Articles Posted in Recalls

DePuy has issued a recall for hip replacement parts already implanted in 93,000 patients. The DePuy recall was prompted by continued problems with these hip replacements. These problems include the need for additional surgery from loosening parts, fractures, dislocations, and sensitivity to metal and pain. To say the least, these are troubling complications for someone who already had to deal with the trauma of needing a hip replacement in the first place. For victims of this defective DePuy hip replacement, it is an insult on top of injury because, obviously; it is a little hard to actually recall a hip implant.

DePuy is owned by Johnson and Johnson, which has had more than its share of problems lately. What is frustrating about this recall is that the product was withdrawn from the Australian market almost a year ago, ostensibly as the result of problems with the implants.

Many doctors, industry experts, and, more importantly, patients are questioning why DePuy did not recall the DePuy ASR hip replacement system because it had a design defect that made it difficult to implant the hip replacement device properly. It seems clear now that the DePuy ASR cups were designed too shallow. It is hard not to ask: did J&J put profits over people without properly testing whether the device would be safe and as good as other hip replacement options already on the market?

Our lawyers are now looking at potential class action cases involving oral sodium phosphate products. The FDA stated in December, through a MedWatch Safety Alert, that oral sodium phosphates (OSP) bowel cleansing solutions should be available by prescription only.

The MedWatch Safety Alert, with the cumbersome title, “Oral Sodium Phosphate (OSP) Products for Bowel Cleansing: reports of acute phosphate nephropathy, Boxed Warning to be added to labeling,” reported serious kidney injuries were associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to not only colonoscopies but other less invasive procedures. MedWatch also noted something that will be critical in proving these lawsuits: they have found kidney injuries in patients who not only had no prior kidney injury but also had no markers that would make them candidates for this particular kidney injury (acute phosphate nephropathy).

Acute phosphate nephropathy, often called acute nephrocalcinosis, is a very serious kidney injury that can require dialysis or a kidney transplant and can lead to acute renal failure and even death.

The FDA is also concerned with all potential kidney injuries and risks associated with the use of OSP products available over-the-counter (OTC). The reason the OTC problem is more severe is that the injury appears to be dose-responsive.

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