The Food and Drug Administration has issued a number of medical device recalls in 2018 that, as we embark into 2019, may result in substantial litigation. Like many newly issued recalls, the potential for litigation exponentially increases dependent upon the affected population and the severity of the safety risk. While the damages caused by these recalls are not yet fully realized, they are certainly cause for concern going forward into the New Year. Below are a few medical device recalls worth keeping an eye on in 2019:
Zimmer Biomet Long Bone Growth and Spinal Fusion Stimulators
Zimmer Biomet, Inc. has recalled three of its products due to inadequate cleanliness – the EBI Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Spinal Fusion Stimulator, and the SpF-XL llb 2/DM Implantable Spinal Fusion Stimulator. Utilized to heal broken long bones or to help bones fuse after a spinal surgery, these devices lack adequate validation and controls to ensure they are clean and free from bacteria and chemical residue. According to the FDA, the recalled devices may cause infection, tissue death, impaired wound and bone healing, epidural abscess, secondary gastroenteritis, paralysis, organ damage, or death. They may require additional wound surgery or long-term antibiotic therapy. The FDA has issued a Class I recall, the most serious category of recalls, indicating that the devices may cause serious injuries or death. Approximately 1,360 units have been recalled in the United States since Zimmer Biomet, Inc. issued an Urgent Medical Device Recall Notification letter on February 19, 2018.
While no major class action lawsuits have been filed just yet, these recalls are the result of a lengthy history of problems within the company. The FDA issued a warning letter to Zimmer Biomet over quality violations found during inspections in 2016 and 2018, which may have led to the CEO’s resignation.
Roche Diagnostics CoaguChek XS PT Test Strips
Another one on the list of Class I medical device recalls is Roche Diagnostics CoaguChek XS PT Test Strips, a test strip used in conjunction with Roche INC Test Meters to monitor a patient’s response to warfarin, a type of blood thinner. After Roche recalibrated the test strips in January 2018 to correspond to a new standard, the company began receiving reports from patients experiencing abnormal test results. Over 1.1 million packages of test strips have been recalled. The FDA is warning patients and physicians that the strips should not be used to adjust blood thinner dosages, as the inaccuracies could cause serious injuries or death. Patients suffering from atrial fibrillation or recent thromboembolic events, and those with a mechanical heart valve, are particularly susceptible to serious injury from inaccurate INR readings.
Ventana Medical Systems Detection Kits
Ventana Medical Systems has recalled a number of detection kits used to indicate the presence of disease or other biomarkers in patients. Some detection kits have failed to accurately indicate biomarkers, which are used in the diagnosis of certain illnesses, resulting in false negatives for serious health conditions, including cancer. The false negatives appear to be caused by an issue with the staining chemicals, referred to as reagents, used during the immunohistochemistry (IHC) lab tests. The kit’s dispensers release reagents that change color depending upon certain biomarkers. However, the leaking and sticking of reagent dispensers could cause a test result to incorrectly indicate the absence of a biomarker.
Because a false negative may result in a serious illness going untreated, the use of these detection kits pose a serious health risk. As of now, no deaths or serious health issues have been reported. Approximately 38,000 kits have been recalled. The FDA has directed patients and physicians to discontinue the use of all affected detection kits and to perform re-testing if necessary.
BioMerieux VITEK 2 Gram Positive AST Cards
Similar to the Ventana Medical Systems detection kit recalls, BioMerieux has recalled its products used to detect bacteria and yeast. The VITEK 2 Gram Positive AST cards and the VITEK 2 Gram Positive Cefoxitin Screen use antibiotics, cefoxitin and oxacillin, to screen for methicillin resistant Staphylococcus aureus (MRSA), a bacteria that can cause skin infections, sepsis, pneumonia, and infections of the bloodstream. The tests are being recalled due to the possibility of false negatives when detecting certain strains of MRSA. As of now, the cause of the inaccurate results is unknown, and continued investigations will determine the root cause.
Because MRSA is a common cause of infections, it is important to accurately and immediately diagnose the prevalence of the bacteria in a patient. Lack of treatment of a MRSA infection can cause serious health issues, and even death. Categorized as a Class I recall, there have been over 13 million BioMerieux products recalled in the United States.
Compass Health Cushion Seals for Probasics Zzz-Mask SG Full Face CPAP Mask
The Probasics Brand Zzz-Mask SG Full Face CPAP Mask is used for the treatment of obstructive sleep apnea. Continuous Positive Airway Pressure (CPAP) is a treatment that uses a machine to pump air into the airway of the lungs to keep the windpipe open while the patient is sleeping. The pumped air prevents airway collapse. The air is delivered through a mask, which is worn over the nose and mouth. The mask also has a cushion to provide a seal between the face and the mask.
Compass Health has recalled the replacement cushion seals for these masks because they are incompatible and may result in an air leak that can interrupt the airflow to the patient. Although no complaints or injuries have been reported, an improperly fitted cushion seal can pose serious health risks and impede the treatment of sleep apnea. The inability to effectively receive air through these masks may also result in pneumonia, high blood pressure, heart attack, or death. Since the recall was initiated in May 2018, approximately 742 cushion seals have been recalled.
As these recalls are relatively recent, there are a number of unanswered questions concerning the extent of the damage caused. However, in light of the prevalence of these products, it is imperative for affected patients, physicians, and potential litigants to stay apprised on any developments in 2019.