Companies that manufacture and market prescription medication are under the same duty that all manufacturers are under to make sure that their product is safe. Of course, some medications, especially prescription medications, present the risk of serious adverse side effects, even when the drug is taken according to a physician’s instructions. Thus, a manufacturer must clear about the potential side effects that a medication could cause when marketing the drug. A failure to clearly warn patients about a known risk may result in the drug manufacturer being liable in a Maryland product liability case.
While a drug manufacturer may be able to avoid liability by warning of a drug’s dangerous side effects, there is no excuse for medication that is contaminated during the manufacturing process. Late last month, the U.S. Food and Drug Administration (FDA) announced the latest in a series of recalls affecting blood-pressure medication. According to the FDA, two lots of Losartan potassium tablets contain an ingredient that was discovered to contain an unexpected impurity called N-nitrosodiethylamine (NDEA). The FDA notes that NDEA “is a substance that occurs naturally in certain foods, drinking water, air pollution” however, it is also a known carcinogenic in animals and a suspected carcinogenic in humans according to its classification by the International Agency for Research on Cancer.
Losartan potassium tablets are used to treat hypertension (high blood pressure) as well as neuropathy (nerve pain) in patients who have Type II diabetes. The FDA recommends that patients who are currently taking Losartan continue to take the medication, as the risks involved with suddenly stopping the drug without an alternative treatment are high. The FDA advised patients taking Losartan to contact their pharmacist or physician to discuss alternatives to Losartan, at least until the manufacturing problem has been resolved.