Pharmaceutical Whistleblower Attorney
Our Whistleblower Attorneys Represent Pharmacy, Pharmaceutical Company, and PBM Employees Nationwide
Fraud is a major concern in the U.S. pharmaceutical industry. From pharmaceutical companies to pharmacies and pharmacy benefit managers (PBMs), virtually all industry players are in a position to profit from statutory and regulatory violations. As a result, violations are common, and patients and taxpayers are typically the ones that face the consequences.
But, businesses that engage in pharmaceutical fraud can—and should—be held accountable. If you have information about fraud, we strongly encourage you to speak with a pharmaceutical whistleblower lawyer at Oberheiden P.C. We can help you decide whether to come forward; and, if you choose to do so, we can represent you throughout the process.
When Should You Speak with a Pharmaceutical Whistleblower Attorney?
Whistleblowers play an important role in protecting the integrity of the pharmaceutical industry. While federal agencies like the U.S. Department of Health and Human Services (DHHS) investigate pharmaceutical fraud, without whistleblowers, in many cases they simply don’t know when an investigation is necessary.
If you have information—or believe you may have information—about any form of pharmaceutical fraud, we encourage you to speak with a pharmaceutical whistleblower lawyer at Oberheiden P.C. Exposing pharmaceutical fraud is important, and we can help you do the right thing for yourself, your profession, and the patients you serve. Pharmaceutical whistleblowers are entitled to confidentiality and protection against retaliation in their employment. Our attorneys can help preserve your confidentiality, and we can work with the federal government on your behalf to help ensure that the appropriate parties are held accountable for their wrongdoing.
Common Types of Pharmaceutical Whistleblower Claims
At Oberheiden P.C., our whistleblower lawyers handle all types of pharmaceutical whistleblower claims. This includes claims under the False Claims Act (FCA), the FDA Food Safety Modernization Act (FSMA), and other pertinent federal laws. Some of the most common types of pharmaceutical whistleblower claims include:
Failure to Comply with Current Good Manufacturing Practices (CGMPs)
Pharmaceutical companies must comply with the Current Good Manufacturing Practices (CGMPs) adopted and enforced by the U.S. Food and Drug Administration (FDA). The CGMPs are designed to help ensure that all drugs sold in the U.S. are not adulterated, contaminated, or otherwise tainted in any way. When pharmaceutical companies fail to comply with the CGMPs, the subsequent sale of ineffective or dangerous drugs can put patients’ lives at risk—and holding the pharmaceutical companies accountable for CGMP violations is essential for preventing similar violations in the future.
Failure to Comply with Quality Systems Regulations (QSRs)
The Quality Systems Regulations (QSRs), found in 21 C.F.R. Part 820, are also in place to protect patients from dangerous drugs. The FDA enforces the QSRs as well, but it relies on the pharmaceutical companies to self-police in many respects. As a result, violations are not uncommon, and far too many manufacturers choose to prioritize profit maximization over ensuring patients’ safety.
Fraud on the FDA
Along with violations of the CGMPs and QSRs, pharmaceutical whistleblowers can also file claims based on “fraud on the FDA.” Fraud on the FDA involves submitting false information in order to fraudulently represent compliance, including withholding data from the FDA to secure drug approval. If you have information about a pharmaceutical company submitting false information or withholding data from the FDA, we encourage you to speak with one of our pharmaceutical whistleblower attorneys promptly.
Prohibited Off-Label Drug Marketing
Marketing a drug for off-label use is another common form of pharmaceutical fraud. Pharmaceutical companies can only lawfully market their drugs for uses that have been specifically approved by the FDA. Along with marketing drugs for non-approved uses, marketing unapproved dosages and promoting benefits for certain populations without FDA approval is considered fraudulent off-label drug marketing as well.
Compounded Pharmaceutical Fraud
Compounding pharmacies can face federal prosecution for various forms of fraud. These include compounding unapproved medications, “compounding” drugs that are already commercially available, and compounding in batches rather than for individual patients (a practice federal prosecutors refer to as “mass compounding”). We represent employees of compounding pharmacies throughout the United States in pharmaceutical whistleblower claims.
Offering and Paying Kickbacks to Healthcare Providers
Offering and paying kickbacks to healthcare providers violate federal law when these transactions involve Medicare or Medicaid-reimbursed funds. Illicit transactions can lead to civil or criminal enforcement, and pharmaceutical employees who are aware of these transactions should consult with a pharmaceutical whistleblower lawyer promptly to ensure that they take appropriate legal action.
