Regulating the safety of medical devices and drugs falls under the purview of the Food and Drug Administration (FDA). The FDA’s mandate is to guarantee that products are safe for the public and are identified with the proper labels. The 1906 Pure Food and Drug Act instituted the group as in charge of oversight, meaning that they have been in charge of this process for over 100 years – yet, mistakes which have resulted in FDA recalls have occurred, including some major blunders in recent history.
Drug Product Liability: When a drug causes harm or injury, the drug manufacturer may see product liability suits filed against them. Pharmaceutical drug liability is a type of product liability claim which occurs when a drug manufacturer is held liable for providing a defective product to the end user consumer. People within the supply chain (such as the packaging company or the physician) may also be found liable under product liability laws.
Infamous Drug Recalls
Every year, hundreds of drugs are recalled for minor issues, such as impurities or packaging issues. However, occasionally a drug recall occurs as a result of severe injuries and deaths of the patients taking them. Here are some of the more infamous drug recalls in the FDA’s history:
1. Zelnorm was approved for use in 2004. It was marketed by Novartis to treat irritable bowel syndrome (IBS), but was recalled in 2007 when studies indicated that the drug was causing heart problems in some patients. Zelnorm is still available select patients, most notably those who had success with the drug before the FDA recall.
2. Valsartan and Losartin, popular blood pressure medications, were recalled in 2019 after findings showed the were manufactured with possible cancer-causing impurities. There have been so many products containing valsartan and losartan recalled that the FDA developed an information portal to provide information specifically for these drugs.
3. Palladone was formulated and marketed as a narcotic painkiller. The slow-release capsule was shown to cause depression and shortness of breath when mixed with alcohol. (In serious cases, coma occurred.) The drug was pulled from the market in 2005.
4. Rofecoxib was marketed b Merck & Company as a nonsteroidal anti-inflammatory drug to treat osteoarthritis and severe pain conditions. The drug originally gained clearance from the FDA in 1999 but was recalled 5 years later after it was discovered that long-term effects were possible, such as heart attack and stroke. In fact, Rofecoxib (also known as Vloxx, Ceoxx and Ceeoxx) was blamed for up to 140,000 documented cases. It was disclosed in trial that the manufacturer was aware of the dangers before releasing the drug, resulting in massive legal liability.
5. Permax, manufactured by Valeant Pharmaceuticals, was withdrawn from the market voluntarily in 2007. Although approved to treat Parkinson’s disease, it was quickly associated with an increased risk of blood backflow to the aortic valves.
6. NeutroSpec was marketed as a diagnostic imaging agent, helpful in diagnosing appendicitis. The FDA issued a public health advisory in 2005 and the drug was removed from circulation. Patients using the drug were found to experience shortness of breath, drops in blood pressure leading to death, and other serious complications. These complications were occurring within minutes of ingestion, although the FDA had found no significant risks when it approved the drug in 2004.
7. Bextra was a NSAID painkiller developed by Pfizer, but the drug was discovered to increase the risk of serious cardiovascular problems ,as well as severe skin reactions. With safer alternatives on the NSAID market available, the FDA asked the manufacturer to voluntarily pull the drug.
8. Tysabri was introduced by Biogen-Idec as a treatment for multiple sclerosis, but it was withdrawn in 2005 when three patients in a clinical study developed serious brain infections. The drug was reintroduced a year later accompanied with stringent usage guidelines.
9. Baycol, marketed by Bayer as a cholesterol-lowering drug, was introduced in 1997. However, it was removed from the market in 2001 after it was discovered that the medication caused a condition which resulted in skeletal muscle to break down. The drug was eventually tied to 31 deaths.
10. Meridia, approved in 1997 as a weight-loss drug, was discovered to increase stroke, heart attack, cardiac arrest or death by up to 16 percent. It was recalled in 2010.
New drugs are approved every day, and unfortunately, many are recalled every year. If you or a loved one suspect that a prescribed drug is causing you harm, discuss your symptoms immediately with your physician. If you feel that a product liability case may be applicable, call Probinsky & Cole. No one deserves to be harmed by the very medications meant to help you.
