Specifically, problems with DePuy’s ASR Hip Resurfacing System, its ASR XL Acetabular System and its Pinnacle Hip System have resulted in massive amounts of litigation at both the state and federal levels, costing the device maker billions.
Problems with Metal-on-Metal Hip Devices
Though hailed as a groundbreaking innovation likely to reduce the rate of device failure, metal-on-metal technology has not proved as helpful in practice as many had hoped. Rather than solving existing problems plaguing older generation devices, metal-on-metal systems in fact introduced several new, more dangerous ones, including:
- Joint loosening
- Bone fractures near site of implant
- Reduced mobility
- Joint dislocation
- Potential boost in cancer risk
These complications have forced thousands of patients to undergo costly, uncomfortable, and inconvenient revision surgery, with many never getting complete relief from their symptoms. As a result, large numbers of patients have turned to DePuy hip lawsuits in the courts in order to secure financial compensation, while seeking to hold DePuy accountable for the serious harm they have sustained.
Criticisms of FDA Approval Process and the DePuy Medical Device Failure
The alarming failure rates of many hip replacement implants has led to increased discussion of the device clearance process utilized by the U.S. Food and Drug Administration (FDA). DePuy’s Pinnacle System was approved for use in the U.S. in 2000, with the ASR XL System following in 2005. Each received clearance via the controversial 510(k) clearance process used by the FDA which reduces the amount of testing and trials required for the introduction of new devices that are deemed “substantially similar” to devices already awarded approval. According to many observers, this abbreviated process allowed large volumes of patients to receive the defective implants before their potential dangers and high failure rates were fully understood.
Adverse Event Reports Emerge in DePuy Hip Replacements
As the FDA began to accumulate a significant number of adverse event reports concerning the failure of DePuy metal-on-metal hips, the regulatory agency, the manufacturer, and researchers all began to take notice. In 2010, DePuy issued a global recall of both ASR hip systems, going so far as to acknowledge a failure rate greater than average. The British Orthopaedic Association conducted a study, which revealed that within six years of implantation, nearly half of all devices required replacement. Under mounting pressure from litigants as well as from the FDA, DePuy discontinued Pinnacle metal-on-metal systems in mid-2013.
DePuy Hip Lawsuit Numbers Swell
Victims of defectively designed and manufactured DePuy hip implant systems have been filing suit against the device maker over the last several years, resulting in real progress for many. Thousands of litigants have sued the manufacturer alleging negligent production of a dangerous product, failure to warn and failure to conduct proper testing of the implants. Federal multidistrict litigation (MDL) consolidating thousands of Pinnacle hip lawsuits was created under the supervision of the U.S. District Court for the Northern District of Texas, and an ASR system MDL in the Northern District of Ohio resulted in DePuy’s agreement to pay more than $4 billion to settle claims with hip replacement patients. Many more cases remain pending in courts across the country with ultimate resolutions yet to be determined.
Those who have experienced significant harm stemming from a DePuy hip implant and who have decided to pursue litigation against the device maker frequently seek compensation for the following, including:
- Loss of earning capacity and lost wages
- Diminished mobility and diminished quality of life
- Pain and suffering
- Emotional and psychological distress
- Compensation for costs associated with future hip replacements
- Compensation for medical conditions treated as aggravated by the faulty hip replacement
While each case is unique, many plaintiffs are finding success in their quest to receive a fair financial recovery for their injuries, while also demanding accountability from a corporate entity otherwise acting negligently and against the public interest.