USA Trends and Developments Contributed by: William Lavery, Joseph Ostoyich, Dodi Allocca and Timothy Lyons, Clifford Chance LLP
Healthcare and Life Sciences FTC v Edwards Lifesciences and JenaValve Technology (DDC) In August 2025, the FTC filed suit in DC federal court to block Edwards Lifesciences Corporation’s pro - posed acquisition of JenaValve Technology, Inc. The lawsuit centred on the development of transcatheter aortic valve replacement devices designed to treat aortic regurgitation (TAVR-AR). The FTC argued that because Edwards had previously acquired JC Medi - cal, the only other company running US clinical trials for a TAVR-AR device, the proposed acquisition of JenaValve would eliminate the last meaningful com - petitor for TAVR-AR devices. Following a six-day evidentiary hearing, Judge Rudolph Contreras granted the FTC’s petition for a preliminary injunction, blocking the acquisition pend - ing resolution of the FTC’s separate administrative proceeding. The court found that removing JenaValve as an independent competitor would slow innovation and reduce the likelihood of a less invasive treat - ment reaching patients. Notably, the court accepted the FTC’s proposed relevant market built around a product that had not yet launched commercially in the United States. Applying a largely qualitative analysis grounded in business documents, expert testimony and industry evidence, the court recognised a relevant market for the “research, development, and commer - cialisation of TAVR-AR devices”, even in the absence of commercial sales data. The parties abandoned the transaction following the ruling. In re Generic Pharmaceuticals Pricing Antitrust Litigation (ED Pa) Proceedings continue in one of the most expansive ongoing antitrust cases in the USA – a multidistrict litigation pending since 2016 before Judge Cynthia M Rufe in the Eastern District of Pennsylvania, In re Generic Pharmaceuticals Pricing Antitrust Litigation , along with related proceedings by state attorneys general in the District of Connecticut. Plaintiffs, includ - ing healthcare providers, health insurers, pharmacies, consumers and state attorneys general, allege that dozens of generic drug manufacturers conspired to fix and raise prices, rig bids and allocate markets for a large number of generic drugs through direct com -
pany-to-company contacts and joint activities under - taken through trade associations. The litigation has proceeded on parallel civil and crimi - nal tracks. On the civil side, the multi-district litigation has grown to encompass claims against dozens of defendants across multiple drug-specific complaint tracks. On the criminal side, the DOJ has secured guilty pleas from several companies and individual executives. Trial proceedings are expected to contin - ue in 2026, including a bellwether direct-action case. Separate bellwether proceedings involving clobetasol and clomipramine remain stayed pending appellate review of the district court’s rulings granting class cer - tification. Total recoveries across class settlements, criminal penalties and state enforcement actions have already exceeded USD1 billion, according to a 2024 press release from the DOJ, and 2026 alone has seen settlements valued at over USD300 million in the aggregate receiving final approval. Co-Ordination in Advertising Recent federal enforcement and private litigation have converged on co-ordinated advertising decisions as alleged violations of the antitrust laws. In 2025, the FTC conditioned its approval of the Omnicom-Inter - public merger on a consent order addressing allega - tions that the agencies had engaged in co-ordinated advertising practices. In spring 2026, the FTC entered consent orders resolving investigations into WPP, Publicis, Dentsu and Havas, alleging that their col - laborative “brand safety” initiatives encouraged uni - form advertising decisions that insulated them from competition. The consent orders generally prohibit co-ordination among advertising agencies regarding advertising placements, sponsorships and pricing. Private litigation has complemented these enforce - ment efforts, with lawsuits by X Corp and Rumble against the World Federation of Advertisers contend - ing that co-ordinated advertising decisions unlawfully restrict competition by depriving targeted platforms of advertising revenue. The FTC also opened a cartel investigation into whether advertisers agreed to boy - cott online publishers that published false or other - wise brand-damaging information, but withdrew its investigative demands after those nonprofit-reporting
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