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Artificial Hip Manufacturer Gets Second FDA Warning Letter for Sterilization Problems

As a defective medical device attorney, I was interested to see news reports about a second FDA warning for a company that makes artificial joints. As Reuters reported Dec. 29, Smith & Nephew, a British medical device company, received an FDA warning letter Dec. 21 saying the FDA was not satisfied with the company’s quality control. Smith & Nephew’s regulatory problems date from the summer of 2010, when the FDA inspected a plant in Germany and found problems with the way artificial hips were being sterilized. The new warning letter says the FDA feels the steps Smith & Nephew has taken are inadequate. The warning is not expected to make the artificial hips unavailable, as Smith & Nephew also has plants in Tennessee and Britain.
The problem is specifically with the manufacturing of the company’s R3 Ceramic Acetabular Systems, artificial joints used in hip replacement surgery. The FDA inspected the German plant in mid-July of 2010 and found that sanitizing procedures were not up to the legal standards required of all medical device manufacturers. For example, the FDA said Smith & Nephew’s irradiation procedures didn’t meet the specified minimum dose of radiation, which is intended to prevent infection. Despite this, the company also allegedly used those inadequately irradiated products. Smith & Nephew said it addressed those and other issues raised by the FDA, but in the Dec. 21 letter, the agency said those measures were not adequate. The company must contact the FDA within 15 days to explain what steps it is taking to solve the problems.
This back-and-forth between the FDA and the company looks familiar to me, as a dangerous medical device lawyer, because something very similar happened with the McNeil/Johnson & Johnson recall of many over-the-counter medicines. Unlike that case, however, this one involves medical devices that patients receive surgically rather than buying at a drugstore. That limits our ability to protect ourselves from potential health effects by throwing out or returning tainted products. And patients receiving artificial hips must rely on doctors to make sure the products they’re surgically implanting are safe and free of infection. An infection is particularly serious after an artificial joint replacement because the body can only fight off infection of its own tissues — not of the artificial materials in the false joint. As a result, the artificial hip would most likely need to be removed in the event of infection, a painful and expensive prospect.

Based in St. Louis, Carey, Danis & Lowe represents people around the United States who suffered serious injuries or illnesses after using a medical device they thought they could trust. Under federal and state law, medical devices must be safe to use as directed, and manufacturers must warn patients about any safety risks. If they don’t take those steps, and patients are harmed as a result, those patients can sue over all of their injuries and suffering. Our medical device liability attorneys help patients do that, either as individuals or as part of a class action that brings together many patients with similar complaints. In a legal claim, patients can recover all of the money the defective device has cost them, including past and future medical treatment costs, lost wages from missing work and more. Just as importantly, they can claim damages for the lost quality of life the injuries caused, or the loss of a loved one taken too soon.
If you or someone in your family fell ill or suffered an injury because of a defective medical device, you should call Carey, Danis & Lowe to learn more about how we can help. To set up a free consultation, call us anytime at 1-877-678-3400 or send us a message through the Internet.