Johnson & Johnson
Medical Device R&D and Manufacturer
Recently, a bombshell message has caused a stir in the pharmaceuticals industry. A subsidiary of Johnson & Johnson was involved inHIVIllegal Operations in Drug Marketing and Promotion Result in Federal Judge's Penalty16.4billion dollars. This incident not only dealt a huge blow to Johnson & Johnson itself but also sounded an alarm for the compliant development of the entire pharmaceutical industry.
The case stemmed from a lawsuit initiated by a whistleblower. Judge of the Trenton Region in New Jersey, United StatesZahid QuraishiAfter deliberation, it was ruled that,Johnson & Johnson subsidiary Janssen (Janssen) in promotionHIVDrugPrezistaAndIntelenceAt the time, there were illegal activities.
According to the verdict, Johnson & Johnson must pay the U.S. government3.6billion dollars to compensate for its violation of the federal False Claims Act. In addition, it must bear12.8Hundreds of millions of dollars in civil penalties.This civil penalty corresponds to the jury's determination thatMedicare、MedicaidAnd projects such as the AIDS drug assistance program submitted by 159574False claims, with an average fine per claim8000USD.
However, due to insufficient evidence,QuraishiThe judge dismissed the jury's verdict regarding violations of state false claims acts. 3000Million USD Compensation Ruling. The verdict was issued on2024Year6Month13The case officially came to an end after a six-week-long trial.
The whistleblower of the improper marketing practices this time is a former sales representative of Yangsen.Jessica PenelowAnd Christine Brancaccio. They pointed out that Johnson & Johnson willPrezistaAndIntelenceFor use in the United StatesFDAUnapproved uses. For example, Janssen claimedPrezistaHas“Lipid Neutral”Characteristics, suggesting that the drug will not affect cholesterol or triglyceride levels, however this is inconsistent withFDAThe content of the approved drug label is clearly contradictory. In addition, the plaintiff also revealed that Janssen paid doctors to endorse these drugs at dinner and speaking events, and such payments essentially constituted kickbacks.
After a detailed trial, the jury ultimately found Janssen liable for some off-label use allegations but not responsible for the kickback charges.
Johnson & Johnson expressed dissatisfaction with the verdict and plans to appeal. The company believes that the verdict was influenced by insufficient evidence and incorrect jury instructions, and is confident that the verdict will be overturned on appeal.
This ruling has a profound impact on the pharmaceuticals industry. It once again reminds pharmaceutical companies that they must strictly comply with laws and regulations during drug promotion, ensuring that promotional content is truthful and accurate, and refraining from false advertising or misleading marketing. At the same time, it highlights the regulatory authorities' high emphasis on compliance within the pharmaceuticals industry, with any violations facing severe penalties.
