Medical Products Liability Posts in November, 2013

FDA Implements Unique Codes to Track Medical Devices

The FDA announced recently that federal health regulators will be able to track millions of medical devices around the country soon with a new electronic system. The goal of the program, which works with pacemakers, hip replacements, and a broad array of medical devices, is to protect patients by identifying problems early on. Serious problems from defective medical devices have led to complications, follow-up surgeries, and attorneys tackling the issue head-on....
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Johnson & Johnson Faces More Damage Because of Risperdal

Johnson & Johnson has agreed to pay $2.2 billion to settle charges with the U.S. Department of Justice over the alleged illegal marketing of Risperdal, Invega and Natrecor.  Johnson & Johnson has been accused of improperly promoting the antipsychotic drug Risperdal for the elderly, children, and people with developmental disabilities.  The Food and Drug Administration had only approved the drug for limited pediatric uses in 2006....
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FDA Creates New Identification System to Combat Defective Medical Devices

The Food and Drug Administration recently announced a new regulatory requirement for medical devices. All devices must now have a unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices. The development and safe operation of medical technology is literally of life and death importance, and manufacturers must uphold high standards in both quality and safety....
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Johnson & Johnson Fined $2.2 Billion by Justice Department

The United States Department of Justice has announced that global health care company Johnson & Johnson will pay more than $2.2 billion in criminal and civil fees in a defective medications lawsuit alleging that the company marketed medications to improper audiences from 1999 to 2005. The judgment represents the third-largest health care fraud settlement in United States history....
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Defective Medical Devices: An Overview

Every year, defective medical devices affect thousands of Americans and the problem only seems to be growing, according to Consumer Reports. Medical devices that are implanted into bodies (including but not limited to defibrillators, surgical mesh, and artificial joints) often go untested....
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Metal-on-Metal Hip Replacements Banned in UK

The metal-on-metal hip replacements that have caused such a catastrophe for so many U.S. patients have been banned in the U.K., according to the Daily Telegraph. According to the U.S. Food and Drug Administration (FDA), there are always risks associated with hip replacements, and metal on metal (MoM) hip replacements carry additional risks unique to MoM hip implants....
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Stryker Hip Recall Suit Spurs New FDA Regulations

In late September, spurred by the massive Stryker hip recall earlier this year, “the U.S. Food and Drug Administration (FDA) is launching a new system for identifying high-risk medical devices… that is says will target product problems more quickly and improve patient safety,”according to Newsday....
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  • Newland & Newland LLP, Attorneys, Arlington Heights, IL