Providing Inaccurate or Incomplete Information to the FDA or Doctors

Drug and Medical device companies are required by law to report complete and accurate information about the safety and efficacy of their products to the FDA and doctors. There are, however, many instances where companies make false or misleading statements about the efficacy, health risks, and other aspects of their products. This can come in the form of manipulation of clinical data, failure to fully and accurately disclose reports of potential side effects, and overstating the benefits of the drug or device. These types of misrepresentations and omissions are serious and can jeopardize patients’ lives. When drug or medical device companies fail to tell the truth about their products, all claims for their products billed against Medicare, Medicaid, and other government programs are potentially actionable false claims, and can result in significant civil and criminal liability for the companies.