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Home » Topics » Regulatory » Courts

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Patent law book and gavel

Masimo sustains injunction for trade secret at Federal Circuit hearing

Jan. 26, 2022
By Mark McCarty
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.
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Another guilty plea in trial data fraud scheme

Jan. 13, 2022
Olga Torres, co-owner of Miami-based Unlimited Medical Research, pleaded guilty Jan. 12 to obstructing a 2017 FDA inspection in connection with an alleged scheme to falsify data in a clinical trial evaluating an asthma drug for children.
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Drug, device companies accused of aiding terrorists to face further scrutiny

Jan. 5, 2022
By Mari Serebrov
Be careful who you’re doing business with. That’s the warning the U.S. Court of Appeals for the District of Columbia Circuit sent this week to multinational drug and device companies doing business in terrorist hot spots around the world. Reversing a lower court, the D.C. Circuit cleared the way Jan. 4 for 21 drug and device companies to potentially be held accountable for doing business with Jaysh al-Mahdi terrorists, operating through the Iraqi Ministry of Health, who injured or killed hundreds of U.S. troops and civilians in Iraq.
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Patent law book and gavel

Federal Circuit doubles down on subject matter eligibility in Cardionet patent lawsuit

Nov. 23, 2021
By Mark McCarty
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.
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Judge's gavel with US flag

DoJ creates program to ramp up False Claims Act litigation for cybersecurity lapses

Oct. 27, 2021
By Mark McCarty
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.
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Gavel and scales

Omni strikes again in false claims case against MD Spine Solutions

Oct. 21, 2021
By Mark McCarty
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.
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Judge's gavel with US flag

Analysis finds VC investment in diagnostics took $9.3B hit in four years after Mayo

Oct. 20, 2021
By Mark McCarty
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.”
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FDA icons

FDA preemption of state law for product labeling at risk in Mississippi court ruling

Oct. 12, 2021
By Mark McCarty
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.
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Gavel and scales
2021 Medtech Conference

Courts often bar defense from raising FDA-related questions in product liability litigation

Sep. 30, 2021
By Mark McCarty
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.
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Biogen office building

Antikickback claims continue for Biogen

Sep. 27, 2021
By Mari Serebrov
Biopharma companies that have agreed to pay the U.S. Department of Justice millions of dollars to resolve allegations that they illegally used charities to cover patients’ Medicare copays for brand drugs are finding those settlements may be just the beginning of their legal woes, even when the companies admit no liability in the settlement.
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