Johnson & Johnson (J&J) has $2.2 billion less to spend on settling metal-on-metal hip lawsuits because the company just agreed to pay the U.S. Justice Department that amount to resolve criminal and civil allegations of promoting prescription drugs not approved by the FDA.
J&J Settles for $2.2 Billion Over Unapproved Drugs
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Secondary
The allegations against the company and its subsidiaries, Janssen Pharmaceuticals, Inc. and Scios Inc., include paying kickbacks to physicians and skilled nursing facility pharmacies to recommend and prescribe Risperdal and Invega, both antipsychotic drugs, and Natrecor, which is used to treat heart failure.
U.S. Attorney General Eric Holder said on November 4, 2013 that the company improperly marketed Risperdal for elderly, non-schizophrenic patients, even though the drug was approved only to treat schizophrenia. He said Risperdol and Invega also were improperly marketed for dementia treatment.
That led insurance companies to pay for claims they never should have been paying, he said. “[The companies] lined their pockets at the expense of American taxpayers (and) patients.”
The figure includes $1.72 billion in civil settlements with federal and state governments as well as $485 million in criminal fines and forfeited profits.
Single Misdemeanor and CIA
As part of the resolution, Janssen will plead guilty to a single misdemeanor violation.
A J&J press release says the company has cooperated with the government since separate investigations began nearly a decade ago, and this agreement resolves all related federal criminal and federal civil liabilities on these matters. Janssen accepts accountability for the actions described in the misdemeanor plea. The settlement of the civil allegations is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations.
The resolution also includes a five-year corporate integrity agreement between the Office of Inspector General of the U.S. Department of Health and Human Services and J&J.
The agreement is the third-largest U.S. settlement involving a drugmaker, according to an Associated Press story. British-based GlaxoSmithKline paid a record-setting $3 billion in fines to settle criminal and civil violations involving ten of its drugs.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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