The US Consumer Product Safety Commission late last month voted to ask the US Department of Justice to seek civil penalties against Dr. Reddy’s Laboratories, one of India’s largest drug makers, for failing to report problems with packaging for several medicines.
In a 4-1 vote that was held two weeks ago, the safety agency determined that the company knowingly violated federal law because issues with child-resistant blister packs for five prescription drugs were not reported within the mandated 24 hours, according to a CPSC spokesman. The violations allegedly occurred between 2002 and 2011, according to a regulatory filing by the drug maker. Dr. Reddy’s disclosed the CPSC vote this week.
Although there a few recalls each year involving packaging violations, the CPSC spokesman noted that this case is different because it been referred to the Justice Department. The allegations, though, have been dogging Dr. Reddy’s, a big supplier of generic drugs around the globe, for several years. Both the CPSC and the Justice Department began probes in 2012, following claims made in a whistleblower lawsuit filed by two former marketing directors.
The former employees alleged the company knowingly shipped drugs in packaging that was not tested and that Dr. Reddy’s decided not to test product packaging in order to save money, according to the lawsuit, which was filed in federal court in Philadelphia. The lawsuit maintained that children were placed at risk because consumers were unaware that packaging for their medicines was not tested.
Among the products were generic versions of the Cipro antibiotic, the Prozac antidepressant, and the Risperdal antipsychotic, according to the lawsuit, which is continuing, by the way. The Justice Department, however, last November declined to intervene or join the litigation, according to a notice filed with the court.
Nonetheless, the CPSC appears confident the Justice Department will act on its request to pursue civil penalties against the drug maker. “We at CPSC take seriously the consumer safety laws we enforce, and I am confident that the US Department of Justice is examining the record in a thorough manner, and, if warranted, will take all appropriate actions,” CPSC chairman Elliot Kaye said in a statement.
A Justice Department spokeswoman wrote us that the agency does not confirm or deny the existence of an investigation, but “takes all allegations involving violations of consumer safety laws very seriously, especially actions that may threaten children’s safety.”
A Dr. Reddy’s spokesman wrote us the company “is not aware of any reports that any child gained access to its products as a result of the packaging or that any of the products caused children harm as a result of the package.” He added that the drugs have not been distributed in the packaging at issue since June 2012 and the company believes it has complied with all packaging and reporting requirements.