Pueblo CO Whistleblower Lawyer
If you are aware of a situation in which a drug company promoted doctors to prescribe drugs for off-label uses, contact a Pueblo CO whistleblower lawyer as soon as possible. Such practices are illegal. This includes giving kickbacks to doctors for prescribing certain prescription medications or failing to follow FDA guidelines and regulations for safety.
You may have gained knowledge of such a situation while you were employed by a drug company or as a healthcare worker. If you are aware of these fraudulent actions, an attorney may be able to help you hold the company responsible and obtain whistleblower compensation. Contact Brylak Law today to learn more.
Marketing Drugs Off-Label
Drugs are typically only approved for treating specific medical conditions. That approval is based on clinical trials and studies that provided objective evidence regarding a drug’s effectiveness and safety. Doctors may sometimes prescribe medications for medical conditions other than their FDA approved conditions. However, the law prohibits pharmaceutical companies from encouraging doctors to do so. This would be considered misbranding of products, which can lead to lawsuits.
Sales representatives or other pharmaceutical company employees may encourage doctors to prescribe drugs for off-label conditions in order to increase sales. However, this is an illegal activity. In fact, one whistleblower lawsuit related to off-label drug marketing resulted in a False Claims Act recovery of $2.5. million. In that case, the pharmaceutical company was promoting the use of an anti-inflammatory drug after cataract surgery.
The law prohibits pharmaceutical companies from compensating doctors for prescribing specific medications. The law prohibits bribes or rebate programs for drugs. Both direct and indirect payments that reward doctors for prescribing medications are illegal. Anti-kickback whistleblower lawsuits may involve doctors who prescribe medications in return for golf trips, wine-tasting events, paid speaking engagements, and more.
Contact a Pueblo CO whistleblower lawyer to find out if your situation warrants a lawsuit.
Quality Control Procedures by the FDA
The FDA requires that pharmaceutical companies sell drugs under strict quality control guidelines. If they are adulterated, or not produced according to established procedures at each stage of the production process, then the pharmaceutical company can be found at fault.
All production stages must follow Good Manufacturing Practice (GMP) regulations to ensure that the pharmaceutical company sells safe drugs to the public. GMP regulations address issues like facilities, staff training, and more. Pharmaceutical companies must also maintain records that detail their quality control procedures.
A Pueblo CO whistleblower lawyer can help you determine if an entity has failed to meet FDA quality control guidelines and regulations.
Clinical Trial Fraud and FDA 510(k) Application Lawsuits
All prescription medications must go through clinical trials that ensure their safety for the public. However, pharmaceutical companies will often submit false data regarding those clinical trials in order to receive approval from the FDA. Some pharmaceutical companies fail to reveal all negative side effects of a drug in order to gain approval. These activities can result in liability for fraud.
Section 510(k) of the Food, Drug, and Cosmetic Act allows pharmaceutical companies to sell medications and other medical devices that are similar to approved products without FDA approval. However, sometimes a pharmaceutical company will submit fraudulent 510(k) applications. This can result in serious lawsuits against a pharmaceutical company, including fraud.
The Process of Filing a Whistleblower Lawsuit
If you believe that your employer or another company has engaged in fraud or other illegal activities, you may need to file a False Claims Act lawsuit against the entity that is committing fraud. You may also file a qui tam lawsuit. This will keep all information confidential from parties while the Justice Department investigates the situation. The accused party will not have immediate knowledge of the lawsuit. But you and your Pueblo CO whistleblower lawyer can prepare your side of the case.
Your False Claims Act lawsuit may be sealed for up to 60 days. During that time, the government will determine if it wishes to join the case. The government rarely joins qui tam lawsuits. However, if it does, you will have better odds of winning your case.
The favored outcome in a qui tam lawsuit is often a settlement. In this situation, the government will reveal the accusations to the company and try to obtain a settlement that rectifies the situation. This might involve compensation for those who were victims of the wrongdoing.
If the government acts on the case and decides to provide compensation, you may be able to receive between 15 and 25 percent of the recovery funds. If the government does not participate, but you win the case, then you may recover 25 to 30 percent of the funds.
Contact a Pueblo CO Whistleblower Lawyer Today
Whistleblower lawsuits can be complex. You will likely have to go up against powerful companies and their teams of lawyers. It’s best to work with a Pueblo CO whistleblower lawyer who can guide you through the legal process. Call Brylak Law today to learn more.