Certain Products or Product Classes have unique characteristics that necessitate their Products Liability be excluded from the General Liability policy for the organization and therfore, their own separate Products Liability coverage. This may mean, and also make available, unique or specific loss control assistance as well a coverage protection. Loss Control Services are a primary benefit to emerging and mature companies as processes and procedures are being developed.
The Life Sciences and Medical Device Fields are examples of classes that may require separate Products Liability Policies. Products Liability can be greatly affected by the Vendor and Supplier relationships involved in the Development/Production/Sales & Distribution channels.
Clinical Trials Risks add another unique dimension to Products Liability and is often the trigger for emerging companies to seek Products Liability Coverage. Examples of Clinical Trial Risks may include:
During a clinical trial, allergic reactions and invections were not anticipated and were poorly addressed. Patients were not properly pre-screened. Failure to disclose to patients that FDA approval had not yet been obtained for the use being studied.
Vendor & Supplier Risks:
No written agreement between the Original Equipment Manufacturer and the Contract Manufacturer. Raw Materials or components not evaluated before they are put into production. No Liability Insurance coverage in place by the Vendor/Supplier.
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