In Their Own Words—Quotes from Experts in Leading Medical Journals Highlights Dangers of Complete Immunity Preemption

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In Their Own Words—Quotes from Experts in Leading Medical Journals Highlights Dangers of Complete Immunity Preemption  

The dangers of complete immunity preemption highlighted by leading medical experts in the New England Journal of Medicine and the Journal of the American Medical Association. 

“The Wyeth v Levine ruling will have far-reaching and profound implications for patients and drug safety. If the court rules in favor of Wyeth, endorsing preemption, patients will
lose an irreplaceable method for seeking remedies for injuries resulting from pharmaceutical agents that were approved by FDA.”
"Editorial: Prescription Drugs, Products Liability, and Preemption of Tort Litigation," -JAMA, 10/21/08

“If the court rules for preemption in Wyeth v Levine, congressional action will be necessary to remove preemption of state tort litigation involving claims of products liability for prescription drugs. Otherwise, the current system of FDA approval of drugs would have to be changed to preserve the health of the public. Under this alternative approach, no drug could be fully approved until long-term studies with large numbers of participants had been completed and marketing would have to be greatly limited until full FDA approval is achieved. Surely, the drug manufacturers would not be pleased with such a system; however, without such safeguards, patient safety would be jeopardized.”
"Editorial: Prescription Drugs, Products Liability, and Preemption of Tort Litigation," -JAMA, 10/21/08

“Either way, Congress, not the Supreme Court, seems better suited to decide public policy on patient safety, and it is telling that many members of Congress have joined amici briefs to remind the court that Congress already has decided not to grant preemption to drug manufacturers.”
"Editorial: Prescription Drugs, Products Liability, and Preemption of Tort Litigation," -JAMA, 10/21/08

“Therefore, unless and until the FDA drug approval process and the postmarketing surveillance system improve significantly, patients must have a means to seek recourse through tort litigation against product manufacturers. Anything less may well preempt the well-being and safety of the public.”
"Editorial: Prescription Drugs, Products Liability, and Preemption of Tort Litigation," -JAMA, 10/21/08

“Why should doctors be concerned about preemption? In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people. Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices. If injured patients are unable to seek legal redress from manufacturers of defective products, they may instead turn elsewhere.”
"Why Doctors Should Worry about Preemption," -New England Journal of Medicine, 07/3/08

“Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA’s regulatory actions and enhance patient safety. Margaret Jane Porter, former chief counsel of the FDA, wrote, “FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection.” Persons who are harmed have the right to seek legal redress. Preemption would erase that right. But in the past few years, the government’s views have shifted, and the FDA has reversed its position, now claiming that common law tort actions are preempted.”
"Why Doctors Should Worry about Preemption," -New England Journal of Medicine, 07/3/08

“Although frivolous lawsuits should not be condoned, product liability litigation has unquestionably helped to remove unsafe products from the market and to prevent others from entering it. Through the process of legal discovery, litigation may also uncover information about drug toxicity that would otherwise not be known. Preemption will thus result in drugs and devices that are less safe and will thereby undermine a national effort to improve patient safety.”
"Why Doctors Should Worry about Preemption," -New England Journal of Medicine, 07/3/08

“From a common sense perspective, there are deep concerns about the positions staked out by the FDA and the Supreme Court. Is it reasonable for a consumer protection agency, with the concurrence of the nation's highest court, to conclude that injured patients should be effectively barred from recourse against companies that aggressively market hazardous drugs or medical devices knowing the risks? The public might express even greater skepticism if tort immunity were granted to corporations that defraud the agency. But that may be precisely the position of the Supreme Court, which permits a corporation to use FDA approval as a shield against litigation even if it deceived the agency into granting that approval.”
“The Deregulatory Effects of Preempting Tort Litigation FDA Regulation of Medical Devices,”-JAMA, 05/21/08


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