Executive Summary

DePuy Synthes is a franchise of orthopaedic and neurosurgery companies. They have been part of the Johnson & Johnson Family of Companies since 1998. DePuy develops and markets products under the Codman, DePuy Mitek, DePuy Orthopaedics, and DePuy Spine brands. 

Notably, DePuy Orthopaedics also has one of the world’s most comprehensive portfolios of orthopaedic products and services in the areas of joint reconstruction, trauma, spine, sports medicine, cranio-maxillofacial, power tools, and biomaterials. Its primary products aim to reconstructure damaged or diseased joints and for repairing and reconstructing traumatic skeletal injuries.

Most recently, DePuy Synthes has had trouble with its Articular Surface Replacement technology and Pinnacle hip implants, with more than 20,000 people filing lawsuits against the company. Verdicts and settlements in the lawsuits have already totaled more than $6 billion.

History of DePuy Synthes

In 1895, a 35-year-old chemist and pharmaceutical salesman named Revra DePuy came up with the idea of starting a business to manufacture fiber splints that could be customized to fit patients and would be an advance over the wooden splints that were commonly used in the late nineteenth century.

DePuy opened his business, which he named DePuy Manufacturing Company, in a hotel room in downtown Warsaw, a city in northern Indiana that is home to several natural lakes and which DePuy had grown fond of during his work-related travels.

Even before Revra DePuy made his first sale, he made history. His business became the first orthopaedic manufacturing business in the world, and his decision to set up shop in Warsaw was the catalyst for Warsaw becoming the “Orthopaedic Capital of the World.”

Over the next quarter century, until his death in 1921, Revra DePuy continued to make splints and grow his business. He replaced his fiber splints with wire cloth splints. He added more than a dozen employees to the payroll. He also complemented his mail-order business with a small team of salesmen, one of whom was Justin Zimmer, who later started his own splint manufacturing company in Warsaw.

In the decades following Revra DePuy’s death, the orthopaedics industry changed dramatically. New scientific advances led to the development of artificial joints, as well as techniques for correcting spinal deformities, repairing broken bones with internal fixation devices and many other innovations. DePuy Manufacturing not only adapted to the changing orthopaedic industry, it helped shape it. Through a series of leaders, owners, acquisitions, collaborations and joint ventures, DePuy Manufacturing transformed from a company that made splints to a leader in developing and manufacturing implants and instruments to treat a wide range of diseases and disorders of the musculoskeletal and neurological systems.

Along the way, there were many company “firsts.” DePuy introduced the first mobile bearing knee system in the United States, the LCS® Knee System. It pioneered POROCOAT® Porous Coating, which is composed of sintered alloy beads that allow biological fixation to bone without the use of bone cement. During the 1980’s, DePuy’s AML® Hip System became the first cementless porous-coated implant indicated for biological fixation in the world.

Innovation and growth were further fueled by several mergers and acquisitions. In 1990, DePuy’s parent company at the time acquired Chas. F. Thackray Limited (Leeds, United Kingdom). Thackray played a key role in the development of cemented fixation through its work with Sir John Charnley, the “father” of total hip replacement. DePuy’s work in biologic fixation and Thackray’s contributions to cemented fixation continue to shape new innovations to this day. Interestingly, not only did DePuy go on to manufacture and market the CHARNLEY Hip for many years , it also had marketing rights for some time to the Müller® Hip, named after Swiss orthopaedic surgeon Maurice E. Müller, whose cemented straight stem has remained virtually unchanged since its inception decades ago.

In 1998, Johnson & Johnson, one of the world’s largest healthcare companies, acquired DePuy, by then known as DePuy, Inc. Later, in 2012, Johnson & Johnson acquired global medical device company Synthes, Inc., and combined that company with the DePuy franchise to create one of the world’s largest orthopaedic and neurological businesses.

DePuy Synthes Subsidiaries

DePuy Synthes has the following companies operating under it:

• Codman & Shurteff, Inc.
• DePuy Mitek, Inc.
• DePuy Orthopaedics, Inc.
• DePuy Spine, Inc

Popular DePuy Synthes Products

One of DePuy Synthes’ flagship products is the Attune Knee System lineup. The Attune rotating platform design increases the level of conformity to provide stability while delivering freedom of mobility. Rotating platform knees aim to restore more natural movement to the joint by allowing the bearing to rotate in the same manner as an anatomical knee. Rotating knees also are designed to reduce stress and wear on the implant by 94 percent.

