If you’re harmed by an improperly labeled prescription drug you’ve taken, should your ability to hold the manufacturer accountable in court depend on whether that drug was “name brand” or “generic”? Strangely, it does matter, thanks to the 2011 U.S. Supreme Court decision in Pilva v. Mensing. There, the Court held that because of a quirk in the Food and Drug Administration’s (FDA) regulations, generic drug manufacturers were shielded against plaintiffs’ state tort law failure-to-warn claims that alleged that a generic drug’s labeling failed to provide adequate warning of particular health risks. The Court reasoned that since the FDA’s regulations didn’t readily allow generic drug manufacturers to update their labels quickly to warn consumers against any newly discovered risks, it would be impossible for those same generic drug manufacturers to fulfill a separate state tort law duty to provide such warnings through adequate labeling. The impossibility of complying with both legal duties simultaneously compelled the Court to find that the FDA’s regulations preempted the plaintiffs’ state tort law claims.
In the wake of that decision, the FDA has proposed to amend its regulations to eliminate this disparity. Specifically, the proposal seeks to extend to generic drug manufacturers the ability to use the “changes being effected” supplement process (often called “CBE changes”) to make changes to their product labels. It’s a little complicated, but the basic gist is that CBE changes enable drug manufacturers to update product labels relatively quickly whenever they become aware of certain kinds of information regarding the potential risks of their drugs. The goal of the CBE changes process is to empower drug manufacturers to provide consumers and their doctors with relevant risk information as quickly as possible, so that they can make the best-informed decisions possible about whether and how to take a particular drug. The public comment period for the proposal ends this Thursday, and CPR Member Scholars Tom McGarity and Sid Shapiro and I have submitted comments that aim to highlight for the FDA an important, but easily overlooked benefit of this rulemaking—namely, the invaluable role that a vibrant state civil justice system can play in complementing and reinforcing the FDA’s regulatory programs so that they are better able to protect the public against unreasonably dangerous drugs.Full text
EPA’s budget is in free-fall. Members of Congress brag that they have slashed it 20 percent since 2010. President Obama’s proposed budget for 2015, released on Tuesday, continues the downward trend. The budget proposal would provide $7.9 billion for EPA, about $300 million, or 3.7 percent, less than the $8.2 billion enacted in fiscal year 2014.
To cope with these cuts, the agency plans to fundamentally change the way it enforces environmental laws. A draft five-year plan released in November signals that the agency is retreating from traditional enforcement measures, such as inspections, in favor of self-monitoring by regulated industries. Specifically, the agency aims to conduct 30 percent fewer inspections and file 40 percent fewer civil cases over the next five years as compared to the last five.
Even before releasing the draft plan, the agency had already begun cutting down on enforcement. In February, the agency reported a decrease in the number of in-person inspections and investigations in 2013 compared to the previous year. According to the EPA’s own report, enforcement actions in 2013 resulted in the reduction of 1.3 billion pounds of pollution, down from a high of more than 2 billion pounds in 2012. EPA conducted 2,000 fewer inspections and evaluations and initiated about 2,400 civil cases last year, continuing a downward trend since fiscal 2009 when the agency opened about 3,700.Full text
The media has reported, erroneously, that the Obama Administration’s environmental impact statement concluded that the Keystone Pipeline would have no impact on global climate disruption. The facts are a bit more complicated, and much more interesting. Basically, the final EIS concedes that Keystone would increase greenhouse gas emissions, but it uses a silent political judgment masquerading as scientific analysis to minimize its estimate of the increase’s magnitude. Accordingly, President Obama has ample grounds to reject the Keystone Pipeline application.
Let me explain. The EIS concedes that the construction project creating the Keystone Pipeline would produce .24 metric tons of carbon dioxide equivalents (MMTCO2E) per year until TransCanada completes the pipeline. It also admits that operation of the pipeline after construction would produce 1.44 MMTCO2E per year, about the emissions of 300,000 passenger vehicles.
Although this is a lot of emissions, the really huge emissions come not from the construction and operation of the pipeline, but from the extraction and use of tar sands oil. The EIS concludes that the tar sands oil transported through the pipeline would produce a whopping 147 to 168 MMTCO2E per year in lifecycle emissions, approximating the annual emissions of more than 30 million cars. The huge emissions associated with tar sands oil has led James Hansen, a leading climate scientist, to conclude that exploiting tar sands oil means “game over” for climate change.Full text
The regulatory process has become more opaque and less accountable. We need to fix that.
Every year, thousands of law students take a course in administrative law. It’s a great course, and we wish even more students took it. But there’s a risk that students may come away with a vision of the regulatory process that is increasingly disconnected with reality. Worse, the leading judicial opinions on the subject suggest that judges may suffer from a similar disconnect.
The Administrative Procedure Act is based on the premise that Congress delegates the power to address a problem to an agency, which then applies the statute to formulate a regulation. Policy is driven by the statute along with the views of the agency head, who is appointed by the President and confirmed by the Senate. But the realities are often different. Policy is often driven, not so much by Congress, as by Presidential orders requiring the use of cost-benefit analysis. The final decision about whether to regulate, and even the details of the regulation, may be decided by a White House office called OIRA. The head of the agency is frequently a temporary appointee, generally a lower level agency official who may not have much clout within the executive branch. The regulatory system as it actually operates is much different from the world envisioned by administrative law.
