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Financial Penalties, COVID-19 Liability Top FDLI List Of Top Medtech Lawsuits

 
• By Elizabeth Orr

The report outlines the lawsuits that the Food and Drug Law Institute believes could have the greatest impacts on industries regulated by the US FDA.

Cigar manufacturers and payday lenders may not be what you think of when you think of the device industry, but lawsuits focused on those businesses could have ripple effects on medtech manufacturers, the Food and Drug Law Institute (FDLI) predicted in its annual roundup of the Top Food & Drug Cases of 2020.

That’s because a lawsuit filed by a cigar trade association raises questions about labeling for all products regulated by the US Food and Drug Administration, while a case limiting the...

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More from Legal & IP

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

 
• By Elizabeth Orr

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.

FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

 
• By Elizabeth Orr

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.

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 
• By Brian Bossetta

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.

US Medtech Tariffs: How Will EU Navigate Unchartered Territory?

 
• By Amanda Maxwell

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.

More from Policy & Regulation

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.