A recent study by Kaiser Health News reveals a startling truth: despite inspection by the FDA, tainted drugs are making their way into patients’ prescription bottles and IV drips. The very medicine that patients are given to make them well is actually becoming a source of illness. This played out with devastating results in 12 states where tainted stool softener caused serious bacterial infections in 63 patients.
According to Kaiser, who studied inspection records, letters of warning, recall data, and lawsuits filed regarding tainted drugs, a stool softener known as docusate sodium was the source of a 2016 outbreak of Burkholderia cepacian (B. cepacia) infection. This drug is sold over the counter and is routinely prescribed to patients in hospitals to treat or guard against constipation. In one case, a 1-year-old child awaiting a heart transplant developed a serious respiratory condition that caused life-threatening complications when it combined with a flu-like illness and entered the child’s lungs. The child was ultimately placed on a ventilator to help him breathe. After a six-month-long investigation, it was found that the stool softener was the culprit, harboring B. cepacian and being passed on to unsuspecting patients. Investigators tracked the contaminated stool softener back to a manufacturing plant in Florida.
The big takeaway with the stool softener cases is that the drugs in question had passed the FDA’s inspection and deemed safe for sale. The FDA is the government entity tasked with inspecting all factories that produce medicine for the U.S. market, including factories in the United States and overseas. Despite the job the FDA is asked to do, some 8,000 medicines have entered the drug supply in the U.S. since 2013 that was later recalled by pharmaceutical companies because they were tainted with everything from mold to particles of glass and (as in the case with the stool softener) dangerous bacteria.
Among the recalls, Kaiser found 12,000 boxes of off-brand Aleve that were actually filled with ibuprofen and superpotent doses of the drug Abilify. It also found that 39,000 bottles of an HIV drug called Atripla were recalled when they were found to contain red silicone rubber particulates. These shocking findings shed light on the larger problem: the FDA’s inspection practices are not completely trustworthy.
Consultants in the pharmaceutical industry note that inspectors don’t always find the problems that exist with drugs in factories they inspect because they are “working with confusing regulatory terms and standards that are often decades out of date.” If all of this makes patients feel wary of the medicines they take, it should. Greater regulation and more up-to-date and stringent testing are needed.
If you have experienced a serious side effect of a drug or received a tainted drug that caused you harm, you have a right to hold the responsible party accountable. Contact our California product liability lawyer right away as soon as you discover your drug-related injury. We can help you collect damages that are due to you under the law.