Why Are People Filing DePuy Hip Replacement Lawsuits?
DePuy ASR and Pinnacle hip replacement lawsuits have been filed due to the alleged damages and complications caused by the metal hip replacement devices. Patients have accused DePuy of knowing about the malfunctions for years but still deciding to sell the ASR and Pinnacle devices on the market for use in major hip operations.
It is anticipated that two out of every five patients who received a DePuy ASR hip replacement would require revision surgery within five years. According to records, complications started to arise after one year to 18 months of the hip replacement surgery. It is also reported that Johnson & Johnson, DePuy’s parent company, knew that the ASR hip was risky and poorly designed but continued to make it available regardless.
A DePuy hip recall was issued for the ASR hip model in August 2010. However, despite a large number of adverse event reports and the fact that the ASR system was modeled after the Pinnacle system, a recall for the Pinnacle system was never issued. The Pinnacle device was ultimately discontinued in 2013, but some physicians may have continued use of the device until inventories were depleted and many patients may have received the implant components from outside of the U.S.
More than 11,000 lawsuits have been filed against DePuy Orthopaedics, and this number is expected to increase in the near future. At least 9,800 lawsuits have been filed regarding the Pinnacle implant, and 1,400 cases have been reported for ASR implants.
Below are the DePuy hip replacement devices that have shown a high failure rate:
- Pinnacle Hip Replacement System
- ASR XL Acetabular System
- SR Hip Resurfacing System
Some of the symptoms that patients encounter from these hip replacement devices:
- Pain – mostly in the hip area
- Osteolysis – damaged bone tissue
- Metallosis – a build-up of metal debris in the soft tissues around the implant area
- Pseudotumors – nodular or a soft tissue mass that occurs near the implant area
- Dislocation – occurs when the bones of a joint are dislodged from the socket
What Complications Were There With the ASR XL Acetabular System?
Out of these three hip replacement devices, the ASR XL Acetabular System was reported to be the most dangerous and defective.
Below are complications that patients claimed after receiving this hip implant device:
- Damage to joints, tissues, and organs due to metal toxicity
- Possible development of leukemia and lymphoma
- Impair of bones and muscles that causes long-term disability
- Corrective surgery
Introduced in 2002, DePuy created the Pinnacle device with metal-on-metal (MoM) construction, which differed from other hip devices using multiple materials by eliminating plastics, which showed they may shed particles into the surrounding joint tissue. It was anticipated that MoM construction could reduce the “wear-and-tear” of the devices, resulting in more durable and longer-lasting implants.
Approved in 2005, the ASR devices had been created based on the design of the Pinnacle device and used the same type of MoM construction. Like most hip replacement devices, the DePuy products were approved under the Food and Drug Administration’s (FDA’s) exemption process, known as 510(k) which allowed for the implants to forego clinical testing. Because of the 510(k) process, the devices were never fully tested in humans before being offered to the public. The ASR devices were recalled in the U.S. in 2010 after over 90 thousand implantation procedures had been performed. The Pinnacle device was never actually recalled but manufacturing was discontinued in 2013 after thousands of complaints.
While it was promised that the DePuy hip replacement design would bring stability and long-term durability, the devices could instead discharge metal ions with each movement. When the hip replacement was being used, the metal ball and socket would grind against each other, producing metal particles that would become embedded into the surrounding tissues and the bloodstream. This could cause metallosis, a metal poisoning condition that damages bone, muscle, and other tissues. It can also result in conditions like dislocation and device loosening.
With fewer than 3 years on the market, DePuy ASR devices were already reported to have a 12% – 13% failure rate. In Australia, DePuy had been warned by health authorities at least 7 times regarding its malfunctioning devices and the devices had been recalled in that country by 2009. Despite the data coming from Australia, as well as other international sources like the UK, the DePuy ASR devices weren’t recalled in the United States until a year later.
In 2010, the FDA headed a Class 2 voluntary recall of Depuy’s ASR XL Acetabular System and ASR Hip Resurfacing System. The recall is estimated to have impacted 93,000 patents globally. The recall involved 29 units of prosthetic hip devices that included metal acetabulum devices, or hip sockets, and metal cups. These devices had been in the market since 2003.
For the Pinnacle implant, DePuy defended this metal-on-metal hip device until it was removed from the market in 2013 due to weak sales. The device has also been subject to litigation due to commonly reported issues with the metal material.
People who received their hip surgical implants before July 2003 are not eligible for recall.
An $8.3 million verdict for the plaintiff was issued by a trial jury in March 2013. DePuy won the second trial in April, but in August, the company settled three complaints for $200,000 each. DePuy and Johnson & Johnson reached a $4 billion settlement in November 2013 to resolve roughly 8,000 ASR cases.
Below is a summary of some of the settlements made by DePuy:
- 2013 – a patient filed a lawsuit and has undergone revision surgery.
- 2015 – DePuy resolved 1,800 additional complaints for a total settlement of $420 million.
- March 2016 — awarded $502 million for five plaintiffs which was reduced to $151 million. Cases are set for retrial.
- December 2016 — awarded $1 billion for six plaintiffs which was reduced to $543 million based on exemplary damages limits.
- November 2017 — $247 million for six plaintiffs (reduced to $245 million based on punitive damage limits)
- 2018 – DePuy offered to settle approximately 3,300 Pinnacle lawsuits for $400 million. This settlement would roughly resolve a third of the active hip replacement lawsuits. An average payment of $125,000 per case is estimated.
- 2018 – the court awarded a $245 million verdict in August 2018 after the plaintiffs agreed to separate sums totaling a lower amount.
- 2019 – Depuy reached out to 17 plaintiffs who won jury verdicts to make settlements.
In Ohio alone, DePuy faces more than 1,700 lawsuits. In Texas, there are currently more than 9,700 cases involving the Pinnacle device. DePuy has been settling many of the existing cases, typically for amounts ranging between $200,000 and $500,000 depending on the patient and how negatively their DePuy hip replacement impacted them.