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Pradaxa’s Life in the FDA Fast Lane — Profits Over Safety?

05/11/2012
Articles
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Pradaxa, an anti-coagulant drug marketed by Boehringer Ingelheim Pharmaceuticals, enjoyed an unusually smooth (and quick) ride towards FDA approval.  Rather than spending months pouring over clinical studies and safety data, FDA employees instead approved Pradaxa based primarily on a single study and did so in just six months.  Below are […]

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DePuy ASR Hip Implant Case Update

05/11/2012
Defective Medical Devices
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So far this week, our firm has filed three new DePuy ASR hip implant cases in the MDL proceedings pending before Judge David A. Katz of the United States District Court in the Northern District of Ohio. These multi-district litigation proceedings related to DePuy’s recalled ASR hip implants are also […]

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Tracking Drugs for Consumer Safety

05/3/2012
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The Institute of Medicine (IOM) is taking the U.S. Food and Drug Administration (FDA) to task. In a new report, the IOM says the FDA should conduct more regular reviews of drugs to better catch and track safety issues. In order to better inform patients and the doctors who treat […]

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Dangerous Top Ten Drugs

04/27/2012
Articles
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The Top Ten of anything usually designates the ‘best’ but not in this case. An online report from Adverse Events Inc., an independent company that analyzes the FDA’s database of Adverse Event Reporting System (AERS), has just issued its Top Ten list of Dangerous Drugs for the second quarter Q2 […]

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All That Yaz — Bayer Settlement Update

04/13/2012
Defective Drugs
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Bloomberg is reporting today that Bayer has now settled approximately 500 of the more than 10,000 lawsuits pending against the German drug manufacturer. The reports indicate that the cases were confidentially settled for the sum of $110 million, or slightly more than an average of $200,000 per case. Settlement negotiations […]

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