White-Collar Criminal Law

August 22, 2022 by Duane Morris

Fraud-On-The-FDA Theory Of Liability Reawakened by DOJ Filing

On June 3, the U.S. Department of Justice Civil Division’s Washington, D.C., office filed a statement of interest in a relator’s action, arguing that “[c]onduct giving rise to a regulatory violation can also give rise to” False Claims Act liability.

The case is U.S. ex rel. Patricia Crocano v. Trividia Health Inc., before the U.S. District Court for the Southern District of Florida.

Specifically, the DOJ requested “that the ruling not foreclose the possibility that, under certain circumstances,” conduct that violates the Federal Food, Drug and Cosmetic Act or U.S. Food and Drug Administration regulations “could be material to the government’s payment decisions and provide a basis for FCA liability assuming all necessary FCA elements are demonstrated,”[3] colloquially known as “fraud on the FDA.”

This filing makes clear the DOJ’s decision to reawaken a theory of liability thought to be dead.

To read the full text of this article by Duane Morris attorneys Eric Breslin, Frederick R. Ball and Brittany Pagnotta, originally published in Law360, please visit the firm website.

July 8, 2022 by Duane Morris

Supreme Court Declines to Allow Miranda Violations as a Basis For a 42 U.S.C. § 1983 Claim

By Mario J. Cacciola

On June 23, 2022, the Supreme Court of the United State held that a violation of the Miranda rules does not provide a basis for a claim under 42 U.S.C. § 1983. Writing for the majority in Vega v. Tekoh, 597 U.S. (2022), Justice Alito stated, “The question we must decide is whether a violation of the Miranda rules provides a basis for a claim under § 1983. We hold that it does not.” In reaching its decision, the Court rejected the Ninth Circuit Court of Appeals finding that Miranda constitutes a violation of Fifth Amendment protections, and described Miranda as “set of prophylactic rules” that are “constitutionally based” rather than a de facto violation of the Fifth Amendment. As a result of the Court’s decision, the relief individuals may seek when facing a violation of Miranda is limited to seeking to exclude any wrongfully obtained statements from use at trial. Continue reading “Supreme Court Declines to Allow Miranda Violations as a Basis For a 42 U.S.C. § 1983 Claim”

June 30, 2022 by Duane Morris

Key Questions for New York and New Jersey Businesses Following the U.S. Supreme Court’s Gun Decision

On June 23, 2022, the Supreme Court of the United States recognized a constitutional right for citizens to carry a firearm outside the home for self-defense. The opinion invalidates the licensing regimes for carry permits in California, Hawaii, Maryland, Massachusetts, New Jersey, New York and the District of Columbia. Although New York and New Jersey each allow for licenses to carry, they were previously limited to those who could show some extraordinary need, and therefore not available to the average citizen. In New York Rifle & Pistol Assn. v. Bruen, the Supreme Court held that such restrictions are unconstitutional and that law-abiding citizens have a right to carry a gun for self-defense purposes.

This means that, for the first time since the early and mid-20th century, respectively, residents of New York and New Jersey will be permitted to carry firearms in public.

To read the full text of this Duane Morris Alert, please visit the firm website.

June 28, 2022 by Duane Morris

Fraud-on-the-FDA Theory of False Claims Act Liability Clarified by DOJ

On June 3, 2022, the Civil Division of the Department of Justice filed a statement of interest in a relator’s action in the Southern District of Florida, arguing that “[c]onduct giving rise to a regulatory violations can also give rise to [False Claims Act] liability.” Specifically, requesting “that the ruling not foreclose the possibility that, under certain circumstances, conduct giving rise to violations of the [Federal Food, Drug and Cosmetic Act] or FDA regulations could be material to the government’s payment decisions and provide a basis for FCA liability assuming all necessary FCA elements are demonstrated,” also known as “fraud on the FDA.”

To read the full text of this Alert, please visit the firm website.

June 27, 2022 by Duane Morris

United States Supreme Court Recognizes a Constitutional Right to Carry Firearms for Self-Defense

On June 23, 2022, the Supreme Court of the United States struck down New York’s restrictive concealed carry licensing regime as unconstitutional under the Second Amendment, invalidating licensing regimes in an additional six jurisdictions. In so doing, the Court rejected the long-standing practice of balancing the text and history of the Second Amendment with governmental interest, known as “means-end” scrutiny.

