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Category: Defective Drugs

Proposed FDA Label Changes Irking Generic Drugmakers

03/10/2014
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Generic drugmakers are increasingly becoming more frightened of the threat of products liability lawsuits because of a proposed rule that would require them to change their labels if the company receives new safety information about the drug. These label changes would overturn a three decade old regime of prohibiting generic […]

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Generic Drug Preemption

03/10/2014
Defective Drugs
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In 2009, the U.S. Supreme Court in Wyeth v. Levine held that brand-name drug manufacturers are responsible for their warning labels and may be liable for not adding additional warnings when new risks are discovered. However, in 2011, the Supreme Court held that failure-to-warn claims brought against generic drug makers […]

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New Opioid Pain Pill to Hit the Market

03/3/2014
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Do we really need a new highly addictive opioid analgesic on the market to treat chronic pain, especially considering the high rates of drug addiction in the U.S? The drug Zohydro is set to be marketed come March and its approval is sparking a firestorm from consumer, drug addiction and […]

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Spoliation and Sanctions

02/19/2014
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Spoliation of evidence has been defined by the courts as “the destruction or significant alteration of evidence, or the failure to preserve property for another’s use as evidence in pending or reasonably foreseeable litigation.” The concept behind this word defies one of the basic tenants in our legal system – […]

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FDA Eyes Pradaxa Again

02/6/2014
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Despite all the company assurances that the anticoagulant Pradaxa is a superior alternative to warfarin, the Food and Drug Administration (FDA) plans to once again compare the two. Pradaxa was approved in 2010 but has since then brought a high complication rate to its users  – including dangerous and uncontrolled bleeding […]

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