In a recent paper, Anne Joseph O’Connell and I document this disconnect and discuss its consequences. We think it likely that something like the current system will persist. Administrative law aims to make the regulatory process more open and transparent, more faithful to statutory mandates, and more attentive to scientific expertise - all while respecting the primary role of the executive branch in issuing regulations. To further these goals given current realities, OIRA process must become much more transparent and accountable. Transparency will help ensure that an agency’s statutory mission and its scientific expertise don’t get submerged by OIRA staff who care only about their own policy goals and lack deep expertise. Regardless of whether you share OIRA’s passion for cost-benefit analysis or revile it, we should all be able to agree on the need for improving the process.
In recent weeks, celebrations throughout the Pacific Northwest marked the 40th anniversary of the “Boldt decision” – the landmark decision in the tribal treaty rights case, U.S. v. Washington. This decision upheld tribes’ right to take fish and prohibited the state of Washington from thwarting tribal harvest. Judge Boldt’s 1974 decision was intended to close a chapter in our history during which tribal fishers were harassed, beaten, and imprisoned for the act of fishing. In recognition of this anniversary, the Washington state legislature voted to clear the criminal records of all the tribal people who had been arrested for fishing – that is, for exercising the rights they had been guaranteed under the treaties. Yet the legacy of this shameful era may be revived if Washington’s Department of Ecology calculates water quality standards so as to reflect and perpetuate the time when tribes could not harvest salmon and other fish.
Water quality standards determine how much pollution will be allowed in our waters and, as a consequence, in the fish we all eat. Water quality standards are human health-based; they are currently set by means of risk assessment. Environmental agencies such as Ecology enlist risk assessment equations that determine how much of each toxic pollutant – PCBs, mercury, dioxins, PAHs – can safely be present in a water body so that humans who eat the fish from that water won’t risk cancer or suffer irreversible neurological damage or other harms. There are several variables in this equation. The value for each of these variables is determined by intertwined “science” and “policy” choices. Agency risk assessors consider the degree to which a given pollutant bio-accumulates in fish tissue; the amount of fish people can be expected to consume; the number of years over which people will likely consume fish at this rate; and other variables. The plausible value for some of these variables spans two orders of magnitude; for other variables, the range is less dramatic, but there is still room for play.
And play is precisely what industrial polluters and their consultants do, as they take aim at each variable, with the ultimate goal of weakening the resulting water quality standards. I have discussed some of these efforts in the Pacific Northwest here and here, as well as here.Full text
It sounds like a rare piece of good news about climate change: emissions of carbon dioxide, the principal cause of global warming, grew at a slower rate after 2000 in the United States, and have actually dropped since 2007. In Europe the story sounds even better, as overall emissions dropped from 1990 to 2008, often roughly matching, or in some cases exceeding, the reductions promised under the Kyoto Protocol.
Yet the apparent progress on emission reductions in rich countries has occurred at a time of widespread outsourcing of manufacturing to China and other developing countries. In the process, we have effectively outsourced our carbon emissions as well. If consumers are responsible for the emissions from making the consumer goods they buy, then we have not solved the problem. We have just made it harder to see - and much harder to measure.
Here's the problem: if a Chinese steel mill sells steel to Toyota in Japan, which uses it to make cars sold to Americans, which country is responsible for the steel mill's emissions? America seems like the logical answer; the Chinese emissions happened in order to make something that was bought and used in the United States. Those emissions, however, belong to China in all standard statistics, and in most discussion of climate targets and responsibilities for emission reduction.Full text
Today, Center for Progressive Reform analyst Michael Patoka testified at a Maryland Senate Finance Committee Hearing in support of SB 774, which would require construction companies contracting with the state to be prequalified based on their worker health and safety performance measures.
The widely supported legislation would ensure unscrupulous employers do not receive contracts funded by taxpayer dollars.
In his testimony Patoka notes:
Currently, construction firms are screened on a number of factors prior to bidding, but worker-safety considerations are not included. As a result, agencies can easily end up financing companies that operate hazardous worksites and endanger Maryland workers. Indeed, the current system encourages firms to cut corners on worker safety, since by doing so they may be able to offer lower bids than their more responsible competitors and thus have a better chance at winning lucrative contracts.
The construction industry is responsible for a disproportionately high number of fatalities and injuries. From 2008 and 2010, between 25 and 33 percent of all workplace deaths in Maryland were in the construction industry, and each of those years saw between 5,800 and 6,900 construction-related injuries. These incidents impose unbearably high costs on individuals and families in Maryland, as well as burden the local economy. Between 2008 and 2010, construction deaths and injuries cost Maryland $712.8 million in medical services, lost productivity, administrative expenses, and lost quality of life. Public agencies are among the largest purchasers of construction services in Maryland, so they are in a unique position to improve worker protections through the use of their considerable buying power. The impact of this bill would reach far beyond public contracts, since any companies hoping to remain eligible for bidding would have to maintain a good safety record in all their work.
