FDA regulations and litigation trends play a crucial role in shaping industries, from healthcare and pharmaceuticals to insurance and legal services. While some may assume these topics are niche concerns, the numbers tell a different story. FDA-regulated products alone account for a significant portion of consumer spending, and litigation costs are rising at an alarming rate.
If you didn’t take our quiz, no worries—we’ve gathered the key insights here so you can stay informed on the latest trends.
FDA-Regulated Products: A Massive Market Share
Did you know that FDA-regulated products account for 20 cents of every consumer dollar spent in the U.S.? That’s right—one-fifth of all consumer spending is on products overseen by the FDA, including:
- Prescription and over-the-counter medications
- Medical devices
- Food and dietary supplements
- Cosmetics and personal care items
With more than 20,000 FDA-approved drugs and 6,500 different medical device product categories, the scope of FDA regulation is vast, affecting nearly 270,000 registered establishments worldwide.
For businesses operating in these industries, understanding the evolving regulatory landscape is essential to managing risks and staying compliant.
The Rising Cost of Litigation: A $529 Billion Problem
While FDA regulations shape industries, litigation is reshaping their financial realities. In 2022, U.S. tort litigation costs reached $529 billion, which accounted for 2.1% of the GDP. That translates to an average cost of $4,207 per American household.
More concerning, litigation costs are growing at an annual rate of 7.1%, outpacing both GDP growth and inflation. This trajectory indicates that legal expenses and claims will continue to rise, impacting businesses and consumers alike.
One of the biggest factors driving this growth?
The Hidden Force Behind Litigation Growth: Third-Party Funding
An often-overlooked driver of litigation costs is third-party litigation funding—a practice in which hedge funds and financial entities secretly invest in lawsuits. While this may sound like a niche legal strategy, its impact is substantial.
By funding lawsuits, these financial backers:
- Encourage more litigation—even in cases that may not have moved forward otherwise.
- Prolong legal battles as they aim for larger settlements.
- Increase overall costs for businesses defending against lawsuits.
This growing trend raises important questions about the transparency and fairness of the litigation system and how businesses can protect themselves from rising legal risks.
What This Means for You
With FDA regulations influencing a major portion of the economy and litigation costs rising rapidly, businesses in affected industries need to stay informed and proactive.
Understanding these trends isn’t just about compliance—it’s about risk management, financial planning, and long-term business strategy.
Want to Learn More? Join Our Webinar!
Join Kate Tarallo Klaus, Esq., Senior Risk Management Attorney & FDA Specialist at Medmarc Insurance, for an exclusive webinar exploring these industry-shaping trends and their impact on businesses like yours.
Interested in attending? Email Illana Goldfinger at igoldfinger@one80.com to let us know!
Final Thoughts
Whether you’re in healthcare, insurance, pharmaceuticals, or legal services, these trends will impact the way you do business. Now is the time to stay ahead of the curve and prepare for the evolving regulatory and litigation landscape.
If you found these insights valuable, consider joining our upcoming webinar to hear from industry experts on what’s next and how to navigate these challenges.
Want to be part of the conversation? Email Illana Goldfinger to express your interest!