The Cleveland Clinic has released its picks for the top medical devices for next year. The short list was chosen by a panel of Cleveland Clinic physicians and scientists who believe that due to the changing nature of healthcare, these “innovations” will significantly improve patient care all over the globe. Let’s face it: anything newly released in the medical field is a coin toss as to what the future holds for patients who resign themselves to testing the invention. The questions become, how serious will the repercussions be for any victim down the road who experiences an adverse reaction, and just what that reaction might be?
What 2020 will hold for us as far as defective drugs and devices go remains to be seen, but 2019 experienced a lot in that realm. There are reasons believed to be at the root of the increases in recalls. Competing for the generic drug market leads to poor, sometimes deadly manufacturing protocols because corners are cut to save a buck. Using the same FDA inspector for subsequent visits can result in slackened scrutiny of the manufacturing plant that would otherwise reveal early warning signs that a recall may be necessary. Managerial discretion is also affecting recalls when plant managers place the burden on doctors to recognize which devices are defective before using them.
The Cleveland Clinic’s list of creations that we can anticipate seeing next year includes:
- A dual-acting osteoporosis drug being released under the name “Evenity”
- Abbott MitraClip transcatheter mitral valve repair device
- Vyndaqel to reduce transthyretin amyloid cardiomyopathy related deaths
- A new peanut allergy therapy medication
- Closed-loop spinal cord stimulation to more effectively reduce pain and the need for opioids
- The use of biologics in orthopaedic repair to reduce recovery time
- Medtronic Tyrx Envelope, which is an antibiotic-embedded envelope to reduce infection in patients with implanted cardiac devices
- Bempedoic acid to lower cholesterol in statin-intolerant patients
- PARP inhibitors for ovarian cancer therapy that helps prevent cancer cells from repairing themselves
- Forxiga, typically used to treat type 2 diabetes is now cleared to treat diastolic heart failure
In taking a look at the risks associated with some of these new innovations, there’s already concern enough to keep these on your defective drug and medical device watch list:
- Evenity (Romosozumab-aqqg) for osteoporosis: This medication has the potential to cause myocardial infarction, stroke and cardiovascular death.
- Expanding use of mitral valve surgery: This valve operates to allow blood flow in the heart, but the valve is defective in 10% of patients over 75 years of age, causing regurgitation. The FDA has reconsidered the alternative in these patients potentially being death, and is allowing the Abbott MitraClip to be used in certain patients whose health has otherwise not improved.
- Vyndaqel / Vyndamax (Tamafidis): This drug was fast-tracked by the FDA for patients with transthyretin amyloid cardiomyopathy, a fairly underdiagnosed cardiovascular disorder that leads to death. According to Pfizer’s website, the drug has no known side effects, however it also mentions discussing liver problems and pregnancy or breastfeeding with your doctor prior to taking the medication.
- Medtronic Tyrx Envelope: This company received a warning letter from the FDA in 2016 about this very product. Whether or not the deficiencies were al corrected remains to be seen. However, Medtronic’s website states that potential complications in using this device include bleeding and infection… which the device is supposed to prevent.
- Forxiga (dapagliflozin): This drug, while seemingly promising, comes with a laundry list of known warnings, including a Fournier’s gangrene in the genital area, and acute kidney injury.
Maybe something about these devices and drugs will be different than anything that has come before them, but if history tells us anything, something on this list will likely be recalled for causing harm rather than healing. Keep an eye out to see whether these doctors chose well or just hoped that they had.
When doctors and medical professionals create new products, they have an obligation to their potential future patients and their families to ensure patient safety. With recalls increasing at a rapid rate annually, it appears to be the same old story – money over ethics.
If you or a loved one has been injured or killed due to a recalled medication or medical device, your damages may entitle you to receive compensation for a number of harms you have endured. To learn more about your legal rights and how to hold the manufacturer accountable for their negligence, speak with the trusted Alabama defective drug and medical device attorneys at Mezrano Law Firm. We take pride in serving the citizens of the State of Alabama with offices located in Birmingham, Mobile, Florence, Tuscaloosa, Gadsden, and Montgomery for your convenience. To schedule your free case evaluation, reach out to us through our contact page, or call 205-206-6300 today.