Caging Prohibition Act of 2009

Mr. President, I am proud to join my colleagues in reintroducing the Medical Device Safety Act. This legislation reverses the Supreme Court's erroneous decision in Riegel v. Medtronic. There, the Court misread a statute designed to protect consumers by giving the Food and Drug Administration, FDA, the authority to approve medical devices as preempting State tort claims when a medical device causes harm. Riegel prevents consumers from receiving fair compensation for injuries sustained, medical expenses incurred and lost wages, and it must be reversed.

Congressional action should be unnecessary. When Congress passed the Medical Device Amendments, or MDA, in 1976, it did so ``[t]o provide for the safety and effectiveness of medical devices intended for human use.'' In other words, Congress passed the MDA precisely to protect consumers from dangerous medical devices. Towards that end, Congress gave the FDA the authority to approve, prior to a product entering the market, certain medical devices. For over 30 years the MDA has been in effect, and over that period FDA regulation and tort liability have complimented each other in protecting consumers.

Given the MDA's purpose, and the fact it has operated successfully for 30 years, I was disheartened to find the Court twist the meaning of the statute to strip from consumers all remedies when a medical device fails. In contorted logic, the Court found that the FDA's requirements in approving a medical device preempted State laws designed to ensure that manufacturers marketed safe devices. In other words, the Court believes that a company's responsibility to its patients ends when it receives FDA approval. I strenuously disagree.

In fact, there is absolutely no evidence that Congress intended that under the MDA consumers would lose their only avenue for receiving compensation for injuries caused by negligent or inadequately labeled devices. Not a single Member or committee report articulated the view that the statute would preempt State tort law.

Nevertheless, because of the Court's decision, it is imperative that Congress act to ensure that those harmed by flawed medical devices can seek compensation. The bill introduced today addresses the Court's action by explicitly stating that actions for damages under State law are preserved. Specifically, it amends section 521 of the Federal Food, Drug, and Cosmetic Act to state that the section shall not be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State. And the bill applies retroactively to the date of the enactment of the MDA, consistent with Congress's intent when it passed that act over 30 years ago. Practically, that means that it applies to cases pending on the date of enactment of this legislation or claims for injuries sustained prior to enactment.

The harm from Riegel, unless Congress acts, cannot be more real. In the year since Riegel was decided alone, courts across the country have dismissed product liability claims. Take Charles Riegel. During an angioplasty, a catheter burst and caused him serious injuries and disabilities, and a State jury found Medtronic negligent. Because of the Supreme Court's decision, however, Mr. Riegel's wife will receive no compensation for the defective design and inadequate warning. Take Gary Despain. A defective hearing aid caused severe damage to his right ear, and he became disabled and unemployed. Because of the Supreme Court's decision, Mr. Despain has no ability to see remedies for his injuries.

Recently, a court dismissed the claims of almost 1,500 patients who brought suit arising from Medtronic's Sprint Fidelis defibrillator-- specific models of thin wires that connect an implantable cardiac- defibrillator directly to the heart. In October 2007, the product was recalled after lead fractured in several cases and was thought to contribute to deaths and serious injuries. Again, because of the Court's ruling, injured plaintiffs have no recourse against the company that caused the harm.

While FDA approval of medical devices, moreover, is important, it cannot be the sole protection for consumers. FDA approval is simply inadequate to replace the longstanding safety incentives and consumer protections State tort law provides.

As a senior member of the Health, Education, Labor and Pension Committee, which has oversight over FDA, I have worked hard to ensure that the FDA performs its job. No matter how effective the FDA is, however, the FDA simply cannot guarantee that no defective, dangerous, and deadly medical device will reach consumers. As the former Director of the FDA's Center for Devices and Radiological Health acknowledged, the FDA's ``system of approving devices isn't perfect, and that unexpected problems [with approved devices] do arise.'' In 1993, a House report identified a ``number of cases in which the FDA [had] approved devices that proved unsafe in use.''

The fact is, the FDA conducts the approval process with minimal resources and simply does not have adequate funds to genuinely ensure that devices are safe or to properly and effectively reevaluate approvals as new information is available.

Further, the FDA approval process is based on partial information. A principal shortcoming is that the device's manufacturer compiles the studies and data supporting an application, and the data is often unreliable. And the FDA does not conduct independent investigations into a device's safety. A manufacturer, moreover, is not required to submit information about development of the device, including alternative designs, manufacturing methods, and labeling possibilities that the manufacturer considered but rejected.

