Legal & IP
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.
As the 6 May deadline to implement the FDA’s final rule on lab-developed tests approaches, attempts to stop the rule from taking effect are set to play out in court. A panel of experts discussed the potential impact of these legal efforts, should they be successful, at the Medtech Conference in Toronto.
The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.
The owner of a Chicago COVID-19 testing lab plead guilty to wire fraud for billing the government for COVID-19 tests that were not performed. Also, test developer Talis Biomedical agreed to pay $32.5m to settle a shareholder suit.
This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.
J&J’s “pants down” moment with Auris could permanently change how medtech M&A is conducted. Build-to-buy arrangements, which leave companies’ destinies in the hands of their owners, are likely to replace current earn-out models.
In a letter to US lawmakers, the Association for Diagnostics and Laboratory Medicine says the FDA’s final rule regulating lab-developed tests will stifle innovation and that Congress needs to step in and stop it.
Clue Plus members will have access to 50% off a Headspace subscription for tailored guidance, support and validation to help manage cycle-related stress and improve overall well-being.
With the reversal of the Chevron doctrine in June, lower courts will now have more say in deciding regulatory statutes when the language is murky. But will that open the door to more legal challenges from the healthcare industry against government regulations it finds unfavorable? A pair of legal experts recently discussed the potential implications of the Court’s decision.
This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.
Former FDA device center head Jeffrey Shuren is facing conflict of interest claims for not recusing himself from regulatory decisions involving clients of his wife’s legal firm. Critics call for an investigation and stricter ethics compliance.
The US government continued its focus on False Claims Act enforcement and collected funds totaling more than $1bn in the first of this year alone – $155m of which was medtech-related.
Philips has filed a lawsuit against a Pennsylvania lab it hired to analyze sound abatement foam that prompted widespread recalls of its CPAP machines. Philips alleges PSN Labs grossly overestimated the risk to patients, which led Philips to initiate a larger recall than it otherwise would have.