Integra Lifesciences Holdings Corp., of Plainsboro, N.J., said in its latest 8K filing that it has decided to voluntarily remove all the company’s Cerelink systems – which are indicated for intracranial pressure monitoring – due to customer reports that these monitors were returning inaccurate pressure readings.
Litigation over how to assign royalties for intellectual property with an offshore subsidiary doesn’t consume the kind of billable attorney hours that patent disputes do, but the question can affect a multinational corporation’s bottom line in significant ways. The U.S. Tax Court recently decided on a method for assigning royalties to a Medtronic plc subsidiary located in Puerto Rico that fell between the rate sought by Medtronic and the rate sought by an appeals court, but that ultimate rate was close to that preferred by Medtronic, handing the company a better outcome than it might have predicted when the IRS filed suit.
Payers are known to have a significant burden in crafting coverage and reimbursement policies for in vitro diagnostics, but Gillian Hooker, chief scientific officer at Concert Genetics Inc., of Nashville, Tenn., told an audience at the Next Generation DX Summit that the dilemma may be more expensive than commonly appreciated. Hooker said administrative costs may add as much as $125 per administered test, an artifact of a fragmented value chain that seems to enjoy few, if any prospects of improvement in the near term.
The recall of CPAP, BiPAP and ventilator devices made by Philips Respironics Inc., of Murrysville, Pa., is now in its second year, but the rate of reported adverse events was exceedingly low prior to the onset of the June 2021 recall. Those numbers continued to climb in May, June and July of 2022, however, reaching 48,000 medical device reports and 44 deaths said to be associated with the recalled devices, a pace that would easily overwhelm the volume of reports seen in the 12 months ending April 30, 2022.
Valentine’s Day is a great day for creating that tingly feeling, but Abbott Park, Ill.-based Abbott Laboratories believes that this is not a good sensation for patients who are in search of pain relief via spinal cord stimulation (SCS) devices. Thus, the company touts its Proclaim Plus as a system that delivers a tightly titrated charge to multiple sites on the spinal cord to generate an analgesic effect without that tingling sensation, an outcome the company said is preferred by 87% of those in need of SCS for pain relief.
The U.S. FDA has identified a recall of Medtronic cardiac electrophysiology devices as a class I event due to the risk of an inadequate delivery of energy to restore normal rhythm, a recall that affects more than 87,700 units in total. Dublin-based Medtronic plc., said, however, that it is developing a software patch that will remedy the issue, a fix the company said will emerge in late 2022.
Medical device product liability litigation can take a number of seemingly unique twists and turns, but the case of Nelson v. Bard took a path that might have been predicted based on FDA-mandated labeling content. The U.S. Court of Appeals for the Fifth Circuit affirmed a lower court’s ruling that the instructions for use for a Bard inferior vena cava filter indemnified the company because the IFU listed the very events seen by the patient, undercutting the patient’s claim that Bard had failed to warn of these events.
The U.S. FDA published a draft guidance for hydrogen peroxide-based contact lens care products (HPCPs), which up until 1997 were seen as class III products requiring a PMA. However, this draft is a response to an increasing number of adverse events associated with these products, a problem that was the subject of a 2017 FDA advisory hearing.
The doctrine of patent assignor estoppel is not found in the U.S. statute, but that omission has led to only limited litigation over the doctrine despite the notoriety of the case of Hologic v. Minerva. Nonetheless, the Federal Circuit reinforced the understanding that an assigned patent is still in force when the disputed claim is not seen has having been materially broadened by the time a patent has been granted in its final form, thus closing one of the principal contractual questions surrounding patents that are handed off from one device maker to another.
After five years, the U.S. FDA finally released a final rule for over-the-counter hearing aids along with an associated guidance, a development that was stipulated by the FDA Reauthorization Act (FDARA) of 2017. Xavier Becerra, Secretary of the U.S. Department of Health and Human Services, was among several HHS officials who appeared on the Aug. 16 briefing to tout the rule, each of which promised that the rule would spark competition that would in turn take a significant bite out of the cost of acquiring a hearing aid.
