In Their Own Words—Quotes from the Congressional Testimony of Leading Experts on Complete Immunity Preemption

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In Their Own Words—Quotes from the Congressional Testimony of Leading Experts on Complete Immunity Preemption 

House Oversight and Government Reform Committee Hearing
May 14, 2008

“My greatest concern with preemption is that it would, I believe, dramatically reduce the incentives for manufacturers to act quickly and responsibly to detect, analyze, investigate and take action on potentially serious and life-threatening adverse reactions, once a drug is on the market.” - Dr. David Kessler

“Even if FDA's funding were doubled or tripled, its resources and ability to detect emerging risks on the thousands of marketed drugs and devices would still be dwarfed by those of the drug and device companies who manufacture those products. For that reason, the tort system has historically provided a critical incentive to drug and device companies to disclose important information to physicians, patients and the FDA about newly emerging risks.” - Dr. David Kessler

Dr. David Kessler- served as FDA commissioner from 1990 until 1997. He is currently a professor of pediatrics and epidemiology and biostatistics in the School of Medicine at University of California, San Francisco.

“There’s nothing new about product liability litigation. There's no argument that for the last 100 years product liability litigation has stifled innovation. We have the most robust medical device and drug industry in the world. Nonetheless, in 2002, the FDA -- which had previously supported and encouraged the existence of state liability litigation as a way of promoting the values the Food, Drug and Cosmetic Act served -- has now taken the position that there ought to be broad premption. Now, what's changed, other than the change of administrations? As far as I can tel, nothing. There is simply no public health justification for this about-face, as the examples with heparin indicate.” - David Vladeck

David Vladeck- a professor of law and co-director for the Institute for Public Representation at Georgetown University Law Center. He also serves as the director of the Center on Health Regulation and Governance of the O'Neill Institute for National and Global Health Law.

“Preemption of common law tort actions against drug and medical device companies is ill advised and will result in less safe medical products for the American people.” - Dr. Gregory Curfman

Dr. Gregory Curfman- is an internal medicine physician, currently the executive editor of the "New England Journal of Medicine.

“Manufacturers' responsibilities for product safety extend well beyond initial FDA approval, and it is apparent that additional consumer safeguards are needed, if we are to improve the safety of medical devices for the millions of patients who enjoy their benefits.” - Dr. William H. Maisel

Dr. William H. Maisel- is a cardiologist, and the director of the Medical Device Safety Institute within the Department of Medicine at Beth Israel Deaconess Medical Center in Boston, Massachusetts. Dr. Maisel previously chaired two FDA advisory panels, and has been a consultant to FDA since 2003.

“FDA approval does not end the process of information development about drug risks and benefits that define the safety of a drug and how a drug should properly be used. Without the possibility of litigation against manufacturers and their executives, we are likely to see greater misrepresentation of safety-related data and more potentially inappropriate use of harmful medications.” - Dr. Aaron S. Kesselheim

“Litigation, and what litigation does in a number of circumstances is, it brings to light both information that the manufacturer had kept internally. And it also brings to light manufacturers' practices and the way that they address safety concerns.” - Dr. Aaron S. Kesselheim

Dr. Aaron S. Kesselheim- is both a lawyer and an internal medicine physician. Dr. Kesselheim is a clinical fellow in the Department of Medicine and Harvard School of Public Health, and an associate physician in the Division of Pharmacoepidemiology at Brigham and Women's Hospital.

“I'm at the hearing today to speak as an engineer and as a Republican in support of legislation to ensure that all medical devices are subject to market forces, including the possibility of lawsuits by injured patients, which I believe is critical to help ensure the safety and effectiveness of those medical devices.”- Christine Ruther

“The reality is that, despite the very best efforts of designers, manufacturers and the FDA, not al device problems are identified in pre-market testing. The potential for being held liable is a key force in assuring the most conscientious testing and the prompt correction of hazards when they are identified.” - Christine Ruther

Christine Ruther- is biomedical engineer and the president and chief engineer of C&R Engineering, Inc.


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