In 1993, an FDA committee found flaws in the design, conduct, and analysis of the clinical studies used to support applications that were ``sufficiently serious to impede the agency's ability to make the necessary judgments about [device] safety and effectiveness.'' It added, ``[o]ne of the main reasons [problems arise after approval] is that the data upon which we base our safety and effectiveness decisions isn't perfect.'' Likewise, in 1996, the inspector general of the Department of Health and Human Services reported ``serious deficiencies . . . in the clinical data submitted as part of pre-market applications.''

Moreover, there is very little FDA oversight once a device reaches doctors

and patients. In fact, even the best designed and most reliable clinical studies by their very nature cannot duplicate all aspects and hazards of everyday use. Moreover, while manufacturers are supposed to report defects and injuries, the FDA has admitted that there is ``severe underreporting'' of defects and injuries.

Given the FDA's limitations, it is crucial that an individual have a right to seek redress. When defective medical devices reach the market, whether or not approved by the FDA, patients are often injured. Those injured are often left temporarily unable to work or to enjoy normal lives, and in many cases never fully recover. State tort law provides the only relief for patients injured by defective medical devices and should not be foreclosed.

Not only does access to State court mean that a person injured can receive fair compensation, but there are other advantages. Such suits aid in exposing dangers and serve as a catalyst to address their consequences. Through discovery, litigation can help uncover previously unavailable information on adverse effects of products that might not have been caught during the regulatory system. Litigants can demand documents and information on product risks that might not have been shared with the FDA. In this way, the public as a whole is alerted to dangers in medical products.

Finally, providing the ability to sue when injured provides an important incentive to manufacturers to use the utmost care. Additionally, threat of product liability suits creates continuing incentives for product manufacturers to improve the safety of their device, even after FDA approval.

As the Supreme Court recognized this week, in Wyeth v. Levine, in holding that failure to warn claims involving FDA approved drugs are not preempted, ``[s]tate tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.'' The Court continued, ``the FDA has long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.''

The same consumer protection that State courts provide which the Court recognized as important in the context of faulty drug warnings is equally important for those consumers harmed by faulty medical devices.

In conclusion, sadly the Court fundamentally misread Congress's intent in passing the Medical Device Amendments in 1976, and Reigel appears to represent yet another victory by big business over consumers. That is not, however, the final say on the matter. To quote Chief Justice Roberts, ``every area involving an interpretation of a statute, the final say is not with the Supreme Court, the final say is with Congress. And if they don't like the Supreme Court's interpretation of it, they can change it.''

Make no mistake, moreover, it can be done. Last year, Congress passed and the President signed the ADA Amendments Act, reversing decisions in which the Court consistently misconstrued the will of Congress and held that the ADA does not protect many people with serious disabilities from discrimination. This year, we were successful in reversing the Court's draconian Lilly Ledbetter decision, making clear that those discriminated against do have a recourse in law.

Those injured by faulty medical devices deserve to have their day in court and are entitled to compensation when they are injured by faulty medical devices, have medical expenses to pay and lost wages, regardless of whether the FDA approved a device. We must reverse this erroneous decision and ensure that those who have suffered serious injury at the hands of others receive justice.

Mr. President, this week, the Nation commemorates the 49th anniversary of ``Bloody Sunday,'' a day which marked a crucial turning point in securing the right to vote for all Americans. On March 7, 1965, in Selma, Alabama, John Lewis and his fellow civil rights activists marched for their right to vote but were brutally attacked by state troopers on the Edmund Pettus Bridge. We remember the acts of courageous Americans who fought through the years for equality. We honor their legacy by reaffirming our commitment to protect the right to vote for all Americans.

On the week of this important anniversary, I am pleased to join Sen. Whitehouse in introducing the Caging Prohibition Act of 2009. This legislation contains commonsense reforms to strengthen the Nation's ability to combat organized efforts to suppress the right to vote and better protect the voting rights of countless Americans.

Senator Whitehouse and I introduced a similar bill two years ago in an effort to bring urgent election reform to protect voters during the 2008 presidential election. Although the Rules Committee held a hearing on the measure, the bill was not reported out of Committee before the Senate adjourned last year. I hope the Senate will do its part to prevent shenanigans from disenfranchising voters during the next Federal election, by promptly passing this bill.

