Yesterday, a big drug company made a deal with the Department of Justice (and state attorneys general) to pay $2,200,000,000 (that’s 2.2 billion dollars) in settlement of criminal allegations and civil assertions that the drug company was promoting its drug and medicine products for things (uses) not okayed by the FDA (Food and Drug Administration) as being safe and effective.
This all started when a brave whistleblower out of Chicago pointed the finger at Johnson & Johnson for doing bad things. And some of these bad things were criminal in nature, including allegations that Johnson & Johnson was paying money under the table (i.e., kickbacks) to doctors and pharmacists who would then prescribe and disperse several of their drug products. (These included Natrecor, a drug used by heart patients and a couple of antipsychotic medications).
Some of the results were shocking: by Johnson & Johnson’s subsidiary Janssen making deals to have people suffering from dementia prescribed Johnson & Johnson’s drug product Risperdal, originally targeted for use by people suffering from schizophrenia, the dementia patients ended up with a greater risk of dying because of taking the Risperdal medication. For this Risperdal allegation, Johnson & Johnson has agreed to plead guilty to one misdemeanor.
From the Justice Department’s news release regarding the Risperal allegations:
The information alleges that Janssen’s sales representatives promoted Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion. The information alleges that the company created written sales aids for use by Janssen’s ElderCare sales force that emphasized symptoms and minimized any mention of the FDA-approved use, treatment of schizophrenia. The company also provided incentives for off-label promotion and intended use by basing sales representatives’ bonuses on total sales of Risperdal in their sales areas, not just sales for FDA-approved uses.
In a plea agreement resolving these charges, Janssen admitted that it promoted Risperdal to health care providers for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients. Under the terms of the plea agreement, Janssen will pay a total of $400 million, including a criminal fine of $334 million and forfeiture of $66 million. Janssen’s guilty plea will not be final until accepted by the U.S. District Court.
This is a huge deal. The $2.2 billion dollar settlement between Johnson & Johnson and the federal government (and the states, too), is reportedly the THIRD LARGEST settlement by a drug manufacturer in U.S. History.
For more information:
Read the Civil Settlement Agreement here.
Read the Criminal Plea Agreement here.
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For more on product liability issues like mislabeled drugs or other medication errors and the damage they can cause victims and their families, check out Kenneth J. Allen Law Group’s web resources page on Defective Products as well as our blog posts on defective products including drugs, including:
