Lawmakers Seek to Return Right to Sue Device Makers - NYTimes.com

Lawmakers Seek to Return Right to Sue Device Makers - NYTimes.com: ". . . [A] Supreme Court decision last year stands as a barrier against suing medical device companies — an obstacle that some members of Congress want to remove. "

Drug Label, Maimed Patient and Test for Court - NYTimes.com

Drug Label, Maimed Patient and Test for Court - NYTimes.com: "In November, the Supreme Court will hear arguments about whether Ms. Levine may keep more than $6 million that a Vermont jury ordered Wyeth, a pharmaceutical company, to pay her for failing to warn her adequately about the risks of one of its drugs. The case, the latest in a brisk parade of similar ones, will help define the contours of a signature project of the Roberts court. In legal jargon, the cases concern “pre-emption,” a doctrine that can bar injured consumers like Ms. Levine from suing in state court when the products that hurt them had met federal standards. The issue is less boring and more consequential than it sounds, and Ms. Levine’s case is shaping up to be the most important business case of the term."

AdvaMed Responds to House & Senate preemption bills - AdvaMed

AdvaMed Responds to House & Senate preemption bills - AdvaMed: "If enacted, this legislation would create a patchwork approach to medical device approvals where state courts would effectively review and regulate medical devices. It would likely result in a dizzying array of conflicting labeling and indications for use and ultimately may result in life-saving, life-enhancing technologies simply not being available for patients."

OPINION: Drug Makers’ Advantage - New York Times

OPINION: Drug Makers’ Advantage - New York Times: "Like the doctrine of pre-emptive war that led to Iraq, F.D.A. pre-emption is a policy concocted in oblivion, an ideology without connection to the ways the agency and industry actually work. The editors of The New England Journal of Medicine recently wrote that that policy would have cataclysmic consequences for patients’ rights, industry accountability and public health. It is not often that doctors defend trial lawyers. Having now heard what the most respected voice in American medicine has to say, we should have no illusions where we are headed."

EDITORIAL - The Dangers in Pre-emption - New York Times

EDITORIAL - The Dangers in Pre-emption - New York Times: "Injured patients should not lose the right to sue if they are harmed by duplicitous manufacturers.Injured patients should not lose the right to sue if they are harmed by duplicitous manufacturers."

Appeals Court Backs Drugmakers in Antidepressant Suicides-WSJ Health Blog

Appeals Court Backs Drugmakers in Antidepressant Suicides-WSJ Health Blog: "Federal appeals court yesterday sided with drugmakers in a case brought by the families of two people who committed suicide while taking antidepressants. The ruling is important because it turns on the concept of preemption, likely to be the most important legal topic in the drug world this year."

Odds Rise for FDA Shield Against Drug Liability-WSJ Health Blog

Odds Rise for FDA Shield Against Drug Liability-WSJ Health Blog: "Johnson & Johnson maintains that it can’t be sued by thousands of women who claim they were injured by the company’s birth control patch because the FDA approved the product as safe and effective.
The seemingly tautologous legal argument is called pre-emption. “After decades of being dismissed by courts, the tactic now appears to be on the verge of success,” attorneys for plaintiffs and drug makers tell the New York Times."

With Democrats in control, trial lobby makes headway - TheHill.com

With Democrats in control, trial lobby makes headway - TheHill.com: "The trial bar, on the defensive when Republicans ran Congress, is moving to make up lost ground on a variety of fronts now that Democrats are in charge, including through a bill-by-bill campaign to keep federal agencies from overriding tougher state consumer protection laws. The bar’s main lobbying group, the American Association of Justice, formerly known as the Association of Trial Lawyers of America, has already had some successes this year in its effort to block what’s referred to as federal regulatory preemption."

Federal Preemption Defense Under Fire In Draft House Bills - Medical Devices Today

Federal Preemption Defense Under Fire In Draft House Bills - Medical Devices Today: "'Clearly, above and beyond all of the other issues that we have concerns about in the draft, ... preemption is absolutely critical to our industry and that is the one we are spending the most time on,' stated a high-level industry insider who did not wish to be identified. 'We think the implications are very strong and very concerning.'"