During my three decades in the Senate, I have devoted a considerable portion of my work to improving democratic participation and make our government more accessible to all Americans. For the past two years, I have been delighted to have Senator Whitehouse as a partner on this important issue. I thank him for his leadership on preserving and strengthening our voting rights.

In recent years, we have seen a surge in a particularly alarming form of voter suppression known as voter caging. In voter caging, a political organization sends mail to addresses on voter rolls, compiles a list of returned mail, and uses that list as grounds for partisan and unjustified purges or challenges of voters' eligibility. During the last two presidential election cycles, we have seen evidence of voter caging efforts emerge in numerous States, including Ohio, Florida, Michigan, and Pennsylvania.

Chief among the problems with voter caging is that it threatens to disenfranchise voters in an unreliable manner. Rather than preventing votes cast by ineligible voters, far too often the practice prevents legitimate voters from casting their ballots. According to a recent report from the nonpartisan Brennan Center for Justice, ``[V]oter caging lists are highly likely to include the names of many voters who are in fact eligible to vote.'' Of course, since government databases are often riddled with typos and clerical errors, these findings are hardly surprising.

Even more troubling, voter caging often aims to disenfranchise minority voters. I recall during a Senate race in Louisiana, in 1986, a memorandum from the Republican National Committee concluded that hiring a consultant to distribute 350,000 mailings marked ``do not forward'' to mostly African-American districts would ``eliminate at least 60- 80,000 folks from the rolls . . . [and] could keep the black vote down considerably.'' That is unacceptable. That is wrong. No one's right to vote should be abridged, suppressed, or denied in the United States of America.

The practice of voter caging chips away at core protections in our democracy. The right to vote, and have your vote count, is a foundational right because it secures the effectiveness of all other protections. Indeed, the very legitimacy of our government is dependent on the access all Americans have to the political process. That is why voting is the cornerstone of our democracy. Any infringement on this right harms the fabric of America.

All too often, voter caging efforts have partisan goals. For example, the Judiciary Committee's investigation last Congress into the mass firings of U.S. Attorneys for political reasons shed light on how Tim Griffin, a former Bush White House aide, participated in a voter caging scheme aimed at disenfranchising African-American voters in Florida. He was later appointed interim U.S. Attorney for the Eastern District of Arkansas.

Rooting out partisan voter caging tactics requires us to give Federal officials the tools and resources they need to investigate and prosecute organized efforts to suppress the right to vote. This bill will do exactly that.

This legislation would prohibit challenging a person's eligibility to vote--or register to vote--based on a voter caging list, an unverified match list, or foreclosure status. A challenged voter may feel intimidated or discouraged, and may leave a polling site and not vote. In America, a person should not lose their fundamental right to vote, nor have that vote challenged, on the sole basis of a mistake, error, or because their mail failed to reach them. Similarly, as the current economic crisis reminds us, Americans should not have their fundamental right to vote jeopardized simply because they lose their jobs to layoffs or their homes to foreclosure.

The bill would also require any private party who challenges the right of another citizen to vote--or register to vote--to set forth in writing, under penalty of perjury, the specific grounds for the alleged ineligibility. This provision deters illegitimate challenges to voters by requiring, at a minimum, a showing of good cause. It properly balances legitimate efforts to clean voting rolls with forbidding unreliable voter purges.

I am pleased that this bill has the support of civil rights and voting rights organizations such as the Leadership Conference on Civil Rights, the Lawyers Community for Civil Rights under Law, the Brennan Center for Justice, and the People for the American Way. They understand that voter caging is a modern-day barrier to the ballot box that has created unique problems for legitimate voters for many years, and that a Federal ban on these undemocratic practices is necessary.

I hope that this year all Senators will support this important legislation and take firm action to stamp out this intolerable voter suppression tactic.

Mr. President, I am pleased to join Senator Kennedy once again in the introduction of this important legislation. The bill that we introduce today will correct the Supreme Court's decision in Riegel v. Medtronic, which misconstrued the intent of Congress and cut off access to our Nation's courts for citizens injured or killed by defective medical devices.

