March 12, 2013

Next Tuesday, the Supreme Court will hear oral arguments in Mutual Pharmaceutical Co. v. Bartlett, a case that raises once again the troubling question of whether federal regulatory agencies should trump local juries in common law tort actions.  The precise question at issue is whether the fact that the federal Food and Drug Administration (FDA) approved a name-brand drug many years ago precludes a state court jury from holding the manufacturer of the generic version of that drug strictly liable for damages to patients caused by marketing the drug. 

The plaintiff in this case, Karen Bartlett, visited her doctor in December 2004 complaining of shoulder pain.  Her doctor prescribed Clinoril, one of many non-steroidal anti-inflammatory drugs (NSAID) that are commonly used to treat arthritis, bursitis, and other painful conditions.  When Ms. Bartlett’s pharmacist filled the prescription, however, it gave her the generic version of the drug sulindac, rather than the brand-name drug.  Under federal law, the generic version of sulindac had to be chemically and biologically equivalent to the brand-name version that had been approved by the FDA.

Not long thereafter, Ms. Bartlett developed a horrific disease called SJS/TEN, which caused massive burns over 60-65 percent of her body.  For the next year, her life was, in the words of her surgeon, a “hell on earth” as she spent 100 days in five hospitals and several months in a medically induced coma.  During this time she was fed by ...

There is Now No OIRA Administrator

by Ben Somberg | March 11, 2013
Last week Rena Steinzor wrote here that  the Acting Administrator of the Office of Information and Regulatory Affairs (OIRA), Boris Bershteyn, was approaching a time limit under the Federal Vacancies Reform Act. That law stipulates that a temporary appointee in a Senate-confirmed position can generally serve for no more than 210 days, unless a nomination is pending, which in this case it is not. Where Bershteyn was previously listed as the OIRA Administrator, the White House has now removed his ...

New Report Reveals Human Toll of Relentless Line Speeds in Poultry Plants, as USDA Prepares to Crank Them Up Even Further

by Michael Patoka | March 08, 2013
A report released yesterday by the Southern Poverty Law Center (SPLC) and the Alabama Appleseed Center for Law and Justice offers a devastating glimpse into the world of Alabama poultry workers.  Forced to hang, fold, gut, or slice more than 100 carcasses each minute, these workers suffer injuries at astounding rates:  of the 302 workers interviewed, almost three-quarters have experienced a significant work-related injury or illness, from deep cuts and debilitating hand pain to chemical burns and respiratory problems.  More ...

It's Past Time to Appoint an OIRA Administrator

by Rena Steinzor | March 04, 2013
It has now been nearly seven months since Cass Sunstein left his job as Administrator of the White House Office of Information and Regulatory Affairs (OIRA). Much has happened in that time, most significantly an election that returned President Obama to the White House, but also a growing recognition that whatever second-term accomplishments the President is able to register on climate change and a number of other issues are likely to be brought about through regulation, not legislation. That's precisely ...

Nuclear Power and Clean Energy Policy

by Joseph Tomain | March 01, 2013
As we consider designing a future clean energy policy, nuclear power cannot be ignored because of its near zero carbon emissions even when considering the entire nuclear fuel cycle.  It is also the case that public opinion of nuclear power has been increasingly positive, largely for those environmental reasons, though certainly it decreased after the accident at the Daiichi plant in Fukushima, Japan.  Nevertheless, a strong argument can be made that nuclear power should not be considered as a clean resource ...

Robert Glicksman Testifies in House Hearing on Regulatory Policy

by Ben Somberg | February 28, 2013
CPR Member Scholar Robert L. Glicksman will testify at a hearing this morning of the House Judiciary Committee’s Subcommittee on Regulatory Reform, Commercial and Antitrust Law. The hearing will promote the notion of "The Obama Administration's Regulatory War on Jobs, the Economy, and America's Global Competitiveness" (sounds awfully familiar), and the solution, the majority will say, is a series of anti-regulatory bills (many of which passed the House, but went nowhere in the Senate, in the last Congress). Professor Glicksman’s ...

Natural Gas in the Big Picture:

by Joseph Tomain | February 26, 2013
With advancements in hydraulic fracturing technology, shale gas has dramatically altered domestic energy in the United States.  Some commentators claim that shale gas can address all of our major energy problems. Some consider natural gas a bridge fuel to a clean energy future.  Bills in Congress proposing a federal “Clean Energy Standard” have included natural gas as a qualifying “clean” fuel source. President Obama’s recent State of the Union address emphasized natural gas and renewable energy as important to reshaping ...

Not-So-Smart ALEC: The Right Wing vs. Renewable Energy

by Frank Ackerman | February 25, 2013
Cross-posted from Triple Crisis. Renewable energy is clean, sustainable, non-polluting, reduces our dependence on fossil fuels, improves the health of communities surrounding power plants, and protects the natural environment. Who could be against it? Answer: The American Legislative Exchange Council (ALEC), a lobbying group that is active in drafting and advocating controversial state legislation. They’re not just interested in energy: in recent years ALEC has supported Arizona’s restrictive immigration legislation, the “Stand Your Ground” gun laws associated with the shooting death of Trayvon Martin, and ...

Justice Delayed

by Catherine O'Neill | February 22, 2013
Outgoing Environmental Protection Agency (EPA) Administrator Lisa Jackson made environmental justice a priority at the agency. As her tenure draws to a close, EPA released its Plan EJ 2014: Progress Report in January, summarizing the agency’s considerable advances toward this important goal. The EPA deserves accolades for the seriousness with which it has treated the issue and for the progress it has made to address the unique and disproportionate burdens that environmental contamination visits on American Indian tribes and their ...

