Clinical trials are conducted on new drugs to ultimately determine whether they are safe and effective. When a pharmaceutical company is trying to get a new drug approved, this critical data is submitted to the U.S. Food and Drug Administration (FDA). Clinical trial fraud is when drug companies submit false data to the FDA in order to get a drug approved. Using false or misleading data in this manner is illegal and can harm patients. Whistleblowers, individuals who file a lawsuit on behalf of the government when they have knowledge of fraud, can play a crucial role in identifying clinical trial fraud. If the funds are recovered, the whistleblower may be entitled to a significant share.
Clinical trial fraud can occur when pharmaceutical companies misrepresent the safety or effectiveness of a drug or medical device by fabricating data or omitting information about side effects. In some cases, medical devices are approved without clinical tests for safety or efficacy. The 510(k) section of the Food, Drug and Cosmetic Act allows manufacturers to circumvent testing if they show that the device is similar enough, or “substantially equivalent” to a previously approved device. Clinical trial fraud can occur when pharmaceutical companies present fraudulent data showing that a device is substantially equivalent to a previously approved device.
It is illegal for companies to retaliate against whistleblowers for reporting fraudulent activities. Individuals who faced retaliatory action, such as being fired or demoted, should inquire about filing a whistleblower retaliation lawsuit.
Parker Waichman LLP provides free legal consultations to individuals who want to file a whistleblower lawsuit. If you or someone you know has knowledge of fraud or are aware of clinical trial fraud and want more information about your legal rights, contact our firm today.
An analysis published in the American Journal of Psychiatry suggested that industry-funded trial were biased; in a trial evaluating five new antipsychotics, nine out of 10 studies promoted the drug manufactured by the sponsoring company.
Whistleblowers have helped uncover a number of clinical trial fraud cases. In July 2012, GlaxoSmithKline agreed to a $3 billion settlement involving allegations of clinical trial fraud. The case stemmed from four whistleblower lawsuits filed under the qui tam provisions of the False Claims Act. According to a press release by the Department of Justice, GSK pleaded guilty to two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce. The company also pleaded guilty to failing to report safety data about Avandia to the FDA. Allegedly, “between 2001 and 2007, GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends. The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia.”
The government alleged that GSK “participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the United States alleges, GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18.”
“Patients rely on their physicians to prescribe the drugs they need,” said U.S. Attorney for Colorado John Walsh, according to the release. “The pharmaceutical industries’ drive for profits can distort the information provided to physicians concerning drugs. This case will help to ensure that your physician will make prescribing decisions based on good science and not on misinformation, money or favors provided by the pharmaceutical industry.”
Whistleblowers have been valuable in detecting fraud and subsequently saving the government and taxpayers money. If you would like to file a whistleblower lawsuit through the False Claims Act or simply want more information, contact Parker Waichman LLP today.