Legal

The AdvaMed Code of Ethics on Interactions with Health Care Professionals in China – the “AdvaMed China Code” or “Code” – serves as a foundational charter for medical technology companies’ compliance programs and encourages the companies to adopt best practices in the ethics unique to their industry.  

In a decisive victory for medtech innovation, the D.C. Circuit Court of Appeals earlier this month held that the Digital Millennium Copyright Act (DMCA) regulations are judicially reviewable. Under this ruling, the Library of Congress must rein in rulemaking that inadvertently could jeopardize patient safety and give away intellectual property by helping unregulated, third-party repair companies hack into highly complex, lifesaving medical devices. Instead, this decision ensures that exemptions to the DMCA anticircumvention provision are subject to the bedrock principle of judicial review. 

Today, The Advanced Medical Technology Association (AdvaMed) commended the U.S. Court of Appeals for the District of Columbia Circuit’s decision in the case Medical Imaging & Technology Alliance and Advanced Medical Technology Association v. Library of Congress and Carla Hayden (Case No. 23-5067), which ruled favorably in AdvaMed’s lawsuit to prevent unauthorized and unregulated repair companies from hacking into life-saving medical devices.

The Supreme Court will soon address the fate of agency deference—an issue presented in Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo—in a ruling expected to have far-reaching effects on how federal agencies regulate medtech and many other industries and how the industries interact with lawmakers, agencies, and the courts.

Third party litigation funding has become widespread in the civil justice system. The growing use of TPLF to generate mass tort litigation, particularly against manufacturers of medical technology, misuses the civil justice system, adversely affects public health, chills innovation, and harms patients.

Although the individual claims may differ, a review of recent products liability claims levied against industries targeted by the plaintiffs trial bar reveals common threads. For example, the drivers of litigation are the same regardless of the industry, such as, government action, studies (whether legitimate or not) implicating products, and areas of advanced innovation with new regulatory safeguards.

This carefully curated program will provide you with a comprehensive understanding of the current medtech compliance framework.

On September 13th, 2023, the U.S. House Oversight Committee held a hearing on the impact of third-party litigation financing, an issue of significant concern to AdvaMed and its members.  Third-party speculators (and the plaintiffs’ attorneys they fund) are gambling on mass tort litigation, hoping to hit the proverbial jackpot while patients, medical device manufacturers, and the public suffer the consequences.  By investing large sums into advertising campaigns, attorneys and their financial backers can generate thousands—or even tens or hundreds of thousands—of cases, many of which are meritless and unsupported.  However, the sheer number of cases creates significant bargaining power and places companies between a rock and a hard place.  They must either expend significant resources to defend against meritless claims or settle to limit litigation costs and reputational risk.  Generating more cases often yields a higher settlement, of which attorneys and third-party financers pocket a significant portion.  What results is, in effect, a shakedown that serves to benefit litigation speculators at the public’s expense.