Another Johnson & Johnson drug manufacturing plant operated by McNeil has received notice of problems with its manufacturing practices from the FDA. The Lancaster, Pennsylvania plant makes the heartburn and gas relief drugs Pepcid, Imodium and Mylanta. These problems, similar to those found in the company’s now closed plant that made Tylenol, come after waves of recalls for defective medications and a congressional investigation into whether the company attempted to hide information from the FDA. As a defective medication lawyer, I believe this news underscores questions about how much consumers should trust medications produced by Johnson & Johnson and its McNeil division. These repeated problems could prompt concerns about any of the company’s many over-the-counter medications.
In July, the FDA issued a Form 483 to Johnson & Johnson about the Lancaster plant. A Form 483 notifies a company that the FDA has found lapses in its manufacturing practices. Of the 12 violations of good manufacturing practices that the FDA found in Lancaster — including faulty lab work, lax hygiene and recordkeeping, and failure to follow up on consumer complaints — five overlapped with those cited at the Tylenol plant in nearby Fort Washington, Pennsylvania. The medications from the Lancaster plant were the subject of several kinds of complaints from consumers, including “mint-flavored Pepcid tablets mixed inside the same bottle as berry-flavored tablets” and “lack of effect” in one lot of products. In addition, the FDA report cited “unlabeled test tubes filled with product sitting out on a counter” and failure to “properly clean utensils used in the drug making process,” suggesting that medications could become contaminated with foreign substances or with other medications. Staff at the manufacturing plant did not follow up to investigate and correct any of these problems, the FDA report said.
Since they did not follow up on the problems, staff at the plant would have been unable to find out whether there were serious safety concerns that consumers needed to know about. In my view as adangerous medication attorney, this is troubling from a consumer safety standpoint as well as legally, since drug manufacturers are responsible for warning consumers about any safety concerns related to their products. Consumers should continue to be wary of medications produced by Johnson & Johnson. If only one plant had these problems, we might be able to dismiss them as isolated to bad management at one site, but the problem appears to be much more widespread. Even though the medications manufactured at the Lancaster plant have not been recalled, a recall may still be coming. After all, the recalls involving the Fort Washington plant’s medications were delayed in similar ways and have only gotten bigger as time has gone on.
These issues raise the question of what Johnson & Johnson has been doing instead of paying attention to its manufacturing practices. Have efforts to create new products or expand existing products’ reach edged out the basic safety concerns that should be at the forefront of any medical manufacturing business’s operations? Or, worse, could the company have intentionally ignored problems in order to avoid bad publicity? Ignoring safety for any reason would be dangerous, legally and morally. Consumers can be hurt by lax manufacturing practices, as KV Pharmaceutical here in St. Louis found out. And those who were hurt have the right to recover financial compensation from the defective product’s manufacturer. Drug manufacturers who fail to warn consumers of risks that they know about can be liable in lawsuits filed by those consumers. This allows a consumer who incurs medical costs, misses work or is unable to work, or whose quality of life suffers because of harm caused by an over-the-counter or prescription drug to require the drug manufacturer to pay these costs.


The dangerous medication attorneys at Carey, Danis & Lowe help people who have been hurt by defective over-the-counter and prescription drugs, or drugs whose manufacturers failed to warn about serious safety problems. If you or someone you love have been seriously harmed by a medication, we can help you recover medical expenses, lost wages, permanent injuries, pain and suffering and more from the medication’s negligent manufacturer. If you have been hurt by a defective drug, please call Carey, Danis & Lowe for a consultation, toll-free, at 1-877-678-3400 or contact us through our website.