Based on the provided source material, I cannot prepare a comprehensive Reveal Company report for nyiQuAsPmvaAaLkdLLnFUCIx as the sources do not contain specific information about this company. However, the sources do contain detailed information about its subsidiaries Crucell N.V. and Acclarent, Inc., particularly regarding legal claims and actions. Below is the available information formatted according to the guidelines:
7) Legal Claims and Actions
Acclarent, Inc. has been subject to significant regulatory enforcement actions and criminal prosecutions related to the off-label marketing of medical devices. In July 2016, two former executives of Acclarent were convicted by a federal jury of ten misdemeanor violations of the Federal Food, Drug and Cosmetic Act following a six-week trial related to the marketing of its sinus spacer product as a steroid delivery device without FDA approval. The convictions were upheld on appeal in December 2023, with the court rejecting claims of First Amendment and Fifth Amendment due process violations.
The criminal case centered on former CEO William Facteau and former Vice President of Sales Patrick Fabian, who were found guilty of unlawfully marketing the Relieva Stratus Microflow Spacer to dispense Kenalog, an off-label and unapproved use. While the device had obtained FDA clearance for use as a spacer to dispense saline solution, Acclarent proceeded to market it for dispensing the steroid without proper authorization, leading to charges of distributing an adulterated and misbranded device. In January 2021, Facteau was sentenced to pay a $1 million fine and Fabian was sentenced to pay a $500,000 fine.
Acclarent reached a settlement agreement with the Department of Justice on July 22, 2016, agreeing to pay $18 million to resolve allegations that it caused healthcare providers to submit false claims to Medicare and other federal healthcare programs by marketing and distributing the Relieva Stratus for use as a drug delivery device without FDA approval. The company did not admit liability in the settlement.
Employment litigation has also emerged from these regulatory issues. In September 2017, former sales representative Melayna Lokosky filed a lawsuit against Acclarent alleging retaliatory termination pursuant to the False Claims Act after she complained internally about the off-label promotion and sales of the Relieva Stratus MicroFlow Spacer. The lawsuit claims Acclarent misrepresented the device’s intended use to the FDA and marketed it for off-label use with Kenalog-40, resulting in the product being misbranded and ineligible for federal reimbursement.
Patent litigation has also affected Acclarent’s operations. In July 2010, Acclarent filed an infringement case against Entellus Medical, alleging that Entellus Medical’s FinESS and XprESS products infringed on Acclarent’s patents covering instruments and methods for treating sinus disorders. The parties subsequently reached a confidential settlement agreement that includes royalty payments from Entellus to Acclarent for the licensed patents and products.
Crucell N.V. has faced multiple patent-related legal proceedings dating back to the mid-2000s. In October 2004, Crucell commenced infringement litigation against CEVEC Pharmaceuticals in the District Court of Düsseldorf, Germany, arguing that CEVEC’s cell line infringes a European patent for its PER.C6 technology. In December 2004, CEVEC Pharmaceuticals acknowledged three out of four claims but defended the remaining claim. During 2005, multiple oppositions were filed before the European patent office against patents related to Crucell’s PER.C6 and AdVac technology.
Crucell has acknowledged potential regulatory compliance risks, noting that it has not notified the European Commission competition authorities of any of its licensing agreements and recognizing the possibility that current or future agreements could be found to infringe applicable competition regulations, potentially leading to fines, damages, and void agreements. The company also faces exposure to product liability claims if third parties allege that its technologies or products have caused harm, as well as potential claims relating to improper handling, storage, or disposal of hazardous materials.