Last year, the Senate Judiciary Committee held a series of hearings to examine the way in which the Supreme Court's decisions in the areas of retirement benefits, consumer product safety, workplace discrimination, and personal finance have consistently trended against the rights of consumers and in favor of big business. In many cases that have profound effects on the lives of ordinary Americans, the Court has either ignored the intent of Congress, deferred to corporate interests, or sided with a Federal agency's flawed interpretation of a congressional statute's preemptive force to disadvantage consumers. The impact of the decisions that were the focus of those hearings continues to be felt by Americans today, whether they are prohibited from seeking redress in the courts for an injury caused by a defective product, paying exorbitant credit card interest rates and fees with no relief from the laws of their own State, or subjected to the unscrupulous practices of some in the mortgage lending industry.

These hearings raised awareness in Congress, and among Americans, about the impact the Supreme Court has on our everyday lives. And I am especially proud that following on these hearings,

and through the efforts of a determined and principled congressional majority, we witnessed our constitutional democracy at work when President Obama signed the Lilly Ledbetter Fair Pay Act. I am heartened that Congress reclaimed the intent of its original legislation and overrode the Supreme Court to restore the rights of Americans to be free from discrimination in the workplace.

Just yesterday in the case of Wyeth v. Levine the Supreme Court foreclosed the need for Congress to act in another important area when it validated the views of many by rejecting the Bush administration and the Food and Drug Administration's extravagant views of a regulatory agency's ability to pre-empt State law. I am glad the Court spoke clearly and decisively on this issue. The Court's decision was not only a vindication of Congress's primary authority to pre-empt State law, but a victory for every American who relies upon pharmaceutical drugs and entrusts the manufacturers of those drugs with insuring their safety. The Court's decision also vindicated the laws and courts of the State of Vermont, and I am proud to have expressed my views to the Court as to Congress's intent in this area and on behalf of Diana Levine.

The bill we introduce today is another important step to correct an erroneous reading by the Court of Congress's intent in enacting the medical device amendments of 1976. This legislation will make explicit that the preemption clause in the medical device amendments upon which the Court relied does not, and never was intended to preempt the common law claims of consumers injured by a federally approved medical device.

The extraordinary power to preempt State law and regulation lies with Congress alone. Where the Court reaches to the extent it did in the Riegel decision to find Federal preemption contrary to what Congress intended, Congress is compelled to act, just as it was in the case of Lilly Ledbetter. I hope all Senators will join us in this effort.

Mr. President, I rise today to introduce two bills that will improve the lives of our Nation's fishermen who are struggling to make a living at sea.

The fishing industry in New England is an important part of our heritage. From our nation's earliest days, fishing has served as an economic driver that has allowed our nation to prosper. Maine's proud fishing heritage is woven deeply into the cultural fabric of our state. Sadly, the global economic downturn and heavy-handed federal regulations threaten the economic stability of this venerable industry. To attempt to assist our fishing families, I am pleased to be joined by my colleague from Massachusetts, Senator Kennedy, in introducing the Working Waterfront Preservation Act and the Commercial Fishermen Safety Act.

All along our Nation's coasts there are harbors that were once full of the hustle and bustle associated with the fishing industry. Unfortunately, there is an erosion of the vital infrastructure known as our working waterfronts that is so critical to our commercial fishing industries. I have drafted legislation that will help combat the loss of commercial access to our waterfronts and support the fishing industry's role in our maritime heritage.

When constituents first called asking me to help them in their efforts to stop the loss of their fishing businesses and the communities built around this industry, I learned that no Federal program exists that supports preserving or increasing waterfront access for the commercial fishing industry. This is especially disheartening because every week we are losing more of our working waterfronts in this country. Quite simply, once lost, these vital economic and community hubs of commercial fishing activity cannot be replaced.

That is why I am introducing the Working Waterfront Preservation Act. This legislation would create a program to support our Nation's commercial fisherman and the coastal communities that are at risk of losing their fishing businesses.

The need for such a program is demonstrated by the loss of commercial waterfront access occurring in Maine. Only 25 of Maine's 3,500 miles of coastline are devoted to commercial access. We are continually seeing portions of Maine's working waterfront being sold off to the highest bidder--with large vacation homes and condominiums rising in places that our fishing industry used to call home.

The reasons for the loss of Maine's working waterfront are complex. In some cases, burdensome fishing regulations have led to a decrease in landings, hindering the profitability of shore-side infrastructure, like the Portland Fish Exchange. In other cases, soaring land values and rising taxes have made the current use of commercial land unprofitable. Property is being sold and quickly converted into private spaces and second homes that are no longer the center of economic activity. With each conversion of commercial waterfront access to private development, a piece of Maine's proud maritime tradition is irretrievably lost.

