Contaminated Children’s Tylenol Plea Underscores Need for Oversight

Scartelli Olszewski P.C.

As experienced personal injury and medical malpractice attorneys in Scranton, Pa., we have seen a lot of cases involving defective drugs, medical malpractice, and negligence.Still, every now and then, a case just makes us shake our heads and wonder what on Earth the people involved were thinking. The most recent example was March 10, 2015, when McNeil Consumer Healthcare pled guilty to federal criminal charges that it knowingly sold tainted bottles of Infants’ and Children’s Tylenol and Infants’ and Children’s Motrin produced at a Pennsylvania manufacturing plant.The case revealed that McNeil, which is owned by Johnson & Johnson, knew about the problem at its plant outside Philadelphia for more than a year. In May 2009, someone who had purchased one of the bottles of medicine complained to the company about black “specks” in the liquid medication, which millions of parents have given to sick babies and toddlers in the middle of the night.The “specks” actually were particles of metal, including nickel, iron, and chromium.

McNeil discovered that the tiny metal fragments were being introduced during production but made no move to immediately correct the situation. The assembly line kept rolling, producing bottle after bottle of children’s medications contaminated with metal. The company continued to distribute the tainted medications to grocery and pharmacy shelves for nearly a year, where unsuspecting parents bought them to give to their sick children.The company eventually traced the metal contamination to machinery inside the factory, and, 11 months after the first documented complaint from a consumer, finally issued a recall in April 2010.That’s not all, though. At the same time that regulators were investigating the metal contamination, FDA inspectors found that raw materials used at the Montgomery County manufacturing plant to make those children’s medications were contaminated with bacteria.In pleading guilty to selling the adulterated medication, McNeil agreed to pay $25 million in fines and penalties to the government to settle the case.Both the company and the government’s prosecutors agree that there were no known illnesses or injuries reported as a result of these incidents.

That said, if you’ve ever spent the extra few dollars to buy a name brand medication because you thought it might be safer than a generic brand, you can appreciate the irony of these defects.We all want to believe that companies which produce products that will go into our bodies are on ever-vigilant watch for manufacturing flaws that could put us in danger. That may, in fact, be the case at many food and drug producers, although we are not necessarily convinced that the FDA is always watching as closely as it needs to be.The problem with that comforting illusion is that these companies employ hundreds, if not thousands, of people, and not all of them take their responsibility for your safety as seriously as they ought to. All it takes is one corner-cutting manager to turn an otherwise safe drug production facility into a distributor of potentially defective drugs. It could be weeks or months before anyone realizes what has happened – perhaps at the expense of people who have been harmed.If you think you’ve purchased a defective medication, notify the company and give them a chance to address the situation. Do not discard the product, though, and keep it in a safe place. Then call the Scranton med mal and personal injury attorneys at Scartelli Olszewski. We can help.