Johnson & Johnson is expecting more legal fallout from its recent recalls of children’s Tylenol and other over-the-counter medicines. According to a Wall Street Journal report, Johnson & Johnson said in a recent regulatory filing it received “civil investigative demands” from various state authorities in connection with the recalls.
Johnson & Johnson has been under scrutiny since April 30, when its McNeil Consumer Healthcare unit recalled more than 40 varieties of children’s Tylenol and other medicines. That recall was just one of six McNeil has issued for its cold and pain relief products over the past year.
McNeil has since shut the Fort Washington, PA facility that made those drugs to address manufacturing problems cited by a Food & Drug Administration (FDA) inspection. The plant is expected to stay closed well into next year, and 75 percent of its workforce has been laid off.
The New Jersey-based company has already been hit with a federal subpoena from the U.S. Attorney’s Office for the Eastern District of Pennsylvania. According to the Journal, Congress is also investigating the recalls, and they have spawned numerous lawsuits against Johnson & Johnson.
In a filing with the Securities and Exchange Commission (SEC) yesterday, Johnson & Johnson disclosed that it has also received multiple subpoenas from federal prosecutors requesting documents “broadly relating to” both the recent recalls and inspections of two factories. It also said it had received demands from multiple State Attorneys General Offices relating to the same issues.
The two Johnson & Johnson factories under scrutiny include the now-closed Fort Washington facility, and another in Lancaster, PA. The Lancaster plant is operated by the joint venture Johnson & Johnson-Merck Consumer Pharmaceuticals and makes over-the-counter products like Mylanta, Pepcid and Imodium.
As we’ve reported previously, the Lancaster facility had recently been issued a “Form 483″ by FDA inspectors. Such a form is issued after an FDA inspection yields unsatisfactory results for compliance with regulations or a violation of good manufacturing practices. The report said the violations uncovered by FDA inspectors indicate “a pattern of ignoring rules for manufacturing and quality, failure to investigate problems that could affect the composition of products, carelessness in cleaning and maintaining equipment, and shoddy record-keeping.” The violations cited in the report included medicine batches made during equipment failures that were not checked for quality.