Pharmaceutical

Testimony in first DePuy trial indicates company failed to act on ASR hip warnings

DePuy ASR hip recall 435x369 Testimony in first DePuy trial indicates company failed to act on ASR hip warningsCourt documents and the recent testimony given by DePuy officials during the first ASR metal hip case to go to trial indicate the company took very little action, if any, to warn prospective patients about the serious risks its all-metal hip implants posed.

DePuy Orthopedics, a division of the Johnson & Johnson health care conglomerate, started selling its ASR Acetabular and Hip Resurfacing Systems in 2003 after the devices were fast-tracked through the U.S. Food and Drug Administration’s approval process. By 2005, DePuy began receiving complaints about the all-metal devices, which were designed to outlast conventional hip implants made with ceramic and plastic components.

Evidence now indicates DePuy may have known a lot more about the faulty ASR hip devices than it shared with the public, information that could have spared thousands of patients from painful injury, metal poisoning, and revision surgery.

In 2007, a study of the ASR hips by a DePuy engineer found that the angle of the implants caused excessive wear between the metal ball and metal cup. The resulting friction allowed particles of cobalt and chromium to escape into the bloodstream where they became ionized, causing muscle, tissue, and bone damage in addition to systemic illness in some cases.

“You need to tell the surgeon everything you know about the safety ramifications of the device, correct?” a lawyer representing plaintiff Loren Kransky, 64, asked another DePuy engineer last week in trial.

“Well, everything we think is relevant,” the engineer answered.

“Well … it’s not up to you to choose what’s relevant, is it?”

“I think it is to a certain extent it is, yes,” the engineer answered.

The same engineer obtained new data in April 2008 demonstrating how DePuy’s ASR hips compared to metal hips made by other companies in terms of shedding metallic debris. “I believe that this data will appear in the journals … and has the potential to seriously affect our business,” the engineer wrote to company officials. “We need to discuss this at the earliest possible opportunity, as I believe it means that we need to start any ASR upgrade sooner than our previous plans had suggested.”

But an upgrade for the faulty ASR hips never came. Instead, DePuy left them on the market for several more months before it started to phase the devices out of production in November 2009. The devices were finally recalled in August 2010 – 19 months after the idea of upgrading the devices to fix the flaws was first addressed by company executives internally.

Meanwhile, about 93,000 patients received the faulty ASR hips worldwide, including about 37,000 Americans. DePuy faces some 10,000 lawsuits in the U.S., with a number of other class actions building in Australia, Canada, the U.K., and other countries.

Sources:

Courtroom View Network
The Economist