April 18, 2013

Possible Consolidation of Stryker Rejuvenate Hip Implant Lawsuits



Andrew Sullo, Managing Partner of Sullo & Sullo, LLP, plans to attend a meeting held in Chicago on May 30, 2013, at which time oral arguments regarding a motion to consolidate Stryker Rejuvenate hip implant lawsuits will be heard. The motion filed in February, 2013, seeks to consolidate federal lawsuits against Stryker Orthopedics for alleged harm done to patients by the company’s Rejuvenate and ABG II hip implants. Multi-county and multi-district lawsuits are used to better manage similar cases; resources are conserved when a single court handles all discovery and pre-trial proceedings.

Plaintiffs can have their cases heard in a timely manner when case consolidation takes place and it is generally felt that more consistent rulings result from multi-district and multi-county case consolidation. Further, an already overburdened court system is generally saved both time and financial resources. Over thirty Stryker Rejuvenate cases are currently pending throughout at least a dozen Minnesota district courts, therefore the consolidation of these lawsuits makes sense. Robert Davis, a plaintiff in the Stryker cases filed the consolidation motion, requesting that litigation against Stryker for the harm suffered by recipients of the Rejuvenate be transferred to a U.S. District Court in the District of Minnesota.

Both the Rejuvenate and ABG II were marketed in 2009 after gaining FDA approval. At that time metal-on-metal hip devices had come under scrutiny for the tiny metal ions which were released when the cobalt and chromium parts rubbed against one another. Those metal shards had been found to wreak havoc in the body, causing inflammation, pain, bone loss, tissue degradation and total hip failure as well as metal toxicity. The Rejuvenate and ABG II were believed to be a viable alternative to the all-metal implants as their modular pieces made them extremely customizable. Surgeons could choose the individual parts which comprised the hip implant device in order to custom fit the implant to the patient, taking into account the patient’s size as well as normal activity levels.

Within a very short period of time, however, recipients of the Rejuvenate and ABG II were sending reports of adverse health effects from the hip devices. In April of 2012, prior to the recall in July, an Urgent Field Safety Notice was released by Stryker warning physicians and hospitals of the risk of corrosion, fretting and metallosis from the implants. When corrosion occurs, tiny metal shards from the metal neck juncture or the metal trunnions on either end of the stem could lodge in the hip tissues or enter the bloodstream of the patient. Should the device fail or the metal toxicity progress to a serious level, revision surgery could be the only option.

The success rate for Rejuvenate and ABG II revision surgery is considerably less than for the original surgery and is considered both risky and complex. The stem of the Rejuvenate is embedded deeply within the femur, therefore when removal is necessary the stem must be literally dug out of the bone. In some cases the femur can shatter leaving nothing to attach the new implant to. Recovery times can be from six weeks to two months, resulting in lost wages as well as astronomical medical expenses.

As many as 53,000 Stryker recalled Rejuvenate and ABG II hip implants were sold and it is believed that the majority of those devices were implanted in patients. Stryker issued a follow-up statement in January, 2013, which warned recipients of these recalled implants to undergo regular testing even if they had not yet experienced any adverse health effects from the device. Although there are relatively few lawsuits filed as of this date, it is believed the numbers will increase significantly within the coming year. Following the recall the number of adverse health effects reported to the FDA has substantially increased as more and more recipients of the devices are suffering from the device.