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.

   

Management of Pseudo-Tumors in Stryker Rejuvenate Hip Implant Recipients—Part Two

Artificial hip implantation has become increasingly common, particularly for younger, active patients who have suffered significant osteoarthritis in their hips. While the five-year survival rate following hip replacement is above 95 percent, recent device failures, implant recalls and instances of chromium and cobalt toxicity as well as other, serious hip implant problems have plagued the artificial hip industry. The number of pseudotumors occurring in those with artificial hips is increasing, particularly in all-metal implants or designs which implement metal neck junctures and metal trunnions such as the StrykerRejuvenate.

Although pseudotumors are not cancerous and do not indicate infection, they can nonetheless be quite serious, causing local tissue destruction. In many cases revision surgery will be necessary during the removal of the pseudotumor. Both the Rejuvenate and the ABG II were part of the Stryker hip replacement recall in July of 2012 due to fretting, corrosion, implant failure and metal poisoning. When the implant is subject to corrosion, microscopic shards of metals are released into the hip tissues as well as the bloodstream. In addition to contributing to the formation of pseudotumors, this metal debris can cause inflammation, chronic pain, tissue necrosis, bone loss and symptoms of metal toxicity such as:

·         Gastrointestinal disorders

·         Neurological problems

·         Cardiovascular, renal and thyroid issues

·         Loss of vision and hearing

·         Balance problems and memory loss

·         Depression, anxiety and irritability

·         Disruption of DNA

One study sought to establish the relationship between levels of metal ions and presence of pseudotumors in patients with metal hip implants. An overall prevalence of asymptomatic pseudotumors of 4-5 percent among those with metal or partial metal hip implant was noted—higher than previously believed. Pseudotumors were found to be more common in women, and patients with pseudotumors were found to have significantly higher levels of cobalt and chromium in their blood and joint fluid. It appears that pseudotumors could well be a reaction to metal debris generated by such hip implants as the Stryker Rejuvenate as well as other metal hip implant devices. Patients with unusual hypersensitivity to metals were also found to have a higher risk of developing pseudotumors.

One doctor investigated the source of wear in the removed implants among patients with pseudotumors as compared to implants removed for other reasons. Implants which were replaced due to the presence of pseudotumors showed much greater wear on the femoral and acetabular cup components. When femoral components come into contact with the edge of the acetabular component, edge loading occurred and in this study the wear on the acetabular cup was always on the edge.  The patients with pseudotumors often experienced edge-loading during walking or other activities while less than one in four patients without pseudotumors experienced edge-loading. 

Surgeons are cautioned to be alert for the presence of pseudotumors in hip implant recipients even when x-rays appear normal. Special care should be taken when positioning hip implant devices in smaller women in order to avoid the occurrence of pseudotumors, and patients should have regular reassessments. Patients with metal sensitivities should reconsider implantation with an all-metal or partial metal device in favor of a ceramic or polyethylene implant. Any unusual pain or swelling requires an appointment with a physician and possible revision surgery depending on the size and location of the pseudotumor as well as whether tissue damage has occurred.

When Stryker Hip Implant Patients Develop Pseudotumors

Pseudotumors are typically large, solid or semi-liquid masses which can form around an artificial hip implant device and can mimic the effects of infection. While pseudotumors are neither infective nor cancerous, they may be reacting to the metals in a hip implant or simply to the presence of a foreign body—no matter what it is constructed of. It appears from research done on hip implant devices that pseudotumors are more likely to form around implants which are either all-metal or have metal parts although they may also form around ceramic and polyethylene implants. When hip implant problems become apparent, a pseudotumor may have been present for a significant length of time.

The Stryker Rejuvenate and ABG II both implement a metal neck juncture in the design and have metal trunnions located on either end of the stem piece. Body fluids can become trapped under the trundles or at the neck juncture, leading to corrosion and fretting. When the hip implant devices suffer corrosion, premature wear can result. In turn, this premature wear releases metal debris into the surrounding hip tissues and bloodstream. Chromium and cobalt toxicity are often found among patients with metal hip implants or those with metal parts such as the Rejuvenate and ABG II. The Stryker hip replacement recall for the Rejuvenate and ABG II was issued in July, 2012, resulting in lawsuits against the company. It is advisable for anyone considering implantation of a metal hip device to be tested for metal sensitivities prior to the surgery. Metal poisoning can lead to a wide variety of serious health symptoms including:

·         Cardiovascular, renal, thyroid and gastrointestinal disorders

·         Diminished hearing or vision

·         Anxiety, depression or irritability

·         Vertigo or other balance issues

·         Memory loss

·         Disruption of DNA

·         Skin problems

·         Neurological issues

Women appear to have a higher risk of developing pseudotumors as do those with a higher-than- normal sensitivity to metals. Considering that among the general population the prevalence of skin reactions to jewelry containing nickel is relatively high—10 percent—it can be expected that a significant number of adults receiving implants will be particularly sensitive to the cobalt and chromium. The smaller component sizes of hip implants required in women are known to be associated with increased wear and are less forgiving to any level of malposition. Women who suffer from premature arthritis may also present during hip surgery with acetabular dysplasia or an abnormal socket inclination.

In many cases pseudotumors will cause neither pain nor abnormal hip mobility and can go unrecognized for months or even years. Once a pseudotumor is discovered, it is likely to have caused significant tissue damage and will require surgery to remove. The most common symptoms from pseudotumors are chronic pain, diminished range of motion, inflammation in the hip joint and difficulty walking or engaging in normal everyday activities. In some cases a pseudotumor can cause a localized rash and a lump may be apparent. A pseudotumor may be explained as the body’s reaction to a foreign body—in this case the metal, ceramic or polyethylene hip implant.  In one study of hip implant devices metal particles were found in every case of pseudotumor development. Although malposition of the implant was suggested, many properly positioned implants showed evidence of pseudotumor development. Blood poisoning from metal toxicity can greatly increase the severity of the pseudotumors, and revision surgery is almost a given in the presence of pseudotumors. Any recipient of an artificial hip, particularly those which are all-metal or have metal components, should undergo x-rays, MRIs and blood testing to determine whether cobalt and chromium toxicity or pseudotumors are present.