by: Jeff S. Gibson , Attorney
Health care products giant Johnson & Johnson has made headlines recently due to a series of concerns and investigations into its marketing practices for drugs and medical devices. Johnson & Johnson disclosed to its shareholders in its most recent quarterly earnings report that a federal investigation is currently underway regarding its marketing practices of the antibiotic Doribax and the sinus device Relieva Stratus MicroFlow Spacer.
Doribax is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. This drug has been approved by the FDA for the treatment of abdominal and urinary infections. Johnson & Johnson had recently been conducting clinical trials to determine the safety and effectiveness of Doribax for treating pneumonia. The trials were halted early because of a high percentage of deaths that occurred. According to a statement by the FDA, 21.5 percent of the patients who took Doribax died as compared to 14.8 percent of patients in the control group during this clinical trial. The FDA did state that Doribax is still considered safe and effective for use in the treatment of abdominal and urinary infections for which it was previously approved.
The Massachusetts U.S. Attorney’s Office is currently investigating the marketing
practices related to the Relieva Stratus MicroFlow Spacer. This medical device is manufactured by Acclarent, which was purchased by Johnson & Johnson in 2009 and is used to keep sinus cavities open.
Johnson & Johnson is nearing a settlement with the U.S. Department of Justice to pay nearly $1 billion for its off-label promotion of the antipsychotic drug Risperdal. The drug was only approved for psychotic disorders like schizophrenia but was marketed by the manufacturer for other uses such as treatment of bi-polar disorder, dementia, and anxiety.
These investigations call attention to an alarming trend of drug and device manufacturers marketing and promoting products for uses other than what has been approved by the FDA. Off-label promotion can put patients at risk for serious injury due to a lack of clinical testing necessary in order to understand the full impact of these drugs and devices on the body.