Pharmaceutical & FDA Fraud

Pharmaceutical whistleblower lawsuits often involve drug companies that promote or encourage doctors to prescribe drugs for off-label uses, give doctors kickbacks to prescribe certain medications, or fail to comply with the FDA’s manufacturing and safety regulations.

Whether you are a current or former drug company employee or executive, a pharmaceutical sales representative, or other healthcare professional, our attorneys may be able to help you collect a sizeable financial reward for reporting pharmaceutical fraud.

Many pharmaceutical employees who have knowledge of fraud are concerned about potential violations of HIPAA’s Privacy Rule. Though pharmaceutical companies themselves are unlikely to tell you this, it’s important to note that the Privacy Rule has a crucial exemption for whistleblowers.

Any documents or other protected information that could demonstrate illegal professional activities may be shared with an attorney, health oversight agency or public health authority. Information of this kind is essential in demonstrating intent to commit fraud or actual instances of fraud in qui tam cases.

If you have knowledge of a pharmaceutical organization that is defrauding taxpayers and the federal government, we will fight with you to hold them accountable and ensure you are compensated. Whether you are ready to blow the whistle or have questions, our attorneys can be easily and confidentially contacted through the phone number above or the form on the right.

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Off-Label Marketing of Drugs

When the FDA approves a prescription drug, the drug is approved only for treating a specific medical condition. This approval is based on clinical trials that demonstrate the drug is effective and safe in treating a particular disorder.

It is illegal for a pharmaceutical company to encourage doctors to prescribe a drug for a use that has not been approved by the FDA. For example, if the FDA has approved a drug to treat bipolar disorder, but the pharmaceutical company tells doctors that the drug is also effective at treating depression or other physiological conditions, the company is misbranding the product and breaking the law.

Misbranding drugs has been the subject of an increasing number of whistleblower lawsuits. In some cases, drug companies have encouraged their sales representatives (commonly known as “drug reps” or “pharmaceutical reps”) to tell doctors about the off-label benefits of a particular drug.

In one recent lawsuit, a whistleblower received a $2.5 million reward for filing a claim under the False Claims Act. In that case, an employee of a drug company provided information regarding a pharmaceutical company that was encouraging doctors to prescribe an anti-inflammatory drug, approved to treat pain following cataract surgery, for off-label uses such as the treatment of pain following glaucoma and Lasik surgeries.

Anti-Kickback Whistleblower Lawsuits

Federal law prohibits pharmaceutical companies from offering doctors any form of compensation in exchange for prescribing the company’s drugs. In addition to prohibiting outright bribes or rebate programs for a particular drug, federal law also prohibits other forms of direct and indirect payments to doctors for prescribing certain drugs. For example, some anti-kickback whistleblower lawsuits have alleged that pharmaceutical companies provided doctors with free golf outings, tickets to wine-tasting events, and paid speaking arrangements in exchange for prescribing certain drugs.

Federal law also prohibits the business practice of “tying” drugs. Tying occurs when a pharmaceutical company gives a discount on one drug to encourage the purchase or prescription of a different drug. Providing other types of incentives, such as discounted rates or rebates, to generate referrals is also prohibited under federal law.

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Whistleblowers and the FDA’s Quality and Control Procedures

The Food, Drug, and Cosmetic Act (FDCA) prohibits the sale of any drug that has been adulterated. Under the FDCA, a drug is adulterated if the methods or quality control procedures used in the manufacturing, processing, packing, or holding of a drug do not satisfy current Good Manufacturing Practice (cGMP) regulations. These regulations are intended to assure that a drug is safe for use and has the quality and purity characteristics that the drug is represented to contain.

GMP regulations also require drug manufacturers to have properly equipped manufacturing facilities, adequately trained staff, and stringent quality control over the drug manufacturing process. In addition, pharmaceutical companies must maintain complete and accurate production and quality control records. Failure to comply with cGMPs is considered pharmaceutical company fraud.

A whistleblower at Ranbaxy USA Inc., a subsidiary of India-based generic pharmaceutical company Ranbaxy Laboratories, received an award of $48.6 million for blowing the whistle on the company’s failure to comply with cGMPs. The drug company’s manufacturing facilities were found to have incomplete testing records, as well as an inadequate program to assess the stability characteristics of its drugs. Such testing is used to determine appropriate storage conditions and expiration dates for the drug, as well as to detect any impurities in the drug. The company failed to file timely “field alerts” with the FDA concerning these violations and agreed to settle the lawsuit for approximately $231 million.

Clinical Trial Fraud and FDA 510(k) Application Whistleblower Lawsuits

Clinical trial fraud occurs when pharmaceutical companies submit false data to the FDA to receive approval of a new drug. If a pharmaceutical company misrepresents the effectiveness of a new drug in clinical trials, it is breaking the law and can be held accountable through a whistleblower lawsuit. In addition, a pharmaceutical company can also be liable for fraud if it fails to include clinical trial data regarding the negative side effects of a new drug or minimizes the severity or frequency of these side effects.

Under Section 510(k) of the Food, Drug, and Cosmetic Act, medical devices can be marketed and sold without going through the FDA’s approval process if they are substantially equivalent to other devices that have already been approved. It is a violation of federal law for a drug company to make misrepresentations to the FDA in claiming that a new medical device is substantially equivalent to an already approved device.

FDA Whistleblower Protection and Patient Confidentiality

It is illegal for a pharmaceutical company to retaliate or take any adverse action against an employee or independent contractor who has blown the whistle on pharmaceutical fraud. If you are retaliated against in any way for filing a whistleblower lawsuit, our attorneys may be able to file a separate lawsuit seeking additional compensation on your behalf.

Furthermore, our attorneys understand the privacy requirements imposed by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and will work with you to ensure that any protected health information associated with your whistleblower claim remains confidential.

If you wish to speak with an experienced whistleblower attorney about pharmaceutical fraud, contact us by phone or the form on the right. Anything you say will be kept confidential, and we will be happy to address any questions or concerns you may have. Whistleblowing is a large and important responsibility. The qui tam lawyers at Morgan & Morgan are here to help you fight for what’s right, and fight on your behalf for compensation.