Supreme Court Just Made a Prosecutor’s Job More Difficult: The Impact of ‘Ruan’

2022/07/21

On June 27, the U.S. Supreme Court expanded the scope of the government’s burden of proof of a defendant’s mental state, or mens rea. The Supreme Court held that in a statute that provided an exception or exemption to prosecution, that is a clause stating “except as authorized,” the government must now prove beyond a reasonable doubt that a defendant knew that he did not fall within the scope of that exception. Although the case related to a federal criminal statute prohibiting the dispensing or distribution of controlled substances by a physician, the ruling can be applied to myriad criminal statutes that carve out exceptions or exemptions to prosecution. This article explains the Supreme Court’s decision and focuses on the ramifications as it pertains to other criminal statutes. It also raises questions regarding the reasonableness standards of the exclusionary rule under United States v. Leon, 468 U.S. 897 (1984). In Ruan v. United States, 597 U.S.        (2022), two physicians in two distinct cases were convicted of dispensing or distributing controlled substances by issuing opioid prescriptions in violation of 21 U.S.C. Section 841(a). Section 841 makes it a federal crime “except as authorized, … for any person knowingly or intentionally … to manufacture, distribute, or dispense … a controlled substance.” The Supreme Court consolidated the cases for purposes of the opinion. The defendants asserted that they were authorized to issue the prescriptions under 21 CFR Section 1306(a)(2021), which allows physicians to write prescriptions for controlled substances only “for a legitimate medical purpose … acting in the usual course of his professional practice.” They further asserted that even if they failed to comply with such standard, they believed they did. In other words, they asserted a good faith defense. The government in both trials argued that the prescriptions issued by the defendants did not comply with the standards set forth in 21 CFR Section 1306(a). Read More

Chambers USA Recognizes Pietragallo as a 2022 Leading Law Firm in Pennsylvania

2022/06/01

Pietragallo Gordon Alfano Bosick & Raspanti, LLP is pleased to be recognized by Chambers USA in its 2022 guide in the area of Litigation: White-Collar Crime & Government Investigations in Pennsylvania.  Chambers ranks leading law firms and attorneys across the U.S. based on the opinion of their clients and peers, and by the quality of their work. Chambers USA acknowledges that the Pietragallo team “is extremely knowledgeable about every facet of the work they are performing. In addition, they are very reliable, responsive and provide an excellent work product.” Clients and peers are quoted as saying, “They are reliable and straightforward. They certainly pay attention to me and keep me informed on matters referred to them.” Additionally, the following partners are ranked: William Pietragallo— Litigation: General Commercial— Pennsylvania: Pittsburgh & Surrounds Marc S. Raspanti— Litigation: White Collar Crime & Government Investigations— Pennsylvania Kevin E. Raphael— Litigation: White Collar Crime & Government Investigations— Pennsylvania   About Pietragallo Pietragallo Gordon Alfano Bosick & Raspanti, LLP is a multi-disciplined business and litigation law firm headquartered in Pittsburgh and Philadelphia with six offices throughout Pennsylvania, Florida, Ohio, and West Virginia from which we are able to serve our clients in all 50 states and the District of Columbia. Read More

Chalon C. Young Appointed Professor of Practice at the University of Pittsburgh School of Law

2022/03/04

Chalon C. Young has been appointed Professor of Practice at the University of Pittsburgh School of Law. This distinguished appointment requires a nomination and unanimous faculty vote. Professors of Practice are accomplished practitioners with extensive experience in a particular field of law, more than would be typical for most adjunct faculty. The purpose of the position is to enable the Law School to take advantage of the substantial practical experience of a highly successful practitioner, at a greater level than would be afforded by an adjunct affiliation. Chalon has served as an adjunct professor at the University of Pittsburgh School of Law for the past three years. Chalon has 20 years of experience in both civil and criminal litigation and has represented clients in criminal defense cases at the State and Federal level. She has represented hundreds of clients in a wide range of criminal jury trials, with most of her representation in homicide, major crimes, complex cases and violent felonies. Her experience includes jury trials for homicide, sex offenses, drug trafficking, human trafficking, kidnapping, firearms offenses, and home invasion robberies, among other offenses. Read More

The Physician Payments Sunshine Act and the Future of Healthcare Transparency: Part 2

March 2, 2022

This is part 2 of a two-part article series. Part 1 was published in the February 2022 issue of Compliance Today and discussed the issues in the healthcare industry that led to the enactment of The Physician Payments Sunshine Act, it’s key statutory language, the potential penalties, and the Act’s evolution. The Physician Payments Sunshine Act (PPSA) took effect in 2013.[1] It requires medical product manufacturers to disclose to the Centers for Medicare & Medicaid Services (CMS) payments or transfers of value made to physicians or teaching hospitals. PPSA also requires manufacturers and group purchasing organizations to disclose any physician’s ownership or financial interest in those companies. The disclosed data is published annually in a publicly searchable database.[2] The rationale behind the public availability of the data is to empower patients through transparency to mitigate the putative effect of financial incentives on clinical behavior and the public and prevent physician-industry conflicts of interest. Part 1 of this article[3] offers a comprehensive analysis of the major healthcare regulatory enforcement statutes and their continuingly expansive use. First, it considers the issues in the healthcare industry that led to the enactment of the PPSA are relevant to an understanding of the current law and its growing enforcement. Next, it discusses PPSA key statutory language and its evolution and considers the impact from a fraud and abuse standpoint. Part 2 of this article reviews the significance of the first examples of Department of Justice enforcement of the act, as well as the likely increase of private PPSA enforcement. Other sunshine acts, including state and international acts, are also highlighted. Finally, an examination of the future of transparency statutes, including the Hospital Price Transparency regulation,[4] the newest major transparency statute proposed; the Prescription Drug Price Transparency Act; and the Transparency in Coverage statute, which support the notion that transparency is a trend in the healthcare industry that will withstand the test of time. Read More

