Medical Device & Medical Implants
Regulation & Product Quality Risks
|As a medical device or implant company, you face various development, regulatory and quality control challenges. With these obstacles lie many risks which can become costly, stalling or even ending your business.|
Consider the following scenarios:
Medical Device & Implant Coverage Solutions
|Britton Gallagher has carrier partners who are claims and loss control specialists focused exclusively on providing broad range of precisely crafted but flexible coverage solutions tailored for your set of unique exposures.|
Implanted Medical Device Coverage
For medical device and implant companies, the consequences of a suspected faulty or failed product can require product recalls, which can be costly, especially when there are patient damages claimed.
Product liability policies are critical to your company; however, even those crafted specifically for life sciences companies may exclude claims for product recalls. Since no bodily injury has occurred, the costs incurred in the repairing, replacing or removing faulty or potentially faulty product is not covered. Typically, these uncovered costs, although costly, are not catastrophic when they are being removed from a warehouse and returned.
However, if the defective product is already implanted in a human body, most life science liability policies exclude the cost of surgically removing an implanted device, again, because it has not caused bodily injury. Britton Gallagher specialized programs make a critical exception to these product liability exclusions, giving you the peace of mind if a product recall occurs after devices have been implanted in patients.
Our recall of products coverage states the exclusion does not apply to the removal of implanted medical devices, transplanted tissues, organs or biological materials resulting from a Class 1 Product Recall or a at the request of a clinical trial participant.
Extended General Liability
Extended General Liability insurance eliminates certain “end of policy period” restrictions for injury or damage. For a company like yours where there can be potentially long time frames between when a product is developed, when it caused injury, when you knew about the injury, and when an insurance claim is filed, this provides significantly broader insurance, and peace of mind.
At Britton Gallagher, we can assist you in designing risk management strategy and a coverage program that meets your company’s specific needs. We work closely with life science insurance carriers to ensure you have the coverage and support you need, when you need it most. Call us today at 216-658-7100 for more information.