States Barred from Protecting Consumers Hurt by Faulty Medical Devices, Says Supreme Court

States Barred from Protecting Consumers Hurt by Faulty Medical Devices, Says Supreme Court

Thursday, February 21st, 2008


BY Nathan Newman

States Barred from Protecting Consumers Hurt by Faulty Medical Devices, Says Supreme Court

In one more example of lax federal agencies being empowered to block tougher state protection of consumers, the Supreme Court ruled yesterday that states are barred from protecting consumers from faulty medical devices, such as breast implants, if the Federal Food and Drug Administration (FDA) has already approved those devices.

These means that a federal agency like the FDA, politicized by a right-wing President and dominated by industry-funded advisors, can unilaterally override laws in all fifty states that hold companies liable for harm to consumers.  This, despite the fact that, as the New York Times described:

The Institute of Medicine, the Government Accountability Office and the FDA's own science board have all issued reports concluding that poor management and scientific inadequacies have made the agency incapable of protecting the country against unsafe drugs, medical devices and food.

Subverting Pro-Consumer Laws: Because it is impossible for any agency to find all problems with products during the approval process, states have long held medical device makers liable for harm to consumers. However, in 2004, the Bush Administration retroactively reinterpreted the 1976 Medical Device Amendments law to preempt state damages against devices approved by the FDA. But as the sole Senate sponsor of that 1976 law, Sen. Edward Kennedy condemned that interpretation of a law meant to protect the public, not protect industry:

In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court's decision. Otherwise, FDA approval will become a green light for shoddy practices by manufacturers.

A Dangerous Trend: We are seeing a cascade of federal agency decisions, backed by federal courts, that are gutting state law protections for consumers and workers. As we described last year, the sub-prime mortgage meltdown might have been averted if courts had not allowed a federal banking agency to preempt state laws that sought to rein in predatory lending practices in the home mortgage industry. This is part of a dangerous trend of industry using federal preemption to limit state government regulation of corporate abuses. It also illustrates the hypocrisy of a conservative ideology that claims to represent limits on federal power, but readily abuses that federal power to sacrifice the rights of consumers and workers for the sake of monied interests.

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Michigan Fights to Ensure PEG Channels Are Available to All

The future is very uncertain for public, education and government (PEG) channels.  These local channels have traditionally been carried by cable companies as a public service to highlight local community and public voices.  Historically, PEG channels have been receivable on both analog and digital service, ensuring that PEG stations were accessible by any individual with a television, regardless of income level or cable package.  Now that the Digital TV transition is just around the corner, the question is what happens to these channels.  Comcast, a service provider, is not required to, nor going to, go "all digital" as of February 2009, but many believe they are using the pending transition as an excuse to reduce access to PEG channels. 

In November, Comcast attempted to move Michigan PEG channels off the "basic" tier of services and stick them in "digital delivery."  This move would place the channels out of the reach of a large number of cable subscribers. When Comcast proposed the change many local officials found themselves trapped.  While local officials wanted to protect PEG channels, the recently enacted uniform video services local franchise act tied there hands and greatly diminished their power to stop Comcast.  

Michigan legislators, in an attempt to protect PEG, drafted house bill 5693 to amend Public Act 480 to ensure that all subscribers could access PEG stations without having to purchase additional equipment.

Michigan's amendment uses language similar to that in California's state video franchising legislation, AB 2987.  One of the provisions in the California bill that aims to protect PEG stations states that PEG should be "receivable by all subscribers, whether they receive digital or analog service, without the need for any equipment other than equipment necessary to receive the lowest cost tier of service." 


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BY Adam Thompson

Amid Court Challenges, Legislators Work to Protect Prescription Privacy

Despite ongoing court challenges, states are moving ahead to protect the privacy of physicians' drug prescribing-history. Most recently, the Washington State Senate passed SB 6241, which prohibits the sale or use, for marketing purposes, of data detailing which drugs a physician prescribes and how often -- a practice called data-mining. In 2006, New Hampshire became the first state to ban data-mining for marketing purposes. 

Prescribing-history is a favorite tool of the drug industry to tailor marketing to medical professionals, jacking up prescription drugs costs in the process. Such steps are more than prudent, given that 90% of the drug industry's shocking $21 billion marketing budget is directed towards doctors. 

The New Hampshire law and those that have followed it, do not restrict legitimate uses of prescriber data, such as health care research, utilization reviews by providers and insurers, and law enforcement. Vermont and Maine soon followed New Hampshire with their own data-mining bans in 2007. Vermont set up a process whereby physicians could "opt-in" and allow the prescribing history to be used for marketing purposes and Maine established a less restrictive system that allows physicians to "opt-out" of the use of their history for marketing purposes. 

All three laws are facing legal challenges from the industry, which is arguing that the bans restrict their commercial free speech. Advocates, including the National Legislative Association on Prescription Drug Prices, have filed briefs countering the industry's free speech claims and asserting the power of states to regulate the use of similar consumer data. A legal analysis reported by Community Catalyst's Prescription Project includes advice on what states can do to preempt industry lawsuits and strengthen data-mining bans.

This year, at least 12 other states and the District of Columbia have proposed or enacted similar bans on data-mining for marketing purposes. In addition to the Washington State Senate, the Vermont House defeated an effort to weaken the state's existing data-mining ban in the face of the industry court challenge.

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New Report

BY Adam Thompson

New Report - Individual Health Care Mandates and the Problem of Affordability

In a new report, Progressive States Network updates a fall 2007 edition of the Stateside Dispatch and discusses the growth of legislative measures to protect consumers from unaffordable health care costs. Individual Health Care Mandates and the Problem of Affordability uses the experience of Massachusetts' individual mandate as a case study to demonstrate the need for strong language ensuring affordability and profiles various legislative models for affordability protections.