The Physician Payments Sunshine Act and the Future of Healthcare Transparency: Part 1

2022/02/02

Part 2 of this article series will be published in the March 2022 issue of Compliance Today and focus on examples of enforcement actions and examine the future of transparency statutes. The Physician Payments Sunshine Act (PPSA) took effect in 2013.[1] It requires medical product manufacturers to disclose to the Centers for Medicare & Medicaid Services (CMS) payments or transfers of value made to physicians or teaching hospitals. The act also requires manufacturers and group purchasing organizations to disclose any physician’s ownership or financial interest in those companies. The disclosed data is published annually in a publicly searchable database.[2] The rationale behind the public availability of the data is to empower patients through transparency to mitigate the putative effect of financial incentives on clinical behavior and the public and prevent physician-industry conflicts of interest. This two-part article provides a comprehensive analysis of the major healthcare regulatory enforcement statutes and their continuingly expansive use. First, we’ll reference the issues in the healthcare industry that led to the enactment of the PPSA that are relevant to an understanding of the current law and its growing enforcement. Next, we’ll discuss key statutory language and PPSA’s evolution. Then, we’ll consider the impact from a fraud and abuse standpoint, which is important to appreciate the significance of the first examples of Department of Justice enforcement of the act that follow, as well as the likely increase of private PPSA enforcement. We’ll also highlight other sunshine acts, including state and international ones. Finally, we’ll examine the future of transparency statutes, including the Hospital Price Transparency regulation,[3] the newest major transparency statute proposed; the Prescription Drug Price Transparency Act; and the Transparency in Coverage statute, which support the notion that transparency is a trend in the healthcare industry that will withstand the test of time. The lead-up to the enactment of the Physician Sunshine Act After years of calls for the healthcare industry to shift toward a more transparent and consumer-friendly environment, the Patient Protection and Affordable Care Act (ACA) passed in 2010, including the PPSA codified at 42 U.S.C. Read More

BEWARE Pension Plan Trustees: The United States Supreme Court has Reinforced Your Responsibility

2022/01/31

On Monday, January 24, 2022 the United States Supreme Court issued its much-anticipated opinion in the Hughes, et al. v. Northwestern University, et al. case. Before the Court was the issue of whether Northwestern University violated its fiduciary duty to a class of employee-investors under ERISA by allegedly including unnecessarily expensive investment options and paying excessive fees although they simultaneously offered low cost options. In short, is it a violation of Northwestern’s fiduciary duty to offer both reasonable and unreasonable investment options if they ultimately allow the employee investor to choose which plan to invest in? The District Court ruled the university satisfied their fiduciary duty and dismissed the case. The Seventh Circuit agreed affirming the lower court. The Supreme Court ultimately disagreed and reinstated the class action finding that employee choice does not cure the universities’ potentially imprudent offerings. The basis for the Supreme Court’s reversal and remand is that the lower courts’ rationale was inconsistent with the explanation of the duties owed by a fiduciary explained in Tibble v. Edison Int’l, including the duty to monitor and oversee all plan investment options and remove any deemed imprudent. 575 U. S. 523, 530 (2015). While the Seventh Circuit also based its opinion on guidance provided in Tibble, namely the duty to offer a diverse menu of plan options, it ignored the duty to remove imprudent offerings. The Court briefly touched on the Petitioners’ allegation including: 1. Northwestern failed to monitor record keeping and investment management fees; 2. Northwestern offered plan options including “retail” share classes while identical and cheaper “institutional” share classes were available; and 3. Northwestern created confusion by offering over 400 investment options. By focusing solely on the university diversifying their plan options and providing participant choice, the Seventh Circuit and District Court ignored other equally important aspects of the duty of prudence owed by a fiduciary. Read More

