Colorado CO Whistleblower Lawyer
If you suspect that a drug company or medical provider has acted illegally, you may be able to receive whistleblower compensation for reporting their fraudulent behavior. Practices such as off-label drug marketing and kickbacks for prescribing medications can negatively impact everyone. If you have knowledge of a situation that violates FDA regulations and other laws, a Colorado CO whistleblower lawyer may be able to help you hold the company responsible. Call Brylak Law for more information about how we can help you with your situation.
Off-Label Drug Marketing
The FDA approves drugs for use in the treatment of specific medical conditions. This approval is the result of in-depth clinical trials and research that ensures a drug’s effectiveness and safety in use. Any other use is considered off-label drug use. However, pharmaceutical companies cannot encourage doctors to prescribe drugs for off-label use. The law considers this misbranding, which can often lead to lawsuits.
When a sales representative or other pharmaceutical company employee encourages a doctor to prescribe drugs in an off-label manner, they are often seeking increased sales. The more medical conditions people can use a drug for, the greater sales will be. However, this can be a dangerous practice. There may not be enough research to support prescribing a drug in an off-label manner. And irresponsible prescribing can make medical conditions worse.
In one False Claims Act that involved off-label drug marketing, a whistleblower provided information that helped recover $2.5 million. In that situation, a pharmaceutical company promoted the use of a drug that had been approved for anti-inflammatory use as a drug to be used after cataract surgery.
The law prohibits doctors from taking bribes or payments in return for prescribing certain drugs. Pharmaceutical companies often offer rebate programs or other bonuses to doctors who prescribe their medications. However, both direct and indirect payments to doctors as rewards for prescribing medications are illegal kickback programs. A whistleblower lawsuit that targeted kickbacks identified doctors who were prescribing medications in return for paid speaking engagements, wine-tasting events, and golf-trips.
Kickbacks are often disguised as typical occurrences. It may be difficult to identify a kickback program or situation. However, by working with a Colorado CO whistleblower lawyer, you can identify kickbacks and reveal the truth about an illegal situation.
FDA Quality Control Procedures
The FDA has strict quality control guidelines that pharmaceutical companies must follow when producing and distributing drugs. Additionally, pharmaceutical production must follow Good Manufacturing Practices (GMPs). This ensures drugs are safe for the public. GMPs address the safety of manufacturing facilities, staff training, record keeping, and more. If the pharmaceutical company doesn’t follow these practices throughout the process, they may be liable for any harm that results.
If you work in a pharmaceutical production facility and feel your employer is not following FDA quality control guidelines or GMPs, report the situation as soon as possible. However, it is understandable that you might be concerned about your job. So you may instead want to file a legal claim against your company to demand compliance. A Colorado CO whistleblower lawyer can help you understand your options.
Clinical Trial Fraud and Fraudulent FDA 501(k) Applications
Prescription medications must undergo clinical trials aimed at determining their safety for consumers. However, pharmaceutical companies sometimes falsify the results of clinical trials in an attempt to get the FDA to approve prescription medications. This can result in pharmaceutical companies releasing dangerous drugs on the market or not revealing negative side effects. When pharmaceutical companies falsify clinical trial information, they can be liable for fraud.
The Food, Drug, and Cosmetic Act has section 501(k), which allows drugs that are similar to other medications to pass through approval without going through intense clinical trials and other research. However, sometimes pharmaceutical companies falsify 501(k) applications in order to avoid the lengthy testing process. Fraudulent 501(k) applications can result in dangerous and untested medications being released on the market.
Understanding the testing that drugs have gone through can be difficult. If you suspect that a pharmaceutical company didn’t comply with FDA requirements for clinical trials or 501(k) requirements, contact a Colorado CO whistleblower lawyer.
If you suspect that your employer or another entity has fraudulently acted regarding pharmaceutical drugs, then you should take action to protect the public. A Colorado Co whistleblower lawyer can help you identify the illegal activities while protecting yourself.
The first step is to file a False Claims Act lawsuit against the company committing fraud. You can file a qui tam lawsuit. This will protect confidential information and seal the case for up to 60 days. During the time that the case is sealed, the government and your Colorado CO whistleblower lawyer can investigate the situation.
If the government decides to act on the case, then you can obtain between 15 and 25 percent of the amount that they recover. However, if the government does not participate and you win the case, you may get 25 to 30 percent of the recovery.
Contact a Colorado CO Whistleblower Lawyer Today
If you are aware of a situation where a pharmaceutical company or medical provider are acting fraudulently or otherwise illegally, you should act right away. You may be able to protect consumers from dangerous drugs or illegal activities. Contact us today to speak to a Colorado CO whistleblower lawyer at Brylak Law.