Lawsuit claims Maryland Doctor Implanted Non-FDA approved Tools during Surgery

Lawsuit claims Maryland Doctor implanted non-FDA approved surgical screws and rods into the backs of unsuspecting patients at Baltimore Washington Medical Center.

It has been reported that a doctor at Baltimore Washington Medical Center may have implanted counterfeit and/or non-FDA approved screws and rods into the backs of hundreds of unsuspecting spinal surgery patients. Several lawsuits have been filed against doctors and hospitals located in California and Maryland relating to the use of counterfeit and/or non-FDA approved spinal implants sold by Spinal Solutions, LLC to doctors and hospitals. The lawyers at Azrael, Franz, Schwab and Lipowitz, LLC are currently investigating potential claims.

A lawsuit, filed in February and recently unsealed, alleges that Spinal Solutions and many doctors and hospitals conspired to use counterfeit and/or non-FDA approved spinal implants and improperly inflate the costs of the devices. The lawsuit alleges that Spinal Solutions paid Dr. Randy Davis to use Spinal Solutions implants in spinal surgeries performed at Baltimore Washington Medical Center in Maryland. It is reported that Dr. Davis performed “several hundred surgeries” using Spinal Solutions implants. Other reports claim that doctors who used Spinal Solutions hardware received lucrative consulting deals, cash, travel in private planes, and tickets to Laker’s games.

Patients trust their doctors and hospitals to use medical implants approved by the Food and Drug Administration. Surgical devices like rods and screws generally require FDA approval, biomechanical tests, liability insurance and other protections that substantially increase the costs of the devices. Spinal Solutions is accused of selling the counterfeit and/or non-FDA approved hardware even though the parts were made at a local tool shop. The counterfeit and/or non-FDA approved hardware are alleged to be inferior and carry an increased risk of infection and failure.

The FDA cited Spinal Solutions in 2012 for a variety of quality control violations. The agency announced that the company recalled spinal implants because problems with the products “could cause patient harm due to implant breakage, movement, or inadequate sterilization.”

Pending Lawsuits

Thousands of these counterfeit screws and rods may have been placed in unsuspecting patients suffering from devastating spinal injuries. Some patients are already suffering pain from the implanted hardware. Additionally, experts believe that because of the non-surgical grade material used, there is the risk of device failure or infection. Several lawsuits have been filed to compensate victims for their pain and suffering.

The threat of counterfeit and/non-FDA approved products is often unknown to patients. If you or a loved one has had spinal surgery at Baltimore Washington Medical Center and believe you may have been harmed by counterfeit and/or non-FDA approved spinal implants, please contact our experienced attorneys at Azrael, Franz, Schwab & Lipowitz, LLC. We do not charge any legal fees and you do not have to reimburse us for any costs unless you receive a settlement. If your claim is not successful for any reason, you do not owe us anything. We put it all in writing for you.

To get started:

Call or email Judson Lipowitz at (410) 821-6800 or jlipowitz@azraelfranz.com to discuss your case. If you have a potential claim, we will start our investigation immediately.

For additional information, please call us and visit our website at azraelfranz.com or go to spinalpartslawsuit.com.

WARNING: There are strict time deadlines for filing claims.

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