We are no longer accepting cases for this medical device.

On April 30, 2010 the FDA ordered Baxter Healthcare Corp. to recall and destroy all Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use in the United States. Sadly for patients, there may be as many as 200,000 pumps in use currently around the globe.

History of Problems

Baxter has had a history of problems with the FDA concerning the Infusion Pump. In fact, beginning in 1999, the FDA has worked with Baxter to correct several design defects/flaws in the device. Numerous recalls have followed (Class I recalls) including for battery swelling, inadvertent power off, and service data errors.

Problems continued into 2006, when 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.  While Baxter has made numerous changes to the Colleague pumps, injuries and problems continued, and it is argued that these changes did not correct the product defect leading to the permanent injunction.

Recently, the problems reached a climax. On April 8, 2010, Baxter submitted a proposed correction schedule to the FDA that stated that Baxter did not plan to begin the latest round of corrections to the adulterated and misbranded pumps until May 2012. The proposal also stated that Baxter does not anticipate completion of the proposed corrections until 2013. On that schedule, a device with known safety concerns would remain in use on patients needing specialized care until 2013. FDA found this proposal unacceptable.

The 2006 consent decree gave FDA authority to take any action it deemed appropriate. The FDA has determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague infusion pumps still in use.

FDA’s Order

The FDA is now ordering Baxter to:

• Recall and destroy all Colleague infusion pumps;
• Reimburse customers for the value of the recalled device; and
• Assist in finding a replacement for these customers.

Damages

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.

If you or a loved one has been injured, recovery is possible for medical bills, pain and suffering, lost income (past and future), and more. Please call today to speak to Tim Edwards or Ed Wallis at 901.527.2125 for more information.

No Recovery, No Fee

Generally speaking, we take cases on a contingent basis. That means that there is generally no cost to you unless we are able to recover a settlement or judgment on your behalf. So, unless your case is resolved by trial, arbitration, settlement, or other resolution, you generally do not have to pay any attorney fees to us, or pay any costs. Litigation costs include filing fees, court reporter fees for deposition, copying costs, experts, and travel. Litigation costs are paid by our firm so you don’t have to have cash to pursue justice against the medical device company. If there is a recovery, we are reimbursed our fronting of litigation costs out of any damages you are awarded. So, in a sense, you do not need cash up front to hire us as your lawyer to pursue a claim for personal injuries, emotional injuries, lost business or property damage.

About us

Mr. Edwards and Mr. Wallis are currently representing injured children and adults on an international level for a failed medical device.  Both have represented clients, filed lawsuits and appeared in courts around the country to protect the rights of the injured including for the Advanced Bionics HiRes90k cochlear implant, the transvaginal mesh device, and more. You can read more about us in the ABOUT US section of this website, and please contact us today for a free case evaluation.