False Claims Lawyer
Novo Nordisk Settles Whistleblower Suits over Diabetes Drug Victoza for over $ 58 Million
September 5, 2017
With persevering False Claims Act qui tam whistleblowers and innovative Murphy Anderson PLLC lawyering in Washington, Boston, and Cincinnati, the False Claims Act has been utilized to help prohibit unsafe drug marketing tactics. In a first-of-its-kind False Claims Act settlement, Novo Nordisk, a Danish company, agreed to pay $ 46.5 million, according to the Department of Justice (DOJ), plus over $ 12 million to the FDA. The settlement resolves whistleblower claims that Novo Nordisk did not comply with safety communications required by federal Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) law. The FDA conditioned its approval of Victoza, a synthetic insulin for diabetes, upon Novo Nordisk's compliance with REMS.
The settlement ends claims by former Novo Nordisk sales representatives, including those represented by Murphy Anderson lawyers Mark Hanna, Michael Anderson, and Ann Lugbill, that Novo Nordisk defrauded federal Medicare, VA, and employee insurance programs and state Medicaid programs. The whistleblower suit alleges that doctors prescribed Victoza without adequate knowledge of safety issues. The Murphy Anderson whistleblowers alleged that Novo Nordisk, in order to maximize sales, failed to adequately inform prescribers of Victoza's medullary thyroid cancer risks.
The case demonstrates that the Civil War-era False Claims Act can be used to penalize pharmaceutical companies that use slick marketing tactics to avoid mandatory drug safety warnings and patient protections required by REMS. REMS was enacted by Congress in 2007, amidst an avalanche of media reports that pharmaceutical companies hid potential risks of harmful or fatal adverse drug effects. REMS requires manufacturers to conduct risk evaluation and mitigation efforts, individually tailored for each drug and its risks. REMS mandates that drug companies engage in ongoing action to study potential drug hazards and warn doctors and patients of risks. Consumers and prescribers alike can monitor current REMS warnings impacting prescription drug decisions.
Ann Lugbill explained that the REMS-False Claims legal theory utilized in this case is so significant that "had REMS' drug safety scheme been in place in the 1990's when opiate painkillers were marketed as safe and effective, our current heroin epidemic might not exist." With REMS in place and deployed with the False Claims Act, observed Mark Hanna, "countless overdoses might have been avoided and billions of dollars in law enforcement, drug treatment, and medical care saved."
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Our falseclaimslawyer.com website is for False Claims Act, SEC, CFTC and IRS tax whistleblowers and their attorneys to learn about the False Claims Act and its qui tam provisions and about SEC and IRS whistleblowing laws. The False Claims Act, SEC, CFTC and IRS whistleblower laws allow individuals to file a lawsuit or claim that could entitle them to a reward, a financial share of Government's recoveries from wrongdoers. Ann Lugbill and Murphy Anderson, PLLC regularly represent whistleblowers in federal court and the IRS and SEC whistleblower offices. This website reflects our decades of experience in representing our whistleblower clients.
Our Attorneys have participated in some of the most successful False Claims Act cases. Murphy Anderson attorneys work together in a team to represent False Claims Act qui tam relators, often with other law firms, to achieve the best results possible for clients. We work hard to augment Government resources by carefully preparing our cases, thoroughly interviewing and "debriefing" whistleblower clients, and providing the Government with a detailed, coherent explanation of the facts of the False Claims Act qui tam, SEC, IRS, or CFTC fraud scheme.
False Claims Act
The False Claims Act, 31 U.S.C. §3729 et seq., was once known as the "Lincoln Law." First enacted during the Civil War, the False Claims Act is designed to help whistleblowers protect themselves and the Government from those who seek to commit fraud when doing business with the Government. Under the False Claims Act's "qui tam" provisions, an individual blowing the whistle on those companies, individuals, institutions, and businesses that cheat state and federal government agencies, can become a qui tam "relator" and bring a lawsuit to expose and prosecute the fraud.
Whistleblowers bringing qui tam lawsuits under the federal and state False Claims Act have successfully recovered over $36 billion from fraudulent government contractors. Far more governmental resources are now focused on investigating and prosecuting fraudulent contractors in the health, defense, and other industries.
The False Claims Act has vigorous enforcement provisions. The Act provides for treble damages and civil penalties of $5500 to $11,000 for each false claim. False Claims Act qui tam relators who successfully bring suit are rewarded with a "bounty" of 15 to 30 percent of the Government's recovery.
The False Claims Act's qui tam provisions are based upon hundreds of years of English and American law. The term "Qui Tam" (rhymes with "Sea Clam") comes from a Latin phrase and means, "he who sues on behalf of the king." A False Claims Act defendant can be legally liable for filing a false claim for payment or by causing another company or person to send the Government a false bill or request for payment. Whistleblowers are like plaintiffs in other litigation, but in False Claims Act qui tam suits are called "relators."
False Claims Act Cases Include:
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Medical Device and Durable Medical Goods Fraud
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Medicare Fraud
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Medicaid Fraud
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Drug and Pharmaceutical Fraud
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Defense Contracting Fraud
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GSA Schedule and Catalog "Best Price" Violations
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Government Contractor Fraud
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Fraudulent Loans & Grants
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State and Local Government Contracting Fraud
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Health Care Fraud
IRS, CFTC, and SEC Whistleblowing
Whistleblowers may have claims under the special, newer statutes designed to encourage IRS (tax), CFTC (commodities) and SEC (investments) whistleblowers to come forward. These whistleblowers may receive a sizeable award of money if they successfully report tax cheats--the Internal Revenue Service then investigates the whistleblower tips. Whistleblowers can share in penalties or fines assessed by the Securities and Exchange Commission (SEC), when they report corporate violations of law and illegal financial transactions.