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Stryker Rejuvenate Lawsuit

Recent years have seen an outgrowth of concern regarding the safety of widely-used metal-on-metal hip implant components used in joint replacement procedures.

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Adverse event reports ultimately led industry leader Stryker Orthopaedics to issue a recall of its Rejuvenate modular-neck stem product, adding fuel to the fire of increasing litigation related to a series of very serious complications suffered by patients nationwide.

Post-market studies have revealed an alarming rate of failure among metal-on-metal components such as the Rejuvenate system as well as their tendency to cause notable levels of corrosion and release of potentially toxic metal particles into the body and to produce inflammation, pain and a loss of mobility in patients who have received these joint replacements. With the numbers of affected individuals climbing at a rapid clip, more and more have decided to initiate a Stryker Rejuvenate lawsuit as a means to obtain the compensation to which they are entitled.

Fundamentals of Stryker’s Rejuvenate Components

Known within the industry as a “modular-neck” joint replacement device with interchangeable components, the Stryker Rejuvenate implant was touted as a revolutionary tool for creating customizable solutions based on the individual biomechanics of patients. Though much of the device is plastic-on-ceramic in nature, the junction of the neck and stem is metal-on-metal construction. It is important to note that the Rejuvenate hip components sold by Stryker received approval from the U.S. Food and Drug Administration (FDA) through its somewhat controversial 501(k) fast-track process, which has been assailed by observers for its worrying lack of trial and testing requirements.

After having been on the American market for a number of years, adverse event reports filed with the FDA began to mount, with most relating to incidents of corrosion near the neck-stem joint area of the Rejuvenate implant. Subsequently, Stryker voluntarily recalled the devices in the summer of 2012, while also ceasing worldwide production, as well as marketing and sales of the model. That same year, Stryker sent an Urgent Field Notice to doctors alerting them to growing suspicions that the Rejuvenate devices were connected to complications such as:

  • Inflammatory reactions
  • Allergic reactions in patients with metal sensitivities
  • Corrosion and release of metal particles around the site of the implant
  • Severe pain and noticeable swelling
  • Tissue damage
  • Reductions in mobility

Rejuvenate Lawsuits Take Shape

Lawsuits involving Stryker Rejuvenate hip implants began to gain steam by the latter portion of 2012, with a multidistrict litigation (MDL) created in June, 2013 to consolidate the growing number of federal lawsuits related to the devices. The volume of litigants in the MDL continued to rise and mass tort litigation in New Jersey also began to develop, signaling to Stryker that it might be time to entertain settlement options. To that end, the company agreed in November 2014 to offer compensation of at least $1 billion to resolve thousands of pending cases.

Arguments Typical to Stryker Rejuvenate Lawsuits

Despite the high number of individual Rejuvenate lawsuits that have been filed thus far, there are a few key allegations found in most complaints. Almost all plaintiffs argue that Stryker was negligent in its failure to warn doctors as well as the general patient population about the startling failure rates known to occur after implantation of the devices. Fraudulent misrepresentation and deceptive marketing has also been alleged, as has repeated breaches of express and implied warranties. Violations of state consumer protection laws have also been included in numerous Stryker Rejuvenate lawsuits.

Stryker’s settlement agreement with a defined pool of litigants is extremely significant in nature, though it does not preclude recovery for individuals who are currently experiencing or have yet to experience a failure of their hip replacement implant. Financial compensation and accountability may still be pursued through the legal system for those who suffer debilitating harm and other losses due to Stryker’s conduct. Victims may be able to obtain payment for:

  • Physical pain
  • Suffering
  • Emotional anguish
  • Lost wages
  • Diminished earning capacity
  • Loss of enjoyment
  • Present, past and future medical bills

Given the prevalence of joint replacement surgery, particularly among older segments of the population, there appears to be a strong likelihood that Stryker Rejuvenate lawsuits concerning the failure of Stryker’s Rejuvenate model will continue to take place. This is the case even in light of the company’s prior willingness to make massive settlement payouts to large numbers of injury victims. For patients, consulting with an attorney with prior experience in dealing with this specific case will prove immensely helpful.

 

Sources:

http://www.fda.gov/safety/recalls/ucm311043.htm

http://www.mnd.uscourts.gov/MDL-Stryker/introduction.shtml

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241594.htm

 

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