The Quincy Patriot-Ledger recently reported that the Food and Drug Administration issued a second warning to Braintree Laboratories about its manufacturing processes. Consumers had submitted 21 complaints to the FDA reporting that they found spiders, insects and insect parts in medications made by the company. Those products include multiple prescription gastrointestinal drugs. As a defective medication lawyer, I wonder what other aspects of the manufacturing process are laxer than they should be. The presence of insect and spider parts in Braintree’s medications suggests that the company has not been as conscientious as their moral and legal responsibility requires them to be.
Five different products, all manufactured at the company’s Holbrook, Mass., facility, were cited in the consumer complaints. The FDA had investigated the company in December and January and found significant violations of Current Good Manufacturing Practice regulations. Braintree Laboratories said that it would increase its monitoring of pest control, analyze consumer complaints more carefully, and determine the origin of the insects and spiders that consumers found. But the FDAsaid the company still couldn’t say whether “facility or raw material quality problems were at the root of these complaints.” The FDA is asking the company to submit its plan to find out where the contamination originated and to carefully monitor its raw materials and packaging suppliers. Braintree has 15 working days to either explain to the FDA how it is working to correct the violations or to ask for an extension. If it doesn’t respond, the FDA could seize its products, issue injunctions or withhold future product approval requests.
From my experience as a pharmaceutical liability attorney, I can say that this isn’t the first time and it won’t be the last time that FDA has had to prod a drug manufacturer to resolve quality issues that affect consumers. Within the last two months, I’ve written about three other companies whose manufacturing practices have been under FDA’s scrutiny, including McNeil Pharmaceuticals, Teva Pharmaceuticals and KV Pharmaceutical. It’s disturbing that adhering to FDA manufacturing standards seems to be so difficult for some pharmaceutical companies. I worry that the companies’ apparently nonchalant attitude toward product contamination could be a sign that they are equally disinterested in their responsibility to warn consumers of potential negative effects of their products. Drug manufacturers have a legal responsibility to warn consumers and the FDA of any ill effects that could befall someone who uses their products — e.g., severe side effects from the medication itself, or harm caused by contamination of the medication. When companies wait for the FDA to crack down on them before they clean up their manufacturing processes, they may not be meeting their responsibility to warn the public about the potential harm that their contaminated products could cause. That harm can be serious, up to and including a risk of death in some of the defective medications mentioned above.
The FDA isn’t the only one that can hold manufacturers of dangerous or contaminated drugs responsible for their failures. Consumers who have been harmed by dangerous or contaminated drugs can sue drug companies that failed to warn them about the dangers of their products. Resolving medical issues caused by defective drugs is frequently very expensive, even with health insurance, since it requires the expertise and resources of doctors and hospitals. Patients often have to miss work for medical appointments and because they aren’t feeling well, costing them even more money. And they may also miss out on important events and milestones with family and friends if they are seriously ill because of a defective or contaminated medication. People who have been hurt in these ways can get help from a defective drug lawyer to sue the drug companies that caused the harm, to recover all these costs as well as compensation for pain and suffering and lost quality of life.
If you have been harmed by a contaminated or defective medication, please call Carey, Danis & Lowe for a free consultation. You can reach us toll-free at 1-877-678-3400 or through our Web site.