Pharmaceutical Whistleblowers

///Pharmaceutical Whistleblowers
Pharmaceutical Whistleblowers2015-06-30T16:32:26+00:00

San Antonio Attorneys Explain Whistleblower Compensation and the False Claims Act

Whistleblower CompensationA Texas whistle blower lawyer may be able to provide representation for those who blow the whistle on drug companies that promote doctors to prescribe drugs for off-label uses. These companies often give kickbacks to encourage doctors to prescribe certain medications or fail to follow FDA guidelines and safety regulations. If you are or were employed by a drug company as an executive, pharmaceutical sales representative or other healthcare worker, you may be able receive whistleblower compensation for reporting fraudulent behavior at your company. If you are aware of fraudulent tax activities within your pharmaceutical organization, a lawyer may be able to hold the company responsible for its fraudulent actions. Even if you are not yet sure whether you are prepared to blow the whistle, a Texas whistle blower lawyer can speak with you confidentially over the phone to provide answers to your questions.

Off-Label Drug Marketing

FDA approval is only for treating a specific medical condition with a certain drug. The approval for such use is based on clinical trials that provide objective evidence of a drug’s effectiveness within that context. Pharmaceutical companies are not legally allowed to encourage doctors to prescribe drugs for non-FDA approved uses. For example, pharmaceutical companies may not encourage doctors to prescribe a drug that has been approved for the treatment of anxiety for high blood pressure. Companies who do this are misbranding their products. Misbranded drugs cause a significant number of lawsuits. Some sales representatives are encouraged to tell doctors about the off-label applications of particular drugs to increase sales. One whistleblower lawsuit resulted in $2.5 million in funds under the False Claims Act. The whistleblower provided valuable information about the company’s practice of promoting an anti-inflammatory drug intended for use after cataract surgery for the treatment of pain after glaucoma and Lasik surgeries.

Anti-Kickback Lawsuits

Federal guidelines also prohibit pharmaceutical companies from compensating doctors for prescribing medications. Outright bribes are prohibited as well as rebate programs for specific drugs. Any indirect or direct payments intended to reward doctors for their prescribing behavior is strictly illegal and may result in a whistleblower lawsuit. Some anti-kickback whistleblower lawsuits allege that doctors are provided with free golf trips, wine-tasting event tickets, and paid speaking jobs if they prescribe specific drugs.

FDA Quality Control Procedures

The Food, Drug, and Cosmetic act states that it is illegal to sell any drug that has been adulterated. Adulterated drugs have not been produced with proper quality control procedures during the manufacturing, processing, packing, or holding stages. All such stages must follow practices that meet current Good Manufacturing Practice regulations that ensure safe products for consumers. GMP regulations require pharmaceutical manufacturers to keep properly equipped facilities, trained staff, and strict quality control procedures in place. They must also maintain complete records of quality control. Companies that fail to comply with GMPs are considered to engage in fraud. One whistleblower in the United States received a $48.6 million award for blowing the whistle on GMPs failures. The company was found to have incomplete records as well as inadequate stability testing programs to ensure that its drugs met FDA quality standards.

Clinical Trial Fraud and FDA 510(k) Application Lawsuits

Clinical trial fraud tends to occur when drug companies submit false data to the FDA in order to receive approval. Pharmaceutical companies may also be liable for fraud if they failed to include clinical trial data about the negative side effects of a new drug. Section 510(k) of the Food, Drug and Cosmetic Act states that medical devices can be sold and marketed without approval if they are significantly comparable to other devices on the market. Companies may not misrepresent the similarity of a new device to an existing device to gain approval.

The Process

If you have proof of fraud and decide to act as a whistleblower, contact a qui tam lawyer to represent your case. Under the False Claims Act, you can file a lawsuit against an individual or a company that is committing fraud. Next, the qui tam lawsuit is filed “under seal,” which keeps the lawsuit confidential from all parties while the Justice Department further investigates. While the accused party still has no knowledge of your lawsuit, the government can work with your attorney to decide whether it will act on the case. It’s important to note that the government rarely joins in on a qui tam lawsuit; nevertheless, the government’s participation in your lawsuit will give you better odds. The False Claims Act can seal a qui tam case for 60 days, although courts can extend the seal to allow the government more time for investigation. Additionally, the government can partially lift the seal on the lawsuit to discuss the investigation and possibly a settlement with the accused party. Settlement negotiations are often the favored outcome of a qui tam lawsuit rather than a court trial. The award for the lawsuit varies according to the depth and quality of investigation in the case. If the government decides to act on the case and the case results in compensation, you (the whistleblower) can receive 15 to 25 percent of the recovery funds. However, if the government does not participate in the case, you can receive 25 to 30 of the recovery funds.

Contact a Texas Whistle Blower Lawyer

Whistleblowers who act under the qui tam law of the False Claims Act are usually responsible for revealing pharmaceutical fraud. If you have information related to possible government-related fraud, contact Brylak Law at (210) 733-5533. A Texas whistle blower lawyer can be a valuable in your fight against fraud.