BioSecure - Life Sciences

Coverages for clinical trials and sold products insureds.

Coverage highlights:  

• Products/Completed Operations
• Errors and Omissions Liability / Professional Indemnity 
• Healthcare Professional Liability / Medical Malpractice
• General Liability (Claims Made or Occurrence)

A wide range of life sciences organizations, including: 

• Medical device companies​
• Sponsors of human clinical trials ​
• Site management organizations​
• Academic research institutions​
• Biotechnology risks​
• Contract research and manufacturing organizations​
• Pharmaceuticals/biopharmaceutical companies ​
• Wholesale/retail distribution​
• Blood/tissue risks  ​
• Clinical research lab/diagnostic services

• The insured surgical device company manufactures a heating pad used to speed up recovery from knee surgeries. A patient fell asleep while using the heating pad, and the pad caused the blanket to catch fire, resulting in burns to the patient as well as property damage from the ensuing fire. The patient filed a lawsuit alleging that the product insert did not adequately warn of the risk of fire.
• The insured medical device company manufactures a dermal resurfacing device that is alleged to have caused burning on a patient’s face. The insured reported that the surgeon used the product with a numbing cream despite the fact that the product insert specifically warns that using the device with a numbing cream can cause burns. However, the insured’s physician alleged that the insured had a representative present at the procedure who both instructed the physician and failed to warn him of the risk of burn from the numbing cream.
• The sponsoring corporation alleged that the insured clinical research organization was negligent in its execution of a clinical trial, resulting in the sponsor’s drug being rejected by the FDA and a pending sale to a large pharmaceutical company falling through. After talks between the sponsor and the CRO failed to resolve the matter, the sponsor filed an action in arbitration pursuant to the master service agreement between the sponsor and the CRO, seeking the amount it believes it lost when the sale did not go through.