As the report emphasizes, health care reform should have the goal of limiting families' exposure to potentially catastrophic health care costs, including a focus not just on premiums, but on deductibles, co-pays, and the total out-of-pocket costs. This can be achieved by limiting all potential family health care costs to a proportion of family income. Such limits should allow for other family living expenses, including housing, transportation, education, food and clothing, and the ability to accrue savings.

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Research Roundup

In a ground-breaking report, Getting Ahead or Losing Ground: Mobility in America, the Economic Mobility Project found that widening gaps in higher education between those coming from rich and poor families as well as disparities between white and minority children, are leading to a downturn in opportunities for the poorest families. Only 11 percent of children from the poorest families have earned college degrees in recent years, trapping most of them in the lowest income brackets in adulthood.

The American Immigration Lawyers Association has just published Navigating the Immigration Debate: A Guide for State & Local Policymakers and Advocates to help legislators and advocates respond to the raft of anti-immigrant measures being proposed around the country. Different sections highlight central arguments, offering factual rebuttal to common myths, current legislative activity around the country, relevant litigation, and a compilation of additional resources from individuals and organizations with expertise to assist advocates.

Also on the immigration front, Virginia's Commonwealth Institute released Fiscal Facts: Tax Contributions of Virginia's Undocumented Immigrants, which estimated that the 250,000 to 300,000 undocumented individuals in the state pay between $145 million and $174 million in state income, sales, excise and property taxes, and their employers pay $4 million to $5 million in unemployment insurance taxes on their behalf. As in many other states, the debate on the impact of undocumented immigration on Virginia's economy has been dominated by a discussion of costs that has altogether ignored the other side of equation of contributions.  This study is the first time anybody in Virginia has put an estimate around the contributions.

In Unequal Access: Neglecting the National Voter Registration Act, 1995-2007, a report by Project Vote and Demos, finds that public assistance agencies are failing to register voters, with a decline of 79% in applications since 1995, and many states fail even to report data on registration as required by federal law. Examples from a few states do show, however, that low-income voter registration can be increased by vigorous enforcement of the law.

In a new analysis, the Center on Budget and Policy Priorities finds that the President's proposed budget would cut $20.5 billion for domestic discretionary programs outside of homeland security -- meaning decreased help for child care, environmental protection, and medical research.

Uninsured or Medicaid-insured patients are far more likely to miss signs of cancer until advanced stages, according to a new American Cancer Society study of 3.5 million cancer patients. Independent of insurance status, black and Hispanic patients were also more likely to be diagnosed only in later stages of cancer compared to white patients, compounding the problem that minorities also are more likely to be uninsured or on Medicaid.

In its First Interim Report, the New Jersey Civil Union Review Commission, set up under the law establishing civil unions in that state, found that many same-sex couples see New Jersey's system as a "failed experiment" that has created a "second class citizenship" for gay and lesbian couples because employers refuse to recognize and grant benefits based on civil unions, while employers in Massachusetts have been prompted to provide equal benefits under that states' marriage equality law. Couples also faced uncertainty during health care crises and exposure to punishment by the military under the "Don't Ask, Don't Tell" policy., produced by the National Institute on Money in State Politics, is an indispensible resource for tracking the influence of special interest campaign spending on state politics and policy. They have revamped the site to include better visual displays and ways to search by individual, contributors, candidates, states, or industries -- all with one click.  Find out "What's New With"

Please email us leads on good research at


States Barred from Protecting Consumers Hurt by Faulty Medical Devices, Says Supreme Court

Progressive States Network - Industry Looks to Federal Rules to Preempt State Regulation

Supreme Court - Riegel v. Medtronic

Public Citizen - Riegel v. Medtronic related materials and Preemption of Consumer Remedies and Related Topics

Online Journal - Regulators and researchers corrupted by Big Pharma 

Washington PostSenators Prod FDA Nominee On Politicization of Agency

Michigan Fights to Ensure PEG Channels Are Available to All

Alliance for Community Media

Save Access

Clippings for PEG Access Television

Cable TV PEG Channels Deserve Lawmakers' Aid
Bill provides for cable channel compromise
"PEG Access in the Digital Age": The Entire Congressional Hearing, in Order, in YouTube Clips
Comcast Defends Michigan PEG-Channel Move

Amid Court Challenges, Legislators Work to Protect Prescription Privacy

National Legislative Association on Prescription Drug Prices - Advertising and Marketing and Model Legislation

Prescription Policy Choices - Best Practices

Community Catalyst, The Prescription Project - The Constitutional Battle Over State Regulation of Data-Mining

NCSL - 2008 Prescription Drug State Legislation

Progressive States Network - Big PhRMA and Marketing Prescription Drugs

Upcoming Events

Mar. 6, Washington, DC - How Progressives Win on Immigration, sponsored by Progressive States Network and the Center for American Progress

Mar. 5-7, New Orleans, LA - The Third International Summit on Equitable Development, Social Justice and Smart Growth

Mar. 13-14, 2008, Pittsburgh, PA - Good Jobs, Green Jobs: A National Green Jobs Conference, sponsored by the BlueGreen Alliance, a partnership of the United Steelworkers and Sierra Club


The Stateside Dispatch is written and edited by:

Nathan Newman, Policy Director
J. Mijin Cha, Policy Specialist
Julie Schwartz, Policy Specialist
Adam Thompson, Policy Specialist
John Bacino, Operations Manager

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