When a dangerous product causes harm to you or someone you care about, you naturally want to know how the terrible situation was allowed to come about. Manufacturers of consumer products are interested in making as much money as possible, like any company. But this can lead to corners being cut. And that can lead to injuries. So who keeps an eye on these companies? Who looks out for you?
In the United States, the federal Food and Drug Administration (FDA) is responsible for protecting public health by ensuring that human and veterinary drugs (including prescription and over-the-counter drugs), vaccines, medical devices, food, dietary supplements, cosmetics, and products that emit radiation are safe. Before a manufacturer may market a medical device to the public, it must obtain FDA approval. The device must go through a series of clinical trials that are intended to determine whether it is both safe and effective as a treatment for a condition or disease. It is important to note, however, that absolute safety is never guaranteed. The FDA merely determines that, overall, the benefits of a medical device outweigh its risks.
Johnson & Johnson (through a subsidiary company, DePuy Orthopaedics) is the manufacturer of two hip replacement products—the ASR Acetabular System and the ASR Hip Resurfacing System—that have been found to deteriorate and release metal flakes into patients’ bloodstreams. Recipients of the replacement hip devices have developed pseudotumors (which result from a reaction to the toxic metal debris), swelling, pain, and difficulty walking. Many orthopedic doctors believe that the products were flawed from the start.
Johnson & Johnson was given special clearance from the FDA in 2005 to market the ASR devices without first performing clinical trials—tests to determine the safety of the products. But since 2008, the FDA has received approximately 400 complaints from patients who received ASR hip replacements. In March 2010, J&J acknowledged that ASR products had a higher-than-normal failure rate after data revealed that approximately 12% of patients who received an ASR device needed “revision surgery.” In August 2010, DePuy issued a voluntary recall of both ASR devices, more than a year and a half after the first lawsuit was filed. Many experts agree that a recall should have been issued sooner, due to the high volume of complaints about the devices.
If you received an ASR replacement hip device, you might need to demand compensation from the manufacturer for injuries you’ve suffered. The Rottenstein Law Group will be your advocate. The knowledge, experience, and preparation of RLG’s lawyers will make seeking compensation for your pain as painless as possible. You’ve taken enough. We’ll take it from here.