Landmark Decision Precedent Could Hinder Even More Personal Injury Lawsuits

Greg Webb

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In late February, a landmark decision by the Supreme Court ruled patients injured by most medical devices cannot sue the manufacturers. This decision expands upon the Bush administration's policy reversal in 2004, contending that if the Food and Drug Administration (FDA) approves a product, the manufacturer of the product is therefore protected against lawsuits at the state level. The recent decision was supported by a legal theory that states the Food and Drug Administration (FDA) sufficiently regulates the drug and device industries and should therefore not be second-guessed by courts. Critics reply they too would agree with this logic if the FDA were doing a better job. http:///www.latimes.com/business/la-fi-fda3mar03,1,414946.story?track=rss&ctrack=2&cset=true

This decision comes at a time in which the FDA has been receiving a lot of criticism for not properly inspecting many different products, such as a Chinese factory that produced the drug heparin that led to as many as twenty-one deaths. Last fall a study found the FDA to be severely understaffed and underfunded, putting American consumers at many safety risks. The current FDA commissioner even admitted that the agency needs a possibly time-consuming systemic overhaul. Supporters of the decision, however, say this is a step in the right direction since manufacturers were scared to create new innovations for fear of lawsuits. This coming fall the ruling could be extended to the much larger pharmaceutical industry as well in the case of Levine v Wyeth. Legal experts and attorneys are worried that if this decision goes the way it did in the medical devices hearing, manufacturers will not be held responsible for putting products on the market they knew were unsafe. http:///www.latimes.com/business/la-fi-fda3mar03,1,414946.story?track=rss&ctrack=2&cset=true