Legal & IP
A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.
Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.
The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.
A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.
Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.
US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.
Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.
A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.
A planned merger between medical device coating manufacturers Surmodics and Biocoat is facing an antitrust lawsuit from the US Federal Trade Commission. The FTC believes the move would create an illegal monopoly.
An attorney representing the ACLA in its lawsuit to stop the US FDA’s final rule on LDTs emerged from a lengthy hearing on the case feeling ‘cautiously optimistic’ and said a decision could come before May.
The EU’s new Product Liability Directive will make it easier for European consumers to seek compensation relating to defective products even if manufacturers are based outside the bloc. Legal experts caution that this could have substantial implications for pharmaceutical companies.
Anita Jackson is facing 25 years for device adulteration and a host of other charges. She says the trial and appeals court failed to consider her defense.
Two US FDA device center websites have been restored under a restraining order. The pages now carry a disclaimer alleging they include "extremely inaccurate" content about gender; however, neither site includes any substantive discussion of trans issues.
The US FDA says in a legal memo that its new guidance on scientific information on unapproved uses (SIUU) is “speech-enabling” and argues that challenges should be interpreted as attempts to roll back the approval process.
Attorneys with law firm Gibson Dunn believe that fewer investors will be investigated for False Claims Act violations under the incoming Trump administration but expect other policy to go full steam ahead.
Despite questions surrounding the SEC rule, including disputes being litigated in the US Eighth Circuit, companies must prepare to meet the new climate disclosure requirements in addition to related mandates in California and abroad. Experts emphasize opportunities beyond compliance.