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Drug and Medical Device Manufacturers
Following a guilty plea last year by a major pharmaceutical company, Associate Attorney General Robert McCallum declared that “[t]he Department of Justice is committed to rooting out and prosecuting health care fraud. It is of paramount importance that the Department use every legal tool at its disposal to assure the health and safety of the consumers of America's health care system.” The tools — the variety of different criminal statutes and theories used to prosecute drug and device manufacturers — are so diverse as to defy easy summary. At one end are the general, long-established offenses, such as the Civil War-era statute criminalizing the submission of false claims to a department or agency of the United States, 18 U.S.C. ' 287 (the “criminal False Claims Act”) or the mail and wire fraud statutes. At the other are highly focused statutes, such as the federal health care “Antikickback Statute,” 42 U.S.C. ' 1320A-7b(b); see also 21 U.S.C. '' 331(t), 333(b) (drug importation and marketing violations), which prohibit, inter alia, “remuneration” to physicians to use drugs or devices that are reimbursable by a federal health care program. See also 68 Fed. Reg. 23,731, 23,734-38 (May 5, 2003) (identifying anti-kickback “risk areas”).
The Statutory and Regulatory Scheme
Congress enacted the Federal Food, Drug, and Cosmetic Act (FDCA or 'the Act'), 21 U.S.C. ” 301-399, in 1938 to protect the public from deleterious, impure, and deceptive goods. FDCA violations include adulterating or misbranding a food, drug, device, or cosmetic and placing it in interstate commerce. 21 U.S.C. ' 331(a)-(b). The Food and Drug Administration (FDA) has used the misbranding provisions of the Act to prosecute a wide range of actions from failure to disclose safety information to marketing of products for 'off-label' uses, though such marketing theories can raise significant constitutional issues. See, eg, Washington Legal Foundation v. Henney, 202 F.3d 331, 336 n.6 (D.C. Cir. 2000) (First Amendment violation). Violators are subject to criminal and civil penalties, injunctions, exclusion from federal health programs, and seizure of goods.
The FDA's Office of Criminal Investigations has primary responsibility for investigating criminal violations of the FDCA, but refers matters to the DOJ when action by a grand jury appears warranted. By regulation, 28 C.F.R. ' 0.45(j), the Assistant Attorney General, Civil Division, through the Office of Consumer Litigation (OCL), has overall responsibility for criminal and civil litigation arising under the FDCA. The Washington Legal Foundation has recently petitioned the DOJ to transfer this role to the Department's Criminal Division in cases involving promotional activities of pharmaceutical companies because of concerns that the “OCL has failed to provide clear guidance and coordination” and “has left senior FDA officials largely in the dark” as to standards for such investigations. See http://www. wlf.org/upload/COMEYLET.pdf. Any individual U.S. Attorney's Office may also carry out grand jury investigations and prosecute violations.
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
Legal Possession: What Does It Mean?
Possession of real property is a matter of physical fact. Having the right or legal entitlement to possession is not "possession," possession is "the fact of having or holding property in one's power." That power means having physical dominion and control over the property.
The Stranger to the Deed Rule
In 1987, a unanimous Court of Appeals reaffirmed the vitality of the "stranger to the deed" rule, which holds that if a grantor executes a deed to a grantee purporting to create an easement in a third party, the easement is invalid. Daniello v. Wagner, decided by the Second Department on November 29th, makes it clear that not all grantors (or their lawyers) have received the Court of Appeals' message, suggesting that the rule needs re-examination.