DePuy Execs to be Held Accountable For What They Knew

Too often it seems that white collar crime pays. That may not be the case for executives of Johnson & Johnson in a couple of high-profile cases moving toward trial.

Not only will Ethicon (a division of J & J) be forced to be deposed in the ongoing transvaginal mesh cases, but will also be deposed in the case of DePuy Orthopaedics (another division of J & J). Eight top execs, including the president and former president, will be required to testify in litigation over the ASR metal-on-metal hip replacement and hip resurfacing medical devices.

DrugWatch reports that the executives will have to provide, under subpoena, documents, notes, records, outlines, and any produced material related to ASR hips, to lawyers trying the consolidated cases in an Ohio federal courtroom. More than 6,000 cases have been referred to the U.S. District Court for the Northern District of Ohio before the Honorable David A. Katz.

Johnson & Johnson recalled about 93,000 ASR metal hips when Australia first noticed, through its medical device registry, that they were failing at an alarming rate. Artificial hip implants are supposed to last about 15 years, but the metal-on-metal (MOM) hips had to be revised after a couple of years.

A study just published in the July 2012 journal, Orthopedics, found that 98 percent of DePuy ASR patients have to have the metal hip removed within three years of surgery, and three-fourths of all metal hips failed within two years. The failures were blamed on metal hypersensitivity, pseudotumor formation, component seizing, and aseptic acetabular loosening. More than half of the time, cup loosening led to an early failure.

A revision surgery is painful and dangerous. A surgeon has no idea what he or she will find when they undertake a metal-on-metal hip removal surgery where portions of the skin, muscle, ligaments and bone may be cut away to make way for the new implant. Often there is a necrosis or dead tissue accompanied by infection. Often patients are left permanently disabled and some never walk again.

As if the revision surgery wasn’t enough, research is emerging that metal shavings made of cobalt and chromium are getting into a patient’s blood when the components grind against each other. This can lead to metal toxicity or metallosis, along with an increased risk of cancer, in both the bladder and kidney.

While the federal cases should start to be heard in the spring of 2013, there are an additional 3,000 cases filed in state courts around the country. So far, settlements in state actions have amounted to about $200,000 a case, not enough compensation for a lifetime of pain and disability.

We will be watching the depositions and testimony of the DePuy president, particularly since the New York Times reported he knew about the early failure rates of the DePuy but continued to sell them despite that information.

Even when the DePuy hip was recalled, the company said it was for business reasons, not about patient safety. In a way he is right – it is very bad business to sell a defective medical device that is implanted with the intention of lasting about 15 years.

What they knew and when they knew it needs to be answered, and those in charge need to be held accountable, at the very least, to send a message to other executives that it will be very bad for their business and their personal bottom line to be caught committing fraud on a widespread scale and in many cases, having the federal government pick up the tab through Medicare payments.