Drug Injury Lawyer Blog

On April 30, 2010, the FDA ordered Baxter Healthcare Corp. to recall and destroy all of its more than 200,000 Baxter Colleague Infusion Pumps due to Baxter’s longstanding failure to correct serious safety problems with the Infusion pumps. These pumps are medical devices designed to deliver fluids, nutrients and medication to patients in a controlled manner. They are widely used by health care practitioners in order to more accurately deliver medications to patients. More than 500 deaths and 56,000 adverse events associated with these infusion pumps have been reported to the FDA in the last five years.

Continue reading "FDA Orders Baxter To Pay Refunds To Purchasers Of its Colleague Volumetric Infusion Pumps: Will You Get Your Refund?" »

According to The Wall Street Journal, the FDA is becoming increasingly concerned about the continuing and increasing number of hardware and software problems associated with insulin pumps, small devices worn by many diabetics to continuously deliver insulin, as an alternative to shots. Incredibly, over the last five years, there have been 18 recalls of insulin pumps, including recalls by manufacturers Johnson & Johnson, Medtronic, Inc., and Roche Holding AG. Tomorrow, the FDA is convening an advisory panel of experts to discuss what needs to be done to “minimize risks associated with the devices in these situations."

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In October, we alerted readers that the FDA became aware of numerous radiation overexposures during CT scans at a particular facility, with patients receiving radiation doses that were approximately eight times the expected level. The article noted that this situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility - putting patients at increased risk for long-term radiation effects.

Continue reading " CT Scan Radiation Causing Cancer " »

In August 2009, Medtronic began informing physicians for the first time that, contrary to the labeling, its Sutureless Connector (SC) intrathecal catheters were incompatible with IsoMed Infusion Pump Model 8472, a drug delivery system for which the catheters were not designed. On September 14, 2009, the US Food and Drug Administration ("FDA") notified Medtronic that it considers the notification a Class I medical device recall, the strongest notice that the FDA can issue, because accidental use of the catheters with the wrong pump may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death. This incompatibility is a design defect and not a result of how the pump is implanted. In fact, it may appear to be connected and secured, but a physical interference between the catheter and the infusion pump may lead to fluids leaking into surrounding tissues and the proper dose of drugs not being delivered.

Continue reading "Another Medtronic Recall For Infusion Pumps" »

Zimmer Holdings, the nation's top artificial joint component manufacturer recently announced that it is re-releasing its Durom Acetabular Cup, a hip replacement part, to doctors again, but only to those who complete special training on its use. This announcement comes after sales of the Durom Cup were suspended by Zimmer in July 2008 after reports that the component was defective and failed to bond in many patients, thereby causing patients to undergo painful revision surgeries. Approximately 12,000 patients had the Zimmer Durom Cup system implanted between 2006 and 2008, and accordingly to Zimmer's own research estimates, almost 8% of the people that received the initial hip replacement required a revision surgery withing a two year period. The high failure rate is caused by the Durom Cup's inability to bond with the host bone, causing the implanted part to loosen and move.

Continue reading "Hip Replacement Failure Due to Defective Durom Cup" »

We have previously reported here that pain pumps used on patients' shoulders post-operatively have led to an increasing number of cases of PAGCL, or postarthroscopic glenohumeral chondrolysis. In fact, almost 63% of patients on which a pain pump was used following shoulder surgery may develop PAGCL. Many patients, however, are reporting problems obtaining the correct diagnosis for their injury and have not been apprised by their doctors of the relationship that exists between their continuous shoulder problems and the pain pump that was used on their shoulder following surgery.

Continue reading "Continuous Shoulder Pain After Arthroscopic Surgery?" »

The Bard® PerFix® Plug, introduced by Davol, Inc. and C.R. Bard, Inc., in 1993, is a medical device used to repair “primary and recurrent inguinal hernias.”

Continue reading "Bard® Perfex® Hernia Plug --- Increased Risk of Nerve Entanglement? " »

On September 26, 2008, the FDA issued a Class-1 Recall of all Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters.

Continue reading "FDA Issues Class-1 Recall of Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters" »

On August 15, 2008, the U.S. Food and Drug Administration (FDA) announced a Class 1 Recall of Boston Scientific’s NexStent Monorail, NexStent Carotid Stent, and Monorail delivery system “because the tip of the stent-delivery system may detach during the procedure.”

Continue reading "Risk of Detached Tips Prompts FDA Recall of Boston Scientific NexStent Carotid System " »