DePuy Orthopaedics, Inc., a division of Johnson & Johnson, the largest worldwide pharmaceutical and medical device company was the first orthopedics device company in the U.S. DePuy has manufactured over 200 successful medical devices, but some have caused serious injury to patients. In particular, three of the hip replacement devices have caused an unexpected high failure rate in some patients including the ASR XL Acetabular System total hip replacement, the Pinnacle Hip Replacement System, and the ASR Hip Resurfacing System which had originally been created for younger patients with more active lifestyle.
A DePuy hip recall was issued for the ASR hip model in August 2010 but 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 product was never issued. The 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.
Status of Lawsuits
More than 10 thousand ASR lawsuits and nearly 7 thousand Pinnacle device lawsuits have been filed against DePuy and its parent company, Johnson & Johnson. The first ASR lawsuit was filed in California after Loren Kransky had received the hip implant in North Dakota in 2007. The filing also included a lawsuit filed by Kransky’s wife, Sheryl Kransky for loss of marital relationship due to the injury. The case was settled with an actual award of $8.3 million in damages in 2013. Three out-of-court settlements were reached in Las Vegas with an agreement to pay each complainant $200 thousand for injuries.
During the same year, Johnson & Johnson agreed to settle the more than 8 thousand federal lawsuits regarding the ASR devices which were consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Northern District of Ohio for an estimated $2.5 billion but the settlement amount may go much higher with an award of approximately $250 thousand for claim. An additional 2 thousand cases remain in California and many more in other states and local courts.
Federal lawsuits regarding the Pinnacle devices have been consolidated into MDL in the U.S. District Court for the Northern District of Texas. The first “bellwether” trial was concluded in October of 2014, resulting in a decision for the defendant but additional bellwether trials are expected to begin in November 2014 and January 2015.
Bellwether trials are “sample” trials, showing what may be expected in the full MDL. Based on the outcome of additional bellwether trials, the company may decide on an out-of-court settlement or may decide to proceed to a full trial. In addition to the federal cases, many Pinnacle lawsuits have been filed in state and local courts as well.
Besides the 10 thousand ASR and 7 thousand Pinnacle lawsuits, many more may be expected. Plaintiffs have claimed that the company of aggressively marketing the devices to younger and more active patients while deliberately concealing high failure rates.
Patients who file suit against DePuy and Johnson & Johnson could receive compensation for actual damages (monetary loss, medical bills) and for punitive damages (to punish the company).
DePuy Hip Design
Introduced in 2002, DePuy created the Pinnacle device with metal-on-metal (MoM) construction, which different from other hip devices using multiple materials, eliminated plastics which showed they may shed particles into the surrounding joint tissue. It was anticipated that MoM construction could reduce “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.
Unfortunately, the MoM construction has caused the grating of metal-against-metal, resulting in metallic debris being shed into the joint tissue. Metal fragments have caused localized tissue toxicity and some patients have absorbed metal ions into the bloodstream. This has resulted in conditions such as dislocation, severe pain and inflammation, and body-wide symptoms of fatigue, headaches, rashes, and increased risk of cancer.
DePuy Hip Side Effects
The DePuy Pinnacle and ASR hip replacement products have caused multiple severe adverse reactions reported by patients and physicians. These side effects have caused permanent injury and a requirement for revision and reconstruction surgery in a number of patients.
Severe side effects resulting from the DePuy devices may include:
- Metallosis – metal fragment shedding into the joint tissue or metal toxins absorbed into the bloodstream
- Poisoning of the joint tissue resulting in large collections of fluid, necrosis of local tissue and dissolution (osteolysis) of bone tissue
- Fracture of bones surrounding the joint (femur and pelvis)
- Dislocation caused by loosening of the device or other manufacturing faults resulting in difficulty with mobility
- Localized pain and inflammation from metallosis
- Systemic metallosis resulting in inflammatory symptoms such as headaches, rashs, fatigue and other cognitive symptoms due to high chromium and cobalt blood levels
Patients who have experienced side effects due to DePuy implants may require revision or reconstructive surgery. Revision surgery is needed to remove the DePuy implant and replace it with a different artificial joint. Reconstructive surgery may be needed to repair bone fractures and other bone issues, also requiring replacement of the failed device. In most cases, the second or further surgeries needed will be more painful, expose the patient to additional risks and will require a longer recovery period than the original surgery.
Estimates have shown that up to 40 percent of the DePuy devices may fail in the first five years after implant, though they were expected to last for 15 years. The first failures of the Pinnacle device began showing in early in the device lifetime including a woman who has claimed that the device resulted in metal poisons being absorbed into her bloodstream and also reported a severe infection. By 2007, a British physician reported his concerns about the DePuy ASR devices, which was corroborated by the national joint registry showing a 12 to 13 percent failure rate after less than 3 years on the market.
By 2009, DePuy had been warned at least 7 times by the health authority in Australia and the device was recalled in that country. Despite evidence from Australia, the UK and other international sources, the ASR devices were not recalled in the U.S. until 2010.
Despite clear evidence of failure and the recall of the ASR devices, the Pinnacle device remained on the U.S. market until 2013 when DePuy discontinued worldwide manufacturing and marketing but a recall was never actually issued which may have allowed physicians to continue using existing stocks of the devices until inventories were depleted. DePuy also has not acknowledged any fault in either the ASR or Pinnacle device failures.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.