Sorrell v. IMS Health Inc. | |
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Argued April 26, 2011 Decided June 27, 2011 | |
Full case name | Sorrell, Attorney General of Vermont, et al. v. IMS Health Inc. et al. |
Docket no. | 10-779 |
Citations | 564 U.S. 552 ( more ) 131 S. Ct. 2653; 180 L. Ed. 2d 544; 2011 U.S. LEXIS 4794 |
Argument | Oral argument |
Case history | |
Prior | Judgement for defendants, 631 F. Supp. 2d 434 (D. Vt. 2009); reversed and remanded, 630 F.3d 263 (2nd Cir. 2010); cert. granted, 562 U.S. 1127(2011). |
Holding | |
A Vermont statute that restricted the sale, disclosure, and use of records that revealed the prescribing practices of individual doctors violated the First Amendment. | |
Court membership | |
| |
Case opinions | |
Majority | Kennedy, joined by Roberts, Scalia, Thomas, Alito, Sotomayor |
Dissent | Breyer, joined by Ginsburg, Kagan |
Laws applied | |
U.S. Const. amend. I |
Sorrell v. IMS Health Inc., 564 U.S. 552 (2011), [1] is a United States Supreme Court case in which the Court held that a Vermont statute that restricted the sale, disclosure, and use of records that revealed the prescribing practices of individual doctors violated the First Amendment. [upper-alpha 1]
In 2007, Vermont passed the Prescription Confidentiality Law that required, among other things, that records containing a doctor's prescribing practices not be sold or used for marketing purposes unless the doctor consented. The law was a response to a Vermont Medical Society resolution stating that using the prescribing history of doctors in marketing was an intrusion into the way doctors practice medicine. [3] [4] The Vermont Medical Society had found that the marketing efforts of pharmaceutical companies used in large part the data of individual doctors' prescribing patterns, sold to the companies by pharmacies without the doctors' consent [5] and successfully lobbied the Vermont legislature to enact the law. [6]
Data mining companies and pharmaceutical manufactures contended that the law violated their First Amendment rights and sought declaratory and injunctive relief against Vermont officials. [upper-alpha 2] The United States District Court for the District of Vermont denied relief; the plaintiffs appealed to the United States Court of Appeals for the Second Circuit which reversed, holding that the law violated the First Amendment by restricting the speech of the companies without adequate justification. [upper-alpha 3] Vermont's Attorney General appealed to the Supreme Court, which granted certiorari to resolve the contradiction of a ruling of the United States Court of Appeals for the First Circuit, which had upheld similar laws in New Hampshire and Maine, concluding that the laws regulated economic conduct, not commercial speech. [7]
Associate Justice Anthony Kennedy delivered the opinion of the Court, which Chief Justice Roberts, Justice Scalia, Justice Thomas, Justice Alito, and Justice Sotomayor joined. The Court held that the law violated the First Amendment and affirmed the judgment of the Court of Appeals.
The first finding of the Court was that the law placed content and speaker based restrictions on speech. [upper-alpha 4] Citing Cincinnati v. Discovery Network, Inc. , the Court noted that these restrictions warranted heightened judicial scrutiny. [upper-alpha 5]
The Court rejected Vermont's argument that the law was only a commercial regulation and not a regulation of speech on the grounds that the law imposed more than an incidental burden on speech. [upper-alpha 6]
The second and final finding of the Court was that Vermont did not meet its burden to justify its content-based law as consistent with the First Amendment. According to Board of Trustees, State Univ. of N. Y. v. Fox , Vermont must demonstrate that the law directly advances a substantial government interest. [upper-alpha 7] The Court rejected Vermont's claims that the law was necessary to protect medical privacy and achieve improved public healthcare. [upper-alpha 8]
Associate Justice Stephen Breyer wrote a dissenting opinion, which Justice Ginsburg and Justice Kagan joined. Breyer argued that the law should be reviewed as an economic regulation, not under a heightened standard applied for First Amendment issues. Breyer found that the legitimate regulatory objectives outweighed the small harm done to First Amendment interests. [upper-alpha 9] Breyer also noted that applying a strict First Amendment standard whenever a legislative program burdened speech would give judges the power to choose to undermine or support legislative efforts. [upper-alpha 10]
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.
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