News & Analysis as of

Healthcare Causation

Bass, Berry & Sims PLC

Causation Split: First Circuit Pauses Teva Appeal; Regeneron Appeal Going Forward

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False Claims Act (FCA) practitioners have been closely watching cases in which courts address the causation requirement in FCA actions based on Anti-Kickback Statute (AKS) violations....more

Bass, Berry & Sims PLC

Seventh Circuit Upholds FCA Judgment Against Constitutional Challenge, Avoids Causation Circuit Split

On May 2, the U.S. Court of Appeals for the Seventh Circuit affirmed a False Claims Act (FCA) trial verdict in part, holding that the judgment was not constitutionally excessive under the Eighth Amendment....more

Mintz

EnforceMintz — Practical Lessons Learned from FCA Litigation in 2023

Mintz on

In 2023, the Supreme Court and the United States Courts of Appeals published a number of significant decisions with implications for entities in the health care and life science industries facing False Claims Act (FCA)...more

Husch Blackwell LLP

IPSE DIXIT: Because My Patient Said So – How to Challenge Medical Experts Who Base an Opinion of Injury Causation Solely on a...

Husch Blackwell LLP on

Plaintiffs often disclose medical experts to opine not only as to the diagnosis or prognosis of an injury or medical condition, but also as to whether the defendant’s actions caused plaintiff’s alleged injury/condition. In...more

Bradley Arant Boult Cummings LLP

District of Massachusetts Split on Causation Standard in Kickback FCA Cases

The District of Massachusetts has joined the growing chorus of courts that have applied a heightened causation standard in False Claims Act (FCA) cases predicated on the Anti-Kickback Statute (AKS). U.S. District Judge F....more

Bass, Berry & Sims PLC

False Claims Act Decisions to Know from Q3 2023

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Below are noteworthy False Claims Act (FCA) decisions from the third quarter of 2023. The main issues in the cases are: Materiality. The Fourth Circuit held that a pharmacist’s efforts to falsify patient eligibility...more

Bass, Berry & Sims PLC

False Claims Act Case Unsealed Against Cerebral, Showing Continued Scrutiny of Telehealth Prescriptions

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A qui tam False Claims Act (FCA) complaint was recently unsealed against Cerebral, a telehealth startup that provides virtual mental-health therapy, in the U.S. District Court for the Northern District of Iowa....more

Bass, Berry & Sims PLC

District Courts Wrestle with Causation in Kickback Cases While Circuit Courts Remain Divided

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Two Massachusetts federal district courts recently addressed—and disagreed about—an important False Claims Act (FCA) issue that has also divided the federal circuit courts: when an alleged FCA violation is based on an...more

Bradley Arant Boult Cummings LLP

Circuit Split on FCA Causation Deepens with Upcoming First Circuit Ruling

The First Circuit will decide the causation standard required in False Claims Act (FCA) cases predicated on the Anti-Kickback Statute (AKS), deepening a circuit split on the issue and potentially teeing up Supreme Court...more

Morrison & Foerster LLP

The Sixth Circuit Narrows the Scope of AKS and FCA Liability

On March 28, 2023, the U.S. Court of Appeals for the Sixth Circuit issued a decision in U.S. ex rel. Martin v. Hathaway limiting the scope of liability under the Anti-Kickback Statute (AKS) and the False Claims Act (FCA) in...more

Dickinson Wright

Sixth Circuit Defines False Claims Standards

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The Federal False Claims Act (“FCA”) imposes civil liability for presenting a false claim to the government for payment. The Federal Anti-Kickback Statue (“AKS”) prohibits medical providers from making referrals in return for...more

Mintz

The Sixth Circuit Adopts Narrow Interpretations of “Causation” and “Remuneration” for False Claims Act Suits Based on Alleged...

Mintz on

On March 28, 2023, the Sixth Circuit issued an important False Claims Act (“FCA”) decision in U.S. ex rel. Shannon Martin, et al. v. Darren Hathaway, et al., No. 22-1463, which (1) adopted a “but-for” causation standard for...more

Proskauer - Health Care Law Brief

Recent FCA and AKS Litigation Highlights Use of Different Standards in Different Circuits

In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Bradley Arant Boult Cummings LLP

False Claims Act - 2021 Year in Review

The year 2021 marks the 10th anniversary of the Bradley False Claims Act Year in Review. In that decade, much has remained the same in FCA enforcement. To start with the obvious: It continues to result in billions of dollars...more

Pierce Atwood LLP

Even With Common Questions, Chapter 93A Deceptive Marketing Claims Are Ill-Suited for Class Treatment

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Earlier this month, in Plastic Surgery Associates, SC v. Cynosure, Inc., United States District Judge Denise Casper denied plaintiffs’ motion for class certification and allowed Cynosure’s motion for summary judgment on...more

WilmerHale

False Claims Act: 2018 Year-in-Review

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Federal False Claims Act (FCA) recoveries in fiscal year 2018 amounted to $2.88 billion, down by roughly $600 million from the prior year and dropping below $3 billion for the first time in eight years. Healthcare cases,...more

Gray Reed

A Measle-ly Lawsuit: Can Parents Who Don’t Vaccinate their Children be Sued?

Gray Reed on

Yearning to leave the frozen wasteland of Dallas, Texas behind her if just for a moment, Penny McCrathy, an outspoken anti-vaccination advocate, took her unvaccinated children to Disneyland in Anaheim, California. Not knowing...more

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