DePuy Synthes, acquired by Johnson & Johnson (J&J) in 1998 is one of the orthopedic franchises involved in manufacturing, designing, marketing products for repairing, reconstructing, correcting, various bone fractures and joint deformities. DePuy provides following product for Hip Replacement Surgery: DePuy Articular Surface Replacement (ASR) Hip Resurfacing System, ASR XL Acetabular System for total hip replacement and Pinnacle hip replacement system being their top hip replacement products.
The DePuy Pinnacle was initially approved by the U.S. Food and Drug Administration (FDA) in 2000. The 510(k) approval was based on similarities to the other implant and hence did not undergo the usual safety tests. ASR and ASR XL have been recalled in 2010 for its failure, whereas the sales of metal Ultamet liner ended in May 2013. However, the sales of Pinnacle hips made from other materials were not affected.
DePuy stated the reason for failure as component loosening, infection, dislocation, component malalignment, fracture of the bone, metal sensitivity and pain. Additional complications include bone staining, necrosis, swelling, increased metal ion levels in the blood, nerve damage, tissue damage and/or muscle damage.
In the year 2017 when Johnson & Johnson (J&J) and its subsidiary company DePuy were busy settling as many as 11,000 DePuy ASR hip implant lawsuits. The orthopedic device manufacturer was confident about their product safety for hip implant surgery. Johnson & Johnson refused to recall the Pinnacle hip implant, despite the more than 9,000 claims from Pinnacle victims. At that time, the Pinnacle hip lawsuits alleged the Pinnacle was defectively designed.
Plaintiffs claimed when they engaged in any level of activity, the metal parts of the implant would come into contact with one another, rubbing together and causing cobalt and chromium ions to imbed into surrounding tissues or to enter the bloodstream.
More than one million patients have received Pinnacle Hip Solutions cups, according to DePuy. The devices are implanted into the pelvis during partial or total hip replacement surgeries to relieve pain or increase mobility. Today, the Pinnacle cups come in ceramic-on-polyethylene and metal-on-polyethylene options depending on patient
In 2010, DePuy recalled its ASR XL Acetabular System and ASR Hip Resurfacing System because a large number of patients required revision surgery after receiving the implants. The company also stopped selling the all-metal versions of the Pinnacle system of implants because large numbers of consumers claimed the devices were faulty and led to a type of metal poisoning known as metallosis.
Plaintiffs in the Pinnacle cases claim that J & J and DePuy were well-aware of the flaws in the Pinnacle device, however rather than issuing a recall of the device, marketing tactics were increased. The companies claimed the Pinnacle was the best hip implant option for younger patients with an active lifestyle, yet some patients found themselves unable to even walk without painless than a year after the device was implanted.
After hip implantation, severe inflammation in the hip and thigh areas can be caused which include chronic pain in the thigh, hip, and groin areas, bone and tissue deterioration, and various other physical damages.
When the cobalt and chromium ions entered the bloodstream during surgery, the effects can be even more damaging which include severe headaches, visual disturbances, memory loss, vertigo, hearing loss, DNA disruption, and gastrointestinal disorders.
Johnson & Johnson reversed its prior position on the Pinnacle hip lawsuits in the year 2019, agreeing to settle the bulk of consumers’ lawsuits which alleged the Pinnacle hips were defective and that J & J and DePuy misled patients about the danger of the implants. While DePuy marketed the Pinnacle implants as having a five-year rate of more than 90 percent, European health regulators found that number to be about 5 percent. This settlement agreement came two weeks after J&J agreed to pay $120 million to resolve claims of deceptive marketing to state attorneys general. In an earlier Pinnacle settlement, Johnson & Johnson paid about $125,000 per case to resolve roughly one-third of the more than 10,000 Pinnacle implant claims.