DePuy (Johnson & Johnson) Hip Implant Products Liability Multidistrict Litigation (MDL) & Recall News: ASR & Pinnacle

Currently in the appeals process is the $247 million verdict against the manufacturer DePuy Orthopedics, inc., whose parent company is Johnson & Johnson, and their line of metal-on-metal hip implants. DePuy is facing $78 million in punitive damages, and Johnson & Johnson is facing $90 million.

The plaintiffs claimed that the companies were falsely reporting the implants as longer lasting than those made with plastics or ceramics. This product is used to treat joint failure caused by osteoarthritis. The plaintiffs recounted to the jurors their suffering and injuries that resulted from using this product. These include tissue damage, which led to permanent muscle loss, loss of hip movement, intense pain, and permanent limps in their walks. They also claimed that the product shed metal into their bodies by a process called metallosis, in which the implants shed microscopic metal ions.

After hearing these testimonies, the jury found Johnson & Johnson and DePuyguilty and was  “liable for design defect, negligent design, inadequate warning, manufacturing defect, negligent manufacture, negligent misrepresentation, fraudulent concealment from the plaintiffs and from the surgeons and deceptive business practices as to the plaintiffs and the surgeons, intentional misrepresentation to the surgeons who performed the initial hip implant surgeries on the plaintiffs.” They also found Johnson & Johnson Johnson & Johnson and DePuy guilty of intentionally misleading their consumers.

plaintiffs. In another bellwether trial, the jury yielded a $500 million reward to five plaintiffs.

In 1995, a senior engineer by the name of Dr. Graham Isaac, who was working with DePuy, allegedly reported that these kinds of implants were unpredictable and likely prone to what they called “catastrophic breakdown.” He also noted that while these implanted “worked well for a period,” they eventually wore down, and the result was metal debris that would be released into the body which would likely turn into toxic levels of metal.

In his 1995 memo, Dr. Isaac examined data on metal-on-metal hips that had been produced by companies making similar implants:

“It is clear from the literature the survivorship of cobalt chromium [the materials used in metal implants], metal-on-metal prostheses in the past have been far from satisfactory. Manufacturing methods have improved. However, simulator testing of such components suggests their performance is as unpredictable as ever, working well for a period before suffering a sudden catastrophic breakdown of the bearing surface accompanied by a release of a large volume of wear debris.”

Even more damning, in 2010, a U.S. orthopedic surgeon by the name of John Irving, wrote an email to the president of DePuy that continuing these implants to market was borderline unethical until these issues were no longer a concern. He stated that the firm was intentionally turning a blind eye to the products and that these products were harming the very patients they were supposed to be helping. This email occurred three years before the implant was discontinued altogether after the United States Food and Drug Administration changed its artificial hip regulations.

At the time of the implants initial release, the FDA did not require DePuy to undergo clinical trials for their product instead; they submitted a section 510(k) premarket notification of intent to market the hip. This means that they were able to avoid safety review usually required because they represented their design as “substantially equivalent” to other hip products that had been currently in the market at the time.