The Missing Energy-Water Roadmap

by Dave Owen | February 19, 2013
In the 2005 Energy Policy Act, Congress recognized that energy and water supply issues are deeply intertwined, and required the Department of Energy (DOE) to report on their nexus and make recommendations for future action within two years. (42 USC 16319).  DOE started this important work, but never finished it.  DOE’s initial report, issued in 2007, hinted at the complexity and seriousness of the energy-water nexus.  It discussed both how supplying energy requires water and supplying water requires energy.  For ...

National Energy Policies and the Environment: Can the National Environmental Policy Act Provide a Harmonizing Framework?

by Robert Glicksman | February 18, 2013
Energy policy in the United States is inextricably linked with questions of environmental protection. Thus, for example, the Obama administration will soon be called upon to decide whether to approve the Keystone XL pipeline, how much (and what kind) of regulation to impose on hydraulic fracturing for natural gas extraction, whether to regulate carbon emissions from existing coal-burning power plants, what proportion of federally owned lands should be devoted to mineral extraction, and whether to allow the expansion of oil ...

EPA's IRIS Program Still on GAO High Risk List

by Matt Shudtz | February 15, 2013
This week, GAO provided a helpful, unfortunately annual, reminder that EPA must do more to keep the IRIS program relevant for chemical risk management.  For the fifth year running, EPA’s programs for chemical risk management (IRIS among them) have been deemed in need of attention to avoid becoming so ineffective as to be considered a waste of agency resources.  GAO notes minimal progress by the IRIS program on completing assessments in the last two fiscal years (4 assessments each year).  ...

Change in Leadership at the SBA Offers Opportunity for Charting a New Course for Controversial Office of Advocacy

by James Goodwin | February 15, 2013
Earlier this week, Karen Mills, the current Administrator of the Small Business Administration (SBA), announced her intention to leave office, opening up another second-term vacancy for President Obama to fill in the coming months.  The SBA position is unlikely to attract as much media attention or pundit speculation as the EPA or Energy Interior posts, but it could have a big impact on whether the Obama Administration is able to take on the long to-do list of public health, safety, ...

Two Years Later, OSHA's Rule to Protect Workers from Deadly Silica Still in White House Review

by Thomas McGarity | February 14, 2013
[[Ed. Note: This post is a reprint, with minor updates, of McGarity’s post one year ago on the first anniversary of the proposed silica rule arriving at OMB. Little has happened on the issue in the past year – except more people have been sickened or killed by silica exposure.]] Today marks the second anniversary of an event that received little media attention, but marked a major milestone in the progression of a regulation that is of great importance to ...

Phasing out Fossil Fuels

by David Driesen | February 13, 2013
We will phase out fossil fuels.  We have no choice. They are a finite resource and at some point they will run out.  Admittedly, coal will not run out nearly as quickly as oil, but sooner or later all fossil fuel resources will run out.  The only question we face is whether we phase out fossil fuels before we have set in motion climate disruption’s worst effects or instead just allow a phase-out to occur through price shocks and shortages ...

Administration Warns of Food Inspectors Being Furloughed From Budget Sequester -- But Moving Forward Separate Plan to Unilaterally Take Poultry Inspectors Off the Job

by Rena Steinzor | February 12, 2013
This post was written by CPR President Rena Steinzor and Media Manager Ben Somberg. The White House issued a fact sheet last Friday presenting “Examples of How the Sequester Would Impact Middle Class Families, Jobs and Economic Security.” The consequences of the impending budget cuts from the “sequester” are not some abstract problem; they’re serious dangers, like this one: The Food and Drug Administration (FDA) could conduct 2,100 fewer inspections at domestic and foreign facilities that manufacture food products while ...

Subsidizing in Spurts: Our Production Tax Credit Policy, or Lack Thereof

by Lesley McAllister | February 12, 2013
Taxes and energy are subject to constant partisan debate. Both are at play in politically-charged discussions about the government’s role in promoting renewable energy, particularly wind energy. Since 1992, the federal government has granted a production tax credit (PTC) (currently 2.2¢ per kilowatt/hour (kWh)) for production of certain renewable energy. The credit initially focused on wind, closed-loop biomass, and poultry-waste energy resources; in 2004 Congress expanded the program to include open-loop biomass, geothermal, and several other renewable energy sources. With ...

The Legacy of Subsidizing Fossil Fuels

by Alexandra Klass | February 08, 2013
Often lost in today’s debates over whether to continue tax benefits for renewable energy is a historical perspective on the significant support the federal government has provided and continues to provide the fossil fuel industry. Tax benefits for the energy industry as a whole totaled over $20 billion in 2011, which is, and historically has been, about 2% of total U.S. tax expenditures. In general, the United States has used tax benefits to first support development of domestic fossil fuel ...

Workers' Memorial Day 2018

Tracy | Apr 25, 2018 | Workers' Rights

Recipe: Turning the House's Lemon of a Farm Bill into Lemonade

Ristino | Apr 25, 2018 | Environmental Policy

Scholars Call Out Congressional Committee for 'Mythification' of NEPA

Goodwin | Apr 24, 2018 | Environmental Policy

Promoting Energy Innovation

Farber | Apr 13, 2018 | Energy

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