To read the full text of this Duane Morris Alert, please visit the firm website.

June 8, 2022 by Duane Morris

Longtime Federal Public Defender Leigh Skipper to Join Duane Morris at End of June

After leading the Federal Community Defender Office for the Eastern District of Pennsylvania for 14 years, Leigh Skipper is joining Duane Morris’ white-collar defense division at the end of June.

Skipper, who has served as chief federal defender for the Eastern District of Pennsylvania since 2009, is slated to join the firm’s Philadelphia headquarters June 27 after serving his last day at the federal community defender office on June 17. The move brings Duane Morris a public defender’s perspective in government investigations and commercial litigation following a slew of prosecutor-side hires.

To read the full text of this article, which originally appeared in The Legal Intelligencer, please visit the firm website.

June 1, 2022 by Mary P. Hansen

The SEC Ramps Up Efforts to Police Crypto Industry

As the crypto industry continues to grow and market volatility remains high, the Securities and Exchange Commission (SEC) has announced its plan to increase its regulation of the area. The SEC’s Crypto Assets and Cyber Unit, which was created in 2017, will expand from thirty to fifty positions. The unit is tasked with protecting investors from crypto-related frauds and scams. The increase in staffing will allow for more investor protection focused on the areas of crypto asset offerings, crypto asset exchanges, crypto asset lending and staking practices, decentralized finance (DeFi) platforms, non-fungible tokens (NFTs), and stablecoins. The twenty additional positions will mostly consist of supervisors, investigative staff attorneys, trial counsels, and fraud analysts. Continue reading “The SEC Ramps Up Efforts to Police Crypto Industry”

December 13, 2021December 13, 2021 by Frederick R. Ball

DOJ Reinstates and Augments Prior Corporate Criminal Enforcement Policies: Now Requiring Disclosure of ALL Involved Individuals and Consideration of ALL Prior Corporate Misconduct

On October 28, 2021, Deputy United States Attorney General Lisa Monaco issued a memorandum marking the first major announcement on corporate criminal enforcement from the Department of Justice (“DOJ”) under the Biden Administration (“Monaco Memo”). Most notably, this memorandum: (1) reinstates the Individual Accountability Policy originally announced in the Yates Memo and (2) guides prosecutors to look at all prior misconduct, not just those instances similar to the misconduct at issue in the present investigation. Continue reading “DOJ Reinstates and Augments Prior Corporate Criminal Enforcement Policies: Now Requiring Disclosure of ALL Involved Individuals and Consideration of ALL Prior Corporate Misconduct”

September 1, 2021 by Duane Morris

Prosecution for Noncompliance with Agency Guidance Documents Allowed by Attorney General’s Memorandum

On July 1, 2021, U.S. Attorney General Merrick Garland published a memorandum that rescinds two previous memoranda―the Sessions Memorandum and Brand Memorandum―that prohibited Department of Justice attorneys from using noncompliance with federal agency guidance documents as a basis for civil and criminal enforcement cases. Garland’s memorandum states these previous policies were “overly restrictive,” “discouraged the development of valuable guidance” and hindered DOJ’s litigation of cases when relevant agency guidance was available.

To read the full text of this Duane Morris Alert, please visit the firm website.

May 6, 2021 by Duane Morris

Expect Increasing Scrutiny of Wage-Fixing, No-Poach Deals

Companies have long sought to prevent their competitors — particularly in skilled fields like life sciences, health care, software development and engineering — from benefiting from the talents and training of their employees.

Examples of such efforts include noncompete agreements between employers and employees, and carefully worded joint venture agreements that prohibit one partner from insourcing the know-how of another partner.

Although noncompete agreements between employers and employees have been subject to scrutiny for years, agreements between employers to restrict solicitation of each other’s employees or to fix employee wages have largely flown under the radar.

In fact, it was not until a little over four years ago that federal antitrust enforcers signaled that such agreements could be presumed illegal and criminally prosecuted. And even that policy change, significant though it was, did not bring an immediate uptick in enforcement activity.

That wait now appears to be over. The U.S. Department of Justice’s Antitrust Division has recently been aggressively bringing enforcement actions against labor market collusion, with more cases on the horizon.

To read the full text of this article (originally published in Law360) by Duane Morris partners Christopher Casey, Sean McConnell and Brian Pandya, please visit the firm website.