Medicare Part D and Medicaid Fraud
Along with offering and paying kickbacks, pharmacies and pharmaceutical companies can also face prosecution for many other types of Medicare Part D and Medicaid fraud. Upcoding, unbundling, double-billing, and phantom billing are all common forms of fraud that whistleblowers can expose to receive both protection and financial compensation.
340B Drug Discount Program Fraud
Under the federal 340B drug discount program, pharmaceutical companies must offer discounted pricing to qualifying hospitals, clinics, and other healthcare providers. All forms of 340B drug discount program fraud can warrant pharmaceutical whistleblower claims, including improper calculation of discounted rates and submitting fraudulent 340B reports to the Centers for Medicare and Medicaid Services (CMS).
False and Misleading Marketing Claims Based on Bad Data
Pharmaceutical companies can also face prosecution for making false and misleading marketing claims based on bad data. This includes data that have been falsified, misrepresented, or unduly influenced by interested parties. For obvious reasons, misleading healthcare providers and patients about the benefits or risks associated with a drug can be extremely dangerous, and this is another all-too-common form of fraud for which pharmaceutical companies can—and should—be held accountable.
If you believe that you may have information about any form of pharmaceutical fraud, we strongly encourage you to speak with one of our attorneys. While these are some of the most common forms of fraud we see, they are also just examples. We can determine if you qualify as a pharmaceutical whistleblower; and, if you do, we can represent you throughout the process of blowing the whistle, working with the federal government, and obtaining whistleblower compensation.
FAQs: Hiring a Pharmaceutical Whistleblower Attorney to Represent You
How Do I Know if I Qualify as a Pharmaceutical Whistleblower?
Not all pharmaceutical company, pharmacy, and PBM employees who have inside information qualify as whistleblowers. To secure protection as a whistleblower (and to be eligible for whistleblower compensation), you must have actionable information about a violation of federal law. When you contact us, a pharmaceutical whistleblower attorney at Oberheiden P.C. can determine if you have sufficient information to come forward.
How Do I File a Whistleblower Claim Against a Pharmaceutical Company, Pharmacy, or PBM?
In most cases, filing a whistleblower claim against a pharmaceutical company, pharmacy, or PBM involves submitting a protected disclosure to the U.S. Department of Justice (DOJ). To secure protection against retaliation and establish their right to compensation, pharmaceutical whistleblowers must timely submit their protected disclosures through the proper channels. Our attorneys represent whistleblowers nationwide, and we can guide you through the process step by step.
What Is Involved in Filing a Pharmaceutical Whistleblower Claim?
While filing a pharmaceutical whistleblower claim begins with submitting a protected disclosure to the federal government, this is often just the first step in a much longer process. Whistleblowers must be prepared to work with the federal government as necessary; and, in some cases, they may need to rely on their attorneys to take legal action if the federal government declines to intervene. But, while there are several steps involved, going through the process is well worth it if it means uncovering fraud and securing a substantial whistleblower compensation award.
Will I Receive Financial Compensation as a Pharmaceutical Whistleblower?
Pharmaceutical whistleblowers can receive between 15% and 30% of the amount the government recovers if the information they disclose leads to a successful enforcement action. If you are thinking about blowing the whistle but want to know if it’s worth it, our attorneys can provide a preliminary assessment of the value of your claim so that you can make an informed decision about how to proceed.
Do I Need a Pharmaceutical Whistleblower Attorney?
Given the challenges involved with blowing the whistle and securing protection (and your right to compensation) as a whistleblower, it is strongly advised that you seek experienced legal representation. Typically, it costs nothing out-of-pocket to hire a pharmaceutical whistleblower attorney to represent you. At Oberheiden P.C., we represent whistleblowers nationwide, and we rely on our experience as former U.S. Attorneys and Assistant U.S. Attorneys to work effectively with the DOJ on behalf of our clients.
Schedule a Free and Confidential Consultation with an Attorney at Oberheiden P.C.
If you have questions about blowing the whistle against a pharmaceutical company, pharmacy, or PBM, we encourage you to contact us promptly. We will arrange for you to speak with an attorney in complete confidence as soon as possible. To schedule a free, no-obligation consultation with a pharmaceutical whistleblower attorney at Oberheiden P.C., please call 888-680-1745 or tell us how we can reach you online today.