The purpose of medical devices and medications is to help make people healthy. Unfortunately, the very products that are supposed to help us end up causing serious injury or illness. Sometimes, a dangerous medical product can even cause the death of the patient it was supposed to help.
The high number of recalls issued last year by the Food and Drug Administration (FDA) demonstrates just how lax the approval and regulatory process is in this country. The dangerous and defective medical products the FDA issued recalls and warnings on are all products the agency itself approved, to begin with.
- Most Pediatric Medical Devices Never Tested on Children Prior to FDA Approval
- Concerns about the Use of Medical Devices
- Power Morcellators and Cancer – The Shocking Connection
Issues involving dangerous drugs and medical devices we have written about in 2018 include:
- Deputy Hip Replacement
- IVC Filter Injuries
- Stryker Hip Defects
- Testosterone Replacement Therapy
- Transvaginal Mesh Defects
- Zimmer Knee Defects
There were more than 80 recalls issued for dangerous drugs that were already on the market and available to patients. These include both prescription and over-the-counter medication. Numerous reasons were cited for the recalls including:
- Adverse reactions by patients
- Drug contamination
- Impurities in the medication
- Incorrect dosing information
- Incorrect instructions
- Incorrect labeling
- Labeling mix-ups
- Non-sterile production
- Presence of glass particles
- Visible particulate matter
While some of these drugs made headlines alerting consumers of the recalls – such as the blood-pressure medication Valsartan, which was found to contain a known carcinogen – the majority of these recalls were issued without any media attention.
Just as in drug recalls, none of the medical device recalls last year garnered national headlines alerting consumers of potential dangers. There were more than 30 defective devices recalled, including:
- Balloon pumps
- Blood testing tubes
- Ventricular assist systems
One of the most alarming factors in the country’s issue with the number of medical recalls is that the FDA is charged with both the approval of these products and the recalls. This results in the FDA often dragging their feet in issuing recalls and alerting the public for drugs and products they have already approved. There is far too much reliance on a manufacturer’s clinical testing results that the FDA uses in the approval process, which actually compromises the process and puts us all in danger.
Contact Shapiro & Appleton for Legal Assistance
If you have concerns about an injury or potential injury from a medical device, contact a Virginia defective medical device attorney to discuss what legal options you may have for the pain and losses you have suffered from the injuries the medical device has caused you. You may be entitled to medical expenses for treatment of your injuries or illness, lost wages, pain and suffering, and emotional anguish. If the defective device or medication has left you with permanent disabilities, you may also be entitled to financial compensation for the losses associated with the changes in your quality of life. Contact our office today.
After graduating cum laude from law school at the University of Richmond, Seth practiced personal injury law out of Roanoke, Virginia and in Hampton, Virginia before joining Shapiro & Appleton where he represents personal injury clients in both state and federal courts. In 2016, he was named as a Virginia “Rising Star” lawyer by Super Lawyer’s magazine, an honor bestowed upon only 2.5% of attorneys in the state.