December 17, 2010
The Johnson & Johnson Family of Companies, the world’s largest manufacturer of healthcare products, has had a bad week, with another recall of millions of products, citations from the FDA at its manufacturing plant and a court order to pay $52 million for deceptive trade practices.
On December 9, J&J’s McNeil Consumer Healthcare issued a Rolaids recall of 13 million packages because of consumer reports of wood and metal contamination of the product that occurred at a third party manufacturing facility. CBS news reports that J&J received dozens of consumer complaints including vomiting, unusual smell and injury to teeth and gums from people who used the Rolaids products. Another recall in a long list of J&J recalls of over the counter medicine this year for quality control issues that have resulted in the closing of a manufacturing plant and congressional investigation.
Today, Congressman Darrell Issa, exposed the third party manufacturer, Best Sweet of Mooresville, NC, as the maker of J&J’s recalled Rolaids Soft Chews. Best Sweet also makes other confectionary type health care products. He is calling for an investigation into the matter.
"I am concerned about FDA’s knowledge of Best Sweet’s contractual relationship with Johnson & Johnson in manufacturing Rolaids and whether or not the FDA is acting appropriately to determine if there are other similar public safety concerns about products manufactured by Best Sweet," Issa wrote in a letter to the U.S. Food and Drug Administration (FDA).
Reuters reported on December 15 that a report of a FDA inspection from October to December this year of the company’s Fort Washington, PA plant that has been closed since April for manufacturing problems, revealed that J&J failed to adequately handle consumer complaints, lack of proper record keeping and failure to investigate product quality discrepancies.
According to an ABC News story today, a Pennsylvania court has ordered Johnson & Johnson to pay $52 million in damages and penalties for deceptive trade practices. The court found that J&J falsely reported drug prices to manipulate a drug pricing benchmark used by state agencies to calculate drug reimbursements, resulting in great expense to Medicaid and PACE prescription drug program for seniors.