Maine's lack of commercial waterfront prompted the formation of a ``Working Waterfront Coalition.'' This coalition was comprised of an impressive number of industry associations, nonprofit groups, and State agencies, who came together to preserve Maine's working waterfront.

I am pleased to note that the Working Waterfront Coalition was successful in contributing to the creation of two programs in Maine. The first is a tax incentive for property owners to keep their land in its current working waterfront state. The second is a pilot program for grant funding to secure and preserve working waterfront areas. Since 2006, the Working Waterfront Access Pilot Program has secured 11 properties totaling more than 25 acres of

land that supports more than 300 boats, 400 fishing industry jobs, and more than $26 million in income directly associated with our working waterfronts. The State of Maine has taken positive action to save its waterfronts and is a model for other States in the country facing this problem.

This work is not, however, finished. The loss of commercial waterfront access affects the fishing industry throughout all coastal states. And a modest Federal investment could do so much to save these areas. Preservation of the working waterfront is essential to protect a way of life that is unique to our coastal States and is vital to economic development along the coast. Fishermen are being pushed out of the waterfront as their profitability shrinks and land values soar. Our legislation targeting this exact problem, as no Federal program exists to assist States like Maine, Florida, Washington, and Louisiana.

The Working Waterfront Preservation Act would assist by providing Federal grant funding to municipal and State governments, non-profit organizations, and fishermen's cooperatives for the purchase of property or easements or for the maintenance of working waterfront facilities. The bill contains a $50 million authorization for grants that would require a 25 percent local match. Applications for grants would be considered by both the Department of Commerce and State fisheries agencies, which have the local expertise to understand the needs of each coastal State. Grant recipients would agree not to convert coastal properties to noncommercial uses, as a condition of receiving Federal assistance.

This legislation also includes a tax component. When properties or easements are purchased, sellers would only be taxed on half of the gain they receive from this sale. This is a vital aspect of my bill because it would diminish the pressure to quickly sell waterfront property that would then, most likely, be converted to noncommercial uses, and would increase the incentives for sellers to take part in this grant program. This is especially important given that the application process for Federal grants does not keep pace with the coastal real estate market.

This legislation is crucial for our Nation's commercial fisheries, which are coming under increasing pressures from many fronts. This new grant program would preserve important commercial infrastructure and promote economic development along our coast.

Second, I am introducing the Commercial Fishermen Safety Act of 2009, a bill to help fishermen purchase the life-saving safety equipment they need to survive when disaster strikes.

Every day, members of our fishing communities struggle to cope with the pressures of running a small business, complying with burdensome regulations, and maintaining their vessels and equipment. These challenges have been made worse by the growing economic crisis, which only adds to the dangers associated with fishing.

Year-in and year-out, commercial fishing ranks among the nation's most dangerous occupations. Fatality rate data compiled by the Census of Fatal Occupational Injuries program for 2007 has, once again, listed fishing as having the highest fatality rate among selected occupations. While I am encouraged that 2007 saw a drop in the number of occupational-related fatalities in the fishing industry, we must be doing more to save lives at sea.

The New England fishing community is no stranger to tragedy. Just this year, the Patriot, a 54-foot fishing boat out of Gloucester, MA, sunk off the coast of Massachusetts without warning. The ship's captain Matteo Russo and crew member John Orlando, who were lost in the incident, were unable to send a mayday call in the early morning of January 3, 2009. The unexplained circumstance of their deaths offers little solace to the families and communities that loved them. What is clear is that preventing further loss of life requires that we do all we can to promote safety at sea.

Coast Guard regulations require all fishing vessels to carry safety equipment. The requirements vary depending on factors such as the size of the vessel, the temperature of the water, and the distance the vessel travels from shore to fish. Required equipment can include a liferaft that automatically inflates and floats free, should the vessel sink. Other life-saving equipment includes: personal flotation devices or immersion suits which help protect fishermen from exposure and increase buoyancy; EPIRBs, which relay a downed vessel's position to Coast Guard Search and Rescue Personnel; visual distress signals; and fire extinguishers.

When an emergency arises, safety equipment is priceless. At all other times, the cost of purchasing or maintaining this equipment must compete with other expenses such as loan payments, fuel, wages, maintenance, and insurance.

