The 10 Most Controversial Recalled Drugs and Medical Devices
We hold drug and medical device manufacturers to incredibly high standards, as we do doctors and enterprises that provide them. When drugs or devices fail to perform as intended or patients don’t receive adequate instructions about safely operating or consuming these items, the consequences can be devastating.
Fortunately, measures are in place to prevent these problems. For example, the Food and Drug Administration stringently monitors manufacturers and providers of medical devices and drugs, and it posts consumer information and alerts to keep users informed. These alerts include information about recalls and products that have proven problematic.
The FDA organizes its recalls three classes: I, II, and III. These are collected in a weekly Enforcement Report, which you can access if you’re concerned about a drug you’re taking or a device you’re using. However, some particularly destructive items get to the market before the FDA recalls them. The following list highlights 10 drugs and medical devices that caused extensive pain and suffering.
- Fen-Phen (fenfluramine/phentermine). This weight loss drug became commercially available in 1997. More than 6 million consumers were taking it at the peak of its popularity, but it also led to an unexpected and fatally dangerous condition. The FDA recalled the drug when consumers began presenting with pulmonary problems. The company was ultimately responsible for answering a class action suit filed by more than 50,000 people.
- Transvaginal Mesh. This net-like implant and medical device intended to support one’s organs and prevent prolapse but led to a greater risk of infection and urinary problems among its users.
- Actos. This drug also affected the urinary and circulatory systems. Specifically, Actos increased the likelihood of bladder cancer and heart disease; the FDA pulled it off the market immediately when it uncovered these side effects.
- Customed surgical convenience kits. Not all recalls exclusively affect health care patients; in this case, surgical convenience kits imported from a Puerto Rican manufacturer had a fatal packaging flaw. This was the largest single-day recall in FDA history, warranting a Class I classification.
- Bextra (valdecoxib). The FDA recalled this anti-inflammatory drug after one year on the market. Bextra was for treatment of arthritis and other chronic pains; consumers suffered an increased risk of heart and brain complications such as strokes.
- HeartWare blood pumps. HeartWare had some problems with its blood pumps in 2015. The connection pins in the power connector ports could become twisted or bent, creating a potentially fatal problem. The manufacturer issued more than five Class I recalls for its medical devices that year.
- Diethylstilbestrol (DES). This drug, originally manufactured in 1938, was to prevent pregnancy-related problems. Unfortunately, the drug failed to deliver these benefits and was linked to a rare type of cancer. It was on the market until 1971.
- Phillips’ CT scanners. This manufacturer struggled to meet quality standards. In this case, a software problem was found that could have harmed patients. No one was hurt, but more than 400 units were recalled.
- Zofran. This drug was pulled from the market for causing birth defects. Specifically, mothers who took the medication for morning sickness where at a high risk of giving birth to children with heart defects.
- Tiger Paw. Commonly used in heart surgeries, this medical device failed to close completely. It tore patients’ hearts and could cause bleeding during operations.
Many of these cases end up in court as a class action lawsuit. If you are consuming or using a product that has been recalled, it is important to stop and speak with your doctor as soon as possible. You and your attorney may also work together to file a claim.