DePuy Manufacturing was established in 1895 as the nation’s first commercial orthopedics company. In 1977, the company introduced its low contact stress (LCS) knee system, gaining FDA approval in the early 1980s. The LCS product for full knee replacement surgery was introduced in the late 1990s.
The company was acquired by Johnson & Johnson in 1998 with a price tag of $3.7 billion.
Of the three products that have embroiled DePuy in billion-dollar lawsuits — the Pinnacle Hip Replacement System, the ASR XL Acetabular System total hip replacement, and the ASR Hip Resurfacing System — the Pinnacle was approved by the FDA in 2000. The designs, which feature metal-on-metal construction, were intended for younger hip replacement surgeries, characterized by greater flexibility and range of motion than many other devices.
The Pinnacle system was based on a previously approved DePuy product, the Ultima Metal-on-Metal Acetabular Cup. In 2010, a U.K. study published a failure rate of the Ultima of nearly 14 percent, with 90 hips in 82 patients out of 545 patients requiring revision after the product failed. Revision surgery revealed tissue death, ruptured tendons, and pockets of fluid in the hips.
The ASR XL System was launched in the U.S. in 2005. The DePuy ASR Hip Resurfacing System began being sold internationally beginning in 2003. Both systems were recalled in August 2010 due to higher-than-normal rates of device failure.
Despite the issues associated with hip devices, DePuy continued its success in knee implants with $923.5 million in sales and nearly 23 percent of the market cornered in 2010.
In December 2010, all federal DePuy ASR lawsuits were consolidated into a single pretrial proceeding by the Judicial Panel on Multidistrict Litigation (JPML). The proceeding was relegated to the U.S. District Court of the Northern District of Ohio, presided over by Judge David A. Katz.
In August 2012, Johnson & Johnson settled three different claims with DePuy ASR plaintiffs in state court cases amounting to approximately $200,000 each.
In March 2013, an $8.35 million verdict was handed down in the first DePuy ASR state-court lawsuit. The trial, known as Kransky V. DePuy, took place in the Los Angeles Superior Court.
April 2013 saw the successful defense of an ASR suit by DePuy — in this case, a nurse was seeking $5 million for injuries, which the Illinois state court ruled against. DePuy then settled the first federal court lawsuit that was intended to be the bellwether trial with a fall 2013 scheduling. The multibillion-dollar settlement began with base awards of $250,000, not including medical costs.