Defective Medical Devices
The US Food and Drug Administration, otherwise known as the FDA, is responsible for ensuring drugs and medical devices are safe for the American public to use. Unfortunately, from time to time, the FDA does not fulfill its obligations and people get hurt.
In fact, every year over 200,000 people die from drugs approved by the FDA. As you might expect, litigation against the pharmaceutical giants that manufacture these drugs and devices can be intimidating, complicated and very expensive.
Dangerous Medical Devices
As a patient or consumer, you should be able to trust the medical devices your doctors and other medical staff are using or implanting into your body. However, these devices are not always safe and could cause you or your loved one permanent or fatal injuries.
The FDA is in charge of monitoring all medical devices and drugs available for consumer use. In most cases, a company, including manufacturers and/or distributors, will usually recall their medical devices on their own or voluntarily. However, if a medical device is associated with significant health problems or death, the FDA may require a company to recall a device immediately.
When a company recalls a medical device, it:
- Contacts the customers who received the product from them, and takes steps to reach others who need to be notified usually by press release;
- Supplies information to help users identify the product and take steps to minimize health consequences;
- Takes action to prevent the problem from happening again;
Three Recall Classifications
The FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, Class II, and Class III. This classification process usually takes place after the company has issued its recall.
Class I High Risk
Product may cause serious health problems or death.
Class II Less-Serious Risk
Product may cause temporary or reversible health problems.
Class III Low Risk
There is little chance that the product will cause health problems. The FDA nor the company is required to issue a press release.
Defective Medical Devices Could Include:
- Pacemaker Recalls
- Medtronic Recalls
- Defibrillator Recalls
- IDC Recalls
- Shoulder Pain Pumps
- Transvaginal Mesh
- Surgical Implants
Let Our Firm Represent Your Interest
Brooks Harrison—Attorneys At Law, PLLC is a Texas law firm serving clients in Houston, Pasadena, Deer Park, Galveston, Baytown, Kingwood, Conroe, Woodlands, Crosby, Friendswood, Clear Lake, Katy, Sugar Land, La Porte, Galena Park, the entire Houston metropolitan area, the entire State of Texas, and in all of these United States.
Brooks Harrison—Attorneys At Law, PLLC is a lawyer licensed to practice in every court in the State Of Texas. Please contact us today to schedule a free initial consultation at (877) 402-6658 or email to discuss your legal rights.