Holes in FDA Testing Process Lead to Flawed Designs

 Posted on April 02, 2015 in Food Poisoning

There has been substantial media attention and reaction from affected patients regarding metal-on-metal hip implants over the last decade or so. Of course, one of the most famous examples is the articular surface replacement, or ASR, implant which was manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. Tens of thousands of the devices were implanted in patients before injuries, immobility, and even metal poisoning led to their recall in 2010. More than 7,500 lawsuits have been filed against DePuy and Johnson & Johnson, seeking billions in damages, and class action suits remain ongoing. It can difficult, however, for the average consumer to understand how medical devices such as the ASR implant ever get through the testing process and receive regulatory approval before going to market.

In the case of medical devices, even ones that eventually prove dangerous, substandard manufacturing is not often the problem. Rather, getting to the product to market frequently takes priority over careful design testing processes which allow for potential issues to be remedied prior to effecting patients and consumers. Many assume that industry and government regulators, like the Food and Drug Administration (FDA), would be responsible for ensuring that poorly designed devices never make it to market. They would be partially correct in that assumption, but many device manufacturers have found a loophole in federal regulations that reduce the FDA's oversight in particular situations.

Substantially Equivalent

The FDA's testing and approval processes can be extremely meticulous and stringent for new medical devices. However, the review requirement can be avoided if a manufacturer can show that a particular device is “substantially equivalent” to a piece of equipment already being marketed. Such was reportedly the case with DePuy's ASR implants, as similar devices were already publicly available. It was the differences apart from the “substantial equivalence” that were apparently flawed and ultimately led to the device's problems.

Experts say that medical devices may be put on the market as substantially equivalent to others, but manufacturers will continue to make small changes to the available product. Over time, this can lead to marketed devices that have undergone very little effective testing, often completely within the guidelines of the FDA and other regulators.

Where to Turn

At Newland and Newland LLP, we realize that tens of thousands of various medical devices serve their purpose in an exemplary fashion with very few problems. There are some, however, that fail to meet proper standards due to their being rushed to market and profitability. If you have been affected by a poorly-designed or dangerous medical device, contact an experienced Illinois defective medical device attorney today for your free phone consultation.