The False Claims Act (FCA), also called the "Lincoln Law", is an American federal law that imposes liability on persons and companies who defraud governmental programs. It is the federal government's primary litigation tool in combating fraud against the government. The law includes a qui tam provision that allows people who are not affiliated with the government, called "relators" under the law, to file actions on behalf of the government. This is informally called "whistleblowing", especially when the relator is employed by the organization accused in the suit. Persons filing actions under the Act stand to receive a portion of any recovered damages.
A prescription, often abbreviated ℞ or Rx, is a formal communication from a physician or other registered health-care professional to a pharmacist, authorizing them to dispense a specific prescription drug for a specific patient. Historically, it was a physician's instruction to an apothecary listing the materials to be compounded into a treatment—the symbol ℞ comes from the first word of a medieval prescription, Latin: Recipere, that gave the list of the materials to be compounded.
Many countries have measures in place to limit advertising by pharmaceutical companies.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
Stenberg v. Carhart, 530 U.S. 914 (2000), was a landmark decision of the US Supreme Court dealing with a Nebraska law which made performing "partial-birth abortion" illegal, without regard for the health of the mother. Nebraska physicians who performed the procedure contrary to the law were subject to having their medical licenses revoked. The Court struck down the law, finding the Nebraska statute criminalizing "partial birth abortion[s]" violated the Due Process Clause of the United States Constitution, as interpreted in Planned Parenthood v. Casey and Roe v. Wade.
IMS Health was an American company that provided information, services and technology for the healthcare industry. IMS stood for Intercontinental Medical Statistics. It was the largest vendor of U.S. physician prescribing data. IMS Health was founded in 1954 by Bill Frohlich and David Dubow with Arthur Sackler having a hidden ownership stake. In 2010, IMS Health was taken private by TPG Capital, CPP Investment Board and Leonard Green & Partners. The company went public on April 4, 2014 and began trading on the NYSE under the symbol IMS. IMS Health was headquartered in Danbury, Connecticut.
Randall v. Sorrell, 548 U.S. 230 (2006), is a decision by the Supreme Court of the United States involving a Vermont law which placed a cap on financial donations made to politicians. The court ruled that Vermont's law, the strictest in the nation, unconstitutionally hindered the citizens' First Amendment right to free speech. A key issue in the case was the 1976 case Buckley v. Valeo, which many justices felt needed to be revisited.
IQVIA, formerly Quintiles and IMS Health, Inc., is an American multinational company serving the combined industries of health information technology and clinical research. IQVIA is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services, including consulting services. It has a network of more than 88,000 employees in more than 100 countries and a market capitalization of $49 Billion as of August 2021. As of 2017, IQVIA was reported to be one of the world's largest contract research organizations.
Whalen v. Roe, 429 U.S. 589 (1977), was a case brought before the Supreme Court of the United States. The case involved a New York state prescription monitoring law requiring reporting and storage of information concerning all Schedule II drug prescriptions. Physicians were required to report the name of the prescribing physician; the dispensing pharmacy; the drug and dosage; and the name, address, and age of the patient. This information was then stored by the New York Department of State.
David Franklin is an American microbiologist and former fellow of Harvard Medical School who while employed by Parke-Davis filed the 1996 whistleblower lawsuit exposing their illegal promotion of Neurontin (gabapentin) for off-label uses. Franklin's suit, filed on behalf of the citizens of the United States under the qui tam provisions of US federal and state law, uncovered illegal pharmaceutical industry practices and created new legal precedent that resulted in a cascade of criminal convictions and civil and criminal penalties against Pfizer and several other pharmaceutical companies totalling more than $7 billion. Civil cases also followed Franklin v. Parke-Davis. Insurance companies, led by Kaiser Permanente, sued Pfizer for fraud and violation of the federal Racketeer Influenced and Corrupt Organizations Act; the Kaiser case settled in April 2014 after Pfizer's appeal at the US Supreme Court was rejected. Franklin v. Pfizer also spawned more than a thousand wrongful death (suicide) suits associated with use of Neurontin. Numerous books have addressed the social, economic and healthcare implications of Dr. Franklin's stance and actions. The settlement was the first off-label promotion settlement under the False Claims Act.
Pharmaceutical fraud involves activities that result in false claims to insurers or programs such as Medicare in the United States or equivalent state programs for financial gain to a pharmaceutical company. There are several different schemes used to defraud the health care system which are particular to the pharmaceutical industry. These include: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs. Examples of fraud cases include the GlaxoSmithKline $3 billion settlement, Pfizer $2.3 billion settlement, and Merck $650 million settlement. Damages from fraud can be recovered by use of the False Claims Act, most commonly under the qui tam provisions which rewards an individual for being a "whistleblower", or relator (law).
