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FDA Wins Consent Decree With McNeil Over Unsolved Tainted Drug Problems

By March 16, 2011July 18th, 2019Dangerous Drugs

I’ve written here many times before about the ongoing manufacturing problems at plants owned by McNeil Pharmaceuticals and Johnson & Johnson, which has led to 19 recalls of major over-the-counter drugs such as Tylenol, Motrin and Benadryl. As a dangerous drug lawyer, I was therefore disappointed but not surprised to read that McNeil has agreed to a consent decree with the U.S. Food and Drug Administration, preventing it from making and selling drugs at certain plants until it complies with the law. The consent decree also includes two McNeil executives personally, as the FDA noted. It applies to the plants in Fort Washington and Lancaster, Penn.; and Las Piedras, Puerto Rico that were the sources of the recalled drugs.
The drugs were recalled for a variety of reasons, including too-high concentrations of active ingredients in children’s medications; particles of wood and metal in the drugs; and a “musty” smell determined to come from packaging chemicals, which triggered reports of vomiting and diarrhea. FDA inspections found that the three plants had serious safety problems, including dirty equipment and poor quality control. Executives are also accused of attempting to cover the problems up, including a “secret recall” in which the company sent people to stores to buy up products. As a result, sales are down and the Fort Washington plant is closed.
Under the five-year consent decree, that plant must remain closed; the two others can stay open but must comply with good manufacturing practices or face fines of $15,000 a day. McNeil must also hire an independent expert to inspect the plants and certify them as compliant, which the FDA will follow with its own inspection. And the drug maker is required to destroy all drugs returned since December of 2009. The consent decree must be approved by a federal judge before it goes into effect.
As a dangerous medication attorney, I’m very pleased that the FDA is taking stricter regulatory action against these blatant failures by McNeil to protect its own customers. All tainted drugs pose a potential threat, but the children’s drugs were particularly worrisome because they had higher concentrations of active ingredients than they should have, making it very easy to accidentally overdose a small or slight child. In extreme cases, this could cause serious health consequences. The consent decree comes after more than two years of failed inspections at McNeil plants, so it’s clear that the company has been given plenty of chances to clean up its act independently. And a criminal investigation is reportedly ongoing, though the FDA release doesn’t mention it, suggesting that we may not have heard the last about this.

Based in St. Louis, Carey, Danis & Lowe represents clients from across the United States who have been injured, sickened or lost a family member because of taking an unsafe drug. In the case of McNeil products, that could be many millions of Americans who understandably assumed that over-the-counter drugs wouldn’t be offered for sale if they weren’t safe. Unfortunately, when manufacturers chase profits at the expense of safety, that’s not at all a safe assumption. Our pharmaceutical liability attorneys help victims claim the costs of injuries caused by unsafe drugs, including money for medical bills, lost income from not working and more. We also help clients win compensation for permanent disabilities, pain and emotional suffering caused by the defective medicine.
If you or someone you love was hurt by taking a medication you thought you could trust, Carey, Danis & Lowe can help you understand your rights and your legal options. To set up a free consultation, send us an email or call us toll-free at 1-877-678-3400.