Over the past several years, our firm has handled a number of lawsuits for clients involving simple mechanical devices that are comprise primarily of a simple pump. Our lawyers in the firm’s Mass Torts Section have found that these medical devices have caused lots of problems for persons who have used them to ease pain. More and more cases are being discovered where these simple devices cause severe injuries. We are involved in the litigation involving the pain pumps, representing a number of clients who have suffered severe injuries.
Intra-articular Use: We have previously reported on the abject catastrophes caused by the intra-articular use of pain pumps. The pump is used to inject post-operative anesthesia directly into the joint space for days after surgery. Often the result is a total loss of cartilage in the joint. This is a permanent and debilitating injury. But there are also other uses of pumps that cause problems.
Cold Therapy. Another dangerous use for very low tech pumps is in cryo-therapy. Essentially, a pump is used to circulate water through an ice chest and into a cooling pad which is place on the operative/injury site. In essence, it’s a super ice pack commonly referred to as “cold therapy.” These devices are routinely prescribed by orthopedic surgeons and podiatrists after a surgical procedure. The device is sent home with the patient (who is often on pain medication) with little or no instruction. Without proper instruction, and because the devices have no temperature alarms or automatic shut-offs, the skin and underlying nerves around the affected area (typically, ankles and feet, wrists and hands, shoulders or knees) are essentially frozen. Injuries resulting from these devices can be significant.
There are three main manufacturers of these cold therapy pumps: Donjoy (Iceman); Breg (Polar Care); and Biomet (EB Ice). Interestingly, the devices cost around $46, but retail to patients for $300. It appears only one case involving a cold therapy pump has gone to trial, and it resulted in a $4.1 million verdict.
Infusion Pumps. The FDA sent a letter to Baxter Healthcare Corp. on April 30th ordering the company to recall and destroy all of its Infusion Pumps. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of those pumps currently in use. Infusion pumps are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner. They are widely-used in hospitals, other clinical settings and, increasingly, in the home, because they allow a greater level of accuracy in fluid delivery.
The FDA has been working with Baxter since 1999 to correct numerous device flaws. Since then, its Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors, and other issues. In June 2006, the FDA obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the Colleague pump until the company corrected manufacturing deficiencies and until devices in use were brought into compliance. Since then, Baxter has made numerous changes to the Colleague pumps but these changes have not corrected the product defect, leading to the permanent injunction.
Infusion pumps generally, including the Baxter Colleague models, have been the source of persistent safety problems. In the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, according to FDA data.
An FDA analysis of these adverse events has uncovered software defects, user interface problems and mechanical and electrical failures. Problems with infusion pumps are not confined to one manufacturer or one type of device. If you need additional information please contact Russ Abney, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Russ.Abney@beasleyallen.com.
Source: May 12 Update for Health Professionals
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