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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:
  • Improper Product Use: While in the operating rooms, a company sales representative gives the physician inappropriate direction on using your implantable medical device.
  • Dropped Coverage: After a product recall, your current insurer non-renews your claims made product liability insurance.
  • Failure to Warn: Hundreds of patients claim a hip implant is causing metal debris to enter their bloodstream, damaging tissue and organs resulting in additional surgery. You recall the product and damages exceed 10 million dollars.
As a medical device manufacturer, you could be faced with these and other complex risk situations. With medical technology developing at such a rapid pace, you will face other risks that have not even emerged or been identified.

Medical Device & Implant Coverage Solutions

Britton Gallagher has carrier partners who are claims and loss control specialists focused exclusively on providing a 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's 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 at the request of a clinical trial participant.


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.
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