Johnson and Johnson hip replacement recall – inadequate assessment of risks?

A court has heard how Johnson and Johnson, the parent company of DePuy, carried out an internal review into the failings of the disgraced ASR hip implant manufacturer, revealing a woefully inadequate assessment of risks. The biomedical manufacturer was forced to recall faulty hip implants which 93,000 patients had received with in 2010 which has sparked thousands of lawsuits against J&J which could cost the company billions.

Johnson and Johnson Hip Replacements – was there sufficient testing?

Johnson and Johnson’s internal review found that DePuy had failed to assess risks but had also used inappropriate criteria for risk assessments before the product was made available in 2003. Jimmy Smith, a compliance manager for DePuy was questioned via video-link in the trial and confirmed that engineers at the manufacturer had establish the necessary control measures to identify the risks associated with the product.

Had effective tests been carried out on the product prior to its sale in 2003, engineers may have realised that the product had too many designed flaws to be cleared for market. DePuy failed to carry out any clinical trials of the product in patients and had they done so, they may have realised the problems associated with the implant’s ball and cup mechanism. The components would knock together causing cobalt and chromium to fleck off, thus injuring patients.

Andrew Ekdahl, the president of DePuy was in fact warned before 2003 that the ASR device was poorly designed but nothing was done. As a result, Johnson and Johnson is now facing thousands of claims for medical compensation worldwide and no doubt there are more revelations to come.

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