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More Patients Placed at Risk Due to Lack of Adequate Warnings

A recent article in the New England Journal of Medicine warned that, "Patients in the United States continue to be exposed to underperforming and potentially hazardous medical devices after they have been approved by the Food and Drug Administration (FDA) despite multiple recalls and tragic adverse events." This statement by Dr. Robert Hauser, author of the article, identifies a growing problem in the country: medical products are quickly introduced to the market, and no adequate monitoring system is in place to detect adverse or dangerous incidents after FDA approval.

The latest incident to enter headlines, which sparked Dr. Hauser's article, is a mass recall of St. Jude Medical Inc.'s Riata, a cable used in heart defibrillators already installed in over 70,000 patients in the United States. The company stopped selling the product in 2010 when it became clear that internal wires could break free from insulated cables and cause disturbances to heart function, but the products were only recalled a year later, too late for many patients. Surveillance systems were not in place early enough to detect the problem before it became widespread, despite problems with similar products in 2007.

The FDA screens for problems with drugs and devices before they are approved for sale to the public, but there are still products that prove to be unsafe in the months or even years after receiving approval. Until the pre-and-post product approval process is improved, people will continue to be faced with unexpected medical problems as a result of the items they hoped would improve their health. If you or a loved one has been injured by a dangerous medical device or product, contact a product liability attorney from Arnold & Itkin LLP. We are happy to offer a free and confidential consultation to any individual wishing to explore a medical injury claim. Contact a defective medical device lawyer from our team for any questions or concerns.

Categories: Medical Device


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