The Commercial Fishermen Safety Act of 2007 provides a tax credit equal to 75 percent of the amount paid by fishermen to purchase or maintain required safety equipment. The tax credit is capped at $1500. Items such as EPIRBs and immersion suits cost hundreds of dollars, while liferafts can reach into the thousands. The tax credit will make life-saving equipment more affordable for more fishermen, who currently face limited options under the federal tax code.

We have seen far too many tragedies in this occupation. Please, let us support fishermen who are trying to prepare in case disaster strikes. Safety equipment saves lives. By providing a tax credit for the purchase of safety equipment, Congress can help ensure that fishermen have a better chance of returning home each and every time they head out to sea.

Mr. President, as John F. Kennedy said about 50 years ago, ``The Chinese use two brush strokes to write the word `crisis.' One brush stroke stands for danger; the other for opportunity. In a crisis, be aware of the danger--but recognize the opportunity.''

America has not one crisis, but at least three crises that loom large before us. The economy is in obvious turmoil, pollution is causing the climate to change, and we are far too dependent on oil, particularly oil from unfriendly places around the world. These challenges hamper our security in profound ways.

Fortunately, with a new President and a bipartisan mandate in Congress, the opportunities to change direction and turn crisis into opportunity have never been more abundant. Now is the time to focus our resources on investments that will create jobs today and sustainable economic growth into the future.

I know that we have the technology to use less oil tomorrow then we used today, and even less the day after. We can move quickly toward greater energy independence, but only if we make major investments now in clean energy, like natural gas and electric vehicles and much more efficient fleets, and all produced right here in America and with American jobs.

President Obama's economic recovery plan is a giant step in the right direction. It provides $11 billion for smart grid technology and expanding transmission to renewable rich areas, as well as hundreds of millions of dollars to promote greater use of alternative fuel vehicles, including plug-in hybrids and fueling insfrastructure.

That plan is a massive infusion to help Americans become more energy efficient, including $300 million for energy efficient appliance rebates.

But even if we stopped wasting nearly one-third of the country's annual current energy consumption unnecessarily spending trillions of dollars and sending billions of tons of pollution up into the air we would still need new supplies of clean energy for sustainable economic growth.

Fortunately, Nevada and other parts of the desert southwest have enough solar energy potential to power our country seven times over. If that potential is combined with the wind energy from the Great Plains and the hundreds of thousands of megawatts of geothermal energy deep beneath the earth, the whole country could have cost-free fuel for many generations to come.

Innovators and entrepreneurs in every state have already begun to harness this power. But the field is in its infancy and it will only mature with significant and sustained support and attention at the Federal level.

But we must also focus our attention and investments on planning and siting new electricity transmission and breaking down barriers to a truly national approach. Otherwise, the vast clean renewable power in the sun, wind and geothermal resources of Nevada, off the country's coasts in the oceans, in the biomass on our lands, forests and in our cities, and in the remote and rural areas of the country, will never get to consumers.

Our transmission system and its regulations have been built up over many decades with the main target of assuring reliability and availability. Yet the grid is still fragile and not well equipped to meet the demands of this century's smart technologies or our environmental or national security challenges.

These issues were the topic of focused discussion last week at a genuinely important event a National Clean Energy Summit hosted by the Center for American Progress, CAP. This followed up on a similar gathering that I hosted in Las Vegas last August with John Podesta and the CAP Action Fund and the University of Nevada Las Vegas.

Last week's event was no ordinary meeting. It was admirably moderated by former Senator Tim Wirth and included President William Jefferson Clinton, Vice President Al Gore, Energy Secretary Steven Chu, Interior Secretary Ken Salazar, House Speaker Nancy Pelosi, Senator Jeff Bingaman, Representative Ed Markey, energy executive T. Boone Pickens, and leaders from government, business, labor, and the non-profit communities.

In particular, I would like to note the very constructive participation of the country's State regulatory commissions and authorities, ably represented by Fred Butler of New Jersey, President of the National Association of Regulatory Utility Commissioners. They have extremely difficult jobs maintaining reliability, keeping costs down, and being held responsible for the utilities' every move.

The outcome of our discussion was clear--reforming our energy policies to build a cleaner, greener national transmission system--an electric superhighway--must be a top national priority. However, equally clear was the sense that it will not be easy and will require everyone to work together with common purpose and through a strong public-private partnership to be effective in addressing our grave national challenges.

