DePuy / Johnson & Johnson Hip Replacement
DePuy Orthopaedics is a subsidiary of the health products giant, Johnson & Johnson. DePuy has manufactured hundreds of different medical devices, including a several artificial hip joint products used in hip replacement surgeries. Although most patients who undergo hip replacement surgery experience restored mobility and relief of pain, some DePuy hip replacement procedures result in serious complications for the recipient.
Johnson & Johnson and DePuy have been the subject of thousands of lawsuits filed by patients or family members of those who were injured and experienced serious complications after a DePuy hip replacement.
The most common DePuy hip devices that have resulted in thousands of medical injury lawsuits include:
- DePuy ASR Hip Resurfacing System
- DePuy ASR XL Acetabular System
- DePuy Pinnacle Hip Replacement System
DePuy Hip Replacement Complications
DePuy’s Pinnacle Hip device was first introduced in 2002 and was designed as a metal-on-metal (MoM) device, constructed entirely of metal. MoM devices are intended to be more durable and long-lasting than other devices by reducing “wear and tear” on the device. Using the same MoM type construction, DePuy’s ASR hip system devices including both the ASR XL Acetabular and ASR Hip Resurfacing systems were introduced in 2005. Both of these device types have been troublesome for DePuy and Johnson & Johnson.
Like most MoM devices, the ASR and Pinnacle lines were approved under an FDA shortcut pathway, known as 510(k). The 510(k) pathway allows manufacturers to market products without having ever tested them on human patients, based on the claim that the new products are similar to others already on the market. ASR and Pinnacle devices were not required to be used in clinical trials before being sold for use in the general public.
The problems with MoM design have become apparent over time. Friction and grating of the surfaces of metal components against one another can result in shedcding of metal fragments into joint spaces. Smaller particles known as “ions” may also be absorbed into tissues and into the bloodstream where they can spread throughout the body. As the metals used in MoM devices are alloys which combine Chromium, Cobalt, Titanium and others, metal ions can be toxic to a number of tissues and may cause a significant immune reaction.
Serious side effects or complications from DePuy Hip Replacement devices may include metallosis which contributes to:
- Hip pain and inflammation
- Hip joint infection
- Bone fractures
- Tissue death or necrosis
- Bone dissolution
- Dislocation and loss of mobility
- Immune reaction with flu-like symptoms
In most cases, patients who experience severe complications after a DePuy hip replacement procedure will require hip revision surgery to remove and replace the defective device, and to repair and reconstruct damaged joint tissue. Each additional surgery poses new risk of infection, anesthesia complications and results in lengthier recovery time.
DePuy Hip Implant Failures
Estimates show that a high percentage, possibly up to 40% of all DePuy / Johnson & Johnson hip replacement device recipients may experience early failure. MoM hip implant devices were intended to last for decades, but many DePuy patients have required revision surgery within a few short years.
By 2009, only a few years after the introduction of Pinnacle and ASR device, DePuy had already been the subject of multiple warnings outside of the U.S. and the ASR devices were recalled and discontinued in 2010. The Pinnacle device, however, was never the subject of a recall though it was discontinued in 2013. DePuy and Johnson & Johnson simply stopped manufacturing the device but left implants that had already been sold in place to be used in more patients until supplies ran out. This may have placed many more patients at risk of DePuy hip implant failure.
DePuy and Johnson & Johnson have faced at least 10,000 ASR lawsuits and 10,000 Pinnacle lawsuits, though numbers may actually be higher. DePuy and Johnson & Johnson began offering hip replacement settlements after losing the first trial cases in 2013. Johnson & Johnson set aside more than $2.5 billion for settlements by costs may be much higher.
J&J has also been required to pay $120 million to state governmental agencies due to accusations of misleading marketing claims and improper payments. People who experienced complications or required hip revision surgery after receiving a DePuy hip replacement device should seek legal advice.
- Metal-on-Metal Hip Implants: Information for Patients, U.S. Food and Drug Administration (12/2017)
- $400 Million Settlement Reported in Johnson & Johnson Hip Lawsuits, Orthopedics this Week (12/2018)
- Johnson & Johnson, DePuy closing in on settlements for Pinnacle metal hip claims: reports, Fierce Biotech (2/2019)