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.

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.

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.

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.

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. No longer will companies be able to merely track adverse events but will also have to erect a monitoring plan which accounts for the risks inherent to a medical device’s use.

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.

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.

Australia’s Therapeutic Goods Administration posted a draft guidance dealing with non-mandatory audits for premarket applications, which says that a transcatheter aortic valve replacement (TAVR) device that has been approved by the U.S. FDA may not be subject to such an audit.

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.

The EU has moved aggressively on legislation in recent years, with the AI Liability Directive serving as the latest example of legislation that sparked widespread opposition. Among those opposed are Medtech Europe and 11 other trade associations that called on the European Commission to withdraw the legislation – a bill they argued will hamper competitiveness without a clear benefit to patients and consumers.