Recent news reports have it that Stryker now faces around 180 legal cases coming from patients claiming that Stryker implants have caused them serious injury. The courts have decided to consolidate these cases in Atlantic City, New Jersey to expedite the legal process. The Honorable Judge Carol E. Higbee has been assigned to manage the proceedings as of August 25, 2012.
The most common claim put forth by Stryker patients is that the manufacturer failed to adequately warn them about the potential risks associated with the its devices, including problems such as inflammation and pain, squeaky joints, bone fractures, and implant failures associated with the design. The number of lawsuits against Stryker is bound to increase, according to medical experts, since the number of recalled devices number around 20,000 units.
Potential plaintiffs have also found that Douglas L. Ellsworth, District Director of the FDA in its New Jersey District Office, indicated that the Stryker’s attempts to investigate and identify the root causes of its cup problems and implement corrective actions were inadequate, violating the Federal Quality System Regulation.
Moreover, according to Director Ellsworth, the Stryker hip replacement recall failed to comply with Federal Corrections and Removal Regulations.Stryker had failed to inform FDA of the removal from the market of Trident PLS Acetabular Cups due to the discovery of an operator’s failure to inspect product dimensional features resulting in the release of potentially dangerous devices.
One of the most dangerous potential side effects of these devices is the possibility of it causing metallosis, a rare blood disease. The way the implants cause metallosis is that the pieces of the hip device rubbing against each other and causing small metal debris to be introduced into the blood stream. This can result into surrounding tissue damage which can cause the implant to become loosened. In most cases once the implant has degraded to that point, the only way to correct things is to have revision or replacement surgery.
Now that the information has been given out to the injured Stryker patients, medical experts believe that the number of cases against Stryker will only increase.