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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

FCA cases reach new high in 2024, but value of recoveries no outlier

Jan. 29, 2025
By Mark McCarty
False Claims Act litigation in the U.S. spiked significantly according to a new report by Gibson, Dunn & Crutcher, LLP, at least in terms of the number of cases brought to the courts. However, the report added that the total dollar value of these cases is in line with historical norms, suggesting that the average recovery amount has tapered off significantly.
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Judge's gavel with US flag

Illumina, Molecular Loop square off over patents for NGS systems

Jan. 29, 2025
By Mark McCarty
While the U.S. Supreme Court sidelined itself over patent issues such as subject matter eligibility, the diagnostic patent wars are still in full swing as a casual review of cases at the U.S. Patent and Trademark Office discloses.
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Flag of Australia, sky background

TGA posts draft guidance for non-mandatory application audits

Jan. 29, 2025
By Mark McCarty
Australia’s Therapeutic Goods Administration posted a draft guidance dealing with non-mandatory audits for premarket applications, which says that a transcatheter aortic valve replacement device that has been approved by the U.S. FDA may not be subject to such an audit.
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Gavel and vials

FCA cases reach new high in 2024, but value of recoveries no outlier

Jan. 28, 2025
By Mark McCarty
False Claims Act litigation in the U.S. spiked significantly according to a new report by Gibson, Dunn & Crutcher, LLP, at least in terms of the number of cases brought to the courts.
Read More
U.S. Supreme Court

US Supreme Court to hear case on litigation for the uninjured

Jan. 28, 2025
By Mark McCarty
Litigation against companies in the life sciences has far too often covered those who were not injured by the device or drug, but there are signs that this tide is shifting.
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MHRA logo

UK’s postmarket monitoring mandates to take force in June

Jan. 27, 2025
By Mark McCarty
The U.K.’s new postmarket monitoring requirements do not represent a sea change in device makers’ responsibilities in this area, but the expansions of responsibility are nonetheless significant.
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US flag, gavel, book

Bard agrees to pay $17M to settle FCA allegations

Jan. 27, 2025
By Mark McCarty
Murray Hill, N.J.-based C.R. Bard Inc. agreed to pay roughly $17 million to settle allegations that it violated the Anti-Kickback Statute in connection with the use of a self-referral form for sales of the company’s intermittent catheter.
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Laptop displaying FDA logo

FDA dishes out five device warnings to begin 2025

Jan. 24, 2025
By Mark McCarty
The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted Jan. 14, and dated between Dec. 6 and Dec. 19, 2024, but otherwise seem to have little in common.
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Heart scientific overlay

Impulse Dynamics’ 2022 coverage petition for CCM finally surfaces

Jan. 23, 2025
By Mark McCarty
The backlog of requests for Medicare national coverage analyses is a matter of record, but a new analysis highlights how deep that backlog runs. CMS declared it will review a petition from Impulse Dynamics to consider coverage of cardiac contractility modulation, responding to a request the company filed more than two and a half years ago.
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US flag, gavel, book

Ravgen aces Federal Circuit patent hearing against Labcorp

Jan. 22, 2025
By Mark McCarty
Ravgen Inc. prevailed in a hearing at the Federal Circuit over Labcorp Inc., seemingly bringing a close to a long-running dispute over patents for non-invasive prenatal tests. Ravgen has won damages that will likely exceed $400 million over alleged infringement of its patents for these tests, proof once again that a solid understanding of prior art is essential to avoid costly litigation.
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