In its latest quarterly earnings report filed with the U.S. Securities and Exchange Commission last week, Johnson and Johnson disclosed that the company is under federal investigation for marketing practices related to two products — a drug and a medical device.
The filing notes that Janssen Pharmaceuticals, a J&J company, received a letter in March from the U.S. Department of Justice requesting certain documents related to how the drug Doribax is marketed and promoted. Doribax is an antibiotic that is already approved to treat abdominal and urinary infections. It has recently been in the news because Johnson & Johnson halted a clinical trial early when more pneumonia patients who were given Doribax died instead of recovered.
The second investigation involves a medical device. In the regulatory filing, J&J discloses that Acclarent, which it bought in 2009, received a federal subpoena from the Massachusetts U.S. Attorney’s Office in May related to the marketing of Relieva Stratus MicroFlow Spacer and related products to treat sinus problems.
In late December, Johnson & Johnson agreed to pay $1 billion to the DOJ to settle charges that it engaged in the off-label promotion of the drug Risperdal.
A Johnson and Johnson spokesman declined to comment.
[Photo Credit: FreeDigitalPhotos.net]
By Arundhati Parmar
Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.More posts by Author
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