Tag: Medical Equipment and Devices

The Federal Trade Commission referred a complaint to the Department of Justice alleging that Adam J. Harmon and two companies he controls falsely told consumers that personal protective equipment they marketed during the pandemic, as well as light fixtures they sold, were made in the United States. The complaint alleged that Harmon and ALG made numerous false and misleading claims that their PPE products were all or virtually all made in the United States, even though the products were wholly imported, or incorporated significant imported materials or subcomponents. The defendants also falsely stated that their products were U.S.-origin respirators, certified by the National Institute for Occupational Safety (NIOSH). Under the proposed order, Harmon and his companies must: stop making deceptive U.S.-origin labeling and advertising claims, provide substantiation for all Made in USA and COVID-19-related claims, and pay a $157.683.37 civil penalty.

The Federal Trade Commission required Medtronic, Inc. to divest a key subsidiary of Intersect ENT, Inc. as a condition of acquiring Intersect. Under the FTC consent decree, Instersect’s Fiagon subsidiary, which makes ear, nose, and throat navigation systems and balloon sinus dilation products, will be sold to Hemostasis, LLC. According to the complaint, without this divestiture, the acquisition would pose a threat to future competition in the United States for both ENT navigation systems and balloon sinus dilation products. On June 30, 2022, the Commission announced the final consent agreement in this matter.

Medical device company Boston Scientific Corp. agreed to divest certain assets to Varian Medical Systems to settle Federal Trade Commission charges that Boston Scientific’s proposed $4.2 billion acquisition of medical equipment and pharmaceutical supplier BTG plc would violate federal antitrust law. According to the complaint, Boston Scientific’s acquisition of BTG would harm consumers in the U.S. market for drug eluting beads, or DEBs, which are microscopic beads used to treat certain liver cancers. Interventional radiologists use DEBs, combined with chemotherapy drugs, in a procedure called transarterial chemoembolization. Under the proposed settlement agreement, Boston Scientific was required to divest to Varian its DEB business, as well as its bland bead product line. Bland beads are used in another type of procedure to block the flow of blood to a liver tumor. On Feb. 18, 2022, the Commission announced modifications to the divestiture agreement with Boston Scientific Corp.

In June 2020, the marketers of a low-level light therapy device (LLLT) called Willow Curve agreed to stop making allegedly deceptive claims that the device treats chronic, severe pain and associated inflammation, under a settlement with the FTC. 

In a complaint filed in federal court the FTC alleged that the marketers of Willow Curve promoted the device nationwide since 2014, touting it as a “smart” device that is “clinically proven,” even though they lack scientific evidence to support these claims. The order settling the complaint also requires two defendants to pay $200,000 each to the Commission. In August 2021, the FTC sent refunds totaling more than $350,000 to defrauded consumers.

The Federal Trade Commission required medical device companies Stryker Corp. and Wright Medical Group N.V. to divest all assets related to Stryker’s total ankle replacements and finger joint implant products to remedy concerns, as alleged in the complaint, that Stryker’s proposed $4 billion acquisition of Wright would harm competition in these two markets. Under the consent order, Stryker and Wright must divest all assets associated with Stryker’s total ankle replacements and finger joint implants to DJO Global, allowing it to become an independent, viable, and effective competitor in these markets.  After a period for public comment, the Commission issued its final order on December 11, 2020.

The FTC issued an administrative complaint challenging the merger of two prosthetics manufacturers that are top sellers of prosthetic knees equipped with microprocessors. According to the FTC’s complaint, Otto Bock’s consummated acquisition of FIH Group Holdings (owner of Freedom Innovations) harmed competition in the U.S. market for microprocessor prosthetic knees by eliminating head-to-head competition between the two companies, removing a significant and disruptive competitor, and entrenching Otto Bock’s position as the dominant supplier. Microprocessor knees, which use microprocessors to adjust the stiffness and positioning of the joint in response to variations in walking rhythm and ground conditions, provide a stable platform for amputees. Compared to other products, microprocessor prosthetic knees reduce the risk of falling, cause less pain, and promote the health and function of the sound limb. In addition to issuing an administrative complaint, the Commission authorized agency staff to seek a temporary restraining order, preliminary injunction, and ancillary relief in federal court, should doing so be necessary to ensure the Freedom Innovations business remains viable and to preserve the Commission ability to order effective relief. On Dec. 1, 2020, the Commission announced approval for the divestiture of the Freedom assets.