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FDA Warns DePuy Company To Stop And Comply Or Face Consequences

Johnson & Johnson in the hot seat again, as the U.S. Food and Drug Administration (FDA) just issued a warning to Johnson & Johnson’s DePuy Orthopaedics for marketing a number of unapproved medical device components.

The drug and device giant’s subsidiary sold more than a dozen different orthopedic devices without ever having received required regulatory approval, said the FDA in a just-released warning letter, wrote the Asbury Park Press. The letter also said that DePuy had a quality system in place that was not in compliance with FDA mandates.

The letter, from Steven D. Silverman, FDA’s director of the office of compliance, was sent December 8, 2011 and followed an inspection that took place May 10, 2011 – June 7, 2011 said the Asbury Park Press. In his letter, Silverman said that DePuy manufactured 14 devices, that never received pre-market clearance or approval from the agency.

The products included devices for ankle, knee, hip, shoulder, elbow and wrist replacements.



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This article was written by Mark Sadaka, a seasoned trial lawyer in nationally significant cases. He fearlessly champions clients impacted by fatal or severe injuries caused by others or corporations. Renowned for his expertise in complex litigation, he's featured in books, sought after by media for interviews, and a highly sought speaker. Notably, he exclusively represents individuals facing life-changing injuries or substantial financial losses.

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