A warning letter sent by the U.S. Food and Drug Administration (FDA) puts Johnson & Johnson back in the headlines. On December 8, 2011 the FDA disclosed new information in a warning letter stating one of the company’s subsidiaries sold multiple types of orthopaedic devices with out the required approval from regulators. The letter was based on an inspection of DePuy Orthaepedics from May 10, 2011 to June 7, 2011. The inspection showed DePuy had cleared 14 devices, mostly knee or hip systems, with out receiving proper approval from the FDA.
Unfortunately for Johnson & Johnson, this isn’t the first time for DePuy to make the headlines for negative publicity. In August of 2010 Johnson & Johnson issued a recall for their ASR XL Acetabular Hip Replacement System after receiving hundreds of lawsuits due to the failing device. Before the recall, the company believed the ASR XL Acetabular system was used in more than 90,000 patients, creating a large amount of concern for the majority of those patients.
Since the ASR XL Acetabular recall, Johnson & Johnson has been closely watched by the FDA. With the most recent warning, the company is striving to maintain a positive image. After the warning letter was sent out in December, DePuy responded by stating that the cleared devices were custom-made for certain patients and did not need the regular required approval. However, the FDA argued otherwise stating that, “the fact that the final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices.” The FDA also stated that DePuy failed to obey with quality regulations for the devices. DePuy has currently discontinued all custom-made devices and is trying to answer all questions that raise concern in the warning letter.
If you or a loved one have ever felt that you were not properly warned about a medical device or have any kind of concern don’t hesitate to contact an attorney to discuss your legal options. At Borchardt Law Firm we want to make sure the medical devices patients use are safe and fairly marketed. We currently serve in the Dallas – Fort Worth area and have dealt with several defective medical device cases and feel the work we do will protect future generations of Texans. Feel free to give us a call.
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