New Report Addresses Increase in Medical Product and Drug Recalls
Over the last several years, consumers have learned about dangerous medical devices and dangerous drugs that have been recalled due to defects, including gout drugs like Uloric, testosterone therapy drugs, blood pressure regulating drugs like Valsartan, and many others. According to a recent article in The Conversation, “ severe, life-threatening pharmaceutical drug and medical device recalls have increased steadily over the last decade.” In other words, while the total rate of recalls may have increased, what is especially concerning is that the number of defective products and drugs that pose risks of debilitating or fatal injuries have risen markedly.
Although the news of a medical device recall can be scary, some drugs and medical products are recalled because of a labeling error, or another minor problem that is unlikely to cause serious harm to the patient. In more recent cases, however, medical product recalls have been tied to particularly hazardous products. This includes some of the most recent recalls issued in 2019 as listed by the FDA’s adverse-event warning campaign, MedWatch. For example, in February 2019, the FDA issued a recall for breast implants that were associated with an increased risk of Anaplastic Large Cell Lymphoma, among many other defective or mislabeled implants and medical devices like pacemakers and anesthesia sets.
Why are the rates of defective medical devices and drugs on the rise? According to the article published in The Conversation, a study coming out of the University of Minnesota and the University of Notre Dame suggests that “intense generic drug competition” plays a role in dangerous products ending up on the market and causing harm to consumers. That study showed how “generic drug competition causes firms to cut corners in their manufacturing quality control practices in an effort to remain profitable, leading to an increase in life-threatening drug defects requiring a recall.”
The article also cites a number of other supporting reasons to account for a rise in medical product and drug recalls, and emphasizes that improving FDA inspection methods could help to reduce the dangers in medical products before they end up on the market. Still, medical device and pharmaceutical drug recalls remain a growing problem, rising from 2,303 recalls in the fiscal year of 2013 to 3,202 in 2017, according to the Regulatory Affairs Professional Society (RAPS). The following link offers a list of defective medical products recalled in 2019.
Learning More About Medical Device Recalls
The U.S. Food and Drug Administration (FDA) is responsible for handling defective products and recalls tied to medical devices and drugs. The FDA explains that, when there is a defect or another type of problem with a medical device, one of two actions typically gets proposed:
- Correction, which allows the company to correct the problem while the medical device remains on the market; or
- Removal, which requires the defective medical product or device to be returned to the manufacturer so it can correct the problem, or requires the manufacturer to remove the product from the market completely to protect consumers from future medical harm.
When the FDA calls for correction in a medical product recall, this may take place by repair of the product’s firmware or software, further inspection, or by adding warning labels of potential medical danger to patients, says RAPS. The FDA clarifies that “recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.”
There are three different classes of medical device recalls that vary in severity:
- Class I recall: Device poses a reasonable chance of serious health problems or death;
- Class II recall: Device poses a risk of a temporary or reversible health problems, or a slight risk of a serious health problem or death.
- Class III recall: Device is unlikely to cause a health problem or injury.
Trends in Medical Device and Pharmaceutical Product Recalls
Class II medical product recalls have been leading the trend in the increase of medical device and drug product recalls since 2013, according to RAPS. “2017 was also notable in that it marked the first time a medical device was recalled in the US due to a cybersecurity concern. In August 2017, Abbott announced it was voluntarily recalling 465,000 pacemakers to install a firmware patch to address cybersecurity vulnerabilities identified in six of its pacemakers and implantable cardioverter defibrillators (ICDs),” says RAPS.
If you have questions about medical product recalls, or if you or a loved one experienced debilitating or dangerous side effects from a dangerous drug or medical product, you should speak with a product liability lawyer about your case.