The UK National Institute of Health and Care Excellence has wrapped up its evaluation of the Sherlock 3CG by Bard Access Systems (Salt Lake City), and the agency is recommending the National Health Service cover the device's use. NICE said the associated cost "is similar to that of blind insertion" of a peripherally inserted central catheter (PICC) in a non-intensive care setting, but that the cost savings exceed £100 per patient when used in lieu of fluoroscopy.

FDA awarded Bard a second 510(k) for the Sherlock in 2011 under K113803 using two predicates, a previous version of the Sherlock along with the Sapiens tip confirmation system (also a Bard product). The device employs passive magnetic tracking for catheter placement near the caval-atrial junction, and NICE remarked that in current practice in NHS clinics, "there is substantial variation . . . in the ways PICCs are inserted," both in terms of site of service and the medical professionals charged with insertion.

Bard is said to have filed a total of four published abstracts on the use of PICCs systems, which the review committee augmented with two publications that emerged after Bard wrapped up its filing. One of these, Johnston et al (2014), was a retrospective analysis of 250 patients on whom the device was used in UK hospitals. Eleven patients of the original 250 were lost to the analysis due to two cases of failed insertion, one of inadequate device length, and four failures of clinical staff to interpret electrocardiographic criteria.

Device malposition rates in this study bested blind placement, but was said to have exceeded rates seen in other studies of the device. Possible explanations included difficulty in determining "the exact point of a maximum or biphasic P wave" for patients in intensive care whose EKGs may have been affected by comorbidities and by tip movement prompted by body movement.

NICE said Bard pegged the device's cost at £9990 (the exchange rate for the British pound has varied between $1.55 and $1.47 between Feb. 25 and March 25), with consumables running to £190 per use. Maintenance costs of the system are projected at slightly less than £600 annually.

Use of the Sherlock is said to eliminate the need for confirmatory X-ray, along with the concomitant reduced staffing costs, with reduced stays, and elimination of costs associated with incorrect catheter placement.

However, Bard's filing is said to have omitted data on reduced hospital stays and "treatment delay following catheter placement," and the company noted further that it was unable to report on device-related adverse events "because of a lack of reported evidence."

Willful infringement making noise at CAFC

The Court of Appeals for the Federal Circuit took the time to drop a few added notes to its December 2014 decision in Stryker v. Zimmer, and at least one member of the patent blogosphere sees this as an indication that willful infringement is occupying more bandwidth at the court. The remaining question for many in the legal community is apparently whether the Federal Circuit will take on the question of the standard for demonstrating willfulness before the Supreme Court of the United States grants a request for review.

The Federal Circuit affirmed in a Dec. 19, 2014, judgment the lower court ruling that Zimmer had indeed infringed on Stryker's so-called '329, '807 and '383 patents, but the Federal Circuit disagreed on the willfulness charge. The decision reversed the trebling of damages decided on by the U.S. District Court for the Western District of Michigan, and vacated and remanded the lower court's finding of exceptional case and an award of attorney's fees.

Jason Rantanen of the University of Iowa College of Law (Iowa City, Iowa) posted March 23 at the patent blog PatentlyO that the Federal Circuit had denied an en banc hearing in the case of Halo Electronics v. Pulse Electronics, adding that Judges Taranto and Reyna saw Halo v. Pulse as the wrong case to tackle willful infringement (the America Invents Act did little to address willful infringement beyond affirming case law in that a failure to obtain the advice of counsel or to present such advice cannot be used to argue infringement).

Rantanen said, however, that the Federal Circuit revised its decision in Stryker v. Zimmer via the addition of a footnote. The footnote states that the court has not yet taken up the question of whether either of two cases has "altered the standard of review" for willful infringement at the Federal Circuit. The cases pointed to by the judges are Octane Fitness v. Icon Health and Highmark v. Allcare Health Management.

The footnote addsthat the district court in Stryker "failed to undertake any objective assessment of Zimmer's specific defenses," and thus the lower court "erred under any standard of review." Consequently, the Federal Circuit declared there is at present no need to "address what standard of review is proper regarding the objective prong of willfulness."

Nonetheless, Rantanen said that the footnote to Stryker and the decision to pass on an en banc hearing of Halo suggest "the court may be gearing up to take on a compromise issue in willfulness: namely whether a modified standard of review is appropriate." He also raised the possibility that the Supreme Court of the United States "will take on the bigger question" raised in dissent by Judge O'Malley, who is said to have argued that the willful infringement discussion needs another look on several points, including whether a preponderance of evidence should suffice to demonstrate willfulness.

Thus Rantanen said, Halo "remains an appeal to watch."

Another med-tech lawsuit that could be affected by an appeal of Halo is that of Bard v. Gore, a rather long-running dispute decided Jan. 13 by the Federal Circuit, which affirmed the lower court decision that Bard did willfully infringe on Gore's '135 patent for vascular grafts made of polytetrafluoroethylene. A jury found in 2010 that Gore had willfully infringed, but there are those in the patent bar who see this as yet another in a string of cases that argues for a re-evaluation of the standard for willful infringement.