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.
In addition, and notably, the FDA has ordered Baxter to provide “refunds” to customers or replace the pumps at no cost to the customers in order to help defray the cost of replacement.
On May 3, 2010, Baxter Healthcare responded to the FDA order in a press release, announcing that while it anticipates offering its Sigma Spectrum Infusion Pump as a replacement for Colleague Infusion Pumps without charge to its customers, the final nature of the recall and offer to customers remain subject to an ongoing dialogue.
Clearly, Baxter is not completely on board with the FDA’s decision to have it provide “refunds” to customers of its Colleague Pumps. One of the potential issues involved in this “ongoing dialogue” between the FDA and Baxter is whether the FDA has the authority to obtain restitution for customers who purchased the dangerous Colleague Pumps. According to Jeffrey K. Shapiro, Esq., in his blog entitled “It’s not a Section 518 Mandatory Recall, But the Baxter Infusion Pump Recall Comes Close,” he writes that the FDA obtained a consent decree against Baxter, allowing it to take “any corrective action” to protect the public health or to ensure Baxter’s compliance. Shapiro believes that the FDA views the refund order as part of this catch-all provision.
The ultimate question for consumers of this dangerous medical device, at a cost of between $2,000 and $3,000 per pump, is whether Baxter will provide them with a full refund, a partial refund based upon the pumps depreciated value or current value (which would be worthless based upon the current recall), or no refund at all.
If you have been purchased a Baxter Colleague Infusion Pump and are seeking a 100% refund for your purchase, please contact Pogust, Braslow & Millrood. We are investigating a potential class action suit involving this product.
Also, if you or a family member has been seriously injured by this product, please contact us so we can discuss your potential claim.