The United States Department of Justice announced that medical device company Affordable Healthcare Solutions, LLC has pleaded guilty to charges related to unapproved prescription hyaluronic acid medical devices, as reported by a press release dated September 28, 2021. The devices are “intended for the treatment of pain in osteoarthritis of the knee that must be injected by a doctor or other qualified health care professional.” The company was sentenced for “Receiving Adulterated Devices in Interstate Commerce and Delivery for Pay with Intent to Defraud or Mislead, in violation of 21 U.S.C. §§ 331(c) and 333(a)(2).”
21 U.S.C. § 331(c) prohibits “[t]he receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.” According to the facts admitted during the plea, special agents with the United States Food and Drug Administration (FDA) located and seized foreign-market Supartz, Euflexxa, Synvisc, Synvisc-One, and Orthovisc that were adulterated for lacking FDA approval for distribution and use in the United States.
According to the press release, a review of the devices seized from Affordable Healthcare Care Solutions confirmed various differences between the outer box and carton labels, patient information brochures, and instructions for use between the FDA-approved labeling for Supartz, Orthovisc, Synvisc, Synvisc-One, and Euflexxa versus the labeling included with the unapproved versions being distributed by Affordable Healthcare Solutions. While discussing the seizure, Special Agent in Charge, Justin C. Fielder, emphasized that the “FDA regulates the manufacturing and distribution of medical devices to help ensure the safety of American patients.”
As a result of the plea agreement, Affordable Healthcare Solutions pleaded guilty to a felony, was fined, and was ordered to forfeit $837,000 worth of devices seized by the special agents. Juan Antonio Gonzalez, Acting United States Attorney for the Southern District of Florida, announced the felony guilty plea and stated:
Medical device suppliers whose greed leads them to disregard FDA protocols and approval processes put the public in danger. . . . These are serious crimes and, in our district, companies that put profit over patient safety will be held accountable.
What has been the impact of the COVID-19 health crisis been on the innovation landscape? Sacha Wunsch-Vincent, Senior Economist and co-editor of the GII 2021 at WIPO discusses the report’s key findings.
Charlton Hill, Co-founder and Head of Innovation at Uncanny Valley, a Sydney-based progressive music technology company discusses the company’s ambitions to speed-up, democratize and re-shape music production through the use of artificial intelligence.
Did you grow up with “Monica’s Friends”? Founded over 60 years ago, Mauricio de Sousa Productions has become one of Brazil’s most successful comic book and animation publishers. What role has intellectual property played in this success?
In late summer 2021, athletes with disabilities from around the world competed at the Tokyo 2020 Paralympic Games. Maja Hoock, Manager of Corporate Communications Research and Development (R&D) at the leading German prosthetics company, Ottobock, explains how IP-protected sports prostheses help athletes make the most of their abilities.
In 2021, the WIPO Nigeria Office launched the second WIPO National IP Essay Competition as part of its World Intellectual Property Day activities. Read the winning essay by Oyinkansola Komolafe entitled Intellectual property, SMEs and Economic Recovery in Nigeria.
During this blog post I will provide you with a good idea on the outcomes, expectations, and deliverables of the Individual Research Project (IRP). I will briefly cover how to deal with project management necessary to complete such a significant piece of work, as well as doing an internship abroad for the first time, along ...
The latest issue of Music & Copyright is now available for subscribers to download. Here are some of the highlights. ABBA set to take the burgeoning world of avatar performance to the next level Avatars are beginning to cut through in the music business. TV talent shows are set to provide a new platform for … Continue reading New issue of Music & Copyright with South Korea country report→
Throughout my career, I have always focused on surrounding myself with highest caliber teams and positioning myself on the cutting edge of innovation...
Under the USA’s Post Registration Audit Program, a declaration of use must be filed between the fifth and sixth year of the validity of the registration of the trademark. So, the Applicant has the burden of proof to show proper usage of the mark for all the goods and services provided under the relevant classes. However, India being a common law country and a first-to-use jurisdiction, one would assume that the use of a trademark would be of prime importance and would consequently, be a requirement that is constantly monitored. However, the use of a trademark is rarely monitored subsequent to its registration. In fact, it is of little to no consideration as there is no system or database to monitor the post registration audit of trademarks in India. Under current practices, the Registry itself does not undertake suo motu cancellations of unused trademarks, so it theoretically possible for a mark to be registered indefinitely without ever having been used in commerce.
