News & Analysis as of

Department of Health and Human Services (HHS) Causation

Proskauer - Health Care Law Brief

Recent Circuit Litigation Continues to Highlight “But-For” Causation Requirement for the Government to Demonstrate an FCA...

In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute...more

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2023

Harris Beach PLLC on

From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...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

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

Butler Snow LLP

What About Me? Liability Considerations and Protections For Businesses Outside the Drug and Device Space in the COVID-19 Era

Butler Snow LLP on

It’s been nearly six months since the HHS Secretary declared COVID-19 a public health emergency. As communities emerge from quarantine, businesses are on high alert regarding potential COVID-19 liability. Some businesses...more

Harris Beach PLLC

Doe v. Merck: Vaccine Autism Lawsuit Dismissed as Baseless

Harris Beach PLLC on

The claim that the MMR vaccine caused autism was meritless on its face, held the U.S.D.C., Eastern District of New York (Doe v. Merck & Co, Inc.). The action filed on behalf of “Baby Doe” stemmed from Merck-manufactured...more

Spilman Thomas & Battle, PLLC

What’s That Smell? An Examination of Legal Developments Related to Formaldehyde Products

Is that formaldehyde you smell in your newly floored sunroom? Hopefully, it is not. Formaldehyde is a colorless, flammable, strong-smelling chemical used in construction and household products, such as cabinets, furniture,...more

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