Patient confusion – and anger

Patients with these implants are certainly confused as Stryker has yet to comment on what’s gone wrong – but many are just plain angry. And rightfully so, according to Kreis, who told us that:

Patients have contacted us because they are experiencing squeaking both with and without pain. Those with pain are calling because they need relief. Those without pain, but whose implants are squeaking, are calling because the have to life with constant irritation and moreover their doctors often do not have answers but rather after suggesting additional X-rays (reflecting that the implantation appears satisfactory by X-ray) suggest that the patient either live with the squeak or wait to see if revision will be necessary.

Kreis explained why his firm is getting so many calls from people without pain, but who are experiencing squeaking. “It’s highly annoying and patients are getting angry. Just imagine squeaking every time you move – it’s like having a knee brace. You walk around all the time and you’re squeaking everywhere. Everybody looks at you - it’s embarrassing. More importantly, studies show that the squeaking may be a signal and/or precursor to pain, malfunction and the possibility of needing additional surgery. Red flags are going up in patients’ minds and they’re contacting our office because their doctors are not able to advise of something which Stryker not the physician has information about.”

“It’s like buying an automobile that has a squeaky front axle. You drive your Cadillac around and it’s squeaking all over the place and every time you go up to a light everybody is looking at you. However, in this instance, it’s in you. It’s not like you can go to the consumer complaint department of a retail store and return the product. Basically, you’re stuck. While many patients do have functionality, others do not.”

Doctor confusion – and alleged wrongdoing

Kreis says that doctors are simply left with advising patients based on information that Stryker has made available. He explained, “Doctors know that something is wrong, but that’s all they know. Unfortunately, recently published literature suggests that physicians are blameworthy. However, the practice of blaming the implanting physician is an easy out. We believe that the products are defective and that, expect for rare instances, the doctors are not. Moreover, newly published literature supports this very conclusion.”

Many analysts actually think that some doctors may know more than they’re letting on. In the fall of 2007, several medical companies – of which Stryker was one – were being investigated by the U.S. Securities and Exchange Commission about providing kickbacks to doctors who used their products. According to news reports, Stryker is under federal supervision, but did not face criminal charges because it cooperated with authorities.

FDA says, “Do something!”

The FDA seems to be at the end of its rope with Stryker. It has issued two warning letters to the company for questionable practices in its Mahwah, New Jersey facility and another for its Cork, Ireland facility. Kreis says that Stryker’s recent recall of products manufactured in Ireland was prompted by the FDA’s letter the company that was made public in mid January 2008. “The FDA has told Stryker that it hasn’t done enough. The administration is telling it to ‘do something!”, which after a full investigation has led to the Ireland recall. However, medical device manufacturers are simply not self-regulating and the FDA has only limited resources to tackle the problem both at the front end when the product is being approved and after the product goes to market. Companies like Stryker are responsible for their own testing and developmental investigation and, after sales, their own post-market surveillance. Accordingly, the civil tort system is the only remaining safe-guard available to the consumer.”

If you are experiencing problems with Stryker’s Trident PSL and Hemispherical Acetabular Cups, contact an experienced attorney who has been following this issue to discuss your situation. For a free, no-obligation consultation, please click here.