The need for reform is very clear. That is why I am introducing a bill today that charts a course to a cleaner, greener, and smarter national energy transmission system without sacrificing reliability or affordability. This will ensure a more secure and sustainable energy future for America.

Though this bill is loosely based on my legislation from the last Congress, this new and broader version is the product of input and a shared vision from many important stakeholders. In particular, the Center for American Progress and the Energy Future Coalition must be congratulated for their hard work and leadership in this complicated policy area. They have helped make it understandable to many in Washington, D.C.

But no one can beat T. Boone Pickens in explaining to the American people how critically important it is to transform the nation's electricity grid to accelerate the use of renewable energy. He is a source of immense renewable energy and really helping to drive this issue home.

My legislation will require the President to designate renewable energy zones with significant clean energy generating potential. Then, a massive planning effort will begin in all the interconnection areas of the country to maximize the use of that renewable potential by building new transmission capacity. The states would propose cost allocation means to fund the new lines in the green transmission grid plans. If either process falters, then the federal government would be given clear authority to keep things moving and get the new transmission built on schedule and funded equitably.

This bill is not perfect and has ample room for improvement. But as the bill works its way through the legislative process, I am hopeful that people will come together in good faith and propose revisions that will help solve the problems that we tried to identify at the Summit. There has already been a great deal of non-partisan, thoughtful work that Congress can draw upon in legislating and I look forward to the hearing that Chairman Bingaman has scheduled on this topic for next week.

Here are just a few of the organizations that provided valuable input in the drafting process for this bill: The Energy Future Coalition; the Center for American Progress; the Pickens Plan; Energy Foundation; Sierra Club; Natural Resources Defense Council; National Wildlife Federation; Audubon Society; The Wilderness Society; Bonneville Power Administration; Western Area Power Administration; Tennessee Valley Authority; Bureau of Land Management; Federal Energy Regulatory Commission; Department of Energy; North American Electric Reliability Corporation; National Association of Regulatory Utility Commissioners; California PUC; Working Group for Investment in Reliable and Economic Electric Systems; Florida Power & Light; Midwest Independent System Operator; PJM Interconnection; ITC Transmission; Trans-Elect Transmission; Pacific Gas & Electric; American Electric Power; American Public Power Association; Large Public Power Council; Salt River Project; National Rural Electric Cooperative Association; Solar Energy Industries Association; Bright Source Energy; RES-Americas; American Wind Energy Association; Iberdrola Renewables; Colorado River Energy Distributors Association; Electric Power Supply Association; National Electrical Manufacturers Association; and many more.

Mr. President, I ask unanimous consent that the text of the bill and support material be printed in the Record.

Mr. President, I rise today to introduce the Sunshine in Litigation Act of 2009, a bill that will curb the ongoing abuse of secrecy orders in Federal courts. The result of this abuse, which often comes in the form of sealed settlement agreements, is to keep important health and safety information hidden from the public.

This problem has been recurring for decades, and most often arises in product liability cases. Typically, an individual brings a cause of action against a manufacturer for an injury or death that has resulted from a defect in one of its products. The injured party often faces a large corporation that can spend a virtually unlimited amount of money defending the lawsuit, prolonging the time it takes to reach resolution. Facing a formidable opponent and mounting medical bills, a plaintiff often has no choice but to settle the litigation. In exchange for the award he or she was seeking, the victim is forced to agree to a provision that prohibits him or her from revealing information disclosed during the litigation.

Plaintiffs get a respectable award, and the defendant is able to keep damaging information from getting out. Because they remain unaware of critical public health and safety information that could potentially save lives, the American public incurs the greatest cost.

This concern about excessive secrecy is warranted by the fact that tobacco companies, automobile manufacturers, and pharmaceutical companies have settled with victims and used the legal system to hide information which, if it became public, could protect the American people from future harms. Surely, there are appropriate uses for such orders, like protecting trade secrets and other truly confidential company information. This legislation makes sure such information is protected. But, protective orders are certainly not supposed to be used for the sole purpose of hiding damaging information from the public, to protect a company's reputation or profit margin.

One of the most famous cases of abuse of secrecy orders involved Bridgestone/Firestone tires. From 1992-2000, tread separations of various Bridgestone and Firestone tires caused accidents across the country, many resulting in serious injuries and even fatalities. Instead of owning up to their mistakes and acting responsibly, Bridgestone/Firestone quietly settled dozens of lawsuits, most of which included secrecy agreements. It was not until 1999, when a Houston public television station broke the story, that the company acknowledged its wrongdoing and recalled 6.5 million tires. By then, it was too late. More than 250 people had died and more than 800 were injured as a result of the defective tires.

