Masimo Corp. managed to obtain and uphold an injunction against True Wearables Inc. regarding a pending patent application, which Masimo said would have disclosed a trade secret for pulse oximeters. However, the injunction is only a preliminary injunction, and thus the road ahead may ultimately yield a disclosure of a trade secret that Masimo has dedicated considerable resources to protect.

The U.S. Court of Appeals for the Federal Circuit recently decided an appeal of a patent lawsuit involving Cardionet LLC, of Conshohocken, Pa., invalidating the Cardionet patent for lack of subject matter eligibility. While the patent offers a significant improvement in the functionality of any computer that uses the Cardionet algorithm, the Federal Circuit declared that the invention does nothing more than use the computer as a tool to express an abstract idea.

The FDA has struggled to revise a guidance related to cybersecurity in medical devices, but developers now have more than just lagging FDA guidances to worry about where cybersecurity is concerned. The U.S. Department of Justice (DoJ) has unveiled a program designed to leverage the False Claims Act to pursue entities that come up short of regulatory expectations for cybersecurity, constituting a new vector for liability for makers of devices and medical software.

Enforcement against false claims filed with federal health care programs continues to snare a number of testing clinics as demonstrated by the recent news that a clinical lab has come to terms with federal prosecutors over urine drug testing. MD Spine Solutions LLC, of Reno, Nevada, has agreed to pay up to $16 million to settle allegations that it performed unnecessary urine drug tests, a case brought to the attention of the courts not by a former employee, but by Omni Healthcare Inc., which has been active in the False Claims Act space, thus highlighting the hazards of third-party litigation to clinical lab operators.

Patent subject matter eligibility has emerged as arguably the most controversial patent policy theme of the past two decades, one which has been most keenly felt in the world of in vitro diagnostics (IVDs). A new study pending publication suggests that venture capital (VC) investment in IVDs would have been $9.3 billion higher in the four years following the Supreme Court’s decision in Mayo v. Prometheus, a finding which the author said leads inevitably to the conclusion that the subject matter eligibility crisis “should receive Congress’ immediate attention.”

FDA preemption of state liability law has proven controversial on a number of occasions, a fact of life resurrected by a case arising out of the Supreme Court of the State of Mississippi. The court declared that the FDA must invoke the rulemaking process for its regulation of medical product labels.

Jury trials for product liability litigation are not always the last stop for these lawsuits, but courts are more frequently banning device makers from presenting evidence related to premarket filings in these proceedings. One example of this was the pelvic mesh trial of McGinnis v. Bard, in which the trial judge allowed the plaintiff to make nearly two dozen references to the FDA without allowing rebuttal from counsel for the defense, thus biasing a jury that awarded the plaintiff $68 million without hearing the entirety of the evidence.