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Medical Equipment and Pharmaceutical Products Insurance

Product Liability Insurance for medical equipment and pharmaceutical manufacturers, distributors and importers

Medical and pharmaceutical products require special underwriting expertise to properly evaluate. Don’t be fooled into thinking just any insurance agent understands which insurance markets to approach. Sadler provides ease of doing business and huge savings. We have the flexibility to meet all of your insurance coverage needs for medical and pharmaceutical products.

Coverage Highlights

• Up To $25,000,000 Liability Limits
• Available In All 50 States
• Product Liability Only Or Full General Liability With Product Liability
• Deductible And Self Insured Retention Options Available
• Additional Insured Vendors Endorsement Included
• Ability To Cover Just Specified Products
• Premium Financing Available
• Professional Liability Insurance Add On Available
• Discontinued Product Liability Options Available

Understanding how federal pre-emption trumps state Product Liability Laws

One thing that makes Product Liability Laws unique is the state-to-state variability that is often involved. In other words, states may not only have very different product liability laws, but even similar laws shared by states can be interpreted differently from state to state.  However, when it comes to class III medical devices, Congress has made it clear by passing the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act statute that Federal Laws will trump all state Product Lability laws.

The Medical Device Amendments gave the Food and Drug Administration (FDA) the authority to conduct a cost-benefit analysis, regulate and provide detailed oversight of class III medical devices.  Class III medical devices are those that are considered important to supporting or sustaining human life.  This process requires a medical device manufacturer to submit an application that includes complete reports of all research and investigations of the medical device’s safety and performance.  In all, the FDA spends approximately 1,200 hours reviewing each application and will only grant premarket approval if it finds  “reasonable assurance” of the device’s safety and effectiveness.

Congress has determined that any medical device that has received premarket approval  should not be exposed to additional or contrasting state law stipulations and is protected by express pre-emption.  After a manufacturer has received premarket approval, the manufacturer is not supposed to make any changes to design specs, manufacturing procedures, labeling or any other characteristic that would influence safety or performance without FDA permission.

It is important to point out that federal pre-emption does not apply to all medical devices;   it only applies to  class III devices that have received premarket approval.

Another important point about federal pre-emption for class III medical devices is implied pre-emption.  Implied pre-emption simply means that all business of enforcing the Food, Drug and Cosmetic Act shall be the sole responsibility of the FDA, and specifically prohibits private litigants to file suit for non-compliance with the medical device provisions.

Sample Quotes from our Clients

What do our clients say…

“Everyone was very friendly and helpful. Applying was easy and we got prompt replies, when needed.” -Samantha Babb  Brant-Wald Surgicals, Inc.

“You are professional and do it right!” -Bob Pozgar  Coakley Cane Company, LLC

“Response time was quick. Sales rep/customer service reps all are very professional, courteous and extremely helpful.” – Basil Konstantinidis  Omorphia, Inc.