Vascular Solutions Case (Partially) Points Way Forward For Off-Label Marketing

Attorneys involved with a recent court ruling favoring Vascular Solutions believe the verdict might give manufacturers more latitude to engage in truthful, non-misleading, off-label speech. But caution is necessary.

Device companies might enjoy some more flexibility to convey truthful and non-misleading off-label information in product marketing communications following a recent court ruling, but attorneys involved in the case and expert observers stress that specific legal lines still remain to be drawn and that caution is warranted.

A case against varicose vein products manufacturer Vascular Solutions Inc., as well as CEO Howard Root, ended in a...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legal & IP

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

 
• By 

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.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 

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.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By 

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.

More from Policy & Regulation

Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 

It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.