When Did MoM Hip Manufacturer DePuy Know their Product Was Defective?

Documents have recently surfaced during an investigation by The Daily Telegraph in Great Britain that show experts, both outside of and within the company, had warned DePuy of problems with their metal-on-metal hip design—going back as far as 1995. According to trial testimony, Dr. Graham Isaac, a senior engineer working on the project, was said to have reported that the metal-on-metal construction was unpredictable and prone to suffering a catastrophic breakdown that could release a large volume of debris into the body. Even more disturbing are minutes from a 1995 internal meeting where a number of DePuy employees had this discussion: “we need to be cautious of the legal/litigation issues and lawyers, etc… perception of metal debris and metal-ion release.”

Yet, DePuy began marketing their ASR device in 2005, only to issue a recall in 2010 after posting a 12 percent failure rate—a number thought to be closer to 40 percent in light of evidence revealed by The New York Times in 2013. Company files also contained correspondence from a Hartford, Connecticut-based orthopedic surgeon named Dr. John Irving, who contacted the head of marketing in the U.S. for DePuy—calling the sale of the product borderline unethical as patients were being harmed.

Now, more than 10 years after the first metal-on-metal devices were marketed, it is understood that patient movement caused grinding of the parts, allowing metal particles to accumulate in the joint over time and then enter the bloodstream—resulting in tissue damage and even systemic toxicity.

This news comes at the same time when the Plaintiffs in a recent case against the device manufacturer and parent company Johnson & Johnson asked the Fifth Circuit Court of Appeals to restore the $502 million verdict that has since been reduced to about $150 million due to Texas’ statutory cap on punitive damage awards. Involving a similar product that has yet to be recalled, the bellwether trial ascertained that DePuy and Johnson & Johnson marketed the Pinnacle replacement hip as a high stability, low-wear implant that could be used with a metal liner, yet they did not provide any warning of the risks involved with such a combination.

In a blog from several months back, I considered the outcome of this trial and the third bellwether that resulted in a payout of over $1 billion—ultimately wondering what, if any, lesson Johnson & Johnson might be learning from these verdicts. Whether it was in 2016 or 1995, I’m not sure that this multinational manufacturer of medical devices has had a change of heart when it comes to safeguarding the health of patients they’re purportedly trying to help.