Pietragallo Expands Litigation Practice with Another Round of New Hires

2022/01/24

In another significant expansion of the firm’s litigation practice, Pietragallo Gordon Alfano Bosick & Raspanti, LLP is pleased to announce the addition of four new associates to the firm’s Pittsburgh and Philadelphia Offices. “Despite these challenging times, we remain fully committed to providing our clients with top flight service. We are thrilled to welcome this talented and diverse group of litigators to our team,” said Pietragallo Chairman William Pietragallo, II. The group of four new associates includes: Chalon C. Young joins our Toxic Tort, Medical Malpractice, and Government Enforcement, Compliance, and White Collar Litigation teams in our Pittsburgh office. Chalon brings 20 years of experience in both civil and criminal litigation and has represented clients in criminal defense cases at the State and Federal level. She is an adjunct professor at the University of Pittsburgh School of Law and previously served as the Manager of Training and Director of Internship Programs for the Allegheny County Public Defender’s Office in Pittsburgh, Pennsylvania. She is a graduate of Tulane University Law School. Lee K. Goldfarb joins our Government Enforcement, Compliance, and White Collar Litigation team as a senior associate in our Pittsburgh office. Lee brings over 10 years of experience in both civil and criminal litigation. She began her legal career as an Assistant District Attorney at the Allegheny County District Attorney’s Office in the Child Abuse Unit and then transitioned to civil litigation specializing in defending medical malpractice and tort cases. She is a graduate of University of Pittsburgh School of Law. Angela L. Velez joins our Employment and Labor team in our Philadelphia office. Angela brings over 10 years of experience with the New Jersey Department of Education and New Jersey Office of the Attorney General. As a Deputy Attorney General, she has represented the Department of Education and State universities in complex legal matters in federal and state administrative, trial, and appellate court. Read More

Jeremy E. Abay Serving as Adjunct Professor at Rutgers Law School

2022/01/12

Jeremy E. Abay is serving as an adjunct professor at Rutgers Law School, where he teaches Deposition Advocacy. This skills course is a part of the Law School’s Advocacy and Litigation curriculum. Mr. Abay represents whistleblowers, employees, consumers, and corporations in high-stakes litigation in state and federal courts. His practice covers healthcare fraud (qui tam), wage litigation, and consumer fraud. He has obtained multimillion-dollar settlements for taxpayers, misclassified workers, and victims of consumer fraud. Read More

Pietragallo Partner Timothy Hazel Appointed Board Chair of the Allegheny County Board of Property Assessment Appeals and Review

2022/01/10

Pietragallo partner Timothy Hazel has been appointed the Board Chair of the Allegheny County Board of Property Assessment Appeals and Review (BPAAR). Tim will serve as the Board Chair for a one-year term. The BPAAR is oversees assessment appeals and certify assessment appeal decisions concerning: the valuations of real property used by taxing authorities within the County for the purpose of levying taxes, and whether real property is exempt from real property taxation based upon the applicable law. The board is composed of seven members who are all appointed for three year terms. The BPAAR hears and decides all appeal hearings pursuant to the Board’s Rules (authority under the Allegheny County Home Rule Charter Article X Section 5). Tim’s practice is centered in the real estate, construction, housing, retail, hospitality, and oil and gas industries. For nearly two decades, he has represented lenders, borrowers, developers, contractors, design professionals, big box retailers, landlords, and tenants in a myriad of transactions including: land acquisition and divestiture; project financing; zoning and land use; construction, project and design contracting; leasing (industrial, commercial, retail and office); organization and equity structuring; oil and gas contracting and acquisition at all levels (upstream, mainstream and downstream); and franchising. About Pietragallo Gordon Alfano Bosick & Raspanti, LLP Pietragallo Gordon Alfano Bosick & Raspanti, LLP is a multi-disciplined business and commercial litigation firm headquartered in Pittsburgh with five offices throughout Pennsylvania, Ohio, and West Virginia from which we serve our clients in all 50 states and the District of Columbia. Read More

The differences and similarities between American and Italian healthcare fraud, waste, and abuse laws: Part 3

2022/01/03

Part 1 of this article series, published in the November 2021 issue of Compliance Today, outlined in general the American and Italian healthcare systems. Part 2, published in the December 2021 issue, outlined America’s primary healthcare fraud laws. Part 3 of this series outlines the Italian healthcare enforcement regime, criminal law, and the Anti-Corruption Act. Italian enforcement against fraud and corruption, including in the healthcare field, has traditionally been reserved to criminal courts, with no specific effort to coordinate or combine these actions through civil remedies. In light of the largely state-funded healthcare system in Italy, government corruption is in the foreground of efforts to detect and prevent fraud, waste, and abuse in healthcare. Egregious scandals erupted in Italian healthcare sectors, especially in the 1990s. Perhaps the most notorious case involved Dr. Duilio Poggiolini, the Ministry of Health’s general manager of the pharmaceutical department whose fortune included gold, jewels, and paintings of enormous value.[1] Poggiolini was charged and arrested for using his position for personal benefit, and his sentence of seven and a half years in prison was reduced on appeal.[2] The scandal surfaced during an investigation, called “mani pulite,” by a pool of public prosecutors operating out of the Milan criminal court. They were able to pierce the veil of silence that long protected government corruption. While its success resulted from significant cooperation and solidarity among the prosecutors, their coordination was not officially structured as an institutional team. Italy’s criminal law Italian criminal law always has included crimes of government corruption. The Italian Criminal Code has been amended periodically, not only to increase the sanctions (as, for example, in the latest “Spazza-Corrotti” amendments in 2019), but also with the aim of criminalizing more subtle corruption than an outright offer of cash in exchange for favorable treatment by a public official. Read More