Last week the Department of Justice (DOJ) filed suit on behalf of the Food and Drug Administration (FDA) against Sage Pharmaceuticals, Inc. The company has been accused of distributing misbranded and unapproved medications.
The lawsuit alleges that the defendants, including Sage’s president, Dr. Jivn-Ren Chen, and Director of Corporate Quality, Charles L. Thomas, violated the Federal Food, Drug, and Cosmetic Act (FDCA) when they manufactured and distributed unapproved and misbranded drugs.
The FDCA requires that all drug companies seeking to sell a new drug apply for approval from the FDA and receive that approval before selling the drug.
“The protections that the review process from the FDA confer to consumers and patients cannot be overstated. Companies that seek to subvert those protections and move forward with selling a product before the FDA has made its decision put the public and patients at risk,” commented Daniel Nigh, an attorney with the Levin, Papantonio law firm, who practices in the areas of pharmaceutical, bad drug litigation and defective device litigation.
According to the DOJ’s press release on the case, this is the second lawsuit that has been brought against the pharmaceutical company for the sale of illegal drugs. The company has been stopped in the past for manufacturing and selling unapproved drugs. In the course of its investigations, the FDA found that the defendants, despite a court injunction in 2000, continued to make and sell painkillers, over-the-counter cough and cold remedies and wound cleaners.
At this time, the government is seeking to stop all production from the company until it changes its ways and complies with applicable laws. According to the Shreveport Times, the company has been warned multiple times throughout the past decade to bring its practices into compliance with applicable law but, as the current lawsuit would indicate, has failed to do so.
Running afoul of the law is not something reserved for small pharmaceutical companies, however. Johnson & Johnson faced similar lawsuits from federal and state government parties regarding its false marketing of Risperdal. Johnson & Johnson ended up settling those various lawsuits for a total of $2.2 billion. In addition, Johnson & Johnson has been sued by over 11,000 patients who received a now-recalled DePuy ASR implant. The lawsuits allege that the metal-on-metal implant causes metal ions to be shed from the implant and circulated throughout the body. DePuy, a Johnson & Johnson subsidiary, has subsequently withdrawn production of the metal-on-metal implant.
Joshua is a writer and researcher with Ring of Fire.