The prequalification system that this bill would establish is particularly well-designed. The bill instructs the Department of Labor, Licensing, and Regulation to develop a standardized questionnaire and rating system. The Department would consult with a broad range of stakeholders, including unions, safety experts, and contractors, to ensure that the resulting system is fair and effective.
To read the testimony in full click here.
Cue the majestic fanfare, for this week marks House Republicans’ so-called “Stop Government Abuse Week”—you know they mean business, because they have a clever Twitter hashtag and everything. So how does one celebrate such an auspicious occasion? Apparently, by wasting precious House floor time with a series of votes on several extreme anti-regulatory bills that, if enacted, would make it all but impossible for agencies to carry out their congressionally mandated missions of safeguarding the public against corporate abuses. The jewel in this potentially catastrophic crown is the Regulatory Accountability Act, which has been repackaged as Title II of the overstuffed “Regnibus” bill, officially known as the All Economic Regulations are Transparent (ALERT) Act (H.R. 2804).Full text
A Lancaster County District Court has struck down the governor's decision to approve Keystone XL's pipeline route through the state in Thompson v. Heineman, CI 12-2060 (Feb. 19, 2014). As described in a previous blog, LB 1161 was passed in 2012 to give Governor Dave Heineman the authority to approve the route rather than having the state's Public Service Commission (PSC) make the decision. The court found that the PSC--not the governor--is constitutionally empowered under Nebraska Constitution Art. IV § 20 to play the lead role in approving the pipeline's route. The PSC was created in the late 1800's to prevent precisely this kind of overreaching by politicians who were inclined to grant political favors to powerful railroad executives who wanted to expand their routes through private property. "If such abandonment or abolition of [the PSC's] regulatory control were permitted, the protection afforded to Nebraska citizens by the constitutionally created and empowered PSC would cease to exist." Thompson, supra, at 43.
The court found "no set of circumstances" under which LB 1161 could be upheld. Under the court's ruling, LB 1161 is unconstitutional and void, and the governor's action in approving the pipeline route is also null and void. Accordingly, the court permanently enjoined the state from authorizing the pipeline route pursuant to LB 1161. This means that the state is also prohibited from allowing Transcanada to exercise eminent domain to obtain easements over private property for the pipeline.
Governor Heineman vowed to appeal the ruling, but there's no doubt that the decision could cause more delays in finishing the pipeline. If and when the legislature fixes the constitutional problem by giving authority back to the PSC, the PSC will have to decide whether to approve the current pipeline route. If the PSC alters the route or any other specifications, the State Department will have to prepare another supplemental Environmental Impact Statement or Environmental Assessment to analyze the impacts of any significant changes.
At the very least, President Obama and Secretary John Kerry would be wise to withhold approval until the dust settles on the state's decision-making processes. Better still, President Obama could simply deny the permit as failing the "national interest" test, given the serious potential for pipeline leaks and greenhouse gas emissions, and the broader negative implications for creating a more sustainable energy portfolio for America's future.
No one needs yet another "Unnatural Disaster," as Christine Klein and I explain in our new book.Full text
Yesterday, we wrote about OIRA’s role in delaying and diluting the EPA’s long-awaited coal ash rule, in part by introducing and promoting a weak option that would rely on voluntary state implementation and citizen suits, instead of nationwide requirements and federal oversight, to protect the public from dangerous leaks and spills.
Anyone who thinks the states can be entrusted with regulating toxic coal ash need only take a passing glance at North Carolina’s track record—a virtual “how to” guide for regulatory dysfunction. Governor Pat McCrory himself worked at Duke Energy for 28 years, and Duke-connected sources donated over a million dollars to get him elected in 2012. Once in office, he appointed several former Duke employees to high-level posts, and the newly appointed head of the state’s environmental department saw himself as a “partner” to regulated industries rather than a cop on the beat. The department took no action even after Duke’s own test results showed that the ponds were polluting nearby groundwater.
Citizen suits fared no better. Even in the best circumstances, these lawsuits are expensive and time-consuming for organizations to bring, and unlike comprehensive regulations, they are sporadic in their coverage. But the situation in North Carolina was even worse: environmentalists filed three separate notices of intent to sue Duke in federal court over groundwater pollution, and each time the lawsuits were stymied by the state’s environmental department.
Federal law gives state regulators 60 days after such notices are filed to assert their own jurisdiction over the issue by bringing an enforcement action, which prevents the citizen suits from proceeding. North Carolina’s environmental department brought actions against all of Duke’s remaining waste sites, effectively blocking any additional coal ash suits against the company. The state negotiated a settlement with respect to two sites, under which Duke would pay just $99,111 (the company is worth $50 billion) and wouldn’t even be required to move or close the dumps.
The state has recently backed away from the embarrassing settlement in light of Duke’s high-profile spill. But with all this attention now focused on their improper relationship, both Duke and the North Carolina government have become the subjects of a federal criminal investigation that will examine years’ worth of their emails and memos.
This is the kind of regulatory protection we can expect to see more of if the EPA decides to issue a weak rule under Subtitle D.Full text