FDA and House of Representatives Launch Investigations Into McNeil Recall

By June 10, 2010July 17th, 2019Dangerous Drugs

A few weeks ago, I wrote about the recall of contaminated and overly concentrated children’s medications produced by McNeil Pharmaceuticals, a unit of Johnson & Johnson. Since then, more information has become available about the recall, and the FDA and the House Committee on Oversight and Government Reform have launched investigations. Dr. Joshua M. Sharfstein, the FDA’s principal deputy commissioner, said that the FDA is even considering criminal penalties against McNeil. As a defective drug lawyer, I do not believe McNeil has demonstrated an ability or willingness to protect consumers’ safety from defective or contaminated medications.
For me, the most troubling aspect of the information that has emerged since the recall began on April 30 was McNeil’s apparent sloppiness in both its drug manufacturing and its communications with consumers and the FDA. This applies not just to communications from this year, but going back to at least 2008. First, the April 30 recall turns out to have left out McNeil’s 1-mg grape-flavored Zyrtec, which should have been recalled. The company added this product to the recall on May 5, but as a dangerous medication lawyer, I worry that some consumers may have looked at the original recall, seen that this type of Zyrtec was not included and stopped worrying about it. Missing the new recall announcement would have exposed such families to the same serious injuries they were trying to avoid.
Second, McNeil tested some samples of its recalled infants’ Tylenol and found that it contained up to 24 percent more of its active ingredient than it was supposed to. The company said that these defective medications did not reach the marketplace. However, it said, “we cannot confirm that all the individual bottles were within specification or that 24 percent would have been the maximum,” according to a letter to doctors and poison control officials that was dated May 1. That date was one day after the recall of infants’ and children’s Benadryl, Motrin, Tylenol and Zyrtec.
Third, and most worrisome, these events look like just the latest episode in a pattern of lax quality control, including McNeil’s unnecessary delay in 2008 in reporting problems with Motrin. The company had retailers remove Motrin from store shelves without informing the FDA of the drug’s problems. This “paints a picture of a company that is deceptive, dishonest and willing to put the health of children at risk,” said Rep. Edolphus Towns (D-N.Y.), chair of the House Committee on Oversight and Government Reform. “What we have uncovered so far is very troubling.” McNeil insists that the possibility for harm caused by these defective medications is remote, but the company’s sloppy handling of this situation does not inspire a lot of trust in its assessment.
The company may now have to explain itself to the FDA’s office of criminal investigation and the Justice Department, since the FDA has referred the case to federal prosecutors. If consumer reports of health problems linked with the defective drugs continue — and the FDA has already received some — McNeil may find itself answering in civil court as well. Drug manufacturers have a responsibility to warn the public of potential negative effects their products could cause, and all signs uncovered so far by the FDA and Congress point to McNeil’s not having done so. In such cases, consumers who have been harmed by defective medications can sue the drugs’ manufacturers for compensation for medical costs, lost past and future wages, lost quality of life, pain and suffering. It’s hard enough for parents to see their babies and children sick. When the sickness was caused by medications parents trusted to help their children feel better, the law recognizes that they should not have to bear the financial consequences as well.


At Carey, Danis & Lowe, we specialize in helping families harmed by defective medications by explaining their legal rights and assisting them in choosing the best course of action to set things right. Because of our years of experience in this field, our pharmaceutical liability attorneys know what to expect in dangerous drug cases and how to obtain the best outcomes for our clients. It’s important to speak with an attorney early on in a defective medication case to ensure that all relevant medical records are preserved and to forestall any attempts by the drug company to persuade victims to settle for a smaller amount of money than they deserve. If you or someone you love has been seriously harmed by a prescription or over-the-counter medication, please meet with one of our attorneys who can help recover compensation from the company that caused your injury.
If you have been hurt by a defective medication, please call Carey, Danis & Lowe for a free consultation, toll-free, at 1-877-678-3400 or contact us through our website.