History and Background of DePuy Synthes

DePuy’s origins trace back to 1895 and the company’s founder, Revra DePuy, a chemist and pharmaceutical salesman from Warsaw, Indiana. Known then as the DePuy Manufacturing Company, it was established with the idea of manufacturing fiber splints that could be customized to fit patients and which were superior to the commonly fashioned wooden splints of the day.

DePuy continued to grow and following Revra DePuy’s death in 1921, the company shifted its focus to newer cutting-edge technologies fashioning artificial joints and spinal repair techniques. DePuy’s advances in these fields helped to shape the modern orthopedic device industry and transformed it into a preeminent leader in technology investment and innovation.

Johnson & Johnson acquired DePuy in 1998 for $3.5 billion and in 2012 coupled it with another acquisition of the firm Synthes. Last year alone, the DePuy Synthes unit reported $2.41 billion in revenue for Johnson & Johnson. 

Issues with DePuy Hip Implant Technologies and Product Lines

DePuy ASR XL Acetabular System and ASR Hip Resurfacing Resurfacing Platform (MDL-2197)

DePuy manufactured the ASR Hip Implant Device line and is a business unit of the global device giant, Johnson & Johnson. The ASR XL Acetabular System was made up of three components:

• The metal femoral stem inserted inside of the femur
• The metal femoral head (or ball) connected to the stem; and
• The metal acetabular cup (socket)

Similarly, the ASR Hip Resurfacing Platform involves a metal cap placed over the natural femoral head and replacing the acetabulum with a metal cup.

Beginning in 2008, the FDA started receiving approximately 400 complaints from patients in the United States who were implanted with the devices. These patients complained of pain, swelling, inflammation, and damage to the bone and tissue – as well as a lack of mobility. Many of these patients required expensive and painful revision surgeries.  

In 2010, DePuy issued a voluntary recall of ASR Hip Implant Devices and the first lawsuits naming DePuy soon followed thereafter. The cases were consolidated into an MDL and between 2013 and 2017, DePuy paid nearly $4.8 billion to settle approximately 7,500 cases.

It has been over ten years since the original ASR recall. And although this MDL is technically still open, settlement protocols have a stipulated deadline for potential litigants requiring revision surgery to have been performed no later than July 2017.

DePuy Pinnacle Hip Replacement System with TrueGlide Technology (MDL-2244)

The DePuy Pinnacle Acetabular Cup System was launched in 2001 and offered the option of either polyethylene or metal insert for use with a titanium cup to replace the natural hip socket. This was followed by the launch of the Pinnacle system coupled with TrueGlide technology in 2007.

Although the Pinnacle system was not subject to recall, patients still reported many of the same issues as those suffering from the DePuy ASR devices. Issues with loose implants, inflammation, swelling, and damage to surrounding tissue coupled with the spread of metal debris and contamination throughout the body were not infrequent. Many patients implanted with Pinnacle devices suffered the loss of mobility and went through painful and expensive revision surgeries in an attempt to correct issues.

Lawsuits involving the Pinnacle Hip Replacement System were aggregated into an MDL in a federal courtroom in Texas. In 2016, the second bellwether case in the MDL yielded a verdict in favor of the claimants to the tune of $502 million (later reduced under Texas law limiting punitive damages). A third bellwether case resulted in a $1 billion verdict in favor of claimants (reduced to $543 million on appeal) and a fourth bellwether case wound up with a $247 million verdict in favor of claimants.

In June 2019, DePuy announced that it would settle up to 6,000 of the Pinnacle lawsuits for $1 billion. DePuy is settling each case individually and as a consequence, this MDL remains open with up to 9,155 cases still pending.

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