Thoughts on Tuesday’s Senate Hearing on Preemption

by Matt Shudtz | August 05, 2009

Following up on Ben’s post about Tuesday’s Senate HELP Committee hearing on medical device preemption, I’d like to respond to three issues that came up during the question-and-answer session.

Innovation: Senators Harkin and Hatch had a bit of a disagreement about whether the possibility of tort liability stifles innovation by medical device firms. Peter Barton Hutt, who Senator Hatch lauded as the “dean of all FDA lawyers,” noted that he sits on the board of ten small biotech firms and that “decisions made by venture capitalists based upon such issues as potential liability directly affect every one of those companies.”

Two points here. First, it is a good thing that investors take into account potential tort liability. In the context of FDA-approved medical devices, tort law simply ensures that companies are operating according to a duty of care defined by a standard of reasonableness. It is not a high bar for them to meet and as consumers we should expect companies to only develop and market products that meet that standard. Second, as CPR Member Scholar Tom McGarity told the committee, there is no strong empirical evidence to back up the anecdotal claims like those made by Mr. Hutt. In fact, almost all of the great innovation that has happened in the field of medical devices happened during a time (pre-Riegel) when the firms developing new devices were subject to potential tort liability. There is no reason to believe ...

McGarity Testifies on Medical Device Safety

by Ben Somberg | August 04, 2009
CPR Member Scholar Thomas McGarity testified this afternoon at a hearing of the Senate Committee on Health, Education, Labor, and Pensions on the issue of medical device safety (written testimony, press release). Currently, individuals injured by a faulty medical device generally cannot sue the device manufacturer in state courts if that device was fully approved by the FDA, even if the manufacturer was aware of new research showing faults in the product. The Senate is considering a bill that would ...

The Chesapeake Bay and Beyond: Pollution Targets Met, Not Just Set

by Shana Campbell Jones | August 03, 2009
Today, the Senate Environment & Public Works Committee's Subcommittee on Water and Wildlife is holding a hearing entitled “A Renewed Commitment to Protecting the Chesapeake Bay: Reauthorizing the Chesapeake Bay Program." Here's something that should be on Congress's agenda: making the Bay-wide TMDL (“pollution cap”) enforceable to ensure that it is actually implemented. First, some background: Congress created the Bay Program in 1983, establishing it under the Clean Water Act. The regional partnership, which now includes several federal agencies in ...

CPR Scholars Submit Comments on Reforming ESA's Inter-Agency Consultation Regulations

by James Goodwin | August 03, 2009
Today, I joined CPR Member Scholars Mary Jane Angelo, Holly Doremus, and Dan Rohlf in submitting comments to the U.S. Fish and Wildlife Service (FWS)—one of the agencies charged with primary responsibility for executing the Endangered Species Act (ESA)—suggesting several ways to improve the regulations for implementing interagency consultations under the Act. Under Section 7 of the ESA, which governs interagency consultations, any time that a federal agency like the Department of Defense or the Department of Transportation wants to ...

In NYC Area, Contaminated Fish on the Plate

by Ben Somberg | July 31, 2009
More New Yorkers are fishing off area piers in this economy, and, in many cases, eating unsafe amounts of fish contaminated with PCBs and mercury. That was the thrust of a NY Daily News report earlier this month. They also reported that there were extremely few signs alerting the public to any kind of danger. New York City official soon responded that they'd put up more warning signs. CPR Member Scholar Catherine O'Neill discussed the fish contamination issues on WNYC's ...

'Curiouser and Curiouser!' Cried Alice ... A Tale of Regulatory Policy in the Obama Administration

by Sidney Shapiro | July 30, 2009
Like Alice's adventure, the development of regulatory oversight in the Obama administration is becoming "curiouser and curiouser." President Obama selected Cass Sunstein to be the head of the Office of Information and Regulatory Affairs (OIRA), a curious choice since Sunstein, although one of the country’s most distinguished academics, is in favor of extending the use of cost-benefit analysis, a position so popular with the business community that the Wall Street Journal endorsed his nomination. Sunstein's confirmation hearing was uneventful, probably ...

Reviving OSHA: The New Administrator's Big Challenge

by Sidney Shapiro | July 30, 2009
On Tuesday, the White House announced the appointment of Dr. David Michaels to head the Occupational Safety and Health Administration (OSHA). An epidemiologist and a professor at George Washington University’s School of Public Health and Health Services, Michaels will bring substantial expertise and experience to the job. Besides being an active health research – he studies the health effects of occupational exposure to toxic chemicals – he has also written impressively on science and regulatory policy. His book, Doubt Is ...

Proposed Order on Floodplain Development

by Daniel Farber | July 29, 2009
This item cross-posted by permission from Legal Planet. The White House is considering a new executive order to limit floodplain development.  The proposal covers roughly the same federal licensing, project, and funding decisions as NEPA.  The heart of the proposal is section 4, which unlike NEPA imposes a substantive requirement (preventing or mitigating floodplain development.)  The proposed language is after the jump.  This is a very constructive step — we can’t keep putting people and infrastructure in harm’s way, nor ...

