Just last month a Framingham, Mass., drug manufacturer, New England Compounding Center (NECC), unnecessarily infected more than 400 people across the nation because of a meningitis outbreak traced to a contaminated batch of steroids made by the lab. That outbreak has been linked to a reported 386 illnesses and 28 deaths according to the latest Centers for Disese Control and Prevention data.
The drug that was infected, Methylprednisolone, was under a shortage as two other generic drug makers discontinued production of the injectable drug in 2012. There also were two additional drugs containing significant bacterial contamination discovered at NECC; Betamethasone, a steroid and Cardioplegia Solution, an injectable drug commonly used during heart surgery.
This story, which made national headlines, came as a surprise to many in the general public. How could a sterile drug manufacturer allow this to happen? How could the U.S. Food and Drug Administration allow this to happen? The answer is staggering. According to an article in the New York Times published last month (“Lapses at Big Drug Factories Add to Shortages and Danger.” Oct. 17, 2012) over the last three years, six of the leading sterile injectable drug manufacturers have been warned by the FDA about serious violations of manufacturing rules. According to the article’s author, four of these drug companies closed operations at their factories, or at least slowed production to fix the issues. The article goes on to cite a congressional report which states that nearly a third of the industry’s manufacturing capacity is off line due to these same quality issues warned by the FDA.
These are major companies that produce drugs that are given to many patients in hospitals every day. These companies are violating FDA rules and regulations concerning the safety of the drugs they produce. Until the meningitis outbreak, sickness and death linked to the NECC production gaffe, many people never knew these kinds of violations ever occurred in drug production plants.
Just this month, yet another Massachusetts-based facility producing injectable steroids, Ameridose, was asked to temporarily cease operations by state and FDA officials due to tainted vials and issues with the sterility of production. The pharmacy was owned in part by the same owners of NECC. Ameridose has recalled all their products out in the market, and thus far no cases of infection have been linked to the facility. These shutdowns are now creating a new separate issue, shortages of these various sterile injectable drugs at hospitals across the nation.
What it comes down to is the supply and demand of the drug, profits and simply — money. As generic drug manufacturers stop production on a given drug, the need for that drug primarily never decreases. To compensate, drug makers are attempting to speed up their production times and numbers. Stopping to make corrections, and to sanitize or fix equipment, is becoming too much of a burden for these companies, thus costing them money. The more volume, the more vials of drugs they produce, the more profit the company earns.
What is happening are massive oversights, errors, and a reluctance to be concerned with what the FDA is telling these companies. That was until the contamination of drugs at NECC happened this year. Now drug manufacturers are faced with having to tighten up regulations and enforce maintenance, safety and sanitary conditions at their plants on an hourly basis. And some are now investing millions into proper safety training and facilities to remedy the problems. Their only other option — ignore these FDA warnings and create drugs which could be contaminated leading to the infection of potentially thousands before the drugs are taken off the market, and out of the hands of medical professionals. This leads to a giant PR and legal mess for these drug companies to handle.
This is a lesson which NECC is learning the hard way, after repeated warnings from the state of Massachusetts and FDA were not heeded. Patients who were infected by the tainted drugs are currently filing mass tort lawsuits against the drug company, and the numbers of those infected is only growing. Currently, there are 20 lawsuits filed against NECC from patients in 19 states; however no cases have been reported from patients in Connecticut.
Another recent trend related to medical malpractice which we should all be following is liability issues surrounding the labeling of generic drugs. In a recent article in the New England Journal of Medicine, “Risk, Responsibility, and Generic Drugs,” the subject of generic drug manufacturers and labels which indicate adequate warnings is discussed; this surrounded the 2011 U.S. Supreme Court review of the case Pliva v. Mensing. 131 S. CT. 2567 (2011).
In this case, patients filed suit against drug maker Pliva, for failure to properly warn physicians and their patients, on the drug bottle labels, regarding the risk of developing Tardive Dyskinesia (a slow forming disorder of involuntary, repeated movements of the body) caused by the long-term use of the drug, Metoclopramide.
The original ruling, which was a few years prior, stated that the brand-name drug manufacturer did indeed have the responsibility and duty to update their labels when new drug safety information was revealed, with or without the approval from the FDA. But the same standards were not to be held for generic drug makers who were producing and marketing essentially the same drugs. The Court declared that it was “impossible” to hold the generic drug makers liable for not updating their warnings on the drug labels which, in this case, resulted in the development of Tardive Dyskinesia in patients. After this ruling, a number of similar pending cases were dismissed.
In the U.S. today, 75 percent of all prescriptions are generic drugs. And the responsibility for alerting patients of drug safety information and warnings falls not on the manufacturers but rather defaults to the pharmacists who are filling the prescriptions. After the brand-name drug manufacturer discontinues making the drug, the generic drug maker of the same drug has no responsibility to update any warnings on their labels — potentially causing patient harm.
Whether or not drug makers in both these situations can improve their production quality and boost patient safety precautions is yet to be seen. But what can be said is through vigilant work by the FDA, lawmakers at both the state and federal levels, and law firms everywhere, these companies can be brought to justice and patients can be assured their safety when receiving an injection, or using prescribed medications at home. •