Positive: Professionalism , Responsiveness , Value
Mary Sinanan
3 years ago
The United States medical device industry has seen a sharp increase in the number of recalls in the first quarter of 2018. Patients and doctors rely on the safety and efficacy of medical devices that are implanted into patients across the country for various health problems on a daily basis. When medical devices fail to […]
The United States medical device industry has seen a sharp increase in the number of recalls in the first quarter of 2018. Patients and doctors rely on the safety and efficacy of medical devices that are implanted into patients across the country for various health problems on a daily basis. When medical devices fail to do their job or are defective in any way, there is a risk that patients may suffer injuries, some of which can be fatal.
The purpose of a medical device recall is to take a product off the market to (1) inform medical providers and patients that a product is not safe, and (2) to allow medical device manufacturers to address the safety or efficacy concern associated with the product. Upon recall of a medical device, manufacturers must determine what steps need to be taken to cure the defect so that patients and medical professionals can trust that the products they are using are safe.
During the first quarter of 2018, there was a 126% increase in the number of medical device recalls, the most the industry has seen since 2005. Nearly 94% of recalled units resulted from a manufacturing defect, which was primarily related to one particular defective product. Approximately 22% of medical device recalls related to software errors. With advances in technology, there is a risk that new and novel devices may fail, making a product less safe and effective. Even one seemingly minor software error can have negative consequences.
The increase in medical device recalls in the first quarter of 2018 was more substantial than all medical device recalls for the entire year of 2017, demonstrating that perhaps companies are moving too quickly to get products on the market, failing to ensure their products are functioning as intended. Additionally, many medical devices do not undergo extensive testing on humans but instead, are cleared by the Food and Drug Administration (FDA). If a medical device company demonstrates that a product is as safe and as effective as a medical device already on the market, the FDA has the discretion to “clear the product,” which is not the same as “approving” a product. As such, it is the medical device company’s responsibility to establish safety and efficacy.
Not only have medical device recalls increased significantly in the first part of 2018, but pharmaceutical recalls (such as medications) have also seen a noticeable increase from prior years. Pharmaceutical recalls increased by 52% in the first quarter of 2018, the greatest the industry has seen since the third quarter of 2013. Almost 95% of pharmaceutical recalls pertained to one massive recall where manufacturers deviated from what are called “Current Good Manufacturing Practices (CGMP).” The key reason for pharmaceutical recalls this year has been failed specifications which have continued to be a significant problem for seven consecutive quarters. This year, failed specifications made up 22% of all pharmaceutical recalls.
Unlike medical devices, most pharmaceuticals must undergo testing on humans to ensure the benefit outweighs the risk for most patients who will be taking a particular medication. For example, a new drug to treat Alzheimer’s cannot go to market unless thorough testing has identified all potential risks and how severe each risk is. If studies and testing suggest that a new medication has the potential to cause more harm than good, then the FDA is not as likely to approve the product.
Medical device and pharmaceutical companies can recall a product on their own if they recognize there are safety or efficacy concerns related to a particular product. However, in many cases, the FDA will take action to recall a product based on adverse event reports it has collected for a specific medical device or pharmaceutical product. When medical devices and pharmaceuticals are recalled, there is an indication that a product either does not work as intended or is potentially harmful to patients. Medical device and pharmaceutical companies have an opportunity to identify defects and take the appropriate measures to ensure such defects do not continue to affect patients negatively.
The consequences of defective medical devices and pharmaceutical products can be catastrophic and sometimes deadly for patients. Examples of products (some of which are still on the market) that have caused devastating injuries and deaths to patients include, among others, the following:
Because some devices that have proven to be defective in some way are still on the market, patients and medical providers should be aware of the risks of using a particular medical device or pharmaceutical drug. Filing a lawsuit alleging product liability is one way for injured patients to hold medical device and pharmaceutical companies accountable. Past product liability litigations have demonstrated that many companies are aware of the dangers associated with their products, but they choose to sell them anyway. Even with the cost of litigation, medical device and pharmaceutical companies are still making enough money to justify leaving the defective products on the market.
The FDA periodically issues safety notifications to patients and medical providers to ensure accurate information about the safety of a medical device or pharmaceutical product are communicated to the healthcare industry. As such, it is essential for both medical professionals and patients to be aware of current safety and efficacy information concerning medical devices and pharmaceutical products. Patients deserve to know if a medical device or pharmaceutical product is linked to injuries or death. When medical device and pharmaceutical companies hide information from the medical community that suggests a product is unsafe, including the FDA, medical providers, and most importantly, patients, unsuspecting individuals are at risk for suffering injuries or death.
There are a variety of ways in which medical device and pharmaceutical companies can be held liable for selling defective and unsafe products. Such defects include, but may not be limited to, the following:
Medical device and pharmaceutical companies can be held “strictly liable” if an injured person can prove a product was defective. Strict liability means that a medical device or pharmaceutical company does not need to be found negligent (i.e., fall below the standard of care) to be found liable. However, because the legal process regarding product liability can be complicated, it is best to work alongside an attorney to discuss potential product liability claims regarding defective medical devices and pharmaceutical products.
If you believe a medical device or pharmaceutical product has caused you or a loved one to suffer injuries, it may be time to speak with an attorney to discuss your situation. Time is limited to file a claim, so it is essential to act quickly to seek legal advice. At Parker Waichman LLP, our nationally-recognized trial attorneys have extensive experience handling complex defective medical device and pharmaceutical product cases. To discuss your situation with a qualified Defective Medical Device and Product Liability Lawyer, contact Parker Waichman LLP today by calling (800) YOUR-LAWYER (968-7529) to schedule your free consultation.