Thoughts on EPA's Decision to Reconsider Lead Monitoring Requirements

by Matt Shudtz | July 28, 2009
Last Thursday, EPA announced (pdf) that they would reconsider a rule on monitoring lead in the air that was published in the waning days of the Bush Administration. I wrote about the original announcement, criticizing EPA for turning its back on children in neighborhoods like mine, where certain sources of airborne lead wouldn’t be monitored because of some questionable lobbying by the lead battery industry. Long story, short: After originally proposing and asking the public to comment on lead monitoring ...

Regulatory Czar Sunstein's First Days

by Rena Steinzor | July 27, 2009
Michael Livermore is right to suggest that environmentalists should be focused on Cass Sunstein’s first official day as regulatory czar for the Obama Administration. After months of delay over the Harvard professor’s eclectic and provocative writings, he will eventually take office if he can placate cattle ranchers concerned about his views on animal rights. Whatever their level of paranoia about Sunstein’s ability to grant animals standing to bring lawsuits, the likely character of his reign was more accurately predicted by ...

Protecting the Invisible: The Public Trust Doctrine and Groundwater

by Yee Huang | July 24, 2009
This is the fourth and final post on the application of the public trust doctrine to water resources, based on a forthcoming CPR publication, Restoring the Trust: Water Resources and the Public Trust Doctrine, A Manual for Advocates, which will be released this summer.  If you are interested in attending a free web-based seminar on Thursday, July 30, at 3:00 pm EDT, please contact CPR Policy Analyst Yee Huang or register here.  Prior posts are available here. Groundwater, invisible as ...

Get the Lead Out

by Matt Shudtz | July 24, 2009
The Bush Administration’s anti-regulatory henchmen in the Office of Management and Budget are at it again – fighting to keep EPA and state environmental agencies in the dark about how much pollution is being emitted into the air.   On October 16, EPA announced that it was slashing the National Ambient Air Quality Standard for lead from 1.5 micrograms per cubic meter (µg/m³) to 0.15 µg/m³. (Side note: EPA’s 90-percent reduction in permissible lead levels is good, but it’s still on ...

Wanted: A Wise Latina

by Rena Steinzor | July 23, 2009
This post is co-written by CPR President Rena Steinzor and Policy Analyst Matt Shudtz. Just as the traditional media finished a breathless cycle of reporting on how prospective Supreme Court Justice Sonia Sotomayor had renounced her claim that a “wise Latina” would make different decisions than a white man, an article in USA Today reminded us of the need for many more wise Latinas in the corridors of power in Washington. According to data compiled by the Bureau of Labor ...

Time For Mining Law Reform?

by Holly Doremus | July 22, 2009
This item cross-posted by permission from Legal Planet. Hardrock mining (as opposed to oil and gas drilling) on federal land is a topic that rarely hits the national news. And there are plenty of other high-profile items on the agenda in DC at the moment, like health care reform and climate legislation. So I was a bit surprised, but pleased, to see this editorial calling for reform of the General Mining Law in the NY Times. The Times is right ...

Peer Review Slams Corps's New Flood-Control Study in the Gulf

by Robert Verchick | July 21, 2009
A new report from the National Research Council on Friday slams a long-delayed Army Corps of Engineers hurricane protection study, saying it fails to recommend a unified, comprehensive long-term plan for protecting New Orleans and the Louisiana coast. You know the story: as Hurricane Katrina swept across New Orleans, the city’s levee system broke apart and billions of gallons of water poured into the city. Two independent forensic engineering reports (here and here) found the levee failures were caused by ...

Lights! Camera! Action! The Roles of the Public Trust Doctrine in Water Litigation

by Yee Huang | July 20, 2009
This is the third of four posts on the application of the public trust doctrine to water resources, based on a forthcoming CPR publication, Restoring the Trust: Water Resources and the Public Trust Doctrine, A Manual for Advocates, which will be released this summer.  If you are interested in attending a free web-based seminar on Thursday, July 30, at 3:00 pm EDT, please contact CPR Policy Analyst Yee Huang, or register here.  Water advocacy groups and environmental attorneys have used ...

The Public Trust Doctrine in Action: Increasing the Trust Principal

by Yee Huang | July 17, 2009
This is the second of four posts on the application of the public trust doctrine to water resources, based on a forthcoming CPR publication, Restoring the Trust: Water Resources and the Public Trust Doctrine, A Manual for Advocates, which will be released this summer.  If you are interested in attending a free web-based seminar on Thursday, July 30, at 3:00 pm EDT, please contact CPR Policy Analyst Yee Huang, or register here. As described in this earlier post, the public ...

Water Resources & the Public Trust Doctrine: A Primer

by Yee Huang | July 16, 2009
This is the first of four posts on the application of the public trust doctrine to water resources, based on a forthcoming CPR publication, Restoring the Trust: Water Resources and the Public Trust Doctrine, A Manual for Advocates, which will be released this summer.  If you are interested in attending a free web-based seminar on Thursday, July 30, at 3:00 pm EDT, please contact CPR Policy Analyst Yee Huang, or register here.  While the United States has a strong private ...

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