A congressional meeting was held on Thursday May 27th to address issues related to a recent drug recall instituted by McNeil Consumer healthcare, a Johnson and Johnson company.
The opening statement from Chairman Edolphus Towns reads:
Less than a month ago a Johnson & Johnson company known as McNeil Consumer Healthcare recalled over 40 variations of children’s medicine, including such widely used products as Children’s Tylenol, Children’s Motrin, Children’s Benadryl and Tylenol Infants’ Drops.
Chairman Towns explained that this recall was carried about because of production problems that affected the quality, purity and potency of the medicine. He added that McNeil has received complaints of contamination and tests have shown “super potent” batches of Infant’s Tylenol. The factory in which these potentially dangerous products were manufactured has been shut down
Towns also mentioned an internal document from McNeil:
Just last night, the Committee obtained from the FDA even more disturbing information. According to an FDA document, McNeil knew there was a potential problem with one of its Motrin products that was on the market in 2008, but rather than issue a public recall, McNeil allegedly sent contractors out to stores to buy the product back and told the stores “not to mention” a recall.
After the FDA confronted McNeil about this, McNeil announced a recall of the affected products.
This “phantom recall” warrants further investigation by this Committee. Who at McNeil and Johnson & Johnson knew about this scheme? How high up in the corporate suite was this scheme hatched? Is this a standard operating practice for McNeil?
The hearing continued with prepared statements from representatives of both the FDA and Johnson and Johnson.
From Colleen A. Goggins Worldwide Chairman, Consumer Group, Johnson & Johnson:
The quality and process issues that we found at McNeil, those which led to the recall and others, are unacceptable. On behalf of McNeil and Johnson & Johnson, I apologize to the mothers, fathers, and caregivers for the concern and inconvenience caused by the recall.
She further explained:
McNeil implemented a broad, precautionary recall of liquid children’s and infants’ medicines on April 30, 2010, because quality process deficiencies produced tiny metal particles in a small amount of product. The recall was not prompted by adverse medical events, nor was it prompted by safety concerns regarding two additional quality issues referenced in the recall notice – excess concentration of active ingredient, and inactive ingredients that did not meet McNeil’s testing requirements. Neither of these issues, nor the tiny particle issue, presented anything other than a remote patient safety issue.
FDA described in its testimony a pattern of problems at McNeil and mentions that FDA concerns over the quality of the company’s manufacturing process has led to the FDA taking action. These concerns have led to a number of unsatisfactory inspections and consumer recalls. Dr. Joshua M. Sharfstein, the F.D.A.’s principal deputy commissioner, outlined many of the problems the FDA has encountered and the trouble the FDA has faced regarding compliance on the part of McNeil.
Ultimately the hearing ended with a closing statement form chairman downs in which he expressed great concern with McNeil, Johnson & Johnson, and the practices of these two entities.
Frankly, what we have heard today is not reassuring. The initial story was bad enough: On April 30, Johnson & Johnson announced the largest recall of children’s medicine in history. But it turns out there wasn’t just one recall. What we have heard about today is rolling recalls, a phantom recall, a plant shut down, and management firings.
Downs concluded with the following:
This is an issue of trust. When parents and grandparents give these medicines to their children, they want to be confident that they are not harmful. Johnson & Johnson has the duty to ensure their safety and the FDA has the duty to enforce that duty. One thing we know now is that the FDA needs mandatory recall authority. They shouldn’t have to persuade a company to recall suspect products. I intend to introduce legislation to give FDA that authority. FDA should also have the power to order halt in drug production. At this point, there are still many unanswered questions. We intend to pursue this further.
The Law Offices of Eric H. Weinberg have been successfully litigating pharmaceutical drug cases for over twenty years on behalf of injured persons. If you or a loved one has been affected by this recall feel free to fill out a Free Case Evaluation or contact us at 732-246-7080, or toll-free at 1-877-934-6274 and we will be sure to answer your questions.
To learn about our recent pharmaceutical litigation efforts, please see Yaz and Yasmin Lawsuit, Reglan Lawsuit, and Levaquin Lawsuit.
