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Documents Show Johnson & Johnson Hip Implant “Phaseout” After FDA Safety Request

The information that a defendant knew or should have known is often an important issue in product liability and negligence lawsuits. While product liability suits can be based on theories of “strict liability” where the defendant’s state of mind is irrelevant-various issues even in those cases can hinge on information available to or known by a defendant that was ignored, misunderstood, or hidden. For these reasons, during any legal matter, our Illinois injury attorneys give careful analysis to all information which suggests what a party in a suit might have known about the risks or potential danger of their products and activities.

Understanding a defendant’s knowledge level can be difficult in certain situations. However, learning about the party’s conduct itself it often helpful in discovering what they knew or didn’t know at the time. For example, late last week the New York Times published a story that shared more information about actions by Johnson & Johnson after the company was asked by the U.S. Food and Drug Administration for more safety information about certain hip implant devices that they created.

These and similar devices, made by the company’s DePuy Orthopaedics unit, have made many headlines since this FDA request as the units were eventually recalled. Many patients throughout the country, including in Illinois, have come forward and shared information about how certain “metal on metal” hip implants that they received stopped working properly, causing them harm, permanent disability, and often requiring a risky revision surgery. Our DePuy hip injury lawyers remain available to help those who have been hurt by this product.

An important issue in DePuy hip implants lawsuits revolves around figuring out what the designers and manufacturers knew or should have known about the safety of this product. New documents released by the FDA last week shed more light on those questions. For example, the NYT story explains how amid growing concerns about the product’s safety, the FDA asked Johnson & Johnson for more safety data on certain devices. At that time the company told the FDA that blood tests of some patients who received the product showed “high concentration of metal ions.” Only a few weeks later, the company decided to phase out the implant and sell off its inventories.

Similarly, at this time it was known that the data on the safety of a device from countries outside the U.S. suggested more concerns than the data submitted for use of the device in the United States. For example, as early as mid-2009, information from tests in Australia indicated that the device was failing at rates far faster than expected. Patients were usually told that their devices should last as long as fifteen years. However, many did not last anywhere near that long. These concerns were voiced by the FDA when turning down the company’s request to have the device approved in the United States. However, companion devices to those not approved were already being used in the U.S., with thousands of patients receiving the implants without realizing the growing safety concerns surrounding the product.

Our Illinois DePuy hip lawyers understand that it is important to note that the planned phase-out and information about high failure rates were documented in mind-2009. It was not until August 2010 that all of these suspected devices were recalled by the company and patients were finally no longer given the product. This was more than a year after the FDA’s letter indicating clear concerns about the safety of the product. In other words, the company began plans to phase out the product and sold its inventory to be used in patients almost a year before officially recalling the device.

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