Tort Report (Anemia Drug Recall and Zimmer Spine Dangers)
March 27th, 2013|
Omontys is an injectable drug used to treat anemia in kidney dialysis patients. The manufacturers recalled all lots of Omontys (peginesatide) following reports of serious and potentially fatal hypersensitivity and allergic reactions. These reactions have been reported in patients within 30 minutes of their first injections of the drug.
Immediately following the recall, the FDA issued an alert to healthcare providers citing 19 reports of anaphylaxis from U.S. dialysis centers, three of which resulted in death.
Zimmer Spine Dangers
Zimmer Spine Inc.’s PEEK Ardis Inserter is a surgical instrument designed to implant the PEEK Ardis Interbody Spacer during spinal surgeries. Zimmer Spine claims that the Ardis Inserter is the only proper way to insert the spacer into a patient’s spine during a procedure. However, reports indicate that the spacers can break, or fracture, during surgeries when too much force is applied to the Ardis Inserter.
The U.S. Food and Drug Administration (FDA) issued a Class I recall on the Ardis Inserter instrument, stating there is a “reasonable probability” that use of the product will result in serious adverse health consequences or death. Class I recalls are the most serious type of FDA recall. Complications include:
- cerebrospinal fluid leakage,
- dural tears (tears in the thin covering of the spinal cord),
- nerve injuries, and
- significant blood loss.
For a complete list of the torts we’re tracking, see the Mass Torts Matrix.