If the story ended there, and the Bridgestone/Firestone cases were just an aberration, one might argue that there is no urgent need for legislation. But, unfortunately, the list of abuses goes on. There is the case of General Motors. Although an internal memo demonstrated that GM was aware of the risk of fire deaths from crashes of pickup trucks with ``side saddle'' fuel tanks, an estimated 750 people were killed in fires involving trucks with these fuel tanks. When victims sued, GM disclosed documents only under protective orders, and settled these cases on the condition that the information in these documents remained secret. This type of fuel tank was installed for 15 years before being discontinued.

Evidence suggests that the dangers posed by protective orders and secret settlements continue. On December 11, 2007, at a hearing before the Senate Judiciary Committee Subcommittee on Antitrust, Competition Policy and Consumer Rights, Johnny Bradley Jr. described his tragic personal story that demonstrates the implications of court endorsed secrecy. In 2002, Mr. Bradley's

wife was killed in a rollover accident allegedly caused by tread separation in his Cooper tires. While litigating the case, his attorney uncovered documented evidence of Cooper tire design defects. Through aggressive litigation of protective orders and confidential settlements in cases prior to the Bradleys' accident, Cooper had managed to keep the design defect documents confidential. Prior to the end of Mr. Bradley's trial, Cooper Tires settled with him on the condition that almost all litigation documents would be kept confidential under a broad protective order. With no access to documented evidence of design defects, consumers will continue to remain in the dark about this life- threatening defect.

In 2005, the drug company Eli Lilly settled 8,000 cases related to harmful side effects of its drug Zyprexa. All of those settlements required plaintiffs to agree ``not to communicate, publish or cause to be published . . . any statement . . . concerning the specific events, facts or circumstances giving rise to [their] claims.'' In those cases, the plaintiffs uncovered documents which showed that, through its own research, Lilly knew about the harmful side effects as early as 1999. While the plaintiffs kept quiet, Lilly continued to sell Zyprexa and generated $4.2 billion in sales in 2005. More than a year later, information about the case was leaked to the New York Times and another 18,000 cases settled. Had the first settlement not included a secrecy agreement, consumers would have been able to make informed choices and avoid the harmful side effects, including enormous weight gain, dangerously elevated blood sugar levels, and diabetes.

This very issue is currently before a Federal judge in Orlando, FL. There, the court is faced with deciding whether AstraZeneca can keep under seal clinical studies about the harmful side effects of an antipsychotic drug, Seroquel. Plaintiffs' lawyers and Bloomberg News sued to force AstraZeneca to make public documents discovered in dismissed lawsuits. Late last month, the court unsealed some of the documents at question, and is still deciding whether to unseal the remainder of the documents. This is exactly the sort of case where we need judges to consider public health and safety when deciding whether to allow a secrecy order.

There are no records kept of the number of confidentiality orders accepted by State or Federal courts. However, anecdotal evidence suggests that court secrecy and confidential settlements are prevalent. Beyond General Motors, Bridgestone/Firestone, Cooper Tire, Zyprexa and Seroquel, secrecy agreements have also had real life consequences by allowing Dalkon Shield, Bjork-Shiley heart valves, and numerous other dangerous products and drugs to remain in the market. And those are only the ones we know about.

While some states have already begun to move in the right direction, we still have a long way to go. It is time to initiate a Federal solution for this problem. The Sunshine in Litigation Act is a modest proposal that would require federal judges to perform a simple balancing test to ensure that in any proposed secrecy order, the defendant's interest in secrecy truly outweighs the public interest in information related to public health and safety.

Specifically, prior to making any portion of a case confidential or sealed, a judge would have to determine--by making a particularized finding of fact--that doing so would not restrict the disclosure of information relevant to public health and safety. Moreover, all courts, both Federal and State, would be prohibited from issuing protective orders that prevent disclosure to relevant regulatory agencies.

This legislation does not prohibit secrecy agreements across the board. It does not place an undue burden on judges or our courts. It simply states that where the public interest in disclosure outweighs legitimate interests in secrecy, courts should not shield important health and safety information from the public. The time to focus some sunshine on public hazards to prevent future harm is now.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.