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Statement from Chairman Elliot F. Kaye Regarding the Referral of a Matter Involving Dr. Reddy’s Laboratories, Inc. to the Justice Department

June 01, 2016

Chairman’s Statement:

"The U.S. Consumer Product Safety Commission (“CPSC”) recently voted 4 to 1 to refer to the U.S. Department of Justice a case involving Dr. Reddy’s Laboratories, Inc. (“Dr. Reddy’s”) with the recommendation that the Department initiate a civil penalty action, and any other appropriate remedies, against Dr. Reddy’s for allegations that the company knowingly violated the Consumer Product Safety Act (“CPSA”).  Dr. Reddy’s allegedly failed to immediately report a non-compliance, defect and unreasonable risk to the CPSC regarding non-child resistant “blister packs” of five prescription drugs as required by section 15(b) of the CPSA. Commission statutes and regulations require that a company report such information within 24 hours.  Failure to immediately report can, among other things, subject a company to substantial civil penalties and other equitable relief."

"We at CPSC take seriously the consumer safety laws we enforce, and I am confident that the U.S. Department of Justice is examining the record in a thorough manner and, if warranted, will take all appropriate actions."

Firm’s Response:

“Dr. Reddy’s takes seriously the safety of patients and consumers. The five products have not been distributed by Dr. Reddy’s in the packaging at issue since June 2012. Dr. Reddy’s believes that it has complied with applicable requirements of the Consumer Product Safety Act and related regulations, including any applicable packaging requirements. Dr. Reddy’s is not aware of any reports that children gained access to or were injured by these Dr. Reddy’s products as a result of their packaging.  Dr. Reddy’s intends to continue to cooperate fully with the DOJ as it has throughout this investigation and to provide DOJ with information to support the company’s position.”

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