in June 2008, Stryker Orthopaedics, a major U.S. medical device manufacturer, received FDA approval for its Rejuvenate Modular Hip System. FDA approval was based on Stryker’s representation to the FDA that the design was substantially similar to a product that had already been approved by the FDA, Wright Medical Techology’s Profemur Total Hip Modular Neck System. Thus, under the FDA regulatory approval system, the Rejuvenate Modular Hip System was essentially grandfathered in with very littlle pre-market scrutiny. P.S. Wright Medical’s Profemur system was subsequently linked to high failure rates, resulting in many patients having to receive revision surgeries to remove the Profemur.
In February 2009, Stryker released its Rejuvenate Modular Hip System, and marketed it to more active, younger patients.
In April 2012, Stryker issued a field safety notice, an urgent Safety Alert warning doctors and distributors, of problems that have been identified with the company’s Rejuvenate prosthetic hips.
The urgent saffety alert warned that these artificial hips, made from varying combinations of metal, ceramic and polyethylene, are capable of improperly releasing potentially dangerous amounts of metal debris or metal ions into the bodies of hip replacement patients. Unlike the metal on metal hips which deal with problems from the articulation of a metal ball and cup, the problem with Stryker’s Rejuvenate device involves the junction of the neck of the implant, which, according to Styker’s urgent notice, may be subject to fretting and corrosion. Such fretting and corrosion can degrade the device’s metal components, potentially putting patients at risk.
The adverse side effects can include metallosis (a build-up of metallic debris), necrosis (the cell death of affected tissues), and osteolysis (the death of bone cell due to blood supply issues) – any of which can necessitate revision surgery.
In May 2012, Health Canada recalled the Rejuvenate Modular Hip System. Stryker kept the device ont the U.S. market for a few months with new warnings and instructions. However, during that time the FDA continued to receive numerous complaints, which called into question the efficacy and safety of the device. Better warnings are useless if they cannot prevent the risks of the product.
So, in July 2012, Stryker recalled its Rejuvenate Modular Hip System and its ABG II modular-neck hip stems.
Stryker put up a website announcing its “voluntary recall” of Stryker Rejuvenate Modular and ABG II modular-neck hip stems. Here is the link to the Stryker website.
Not surprisingly, patients affected by allegedly defective Rejuvenate hip systems are seeking attorneys, and attorneys are seeking these cases. Patients need to be as selective in choosing their attorney as they were in choosing their surgeon. Like all product liability cases, these cases will be very complicated and expensive. If you are an affected patient looking for an attorney, make sure your attorney has significant product liability experience. Before one can learn about the experience of a prospective attorney, one needs to know the identity of the attorney. Here’s one advertisement for Stryker Hip Implant legal help in my state, which fails to identify the name of any law firm or lawyer who will be handling the case. I called the toll free number and gave the state from which I was calling. The operator still could not identify any lawyer who was available to represent me. I’m not commenting on the quality of representation one might receive after contacting this legal referral web site. My point is that one has no way of knowing whom one is contacting. Why does the site hide this information from the consumer?
Consumers need to know that there are a few different types of legal entities interested in representing consumers who received defective hip implants. Some are simply marketing groups or advertising collectives that have been formed to gather as many cases as possible, only to refer them out to trial attorneys who are competent to handle the cases and who agree to pay a referral fee to the former.
There are big, mass tort plaintiff firms which have the fire power and finances to handle mass numbers of these cases. These firms provide to consumers the benefits of economies of scale and leverage. By spreading common litigtion costs (e.g, experts, product testing, research, document collection and review, etc.) among thousands of clients, mass tort firms are theoretically able to charge each client relatively less for litigation costs. [Any consumer hiring a lawyer to handle such a case should expect to pay a percentage fee based on the amount of recovery plus all hard costs incurred by the law firm]. Likewise, during settlement negotiations, mass tort firms have the leverage of being able to try or settle large numbers of cases against or with the defendant corporaton. The complaint one sometimes hears from clients of some mass tort firms is that they have so many clients that the individual clients can feel as though they are just a number or that insufficient attention and detail is being paid to their individual case.
There are also competent, local product liability trial attorneys in every state who may agree to take a mass tort case. For these attorneys, it is often advisable to associate with a top-notch mass tort firm. This “two for the price of one” approach provides the client a combination of the power of strength in numbers with the indvidual attention the client wants and deserves. In this arrangement, the local attorney is often the main client contact, as well as the attorney responsible for preparing witnesses for and handling of the deposition and trial testimony of the client, the client’s local physicians, and the client’s family, friends, and co-workers. Consumers should not agree to pay any additional fee for this joint representation.