The second-most popular product made by DePuy Synthes is the Pinnacle Acetabular Cup System (ACS). It is a modular cup system designed with a wide range of acetabular cup options, biological and mechanical fixation alternatives and advanced bearing technologies that allows surgeons the flexibility to choose intraoperatively from among the most advanced technologies available depending on their patients’ individual needs.

DePuy also manufactures the RECLAIM® Modular Revision Hip System, which combines design features with comprehensive testing and engineering. Designed to be a durable and flexible system to manage the unexpected in moderate to severe hip revision surgery.

Another product marketed by DePuy is the SUMMIT® Tapered Hip System, which has achieved over 15 years of clinical history, and it remains a viable treatment option for patients today. A comprehensive set of implants, featuring both cemented and cementless options, treat a wide range of patients with differing needs. The SUMMIT Tapered Hip System utilizes a common set of instrumentation. The streamlined approach maximizes efficiency in the operating room, while still providing intraoperative flexibility.

For the spine, DePuy manufactures the EXPEDIUM® 5.5 System, which provides technological advancements to treat a range of spinal pathologies. The EXPEDIUM Spine System offers a comprehensive solution for rigid posterior fixation of the thoracolumbar regions of the spine.

DePuy Synthes Product Recalls and Lawsuits

1. In 2010, DePuy Orthopaedics recalled its ASR XL Acetabular metal-on-metal hip replacement system on August 24, 2010. The recall came after data from a study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients. Even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that may not be discovered for years. DePuy identified reasons for the failure of the hip replacement system as component loosening, component malalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain. Additional complications from the hip replacement system may include increased metal ion levels in the blood, bone staining, necrosis, swelling, nerve damage, tissue damage and/or muscle damage.

About 93,000 persons worldwide received an ASR implant. The first lawsuit in the United States against DePuy Orthopaedics was filed on June 15, 2010. 

On March 17, 2016, United States District Judge Ed Kinkeade, after receiving the juries verdict, signed final judgment and issued a combined award of $120 million against DePuy Orthorpaedics Inc, and a combined award $240 million against Johnson & Johnson.

1. In December 2017, DePuy Synthes recalled a stand-alone element of its Sigma HP partial knee replacement, the Sigma HP PFJ cemented trochlear implant, “based on elevated revision rates observed as part of the company’s post-market surveillance process.” “Further distribution or use of the affected implants is to cease immediately, and the product is now discontinued. The company recommends that surgeons use alternative implants or consider a total knee replacement,” the company said in a field safety notice dated December 2017.
2. More than 20,000 people have filed lawsuits over DePuy’s Articular Surface Replacement (ASR) and Pinnacle hip implants. Verdicts and settlements in the lawsuits have already totaled more than $6 billion. The metal-on-metal technology used in DePuy’s Articular Surface Replacement (ASR) and Pinnacle hip implants offered high-hopes of long-lasting implants when it first hit the market, but it was plagued with problems and many implants failed within just a few years.
3. Plaintiffs say friction between the all-metal parts released metal ions into the body, which led to complications and implant failures – and, ultimately, 20,000 lawsuits. Settlements and verdicts involving the hip implants total roughly $6.2 billion, though courts have reduced some of the jury awards. As of July 2019, there were more than 11,000 lawsuits still pending over DePuy hip replacements and more lawsuits are likely to be filed. Of those, 9,893 were lawsuits over the Pinnacle hip and 1,434 were over the ASR hip.

DePuy Synthes Settlements

1. In December 2018, Bloomberg reported that DePuy offered to settle roughly 3,300 Pinnacle lawsuits for $400 million. That would have resolved roughly a third of the active lawsuits over the hip replacement. Bloomberg relied on court documents from the MDL in Texas federal court for its reporting. 

In February 2019, HarrisMartin Publishing reported that DePuy was also willing to reach settlements with 17 plaintiffs who won jury verdicts in three bellwether trials. That announcement came as the MDL court was preparing to retry one of the cases. No details of the negotiations were released at the time.

Sources: https://projects.propublica.org/docdollars/company/100000005601https://www.drugwatch.com/hip-replacement/depuy/lawsuits/https://www.jnjmedicaldevices.com/en-US/companies/depuy-syntheshttps://www.beckersspine.com/orthopedic-a-spine-device-a-implant-news/item/44397-depuy-synthes-reports-1-9-drop-in-sales-for-2018-5-things-to-know.htmlhttps://www.jnjmedicaldevices.com/en-EMEA/product/expedium-55-spine-systemhttps://www.massdevice.com/revision-rates-prompt-recalls-johnson-johnsons-depuy-synthes-zimmer-biomet/