Whistleblower (Qui Tam) Law Pharmaceutical and Medical Device Fraud
Pharmaceutical companies have millions, and sometimes billions, of dollars at stake in the development and marketing of new drugs. Patients’ best interests can often be lost in the drive for profit. Ashcraft & Gerel’s pharmaceutical and medical device fraud lawyers are deeply familiar with the industry and the regulations surrounding common areas of fraud.
We are committed to protecting those who want to protect consumers by revealing instances of off-label marketing, kickbacks, scientific study fraud, or other instances of pharmaceutical and medical device fraud within the organizations they work for.
While doctors may prescribe drugs for any use in the exercise of their professional judgment, drug companies may not legally promote the use of a drug for purposes that are not approved by the FDA. Many of the recent large settlements between the Department of Justice and pharmaceutical companies like Glaxo SmithKline, Pfizer, Eli Lilly, Abbott, and Amgen resolved allegations of off-label marketing.
It is a violation of the federal Antikickback Statute for drug companies to offer or pay doctors and other medical professionals money or other items of value (like free medical equipment or travel to luxury resorts, for example) to prescribe certain drugs or perform certain procedures. Similarly, doctors are prohibited by the federal Stark law from referring cases to hospitals or other institutional providers in which they have a financial interest. The government has settled dozens of cases resolving allegations that pharmaceutical companies paid kickbacks in exchange for prescriptions over the past decade.
Scientific Safety Fraud
In recent years, drug companies have been investigated for deliberately altering, covering up, or fabricating the results of a clinical drug trial in order to gain FDA approval for a drug or to hide drug risks that might affect sales.
Good Manufacturing Practices
Federal law sets standards called Good Manufacturing Practices (GMP) that drug manufacturers are required to follow to ensure the safety of drugs. Violations of these GMPs can result in serious harm to patients, as is clear from recent news coverage of the meningitis outbreak caused by alleged failures to follow GMPs at the New England Compounding Center.
Contact Us Today
Our pharmaceutical and medical device fraud lawyers encourage you to know your rights and report fraud against the government in the pharmaceutical industry. If you have information about your employer engaging in the types of fraud described above, contact us today.