Stryker’s Post Recall Conduct – Adding Insult to Injury

In July of 2012, Stryker recalled its Rejuvenate and ABG II hip implants. Recipients of the device have reportedly suffered heavy metal poisoning both in the tissues surrounding the hip and in the bloodstream.

Unlike DePuy, Stryker has not implemented a plan to efficiently and transparently promise victims of its defective and recalled device that they will not suffer financially due to Stryker’s carelessness. Victims are facing financial ruin due to the expense associated with having revision surgery and losing time from work. Shame on Stryker.

This week, my personal disgust with Stryker’s response to its recall is off the charts. I now represent well over 100 Rejuvenate and ABG II victims and have started conducting conferences with their surgeons. Many of these doctors are quite put out with the fact Stryker heavily marketed this device and have totally failed to step up to the plate and pay for the expenses being incurred by their patients. At least one has quit using Stryker products completely.

A conference I had this week with an implanting surgeon really alarmed me. The doctor was impeccably trained. He was an experienced and respected surgeon. He put many of these devices in patients. Unlike some surgeons, he has chosen not to follow Stryker’s lead and regardless of whether his patients have symptoms, he has called them all in for blood testing and an MRI. What he told me is shocking.

It seems that as many as 30% of his asymptomatic patients (those who have no pain or swelling) have elevated Cobalt in their blood and evidence of tissue destruction on MRI scanning. That means these patients are being poisoned and they don’t even know it. In addition, they are losing soft tissue and muscle around the hip joint. According to this doctor this is a very important determining factor in the patient’s prognosis after revision surgery.

Consider this evidence in light of Stryker’s written position on which patients with the recalled hips even need to see their doctor.

According to Stryker, “If you have no symptoms, you should continue to follow the post-operative plan that your surgeon has outlined for you.” Only if you have symptoms of pain or swelling should you see your doctor. This statement is contained in the written notice Stryker gave to doctors for transmission to their patients. Since some patients are one to two years out from surgery, many have been released by their doctors. That means they won’t see a doctor until they have symptoms.

Since Stryker continues to claim that one-half of one percent of Rejuvenate and ABG II patients have failed hips, that means that there are almost twenty thousand patients in the United States with recalled hips who have no symptoms. If this doctor’s experience holds true across this patient population, there are as many as six thousand asymptomatic Rejuvenate and ABG II patients out there who are being poisoned but have been told by Stryker they don’t even need to see their doctor.

I have also spoken with many symptomatic patients who have been to their doctor, have elevated cobalt levels and abnormal MRIs only to be told that they can come back in 90 days for a recheck of their blood levels. Incredibly, I have also spoken to symptomatic patients whose surgeons have told them there is no need to have their blood levels checked and that there is certainly no need to have an MRI.

Simply put, Stryker made the defective device, marketed and sold it to thousands of patients and now has recalled the device. Instead of taking a leadership role and establishing objective standards for the efficient and thorough evaluation of these poor victims, the company has actually done the opposite. It has misled patients into believing that they are okay if they don’t have pain.

What does this mean for patients? According to this surgeon, the single most important predictor for how well a poisoned patient will do after having the device replaced is the amount of tissue damage suffered before revision. All things being equal, the longer the device stays in, the more tissue damage is caused. The cascade of events is progressive. Once the damage is done, it is irreversible.

Extensive soft tissue damage prior to revision substantially increases the patient’s risk of dislocation after surgery. I met with a client yesterday who just three weeks after revision surgery suffered a dislocation. She was taken by ambulance to the emergency room where her hip was relocated under anesthesia. She is back to using a walker. This lady was not so fortunate to undergo her revision surgery before a large pseudotumor had grown in her hip. She underwent extensive debridement of the necrotic tissue and muscle during revision surgery. As her doctor explained to her, she simply does not have the tissue and muscle mass to hold her new hip firmly in place. She was told to alter her lifestyle and to avoid any movements that might cause the hip to come out of the socket. Also, because her hip has dislocated once, the risk of further dislocations increases.

I am not a physician. But, I have spoken to many doctors and victims. If I had one of these devices in me, I would demand that my doctor do blood tests and perform an MRI, no matter if I had pain. If elevated cobalt levels were found and the MRI showed evidence of tissue reaction, I would demand that the device be removed.

Unfortunately, the vast majority of Rejuvenate and ABG II patients don’t have access to the information I have. It’s time for Stryker to step up to the plate and disseminate clear, objective information to patients who have these recalled products implanted in their bodies. It’s the right thing to do.