Public Citizen has been working for years to oppose industry claims of preemption in the courts and in federal regulations. They are now pushing regulation and an executive order by President-elect Obama to stop this immunization of manufacturers. The Obama Administration must restore consumer rights, focus regulatory duties on protecting health, safety, and the environment. The following is a statement by Joan Claybrook, President of Public Citizen, setting out her thoughts and Public Citizen’s goals:
If President-elect Barack Obama wants to set a different course than the Bush Administration, which resisted and turned back critical health, safety and environmental protections, he can start by striking down his predecessors eight-year effort to tilt the regulatory field heavily toward big business and industry. In a letter sent Tuesday to Peter Orszag, the incoming Office of Management and Budget director, and Cass Sunstein, who is expected to serve as Obama’s regulatory czar, Public Citizen reiterates its request that President-elect Obama make the health and safety of American families the underlying goal of all federal regulations. The new President can take an important step in this direction by amending a key executive order to reverse the erosion of consumer rights that occurred under the Bush Administration. Public Citizen, which was joined by other public interest groups, outlined in a letter sent to the transition team last month how the order could be drafted.
Specifically, the order should prohibit the abusive practice of inserting language in the preambles of or in federal regulations for the purpose of immunizing manufacturers from liability for injuries caused by faulty products. Through these preambles, the Bush Administration has been attempting to block consumers from holding manufacturers accountable for harm caused by hazardous drugs, medical devices, motor vehicles and other products. Under the Bush preemption doctrine, if a federal rule provides just a minimum floor of protection -for example, ensuring simply that a new drug isn’t snake oil – then the manufacturer should be immune from all liability for harm the product causes, no matter how negligent or irresponsible the company was in designing, testing, labeling or marketing the product.
In a despicable abuse of its authority, the Bush Administration in its last days continued to issue new regulations that contain these anti-consumer preambles – a last hurrah for an Administration that did everything it could to enrich its friends in Corporate America. Public Citizen has fought against this campaign to preempt consumer and state rights at every level. We have opposed harmful regulations at the administrative level, and we have filed numerous petitions for reconsideration of rules issued by the Bush Administration containing immunity clauses to stop them from taking effect until the new Administration can review them. We have backed legislation in Congress that would restore consumer rights and argued against preemption all the way to the Supreme Court.
The ability to hold manufacturers responsible in court for their defective products is one of the greatest safeguards the public has to ensure quality and accountability in the marketplace. In the coming months, Public Citizen attorneys will serve as lead counsel on a number of key cases involving preemption. For instance, we represent injured consumers against claims by generic drug manufacturers that they are entitled to special preemption protection. We also are involved in a series of cases in which food manufacturers assert that federal preemption immunizes them from claims that their product labels are false and misleading. And we are part of the team representing actor Dennis Quaid and his wife, whose infant twins almost died after being administered a mislabeled drug meant for adults. There, the drug’s manufacturer is claiming preemption simply because the product was approved for marketing by the federal government.
We will also lobby aggressively for the reintroduction and passage of the Medical Device Safety Act, which would overturn the 2008 Supreme Court decision in Riegel v. Medtronic. In that case, the U.S. Supreme court held that pre-market approval of a medical device by the Food and Drug Administration immunizes the manufacturer from tort liability. The decision deprives injured patients of any compensation for their injuries. We have convened a group of leading public interest organizations to monitor and act on preemption issues before Congress and the executive branch. We hope that President-elect Obama, who as a U.S. Senator co-sponsored the Medical Device Safety Act, Professor Sunstein, and Director Orszag will move quickly and urgently to undo the damage to consumer rights done by the past Administration.
Public Citizen has been a strong supporter of consumer rights and has fought very hard to protect all Americans from defective and dangerous products. It has been a defender of the civil jury system and we all owe Public Citizen a debt of gratitude.
Source: Public Citizen
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