Stryker Hip Lawsuit Alleges Implant Defects, Need for Revision Surgery
A new Stryker hip lawsuit has been filed in Michigan federal court. In the complaint, the plaintiff alleges she has experienced multiple complications since her initial hip implant procedure that will require revision surgery. The plaintiff states that due to failure to follow federal regulations involving medical devices, the manufacturer of her Stryker hip device, Howmedica, is now liable for her injuries.
Stryker hip lawsuit allegations
The lawsuit was filed in U.S. District Court for the Western District of Michigan on July 9, 2013. The plaintiff in the case, Giniva Luque, claims she received two Stryker hip replacement devices – one in September, 2012, and the second in March, 2011. After her hip replacement surgeries, the plaintiff claims she suffered severe pain and discomfort in the area around her implants. Because of her complications, Luque claims she will need to have revision surgery in both hips to remove the faulty implants and replace them with new devices.
The Stryker Rejuvenate system was introduced to the U.S. market by Howmedica in 2008, after the manufacturer received approval from the FDA. By 2012, a voluntary recall was issued for the modular-neck stems of both the Rejuvenate and ABG II devices. Howmedica cited risks of fretting and corrosion at the modular neck junction as the reason for the recall. These devices, which use a chrome cobalt neck inserted into a titanium stem, have been linked to metallosis – a type of blood poisoning caused by the release of metal particles and ions from the components into surrounding tissue and the bloodstream.
Rejuvenate recall too late for many patients
Unfortunately, the Stryker hip recall came too late for Luque and many others who were implanted with the devices between 2008 and 2012. Some of those patients, like Luque, have experienced serious complications with their Stryker hip replacements. Also like this plaintiff, the majority have required revision surgery to replace the defective hip implants. According to the American Academy of Orthopedic Surgeons, joint revision surgery has increased risk over the initial implant procedure, including a higher risk of migration and loosening of the new implant due to bone and tissue damage in the joint area.
Growing litigation prompts Stryker MDL
Following the recall, Stryker hip lawsuits were filed nationwide, as injured patients headed to court to pursue damages for their injuries. In June, 2013, the United State Judicial Panel on Multidistrict Litigation approved the coordination of federal cases involving the Stryker Rejuvenate and ABG II modular-neck implants. The coordination was established to make early trial proceedings more efficient by eliminating duplicate discovery and conflicting rulings from different courts.
At the time the MDL was established, the motion to coordinate involved 41 complaints pending in 16 courts around the country. In addition, the Panel had been notified of 110 additional cases that could also be eligible for transfer to the MDL. Because this new complaint was also filed in federal court, it may be slated for transfer to the Stryker Rejuvenate MDL as well.
Like other plaintiffs with cases already pending in the MDL, Luque claims that Howmedica failed to notify medical providers and consumers about the risks associated with metal-on-metal implants. In her Stryker hip lawsuit, Luque lists a number of federal regulations Howmedica was obligated to follow, including timely reporting of adverse events, notification of problems to the FDA and investigations into adverse reports. The plaintiff argues that because the company failed to follow these regulations, patients were exposed to unnecessary risks posed by potentially defective medical devices.
Luque lists a number of counts in her lawsuit against Howmedica, including strict products liability, failure to warn, negligence, and fraud. Luque is seeking general, special and punitive damages against the defendant, in an amount to exceed $75,000.
Resources
- FDA, Stryker Initiates Voluntary Product Recall of Modular Neck Stems http://www.fda.gov/safety/recalls/ucm311043.htm
- American Academy of Orthopedic Surgeons, Questions and Answers about Metal-on-Metal Hip Implants http://orthoinfo.aaos.org/topic.cfm?topic=A00625
- United States District Court, District of Minnesota, Stryker Rejuvenate MDL 13-2441 http://www.mnd.uscourts.gov/MDL-Stryker/index.shtml