Despite Assurances that the DePuy ASR Was Performing Well, Internal Documents Tell a Different Story

ASR-internal-docs-tell-diferent-story

Metal-on-metal hip implant devices were created for greater durability and longevity, with the intention that they would be far superior over their more traditional counterparts that are constructed with plastic or ceramic components. In recent years, the metal devices have come under fire for failing at unexpectedly high rates and leaving patients with significant and, often, life long injuries. Some experts say that European and American regulators worked to ensure patients were unaware of the devices’ risks.

As we’ve long been writing, research has linked the controversial metal-on-metal hip devices to adverse events that include tissue necrosis, implant site pain that can spread to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and fluid collection/solid mass development around the hip joint.

In response to mounting adverse event reports, litigation, regulatory and medical probes, and global recalls, the U.S. Food & Drug Administration (FDA) announced that metal-on-metal devices can lead to pain, soft tissue damage, and metal shedding in the area where the device’s components meet—typically at the ball and cup junction. Metal shedding can occur when the device’s socket is in normal use, such as during walking or running. From a legal standpoint, this announcement and related changes are an important step in attempting to hold manufacturers responsible for dangers associated with their products.

Now, the first of some 10,000 cases filed against Johnson & Johnson over the DePuy ASR is being heard; proceedings started this week and have revealed some interesting behind-the scenes situations concerning the recalled device.

For instance, Johnson & Johnson appointed Andrew Ekdahl to head its DePuy Orthopaedics division, saying that the move was part of a fresh start it was making following recall of the DePuy ASR. In fact, Ekdahl had been in charge of the ASR’s introduction in the United States and was also advised by a key company consultant—three years before the recall—that the device was faulty, noted The New York Times.

Prior to the DePuy ASR’s recall in late 2010, Ekdahl and other executives at the firm publicly stated that the hip device was performing very well; however, said the Times, newly released internal documents reveal a different situation.

Consider that Ekdahl was also working at Johnson & Johnson in a senior marketing position when the firm opted to keep significant information about the device from officials outside of the U.S.; specifically, officials were not told that U.S. regulators denied approval of another version of the device, the Times pointed out.

Ekdahl’s long involvement in the worldwide ASR debacle was revealed yesterday in Los Angeles Superior Court during the first patient trial against DePuy Orthopaedics, a unit of Johnson & Johnson. As the Times noted, the recently revealed information pointing to Ekdahl’s long and deep involvement with the faulty implant will likely raise more questions about the ASR scandal.

As we’ve mentioned. Ekdahl has continually maintained that the DePuy ASR was pulled, not over safety concerns but “because it did not meet the clinical standards we wanted in the marketplace,” according to his taped remarks. Portions of Ekdahl’s previously videotaped deposition were shown to jurors yesterday.

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