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Novartis Agrees to $422.5 Million Settlement

PHILADELPHIA – The US Attorney’s office in Philadelphia announced last Thursday that Swiss pharmaceutical company Novartis has agreed to a $422.5 million settlement resolving civil and criminal investigations by the Department of Justice into off-label and illegal marketing of its anti-seizure drug Trileptal and several medications.

The federal government had accused Novartis Pharmaceuticals Inc. of marketing Trileptal, Diovan, Exforge, Tekturna, Zelnorm, and Sandostatin for uses not approved by the Food and Drug Administration (FDA). While physicians are allowed to prescribe a drug for any medical reason, drug makers and marketers are only allowed to promote the drug for FDA-approved uses. However, Novartis specifically targeted physicians and psychiatrists who were known to prescribe Trileptal and compensated off-label prescribers with illegal kickbacks in the form of paid speaking engagements, trips, and meals.

This off-label marketing and illegal kickbacks are costly to taxpayers and potentially dangerous to patients. The US government is one of the world’s largest purchasers of prescription drugs through Medicaid, Medicare, TRICARE, and other government-funded healthcare programs. Whistleblowers within Novartis reported the off-label marketing, acting under the False Claims Act, which empowers the whistleblowers to file suit on behalf of the government when illegal activity results in improper or “false” claims paid by these government programs.

One reason off-label is so risky to patients is because it raises the risk of pharmaceutical injury from defective or improperly prescribed drugs. Illegal kickbacks to physicians further harm the doctor-patient relationship by offering incentives for doctors to prescribe off-label. This results in more patients being treated with drugs that are not approved by the FDA for that purpose, greatly increasing the risk of dangerous prescription drug side effects like heart disease and stroke.

Doctors who accept kickbacks or cause injury to a patient by prescribing off-label are not only vulnerable to criminal charges, but may also increase their exposure to medical malpractice lawsuits.

If you have become ill or been injured by a pharmaceutical drug prescribed off-label, please contact the experienced prescription drug injury lawyers of Schlichter, Bogard & Denton today for an evaluation of your case.

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