Madsen v. Women's Health Center, Inc., 512 U.S. 753 (1994), is a United States Supreme Court case where Petitioners challenged the constitutionality of an injunction entered by a Florida state court which prohibits antiabortion protesters from demonstrating in certain places, and in various ways outside of a health clinic that performs abortions.
Franklin v. Parke-Davis is a lawsuit filed in 1996 against Parke-Davis, a division of Warner-Lambert Company, and eventually against Pfizer under the qui tam provisions of the False Claims Act. The suit was commenced by David Franklin, a microbiologist hired in the spring of 1996 in a sales capacity at Parke-Davis, a pharmaceutical subsidiary of Warner-Lambert. In denying the defendants' motion for summary judgment, the court for the first time recognized off-label promotion of drugs could cause Medicaid to pay for prescriptions that were not reimbursable, triggering False Claims Act liability. The case was also significant in exposing the degree to which publication bias impacts the randomized controlled studies conducted by pharmaceutical companies to test the efficacy of their products. Ultimately, the parties reached a settlement agreement of $430 million to resolve all civil claims and criminal charges stemming from the qui tam complaint. At the time of the settlement in May 2004, it represented one of the largest False Claims Act recoveries against a pharmaceutical company in U.S. history, and was the first off-label promotion settlement under the False Claims Act.
Reed v. Town of Gilbert, 576 U.S. 155 (2015), is a case in which the United States Supreme Court clarified when municipalities may impose content-based restrictions on signage. The case also clarified the level of constitutional scrutiny that should be applied to content-based restrictions on speech. In 2005, Gilbert, Arizona adopted a municipal sign ordinance that regulated the manner in which signs could be displayed in public areas. The ordinance imposed stricter limitations on signs advertising religious services than signs that displayed "political" or "ideological" messages. When the town's Sign Code compliance manager cited a local church for violating the ordinance, the church filed a lawsuit in which they argued the town's sign regulations violated its First Amendment right to the freedom of speech.
Marketing of off-label use is advertising the use of drugs for purposes not approved by the regional government. The practice is often illegal and has led to most of the largest pharmaceutical settlements after Franklin v. Parke-Davis, in which a court ruled off-label marketing a violation of the False Claims Act.
National Institute of Family and Life Advocates v. Becerra, 585 U.S. ___ (2018), was a case before the Supreme Court of the United States addressing the constitutionality of California's FACT Act, which mandated that crisis pregnancy centers provide certain disclosures about state services. The law required that licensed centers post visible notices that other options for pregnancy, including abortion, are available from state-sponsored clinics. It also mandated that unlicensed centers post notice of their unlicensed status. The centers, typically run by Christian non-profit groups, challenged the act on the basis that it violated their free speech. After prior reviews in lower courts, the case was brought to the Supreme Court, asking "Whether the disclosures required by the California Reproductive FACT Act violate the protections set forth in the free speech clause of the First Amendment, applicable to the states through the Fourteenth Amendment."
Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626 (1985), was a United States Supreme Court case in which the Court held that states can require an advertiser to disclose certain information without violating the advertiser's First Amendment free speech protections as long as the disclosure requirements are reasonably related to the State's interest in preventing deception of consumers. The decision effected identified that some commercial speech may have weaker First Amendment free speech protections than non-commercial speech and that states can compel such commercial speech to protect their interests; future cases have relied on the "Zauderer standard" to determine the constitutionality of state laws that compel commercial speech as long as the information to be disclosed is "purely factual and uncontroversial".
Agency for Int'l Development v. Alliance for Open Society International, 591 U.S. ___ (2020), also known as Alliance for Open Society II, was a United States Supreme Court case in which the Court held that compelled speech required as a condition for funding on foreign non-governmental affiliates of U.S. non-government organizations does not violate First Amendment rights.
Barr v. American Assn. of Political Consultants, Inc., 591 U.S. ___ (2020), was a United States Supreme Court case involving the use of robocalls made to cell phones, a practice that had been banned by the Telephone Consumer Protection Act of 1991 (TCPA), but which exemptions had been made by a 2015 amendment for government debt collection. The case was brought by the American Association of Political Consultants, an industry trade group, and others that desired to use robocalls to make political ads, challenging the exemption unconstitutionally favored debt collection speech over political speech. The Supreme Court, in a complex plurality decision, ruled on July 6, 2020, that the 2015 amendment to the TCPA did unconstitutionally favor debt collection speech over political speech and violated the First Amendment.
Ruan v. United States, 597 U.S. ___ (2022), was a case decided by the Supreme Court of the United States.
