The controversies over the use of ethylene oxide (EtO) as a medical device sterilant were quelled by the COVID-19 pandemic, but the U.S. Environmental Protection Agency (EPA) has resurrected the issue.
The difficulty in resolving multiple rounds of patent litigation can foster a willingness on the part of both parties to settle their differences and go on their respective ways, which seems to be the end result of litigation between San Diego-based Illumina Inc., and subsidiaries of BGI Group of Shenzen, China. While Illumina is on the hook for a $325 million payout in this agreement, the company will receive a license to practice some of BGI’s affiliate’s patents, but the handshake also forecloses any further litigation over the disputed patents for three years.
The U.S. FDA’s breakthrough devices program has engendered a tremendous amount of interest on the part of industry, but an Aug. 2 report by the law practice of Epstein Becker & Green P.C., suggests that the value of the program may be overblown. The report states that only 44 of the more than 600 devices that have been granted access to the program have successfully emerged – a number that was updated Aug. 3 by the FDA to 54 – which is still a rate that suggests that the breakthrough devices program might not be as helpful as billed.
The U.S. Centers for Medicare & Medicaid Services (CMS) has wrapped up its rulemaking for the next Medicare inpatient prospective payment system, and several companies managed to score important rate-setting wins for their devices. Microtransponder Inc., of Dallas, won a new technology add-on payment (NTAP) for its Vivistim device for treatment of stroke, as did W.L. Gore & Associates Inc. for its TAG thoracic branch endoprosthesis (TBE), just two among several winner in the Medicare inpatient final rule for fiscal 2023.
Patent litigation is notoriously drawn out in some instances, as is the case with disputes between Boston Scientific Corp. (BSX), of Natick, Mass., and Nevro Corp., of Redwood City, Calif. However, the two announced Aug. 1 that they have come to terms over several lawsuits, with each enjoying the right to practice some of the disputed patents and Nevro taking in a net payment of $85 million.
The U.S. FDA posted notice of a class I recall for two hemodialysis catheters made by Covidien Inc., the Palindrome and Mahurkar catheters, due to a catheter hub defect that could lead to mixing of venous and arterial blood. No deaths and only one injury have been reported in connection with the defect, but the recall affects more than 1 million devices that went into distribution starting in June 2017, one of the numerically larger recalls in recent years.
The U.S. FDA has proposed to down-classify optical diagnostic devices and electrical impedance spectrometers from class III to class II, but there was little support for such a change in the first day of a two-day advisory hearing. The panelists saw the risk of a false negative for melanoma as too high to allow such devices to go through the 510(k) program, and thus manufacturers of these devices may continue to be required to file PMAs, replete with costly studies and long timelines to approval.
Drug and device makers that offer health care professionals opportunities to earn continuing medical education (CME) points have a fine line to walk when sponsoring those programs, but a new advisory opinion by the Office of Inspector General (OIG) at the Department of Health and Human Services seems to draw a very clear line around those programs.
The FDA’s ability, or lack thereof, to churn out guidances is not always the stuff of industrial outrage, but manufacturers of laser-assisted in situ keratomileusis (LASIK) systems might find the timing of a new draft guidance on the procedure somewhat odd. The draft guidance arrives nearly a decade and a half after an April 2008 advisory hearing.
Med tech patents have been especially vulnerable to litigation in recent years, and a new decision by the Court of Appeals for the Federal Circuit affirms yet again the vulnerability of patents undergoing litigation. The Federal Circuit said nine claims found in two patents held by Becon Medical Ltd., of Batavia, Ill., were invalid due to obviousness, presenting the company a significant loss in its infringement litigation with Talexmedical LLC, of Malvern, Pa.
