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.

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.

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.

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.

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.

Constitutionality of Peremptorily Striking Jurors Who Support the Black Lives Matter Movement

By Matthew Caminiti

The appeal of a 2016 murder conviction in Contra Costa County Superior Court, California has brought front and center a new problem facing trial courts: the constitutionality of peremptorily striking jurors who indicate their support of the Black Lives Matter movement. Continue reading “Constitutionality of Peremptorily Striking Jurors Who Support the Black Lives Matter Movement”

U.S. Department of Justice Files Civil Complaint for COVID-19-Related Fraud

By Brett M. Feldman and Jessica Linse

Since the outbreak of the COVID-19 virus, law enforcement officials throughout the country have publicly committed to aggressively combatting pandemic-related fraud. Those pronouncements have translated into action focused, at least at this early stage, upon frauds which might impact consumers’ health and safety. The first federal civil enforcement action took place on Saturday, March 21, 2020. On that date, the U.S. Department of Justice, in coordination with the U.S. Attorney for the Western District of Texas, filed the first civil enforcement action against a COVID-19 related fraud. Prosecutors sought an injunction shutting down a website, which purportedly offered to provide “free” coronavirus “vaccine kits” for a $4.95 shipping and handling fee. This request for injunctive relief, which resulted in a temporary restraining order pursuant to 18 U.S.C. § 1345, is likely an omen of more to come. Continue reading “U.S. Department of Justice Files Civil Complaint for COVID-19-Related Fraud”

Second Circuit Decision in NY Assembly Speaker’s Bribery Conviction Reversal Opens Possible Loophole

Sheldon Silver, former speaker of the New York State Assembly, was convicted of a number of political corruption crimes in 2015, namely accepting bribes in exchange for favorable “official acts” that benefited some bribe payors. He appealed his conviction to the Second Circuit on two grounds: first, that the trial court erred by failing to require that the prosecution establish that he and the bribe payor had a “meeting of the minds” on the specific official act to be performed in exchange for the bribes; and second, that the trial court erred by allowing the prosecution to proceed on a theory that allowed conviction based on a “nonspecific promise to undertake official action on any future matter beneficial to the payor.” (Emphasis added.)

On January 21, 2020, the United States Court of Appeals for the Second Circuit partially reversed Silver’s conviction and remanded the case for resentencing. The court’s logic and findings are significant and merit close attention.

View the full Alert on the Duane Morris LLP website.

Three Years After Policy Shift, Still No Wage-Fixing or No-Poach Prosecutions from DOJ

In an October 2016 guidance document, the United States Department of Justice Antitrust Division (DOJ) and the Federal Trade Commission alerted human resources professionals to potential violations of the antitrust laws in hiring and compensation decisions. The guidance included the announcement that, “Going forward, the DOJ intends to proceed criminally against naked wage-fixing or no-poaching agreements.” A naked agreement is one that is not ancillary to a broader, legitimate collaboration between businesses.

The DOJ’s decision to proceed criminally against such agreements is significant. Although the Sherman Act allows the DOJ to proceed either criminally or civilly against antitrust violators, before the guidance was issued the DOJ had treated agreements between competitors not to solicit each other’s employees as merely civil violations. Following the guidance, companies and individuals suddenly had to worry about criminal fines and potential jail sentences for entering into such agreements. Nevertheless, three years have now passed without a single such indictment being filed.

View the full Alert on the Duane Morris LLP website.

Discovery Ruling in District of Minnesota May Have Far-Reaching Implications for FCA Defendants

In a concise, six-page discovery order, a federal judge in Minneapolis may have just started the proverbial shifting of tectonic plates undergirding routine defense procedures in False Claims Act (FCA) litigation by requiring a defendant in an FCA lawsuit to produce the information provided to the Department of Justice (DOJ) during the DOJ’s process of determining whether to pursue the matter.

The FCA creates liability for persons or entities found to have knowingly submitted false claims to the government or having caused others to do so. Like some other federal laws, the FCA creates a private right of action; under the act, a private party—a whistleblower or “relator”—may bring a qui tam action on behalf of the government. When initially filed, the court seals the complaint pending the government’s investigation of the case. If the government chooses, it may intervene and pursue the matter. If not, the relator may pursue the case on its own. (In either case, the relator is entitled to a percentage of the government’s recovery.)

View the full Alert on the Duane Morris LLP website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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