DePuy Synthes is an orthopedics company which is a subsidiary of healthcare giant, Johnson & Johnson. The company is a leading designer, manufacturer, and distributor of medical devices and supplies, mainly focused on orthopedic devices.
DePuy is the world’s oldest manufacturer of orthopedics devices and remains one of the largest. With estimated 2021 revenue of $14 billion, the company is the second largest orthopedics manufacturer in the world.
The company maintains a number of orthopedic products including multiple joint replacement devices, along with products for spinal reconstruction and maxillofacial surgery, as well as devices used in the practice of sports medicine.
DePuy has also been an industry leader in computer-assisted technology and robotic surgery systems. The digital and computer assisted technology is designed to work specifically with DePuy devices to aid in fitting of the implants and surgical placement.
While a many DePuy products have been highly successful, the company has faced numerous challenges including thousands of complaints from patients who received ASR and Pinnacle hip replacement devices. More than 10,000 lawsuits have been filed against DePuy regarding injuries sustained from hip devices. A number of these federal claims were consolidated into multidistrict litigations.
Additionally, controversy surrounds complications that have resulted from DePuy’s Attune and Sigma high-flex knee devices. The company may be facing 10,000 or more injury lawsuits over serious side effects of these devices.
DePuy was originally founded by a traveling pharmaceuticals salesman named Revra DePuy in Warsaw, Indiana in 1895 as DePuy Manufacturing. DePuy’s first product was a fiber splint used for setting broken bones. This splint was a revolutionary product which came to replace wooden barrel staves that had been commonly used. The company increased their product line to include wire cloth splints and hired a number of employees, including Justin Zimmer, who would later go on to form his own company which is still a competitor of DePuy today.
DePuy remained focused on splints, until Revra DePuy’s death in 1921 but as technology developed, focus of the company shifted to development of artificial joints, surgical spine correction and other innovations. DePuy has maintained its position as a first ranked orthopedics company and was the “first” in a number of areas. DePuy created the first mobile bearing knee system and a cementless coating for joint implants.
In 1998, manufacturing giant Johnson & Johnson acquired DePuy and in 2011, added to the company with Synthes, Inc to form DePuy Synthes. DePuy now operates in several countries, such as the United Kingdom, Germany, France, Japan, and Australia under the Johnson & Johnson umbrella organization. The DePuy Synthes portfolio features nearly orthopedic and surgical products.
Most of DePuy’s revenues are from the manufacture and distribution of hip and knee joint replacement implants and surgical equipment including robotic and computer-assisted surgical systems.
DePuy Legal Troubles
Despite its history as a highly successful, progressive company which has introduced a number of “firsts” into the orthopedics industry, DePuy has also had problems with their products. Some of these issues have led to serious patient injuries, product recalls, and lawsuits, particularly for knee and hip replacement devices.
DePuy Hip Implant Lawsuits
The DePuy ASR (Articular Surface Replacement) Hip Resurfacing System and the ASR XL Acetabular System total hip replacement were recalled in August of 2010 by DePuy Orthopaedics and the company also discontinued the all-metal models of the Pinnacle hip devices. DePuy had received numerous reports regarding patients who experienced pain and other serious side effects from DePuy hip replacement devices.
Side effects which may occur with hip implant failure include:
- Loosening or instability of the hip joint
- Hip pain and inflammation
- Infection of hip joint
- Bone fracture
- Joint bone loss or dissolution
- Dislocation and loss of mobility
- Immune reaction with flu symptoms
DePuy has been the focus of thousands of medical injury lawsuits involving substantial problems with the ASR and Pinnacle hip implants. Thousands of patients experienced problems with pain and swelling. Some implants caused severe nerve, muscle, and bone damage due to joint destruction. Blood poisoning has also been reported, due to the material from the metal-on-metal implants.
The Pinnacle devices were withdrawn from the market in 2013, but the company did not issue a recall for the devices, they were simply discontinued. By the same year, DePuy was already facing over 10,000 Pinnacle lawsuits and about 10,000 ASR lawsuits. Most of these federal lawsuits were consolidated into multidistrict litigation (MDL) cases and many have since been settled.
Thousands of ASR hip lawsuits were settled in 2013 for a total cost of $4 billion, and about 6,000 Pinnacle hip lawsuits were settled for about $1 billion. Due to the expected lifespan of a joint replacement device, about 11,000 lawsuits may still be pending and have yet to be settled and more may be expected.
DePuy Knee Replacements
Over 700,000 knee replacement surgeries are performed each year in the U.S. Millions of people have received the DePuy Attune or Sigma knee systems.
The DePuy Attune and Sigma knee replacement devices were designed with state-of-the-art technology to improve stability and range of motion while reducing implant wear. Unfortunately, the devices have not been successful for all of the patients who receive it. Thousands of people have experienced serious complications and been required to undergo knee revision surgery.
Like the DePuy hip device troubles, DePuy may be facing thousands of device injury lawsuits for problems with their Sigma or Attune knee devices.
Some side effects from knee replacement surgery:
- Loosening or instability of implant
- Change in position of device components
- Tibial subsidence (when an implant sinks into the soft bone tissue of the tibia)
- Bends, breaks, or other deformities of the implant
- Infection of the knee joint
Though DePuy recalled Attune Knee Tibial Articulation Surface Instruments due to defects in the surgical kits and has had a number of other small recalls, these are not the problems that have resulted in device failure for hundreds of patients.
DePuy began seeing the first Attune Knee lawsuits in 2017 and more continue to be filed. No dispositions have been announced.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.