Smiths Medical Inc., of Minneapolis, has undertaken a recall of its Medfusion 3500 and 4000 series of syringe infusion pumps because of software issues that could lead to over- or under-infusion of the drug. The U.S. FDA said the devices swept up in this class I recall are associated with seven serious injuries and one fatality, although the manufacturer indicated that a software update is in the works.
Data privacy laws are springing up more regularly in the past couple of years, including in several U.S. states, but Congress seems inclined to step in to avoid a patchwork of regulations across the 50 states. The House Energy and Commerce Committee gave a ringing endorsement of new legislation via a 53-2 vote for H.R. 8152, a bill that would largely preempt the growing list of state privacy laws, but makers of health apps and other digital products might eventually be subject to private litigation under the terms of the bill.
The effects of U.S. Supreme Court case law on patents are well demonstrated, but the latest victims of patent jurisprudence are directed toward a critical need for desperately ill patients. The Court of Appeals for the Federal Circuit ruled that several claims found in three patents licensed to Caredx Inc., of Brisbane, Calif., are ineligible due to a purported lack of inventiveness under Section 101 of the Patent Act, an outcome that sustains what some believe is a trend in case law that is hostile toward diagnostic patents in the U.S.
The U.S. federal government’s crackdown on companies in the health care space shows no signs of slowing down as indicated by an announcement by the Department of Justice (DOJ) that it has achieved a settlement with Opko Health Inc. and Bioreference Health LLC regarding allegations of induced referrals.
Reliance Medical Systems LLC agreed to pay $1 million to address allegations of violation of the Anti-Kickback Statute (AKS), but the company has responded to that outcome with a blistering riposte.
The U.S. FDA has applied a class I designation to the recall of Flow-c and Flow-e anesthesia systems manufactured by Getinge AB of Gothenburg, Sweden, due to reports of faulty on-off switches, which could lead to a failure to provide the needed suction. While no injuries or fatalities have been reported in connection with the problem, the FDA said one possible consequence of device failure is pulmonary obstruction that could ultimately lead to death.
The U.S. Securities and Exchange Commission (SEC) filed insider trading charges against Doron Tavlin, formerly the vice president of business development for Mazor Robotics Ltd., of Caesarea, Israel, over a transaction that took place four years ago. The SEC is charging Tavlin with disclosing the then-impending acquisition of Mazor by Dublin-based Medtronic plc. to a personal friend, but these types of activities are becoming easier to detect thanks to analytics used by the SEC.
The U.S. Federal Trade Commission (FTC) affirmed its proposed order to force Intersect ENT Inc., of Menlo Park, Calif., to divest itself of Fiagon AG before Dublin-based Medtronic plc., can complete its acquisition of Intersect. The announcement comes as no surprise, but serves as a reminder that the FTC is standing by previous threats to tightly control the mergers and acquisitions market in the U.S., a policy stance that has been duplicated in the European Union.
The U.S. FDA’s efforts to improve medical device quality includes a recent draft guidance that pertains to the pilot version of a voluntary improvement program, but stakeholders see a number of critical issues with the draft. A coalition of device makers said this pilot program should include disclosure guardrails that parallel similar guardrails provided for medical device reports (MDRs), a provision related to discovery during product liability litigation that is seen as critical if device makers are to take part in the voluntary improvement pilot.
As was the case for all medical device inspections, the Medical Device Single Audit Program (MDSAP) was hampered by the COVID-19 pandemic, but the participant regulators agreed to allow the use of remote audits to fill in for live MDSAP inspections. This program has been renewed again through the end of September 2022, but the sponsoring regulatory agencies said this will be the last extension, barring exceptional circumstances.
