It takes courage and a strong sense of duty to call out corporate fraud against the government. At Halunen, we’re here to help you stand up and speak out. Because when you’re willing to fight for what’s right, we’re in the fight with you.
For more than 20 years, Halunen Law has represented hundreds of whistleblowers across the country and consistently achieved significant results for our clients. Our Firm represented a whistleblower in a government fraud case that resulted in one of the largest settlements in U.S. history-- $1.5 billion. Our client, and several other whistleblowers related to the case, were awarded a substantial reward for bringing the case to the government for prosecution. Halunen Law is recognized nationally for achieving several seven and eight-figure settlements and favorable verdicts for our clients. With your courage, and our expertise, let’s chart the course to achieve justice.
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What sets Halunen Law apart from most other whistleblower law firms?
What sets Halunen Law apart from most other whistleblower law firms is that we often get involved in a case before a client makes any type of whistleblower report. We are experts in guiding clients through the maze of considerations involved in putting together the strongest possible report. We help to identify potential state and federal regulations that might be implicated and provide guidance on what you might want to include in a report. We also advise you on who to make the report to and how the report should be made. At the end of the day, we help our clients put themselves in the best possible position to win their case at trial. However, over 95% of the cases are settled prior to trial because the potential costs to an employer are often simply too high to risk going to trial. In the end, clients choose us because we are the best at what we do and we win. That “win” is getting you the justice that you deserve and putting an end to the illegal conduct.
The following are examples of common frauds or misconduct that may result in protection from retaliation or a reward for exposing the illegality. However, if your situation does not fall within any of these examples, we encourage you to contact us to discuss the specific facts in your situation because there are as many types of fraud, abuse and misconduct as there are people with corrupt minds to create illicit schemes. What is most important is this—if your gut tells you that some conduct or practice is wrong because it causes harm to others-- or because it may cause harm to others-- or if something you see just doesn’t feel right—either morally or ethically—reach out to one of our experienced whistleblower attorneys to help you navigate this rugged terrain.
Because the medical device market is extremely competitive, medical device manufacturers face significant pressure to maximize sales and profits. Some medical device manufacturers engage in deceptive sales practices and other fraudulent activity to beat the competition. Given the substantial competition, it has become common place in the medical device industry for companies to engage in practices that violate the federal regulations put in place to make ensure that products placed into the stream of commerce are both safe and efficacious. This is known as regulatory misconduct. Halunen Law has had years of experience representing employees of medical device companies who have either been terminated for reporting regulatory fraud or who need assistance making a report of regulatory fraud. Because these schemes are complicated and difficult to detect, it takes brave whistleblowers to come forward and report information about medical device fraud.
Examples of regulatory violations:
Clinical study violations
• Fabricating Data
• Deception in Clinical Research
Failure to investigate and remediate potential device safety issues.
Promotion or advertising of a device outside the FDA-cleared or approved indications for use.
Marketing a device without the appropriate FDA approval.
Failure to disclose device safety issues to the FDA
Big Pharma is the nickname given to the world’s pharmaceutical industry. It also includes the trade group, Pharmaceutical Research and Manufacturers of America (PhRMA). Big Pharma makes billions of dollars every year in profits. They’ve also spent billions on fines, settlements and jury verdicts for engaging in illegal and fraudulent practices involving the sale of their drugs.
Big Pharma is one of the most powerful industries in the world. The global revenue for pharmaceuticals was over $1.3 trillion in 2019. But nowhere else in the world do the drug and medical device industries have as much power and make as much money as in the United States.
The industry has a history of fraud, bribery, lawsuits and scandals. Despite criminal charges and fines, Big Pharma companies continue to make huge profits and executives rarely go to jail.
Generic Drug Fraud
Clinical Study Violations
Failure to disclose drug safety issues to the FDA
Failure to investigate and remediate potential drug safety issues.
Marketing a drug without the appropriate FDA approval.
Violating good manufacturing practices in the design and manufacture of drugs.
Marketing drugs, despite knowledge or reasonable cause to believe that the drug is harmful
Fraud is “the knowing breach of the standard of good faith and fair dealing as understood in the community, involving deception or breach of trust, for money.” Fraud is an intentional deception made for personal gain or to damage another individual, for instance, intentionally falsifying and/or fabricating research data, and misleading reporting of the results. Misconduct may not be an intentional action, rather an act of poor management. It also includes failure to follow established protocols if this failure results in unreasonable risk or harm to humans. Fraud has an element of deliberate action, which is not the case with misconduct.
Laws and regulations change as quickly as fraud schemes do. Contractors find new ways to cheat in their government contracts. Companies find new ways to take unlawful advantage of investors or others. Banks find ways to bilk customers out of money by charging illegal fees. Medical device and pharmaceutical companies sell unsafe products and pay illegal kickbacks to physicians. Without insider employees stepping up to expose fraud, abuse and misconduct, most such wrongs would go undetected and bad actors would go unpunished. Whistleblowers are essential in keeping others honest in order to maintain integrity in their places of employment.